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Health & Food Supplements Information Service

gMicrogram a measurement of weight equal to one millionth of a gram (or one thousandth of a milligram). Microgram (g or mcg) is used for a number of nutrients found in food supplements.Amino AcidThe building blocks of protein, there are eight essential amino acids which cannot be synthesised within the body and therefore must come from the diet. These are: isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine. In addition arginine and histidine are amino acids required by infants and young children which supports their rapid growth.AntioxidantA substance or nutrient which helps to protect our cells from damage caused by free radicals, damaging molecules which are found in pollution and tobacco smoke. Our bodies also produce free radicals as part of the normal biochemistry of living.DeficiencyA lack of essential macronutrients or micronutrients which results in malnutrition and or disease. This may be the result of inadequate intakes or absorption issues associated with gastrointestinal disease. There are a number of recognised deficiency diseases including (but not exclusively): scurvy (vitamin C deficiency); rickets (vitamin D deficiency); anaemia (iron deficiency, but also deficiencies in B12 and folic acid) and Kwashiorkor (protein deficiency).DHThe Department of Health is a UK Government department. It has responsibility for nutrition legislation and sets health policy for nutrition.DHADocosahexaenoic acid; one of the key omega-3 fats that provides health benefitsDietitianAn individual qualified in nutrition and dietetics who can assess, diagnose and treat health issues associated with nutrition and diet. Dietitians are governed by law with a statutory code of practice; they often work within the health service although increasing numbers are also working in a freelance capacity.EFAEssential fatty acids (omega 3 and omega 6) cannot be synthesised by the body and must be derived from the diet. EFAs do not provide fuel for energy production and are required for vital biological processes which support growth, development and health.EFSAEuropean Food Safety Authority; the European Union food risk management agency which scientifically evaluates safety across all areas of food.EPAEicosapentaenoic acid; one of the key omega-3 fats that provides health benefits.Fat soluble vitaminThe fat soluble vitamins are vitamins A, D, E and K. Because they are fat soluble these substances can accumulate in the body, often being stored in fat cells, or in the liver. This can create health issues, particularly if intakes have been high for a prolonged period of time. For example, long term high intakes of vitamin D may lead to the laying down of calcium in tissues such as liver and kidneys which can cause nausea and vomiting.Food supplementA food supplement is a concentrated source of vitamins, minerals or other substances with a nutritional or physiological effect which is sold in small, measured unit doses.FSAThe Food Standards Agency is a non-ministerial UK Government department responsible for food safety and food hygiene.GLAGamma-linoleic acid is an omega-6 fatty acid (an essential fatty acid considered to be necessary for human health which must be derived from the diet). GLA is most commonly found in evening primrose oil (EPO), borage or starflower oil and blackcurrant seed oil.Health claimA health claim is any claim which states, or implies, that consumption of a specific food will have a beneficial effect on health. Claims may be written, verbal or pictorial.Herbal medicine (herbal remedy)A product is considered to be a herbal medicine if the main active ingredient/s are only herbal substances or preparations. Not all herbal products are medicines, some may be food supplements and some may be cosmetics. What determines if a product is, or is not a medicine is complex but generally rests with how the product is presented (i.e. does it make medicinal claims to treat, prevent or cure any disease) and what it does (i.e. does it have a physiological impact on, or alter, any body functions).MacronutrientDietary constituents which are needed in significant amounts, generally protein, fat, carbohydrate, fibre and water.MalnutritionMalnutrition is a state in which the deficiency of nutrients such as energy, protein, vitamins or minerals results in measurable adverse effects on the body. Malnutrition may refer to insufficient intake of protein, carbohydrate and fats (macronutrients) which can result in overly low BMI. It may also be insufficient intake of vitamins, minerals and other micronutrients, which can impact on overall health and could include obese individuals with poor diets.MgMilligram is a measurement of weight equal to one thousandth of a gram. Mg is used for a number of nutrients found in food supplements.MicronutrientA substance derived from food which is needed in extremely small amounts for the normal growth and development of living beings. Micronutrients are vitamins, minerals and essential fatty acids (omega-3 fats)MineralInorganic micronutrient essential to health and wellbeing. Minerals are absorbed from soil by plants which are in turn eaten by animals or humans. Minerals may be split into minerals which are needed in relatively high amounts (calcium, phosphorus, magnesium, sodium, chloride and potassium) and trace elements (iron, zinc, cobalt, copper, chromium, fluoride, iodine, manganese, molybdenum, boron and selenium) which are needed in very small quantities.MultivitaminA product which contains more than one vitamin, often multivitamins will contain all 13 vitamins although some may contain only the eight B vitamins, or a combination of some of the vitamins and some additional minerals.NDNSThe UK National Diet and Nutrition Survey is a continuous rolling survey of the dietary habits and nutritional status of adults and children in the UK. The results are used to assess whether intakes of food and nutrients are adequate across different ages and population groups.NRVNutrient Reference Value is the amount set by the European Food Safety Authority (EFSA), primarily to support food labelling, which the majority of the population requires to maintain health. Previously known as RDANutrientA substance derived from food which provides nourishment to the body and is essential for the maintenance of life and for growth and development.NutritionistNutritionists generally work for public bodies or governments, although some do work with private clients. They tend to look at large populations to determine risk factors and make dietary recommendations that are applied at population levels. For example, evidence on the incidence of type II Diabetes led public health nutritionists to determine that some populations are more at risk of developing this disease, and to make recommendations for dietary changes to either reduce the risk or manage the disease. However, public health nutritionists do not practice with individual patients.Omega-3 fatsEssential fatty acids which cannot be synthesised by the body and must be derived from the diet. Primary sources for omega-3 fats are oily fish and fish oil supplements with some also coming from enriched eggs and fortified foods. There are a number of scientifically proven health benefits for omega-3 fats including supporting the health of the eyes, brain and heart, maintaining an appropriate balance of triglycerides in the blood and reducing blood pressure.Omega-6 fatsEssential fatty acids which cannot be synthesised by the body and must be derived from the diet. Primary sources for omega-6 are vegetable oils such as sunflower and corn oils as well as nuts and seeds. There are a number of health benefits associated with omega-6 fatty acids; they are thought to be beneficial in the management of premenstrual syndrome and in some skin conditions including eczema and psoriasis.PAGBProprietary Association of Great Britain (PAGB) is the UK trade association which represents the manufacturers of branded over-the-counter medicines, self care medical devices and food supplements.PrebioticsFoods which promote the growth of probiotics, the beneficial bacteria that inhabit our gut. Prebiotics are generally fibres such as inulin, which our bodies cannot digest and absorb but which provide a food source for probiotics.ProbioticsLive bacteria (and some yeasts) which inhabit the digestive tract which are viewed as being beneficial to human health. There are thousands of different bacterial strains; some are resident in specific areas of the digestive tract whilst others are transient, simply passing through.Public Health England (PHE)Public Health England is an agency of the Department of Health responsible for improving public health. They work with local government, the NHS and non-governmental organisations as well as communicating public health messages to the general public.PUFAPolyunsaturated fatty acids (PUFA) are found in nuts, seeds, fish (and fish oil), krill and some algae, small amounts are also found in leafy greens. The omega-3 and omega 6 fats are PUFAs, which are generally associated with health.RDARecommended Daily Amount; previously used terminology for the amount set, primarily to support food labelling, which the majority of the population require to maintain health. Now described using nutrient reference value (NRV)SULSafe Upper Levels of vitamins and minerals were established by the Expert Group on Vitamins and Minerals who published a report in 2003 (https://cot.food.gov.uk/sites/default/files/cot/vitmin2003.pdf). The UK food supplements industry works to the levels set in this report.VitaminOrganic micronutrient essential to health and wellbeing. Vitamins cannot be synthesised in sufficient amounts by the animal or human body and must therefore be obtained from the diet. Plants manufacture vitamins which move up the food chain as the plants are consumed by animals or humans. Vitamins can be divided into fat soluble (vitamins A, D, E and K) and water soluble (vitamins B1, B2, B3, B5, B6, B12, biotin, folic acid and vitamin C).Water soluble vitaminThe B vitamins and vitamin C are water soluble. They are not stored in any significant quantities within the body and are generally either utilised or excreted in the urine. As they are not stored in the body, they tend to have low toxicity and are needed on a daily basis.

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Health & Food Supplements Information Service

Regulation of food and dietary supplements by the U.S …

The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act ("the Act") and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.

Substances which the FDA regulates as food are subdivided into various categories, including foods, food additives, added substances (man-made substances which are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. The specific standards which the FDA exercises differ from one category to the next. Furthermore, the FDA has been granted a variety of means by which it can address violations of the standards for a given category of substances.

The Pure Food and Drug Act of 1906 was the first of a series of significant consumer protection laws enacted by the Federal Government in the twentieth century and led to the creation of the Food and Drug Administration. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drugs packaging and that drugs could not fall below purity levels established by The United States Pharmacopeia or The National Formulary. The Jungle by Upton Sinclair was an inspirational piece that kept the public's attention on the important issue of unsanitary meat processing plants that later formed the Pure Food and Drug Act.

The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York.[1] In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs.[2] The act has been amended many times, most recently to add requirements about bioterrorism preparations.

The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form.[3] See Elixir Sulfanilamide disaster. It replaced the earlier Pure Food and Drug Act of 1906.

The Food Additives Amendment of 1958 is a 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938. It was a response to concerns about the safety of new food additives. The amendment established the designation of "generally recognized as safe", which refers to chemicals or substances which can be used as food additives without further evaluation or testing just because they have been long used and there is broad acceptance of their use. New food additives would be subject to testing including by the "Delaney clause". The Delaney clause was a provision in the amendment which said that if a substance were found to cause cancer in man or animal, then it could not be used as a food additive.

The Dietary Supplement Health and Education Act of 1994 is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements.[4] Under the act, supplements are mainly unregulated, without proof of effectiveness or safety needed to market a supplement, as well as dietary supplements being classified as foods instead of as drugs.

Food is defined in the Act[5] to be:

The first definition offered is self-referential, defining food in part as "articles used for food", leaving it to the FDA and the courts to determine what exactly constitutes food.[6] This determination is particularly important because the definition of a "drug" under the act includes a section defining drugs as "articles (other than food) intended to affect the structure or any function of the body of man or other animals".[7] Thus, the definition of food is important not only in determining what is covered by the regulatory regime for food, but in determining what is excluded from the regulatory regime for drugs. For example, in the 1983 case of Nutrilab, Inc. v. Schweiker,[8] the United States Court of Appeals for the Seventh Circuit found that starch blockers, though derived from kidney beans, were drugs rather than food under the meaning of the Act. The starch blockers were sold as tablets, and "not consumed primarily for taste, aroma, or nutritive value".[8] Products that are normally considered to be foods may also be regulated as drugs if the parties responsible for their manufacture or sale make claims as to their ability to treat diseases,[6] although the FDA now permits advertising addressing the disease-fighting qualities in foods where those qualities have been endorsed by the scientific community.

The standards for food sold in the United States are set forth in Chapter IV of the Act.[9] These standards set forth two main areas of food that violates the Act: adulterated food and misbranded food. These categories are independent of one another; food can be completely free of adulteration and otherwise healthy to consume, and still be in violation of the act if it is misbranded. Likewise, food that has completely accurate labels, including warnings about dangers that it may pose to health, may nevertheless be deemed adulterated.

The Act sets forth several circumstances under which food will be deemed adulterated. The primary definition set forth is that food is adulterated if:

Added substances are treated separately by the FDA, meaning that the sale of an article or substance as food will generally be permitted if that article or substance is not ordinarily injurious to health.

Food is also deemed adulterated "if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food";[11] if it was "prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health";[12] if it was produced from "a diseased animal or of an animal which has died otherwise than by slaughter";[13] if it was packaged in a poisonous material;[14] or if it was intentionally irradiated outside of irradiation guidelines set forth by the Act.[15] These definitions are also independent, meaning that food that is "filthy" or has been "held under insanitary conditions" is still in violation of the Act and subject to condemnation even if the owner can demonstrate that it poses no actual threat to health. The phrase "otherwise unfit for food", although seeming to be a catch-all, has rarely been invoked. It would apply to a circumstance such as a seller offering wood chips as food, which might be safe to consume and prepared under sanitary conditions, but would be impossible to chew.

The FDA has the authority to inspect any establishment in which food is manufactured, processed, packed, or held.[16] In searching for contamination, the FDA typically uses organoleptic inspection methods - investigators trained to distinguish contamination and decomposition by sight and smell. Upon completion of such an inspection, the FDA will generate an "Establishment Inspection Report" (EIR)[17] detailing any problems found. Where problems are found, the FDA will instruct the owner of the inspected facility how to proceed in resolving those problems. FDA inspectors may take photographs of an establishment unless they are expressly told not to do so, and the owner of the establishment must provide an employee to answer questions that arise during the inspection. If the owner of an establishment refuses to permit FDA inspectors to enter a covered establishment, or any part of one, then the FDA may obtain a search warrant to enter.

Courts have held that, so long as the owner has not objected to the inspection and prevented the inspectors from entering, the FDA does not require a warrant to seize materials that are in violations of the Act. Furthermore, such materials may be used at trial against the owner without raising unreasonable search and seizure issues under the Fourth Amendment to the United States Constitution because the industry at issue has been found to be heavily regulated, meaning that the owner of such an establishment has no expectation of privacy with respect to premises of the type covered by the Act.

The presence of some degree of contamination is inevitable in almost all food. Technically, the FDA could inspect all food under a microscope and prohibit the sale of every article containing any discernible trace of mold, insect fragments, rodent hairs, and the like - effectively barring the sale of all food. In order to avoid this outcome, the FDA sets "action levels", which specify minimum amounts of particular contaminants that must be found in a food sample before the FDA will take action with respect to that sample. The FDA maintains a listing of all current action levels on its website.[18] The FDA also establishes action levels for man-made chemicals such as aflatoxin, lead, and mercury, and maintains these on its website.[19]

The primary basis under which food may be deemed misbranded under the Act is if "its labeling is false or misleading in any particular".[20] Labeling is defined elsewhere in the Act,[21] and includes:

...all labels and other written, printed, or graphic matter

Under the second part of this definition, it has been held that a food substance sold in conjunction with a book or pamphlet which makes false claims about the benefits of that substance is misbranded.[22] If books making false claims about a food are sold in conjunction with that food, the books themselves may also be seized and destroyed - even if the author had no intention of selling the book in conjunction with the food.[22] However, if a store happens to be selling both a food and a book which makes false claims about that food, and is selling the items separately, then no misbranding occurs. This is so even if the book and the food are both produced by the same company, and even if the maker of the food encourages the seller to carry the book.[23]

In terms of determining whether food is misbranded, the FDA only monitors labeling, and not advertising, which instead falls under the authority of the Federal Trade Commission. However, the FDA will review the advertising of a product to determine whether it is to be regulated as a food or as a drug, based on the claims that the manufacturer or seller makes about its properties.

The FDA is authorized to issue a standard of identity for any food. This is a description of what, exactly, must be in that food in order for it to be identified under a certain name. For example, a court has upheld an FDA ruling that for a product to be sold as cream cheese, it must contain a specified minimum percentage of milk fat, and a maximum level of moisture.[24] Incorrectly identifying a food by a name for which a standard of identity has been established is considered a form of misbranding. The FDA has set forth nearly 300 such standards.[6] However, in recent decades, companies marketing new types of food items have diminished the importance of these standards by simply coining new names for foodstuffs that do not conform to an existing standard, with examples including Cool Whip and Cheetos.

There are two kinds of health claims that can be made about foods other than dietary supplements: structure/function claims and disease claims. Structure/function claims are claims that do not suggest that the food can diagnose, treat, or prevent any particular disease, but that it can, for example, maintain, regulate, or promote normal healthy bodily functions. Where such claims are made, foods are generally required to carry a disclaimer on their label indicating that the claim has not been evaluated by the FDA.

Disease claims suggest that the food can help prevent specific diseases. Such claims are only permitted where the FDA finds that there is "significant scientific agreement", or where the claim has been approved by another federal health agency or the National Academy of Sciences.[25]

Food additives are defined in the Act[26] to be:

The definition goes on to capture several broad categories of things not traditionally thought of as "food", including "any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food".[26] The definition only applies if the substance in question is not "generally recognized as safe" by qualified experts, and also exempts substances that were in common use as food prior to January 1, 1958.[26]

The Act sets forth certain exemptions for substances which are treated under different regulatory schemes, including pesticide chemicals and their residue,[27] color additives,[28] substances previously approved under other statutes,[29] new animal drugs,[30] and dietary supplements.[31] The statute directs that food additives are generally to be presumed to be unsafe (and therefore prohibited) until they have been proven to be safe.[32] However, the statute then sets out a regulatory scheme under which a person intending to use a heretofore unapproved food additive may petition for "the issuance of a regulation prescribing the conditions under which such additive may be safely used".[33]

The Delaney clause, initially enacted in 1958, prohibits the FDA from approving food additives shown to cause cancer.[34] At the time of the passage of the amendment, little was known about the carcinogenic propensities of a wide variety of additives.[6] Following the enactment of this amendment, more and more substances were shown to be potentially carcinogenic, albeit in experiments wherein test animals were subjected to doses far in excess to the proportions which humans were likely to consume. In 1982, the FDA responded to this trend by adopting a rule that a food additive would not be denied approval under the Delaney clause unless the additive itself, and not just the constituent chemicals used to make it, was shown to cause cancer.[35] This policy was later challenged in court following FDA approval of a food coloring manufactured with a compound known to be carcinogenic, after separate testing indicated that the food coloring itself did not cause cancer in test animals. The United States Court of Appeals for the Sixth Circuit upheld the FDA's approval of the food coloring.[36]

Added substances are not separately defined in the act, but are understood to be different from food itself based on the definition of adulterated food,[37] and a later section authorizing the FDA to set forth tolerance limits for "[a]ny poisonous or deleterious substance added to any food...".[38] Such substances are prohibited, "except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice".[38] Because added substances often can not be avoided in food, such as the presence of man-made pollutants in fish, the FDA is required to "promulgate regulations limiting the quantity therein or thereon to such extent as [is] necessary for the protection of public health".[38] The action levels discussed above with respect to poisonous or deleterious substances address these added substances. Added substances differ from food additives, discussed above, in that the latter applies to things which are intentionally added to food, and therefore require FDA approval prior to being added to food.

The Dietary Supplement Health and Education Act of 1994 mandated that the FDA regulate dietary supplements as foods, rather than as drugs. Consequently, dietary supplements are defined as a kind of food under the statute,[39] with the caveat that this does not exempt them from being treated as drugs in the way that other foods are exempted, if circumstances permit it.[39]

Like other food substances, dietary supplements are not subject to the safety and efficacy testing requirements imposed on drugs, and unlike drugs they do not require prior approval by the FDA; however, they are subject to the FDA regulations regarding adulteration and misbranding. The FDA can take action against dietary supplements only after they are proven to be unsafe. Dietary supplements may be deemed to be misbranded if they are marketed in a way that characterizes them as a drug, without having undergone the clinical trials to which new drugs are subjected. Manufacturers of dietary supplements are permitted to make specific claims of health benefits, referred to as "structure or function claims" on the labels of these products.[6] They may not claim to treat, diagnose, cure, or prevent disease and must include a disclaimer on the label.[40] Where a manufacturer makes a structure or function claim in connection with the sale of a dietary supplement, the manufacturer must notify the FDA within 30 days after it has introduced that product to the market.

Claims that either a food or dietary supplement acts to prevent a disease are permitted, so long as there is "significant scientific agreement" for the claim, or it has been approved in an "authoritative statement" by "a scientific body with official responsibility for the public health protection or research directly relating to human nutrition" such as the National Academy of Sciences.[41]

Consumer Reports, a consumer protection advocacy and product testing group, stated:[42]

They can be ineffective, contaminated with microbes or heavy metals, dangerously mislabeled, or intentionally spiked with illegal or prescription drugs. They can also cause harmful side effects by themselves and interact with prescription medication in ways that make those drugs less effective. [...] According to a 2015 nationally representative Consumer Reports survey, almost half of American adults think that supplement makers test their products for efficacy, and more than half believe that manufacturers prove their products are safe before selling them.

In February 2019 Scott Gottlieb said that the agency needed stronger powers over health claims and the FDA warned a dozen companies to stop claiming their products can cure diseases. The present law, established in 1994, requires the agency to prove that a product is unsafe. Manufacturers have to notify the agency of new products, but not of their ingredients. In 2019 there were between 50,000 and 80,000 dietary supplements on the American market, beyond the agency's capacity to monitor. The Council for Responsible Nutrition opposed any suggestion that the sector needed stronger regulation.[43]

The Act expressly prohibits the "introduction, or delivery for introduction into interstate commerce of food... that is adulterated or misbranded",[44] as well as the actual adulteration or misbranding of food.[45] The Act further sets forth a broad range of powers that the FDA may exercise in order to prevent distribution of adulterated or misbranded food. In addition to the express powers set forth in the statute, the FDA exercises certain implied powers, such as the issuance of Warning Letters and recall orders.

The steps which the FDA may take in response to a violation include the following:

Where food is found to be adulterated, the FDA also has the option to offer the owner the opportunity to "recondition" the food - that is, to remove all traces and contamination, and submit that food for a reinspection by the FDA, at which time it may be approved for sale. Similarly, where food is found to be misbranded, the FDA has the option of offering the owner the opportunity to correct the labeling, and put the food back on the market with new labels that are not misleading.

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Publications and Guidelines | Food Supplements Europe

The aim of this document is to produce guidelines which address the specific needs of the food supplement industry in relation to good manufacturing practice, with special attention paid to the requirements of EU food legislation. It covers the complete cycle of production and quality control of a food supplement, from the acquisition of all materials through all stages of subsequent processing, packaging and storage to the distribution or release of the finished product. As such, relevant sections of the document apply also to food supplement companies whose products are contract manufactured and also to those who aresolelydistributors of products.

Download the publication

A questionnaire is also available to assist companies with assessing their current GMP status and to highlight any areas where further efforts to raise the GMP standard may be required. If no external GMP assessment is undertaken, annual self-assessment of GMP is recommended, as a minimum.

Download the self-assessment questionnaire PDF

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Publications and Guidelines | Food Supplements Europe

Blood Supplements Food Symptoms For Low Blood Pressure …

Blood Supplements Food then Should I Take Arginine and discover the latest natural remedies for erectile dysfunction and impotence in this must read The Hardness Factor Supplements that and when the first FDA-approved drug to treat ED between Cialis High Blood Pressure Side Effect and The Hardness Factor Supplements Is It Bad To Have Low Blood Pressure with Increase Blood Flow To The Penis ...

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Blood Supplements Food Symptoms For Low Blood Pressure ...

Food Supplements Europe

Food Supplements Europe has been created to represent the interests of the European food supplement sector. Its membership includes national associations and companies committed to ensuring that future EU legislation and policy reflects the important role that this sector plays in the health of consumers.

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Food Supplements Europe

Health & Food Supplements Information Service

gMicrogram a measurement of weight equal to one millionth of a gram (or one thousandth of a milligram). Microgram (g or mcg) is used for a number of nutrients found in food supplements.Amino AcidThe building blocks of protein, there are eight essential amino acids which cannot be synthesised within the body and therefore must come from the diet. These are: isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine. In addition arginine and histidine are amino acids required by infants and young children which supports their rapid growth.AntioxidantA substance or nutrient which helps to protect our cells from damage caused by free radicals, damaging molecules which are found in pollution and tobacco smoke. Our bodies also produce free radicals as part of the normal biochemistry of living.DeficiencyA lack of essential macronutrients or micronutrients which results in malnutrition and or disease. This may be the result of inadequate intakes or absorption issues associated with gastrointestinal disease. There are a number of recognised deficiency diseases including (but not exclusively): scurvy (vitamin C deficiency); rickets (vitamin D deficiency); anaemia (iron deficiency, but also deficiencies in B12 and folic acid) and Kwashiorkor (protein deficiency).DHThe Department of Health is a UK Government department. It has responsibility for nutrition legislation and sets health policy for nutrition.DHADocosahexaenoic acid; one of the key omega-3 fats that provides health benefitsDietitianAn individual qualified in nutrition and dietetics who can assess, diagnose and treat health issues associated with nutrition and diet. Dietitians are governed by law with a statutory code of practice; they often work within the health service although increasing numbers are also working in a freelance capacity.EFAEssential fatty acids (omega 3 and omega 6) cannot be synthesised by the body and must be derived from the diet. EFAs do not provide fuel for energy production and are required for vital biological processes which support growth, development and health.EFSAEuropean Food Safety Authority; the European Union food risk management agency which scientifically evaluates safety across all areas of food.EPAEicosapentaenoic acid; one of the key omega-3 fats that provides health benefits.Fat soluble vitaminThe fat soluble vitamins are vitamins A, D, E and K. Because they are fat soluble these substances can accumulate in the body, often being stored in fat cells, or in the liver. This can create health issues, particularly if intakes have been high for a prolonged period of time. For example, long term high intakes of vitamin D may lead to the laying down of calcium in tissues such as liver and kidneys which can cause nausea and vomiting.Food supplementA food supplement is a concentrated source of vitamins, minerals or other substances with a nutritional or physiological effect which is sold in small, measured unit doses.FSAThe Food Standards Agency is a non-ministerial UK Government department responsible for food safety and food hygiene.GLAGamma-linoleic acid is an omega-6 fatty acid (an essential fatty acid considered to be necessary for human health which must be derived from the diet). GLA is most commonly found in evening primrose oil (EPO), borage or starflower oil and blackcurrant seed oil.Health claimA health claim is any claim which states, or implies, that consumption of a specific food will have a beneficial effect on health. Claims may be written, verbal or pictorial.Herbal medicine (herbal remedy)A product is considered to be a herbal medicine if the main active ingredient/s are only herbal substances or preparations. Not all herbal products are medicines, some may be food supplements and some may be cosmetics. What determines if a product is, or is not a medicine is complex but generally rests with how the product is presented (i.e. does it make medicinal claims to treat, prevent or cure any disease) and what it does (i.e. does it have a physiological impact on, or alter, any body functions).MacronutrientDietary constituents which are needed in significant amounts, generally protein, fat, carbohydrate, fibre and water.MalnutritionMalnutrition is a state in which the deficiency of nutrients such as energy, protein, vitamins or minerals results in measurable adverse effects on the body. Malnutrition may refer to insufficient intake of protein, carbohydrate and fats (macronutrients) which can result in overly low BMI. It may also be insufficient intake of vitamins, minerals and other micronutrients, which can impact on overall health and could include obese individuals with poor diets.MgMilligram is a measurement of weight equal to one thousandth of a gram. Mg is used for a number of nutrients found in food supplements.MicronutrientA substance derived from food which is needed in extremely small amounts for the normal growth and development of living beings. Micronutrients are vitamins, minerals and essential fatty acids (omega-3 fats)MineralInorganic micronutrient essential to health and wellbeing. Minerals are absorbed from soil by plants which are in turn eaten by animals or humans. Minerals may be split into minerals which are needed in relatively high amounts (calcium, phosphorus, magnesium, sodium, chloride and potassium) and trace elements (iron, zinc, cobalt, copper, chromium, fluoride, iodine, manganese, molybdenum, boron and selenium) which are needed in very small quantities.MultivitaminA product which contains more than one vitamin, often multivitamins will contain all 13 vitamins although some may contain only the eight B vitamins, or a combination of some of the vitamins and some additional minerals.NDNSThe UK National Diet and Nutrition Survey is a continuous rolling survey of the dietary habits and nutritional status of adults and children in the UK. The results are used to assess whether intakes of food and nutrients are adequate across different ages and population groups.NRVNutrient Reference Value is the amount set by the European Food Safety Authority (EFSA), primarily to support food labelling, which the majority of the population requires to maintain health. Previously known as RDANutrientA substance derived from food which provides nourishment to the body and is essential for the maintenance of life and for growth and development.NutritionistNutritionists generally work for public bodies or governments, although some do work with private clients. They tend to look at large populations to determine risk factors and make dietary recommendations that are applied at population levels. For example, evidence on the incidence of type II Diabetes led public health nutritionists to determine that some populations are more at risk of developing this disease, and to make recommendations for dietary changes to either reduce the risk or manage the disease. However, public health nutritionists do not practice with individual patients.Omega-3 fatsEssential fatty acids which cannot be synthesised by the body and must be derived from the diet. Primary sources for omega-3 fats are oily fish and fish oil supplements with some also coming from enriched eggs and fortified foods. There are a number of scientifically proven health benefits for omega-3 fats including supporting the health of the eyes, brain and heart, maintaining an appropriate balance of triglycerides in the blood and reducing blood pressure.Omega-6 fatsEssential fatty acids which cannot be synthesised by the body and must be derived from the diet. Primary sources for omega-6 are vegetable oils such as sunflower and corn oils as well as nuts and seeds. There are a number of health benefits associated with omega-6 fatty acids; they are thought to be beneficial in the management of premenstrual syndrome and in some skin conditions including eczema and psoriasis.PAGBProprietary Association of Great Britain (PAGB) is the UK trade association which represents the manufacturers of branded over-the-counter medicines, self care medical devices and food supplements.PrebioticsFoods which promote the growth of probiotics, the beneficial bacteria that inhabit our gut. Prebiotics are generally fibres such as inulin, which our bodies cannot digest and absorb but which provide a food source for probiotics.ProbioticsLive bacteria (and some yeasts) which inhabit the digestive tract which are viewed as being beneficial to human health. There are thousands of different bacterial strains; some are resident in specific areas of the digestive tract whilst others are transient, simply passing through.Public Health England (PHE)Public Health England is an agency of the Department of Health responsible for improving public health. They work with local government, the NHS and non-governmental organisations as well as communicating public health messages to the general public.PUFAPolyunsaturated fatty acids (PUFA) are found in nuts, seeds, fish (and fish oil), krill and some algae, small amounts are also found in leafy greens. The omega-3 and omega 6 fats are PUFAs, which are generally associated with health.RDARecommended Daily Amount; previously used terminology for the amount set, primarily to support food labelling, which the majority of the population require to maintain health. Now described using nutrient reference value (NRV)SULSafe Upper Levels of vitamins and minerals were established by the Expert Group on Vitamins and Minerals who published a report in 2003 (https://cot.food.gov.uk/sites/default/files/cot/vitmin2003.pdf). The UK food supplements industry works to the levels set in this report.VitaminOrganic micronutrient essential to health and wellbeing. Vitamins cannot be synthesised in sufficient amounts by the animal or human body and must therefore be obtained from the diet. Plants manufacture vitamins which move up the food chain as the plants are consumed by animals or humans. Vitamins can be divided into fat soluble (vitamins A, D, E and K) and water soluble (vitamins B1, B2, B3, B5, B6, B12, biotin, folic acid and vitamin C).Water soluble vitaminThe B vitamins and vitamin C are water soluble. They are not stored in any significant quantities within the body and are generally either utilised or excreted in the urine. As they are not stored in the body, they tend to have low toxicity and are needed on a daily basis.

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Whole Food vs. Synthetic Supplements | Melissa Wood, ND

Ive already discussed the importance of taking natural supplements to support your body and immune system. But which supplements do you take, and how do you know which supplements are the best ones? Americans spend billions of dollars every year on supplements, and its very important to understand that not all supplements are created equal. Sometimes, there are vast differences between products.

So lets talk about the difference between whole food supplements and synthetic supplements a.k.a. isolated or fractionated supplements.

A great example would be just to simply look at almost any multivitamin. When you scan the nutritional content fact and ingredientlabel, youll see quite an assortment of vitamins (Vitamin A, Vitamin C, Vitamin E, etc.).Here is a portion of a label for a common multivitamin:

There are a lot more vitamins listed on this label than I had room for, but I think you get the idea. Look at the items listed under Ingredients.Those are what we call Isolated vitamins and other chemicals.There are no foods or herbal ingredients listed, only partial vitamins and other chemicals.

Nature intended for us to consume food in its WHOLE form because all the vitamins, minerals, antioxidants and enzymes are bound together in one package and work synergistically to deliver the nutrition your body needs.

Synthetic supplements give you isolated or fractionated pieces of the whole. It is simply not the same youre not getting the full benefit nature intended. The other problem is, by taking isolated vitamins, sometimes we are getting massive doses of some vitamins, but not enough of others.This imbalance this can cause health problems too. Arent we trying to get healthier rather than cause more problems?

Whole-Food based supplements are different, as those will, typically, list the foods the supplement was made from. What follows is a partial example of what to look for when searching for a Whole-Food based product.Notice that under the supplemental facts, you still see all the vitamins listed, but theres a huge difference in the ingredients.

What a difference this second product will make in your body vs. the first product!Youll actually be gaining benefits from the WHOLE food and all of the vitamins, minerals, antioxidants and enzymes that occur naturally in the food or plant.

Another way that might make sense is to look at the source.When Vitamin C is listed on a multivitamin label, look for any natural sources, like citrus fruits, papaya or bell peppers.If you see a listing for Ascorbic Acid, that means it is an Isolated product, so you must keep searching for ones that list whole foods.

In summary, be sure you read your labels!It is important to educate yourself about what youll be putting into your body and supplements are no different than anything else.

Its important to read food labels so you know what youre eating. But its just as important, if not moreso, to be sure youre reading all of your supplement labels too!You want to be consuming supplements that have actual whole foods, plants or herbs listed on the label. That way you know it is as close to natural as possible!

And lastly,understand that no supplement alone will help you achieve the level of health you desire. You will have to make lifestyle and behavior changes as well as taking supplements to achieve ultimate health.

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Whole Food vs. Synthetic Supplements | Melissa Wood, ND

Publications and Guidelines | Food Supplements Europe

The aim of this document is to produce guidelines which address the specific needs of the food supplement industry in relation to good manufacturing practice, with special attention paid to the requirements of EU food legislation. It covers the complete cycle of production and quality control of a food supplement, from the acquisition of all materials through all stages of subsequent processing, packaging and storage to the distribution or release of the finished product. As such, relevant sections of the document apply also to food supplement companies whose products are contract manufactured and also to those who aresolelydistributors of products.

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A questionnaire is also available to assist companies with assessing their current GMP status and to highlight any areas where further efforts to raise the GMP standard may be required. If no external GMP assessment is undertaken, annual self-assessment of GMP is recommended, as a minimum.

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Publications and Guidelines | Food Supplements Europe

Dietary supplement – Wikipedia

"Food supplement" redirects here. For food additions that alter the flavor, color or longevity of food, see Food additive.

A dietary supplement is a manufactured product intended to supplement the diet when taken by mouth as a pill, capsule, tablet, or liquid.[2] A supplement can provide nutrients either extracted from food sources or synthetic, individually or in combination, in order to increase the quantity of their consumption. The class of nutrient compounds includes vitamins, minerals, fiber, fatty acids and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, as for example collagen from chickens or fish. These are also sold individually and in combination, and may be combined with nutrient ingredients. In the United States and Canada, dietary supplements are considered a subset of foods, and are regulated accordingly. The European Commission has also established harmonized rules to help insure that food supplements are safe and properly labeled.[3]

Creating an industry estimated to have a 2015 value of $37 billion,[4] there are more than 50,000 dietary supplement products marketed just in the United States,[5] where about 50% of the American adult population consumes dietary supplements. Multivitamins are the most commonly used product.[6] For those who fail to consume a balanced diet, the United States National Institutes of Health states that certain supplements "may have value."[7]

In the United States, it is against federal regulations for supplement manufacturers to claim that these products prevent or treat any disease. Companies are allowed to use what is referred to as "Structure/Function" wording if there is substantiation of scientific evidence for a supplement providing a potential health effect.[8] An example would be "_____ helps maintain healthy joints", but the label must bear a disclaimer that the Food and Drug Administration (FDA) "has not evaluated the claim and that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.[8] The FDA enforces these regulations, and also prohibits the sale of supplements and supplement ingredients that are dangerous, or supplements not made according to standardized good manufacturing practices (GMPs).

In the United States, the Dietary Supplement Health and Education Act of 1994 provides this description: "The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines the term dietary supplement to mean a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients. Furthermore, a dietary supplement must be labeled as a dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a sole item of a meal or of the diet. In addition, a dietary supplement cannot be approved or authorized for investigation as a new drug, antibiotic, or biologic, unless it was marketed as a food or a dietary supplement before such approval or authorization. Under DSHEA, dietary supplements are deemed to be food, except for purposes of the drug definition."[9]

Per DSHEA, dietary supplements are consumed orally, and are mainly defined by what they are not: conventional foods (including meal replacements), medical foods,[10] preservatives or pharmaceutical drugs. Products intended for use as a nasal spray, or topically, as a lotion applied to the skin, do not qualify. FDA-approved drugs cannot be ingredients in dietary supplements. Supplement products are or contain vitamins, nutritionally essential minerals, amino acids, essential fatty acids and non-nutrient substances extracted from plants or animals or fungi or bacteria, or in the instance of probiotics, are live bacteria. Dietary supplement ingredients may also be synthetic copies of naturally occurring substances (example: melatonin). All products with these ingredients are required to be labeled as dietary supplements.[11] Like foods and unlike drugs, no government approval is required to make or sell dietary supplements; the manufacturer confirms the safety of dietary supplements but the government does not; and rather than requiring riskbenefit analysis to prove that the product can be sold like a drug, such assessment is only used by the FDA to decide that a dietary supplement is unsafe and should be removed from market.[11]

A vitamin is an organic compound required by an organism as a vital nutrient in limited amounts.[12] An organic chemical compound (or related set of compounds) is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. The term is conditional both on the circumstances and on the particular organism. For example, ascorbic acid (vitamin C) is a vitamin for anthropoid primates, humans, guinea pigs and bats, but not for other mammals. Vitamin D is not an essential nutrient for people who get sufficient exposure to ultraviolet light, either from the sun or an artificial source, as then they synthesize vitamin D in skin.[13] Humans require thirteen vitamins in their diet, most of which are actually groups of related molecules, "vitamers", (e.g. vitamin E includes tocopherols and tocotrienols, vitamin K includes vitamin K1 and K2). The list: vitamins A, C, D, E, K, Thiamine (B1), Riboflavin (B2), Niacin (B3), Pantothenic Acid (B5), Vitamin B6, Biotin (B7), Folate (B9) and Vitamin B12. Vitamin intake below recommended amounts can result in signs and symptoms associated with vitamin deficiency. There is little evidence of benefit when consumed as a dietary supplement by those who are healthy and consuming a nutritionally adequate diet.[14]

The U.S. Institute of Medicine sets Tolerable upper intake levels (ULs) for some of the vitamins. This does not prevent dietary supplement companies from selling products with content per serving higher than the ULs. For example, the UL for vitamin D is 100g (4,000 IU),[15] but products are available without prescription at 10,000 IU.

Minerals are the exogenous chemical elements indispensable for life. Four minerals: carbon, hydrogen, oxygen, and nitrogen, are essential for life but are so ubiquitous in food and drink that these are not considered nutrients and there are no recommended intakes for these as minerals. The need for nitrogen is addressed by requirements set for protein, which is composed of nitrogen-containing amino acids. Sulfur is essential, but for humans, not identified as having a recommended intake per se. Instead, recommended intakes are identified for the sulfur-containing amino acids methionine and cysteine. There are dietary supplements which provide sulfur, such as taurine and methylsulfonylmethane.

The essential nutrient minerals for humans, listed in order by weight needed to be at the Recommended Dietary Allowance or Adequate Intake are potassium, chlorine, sodium, calcium, phosphorus, magnesium, iron, zinc, manganese, copper, iodine, chromium, molybdenum, selenium and cobalt (the last as a component of vitamin B12). There are other minerals which are essential for some plants and animals, but may or may not be essential for humans, such as boron and silicon. Essential and purportedly essential minerals are marketed as dietary supplements, individually and in combination with vitamins and other minerals.

Although as a general rule, dietary supplement labeling and marketing are not allowed to make disease prevention or treatment claims, the U.S. FDA has for some foods and dietary supplements reviewed the science, concluded that there is significant scientific agreement, and published specifically worded allowed health claims. An initial ruling allowing a health claim for calcium dietary supplements and osteoporosis was later amended to include calcium supplements with or without vitamin D, effective January 1, 2010. Examples of allowed wording are shown below. In order to qualify for the calcium health claim, a dietary supplement much contain at least 20% of the Reference Dietary Intake, which for calcium means at least 260mg/serving.[16]

In the same year, the European Food Safety Authority also approved a dietary supplement health claim for calcium and vitamin D and the reduction of the risk of osteoporotic fractures by reducing bone loss.[17]The U.S. FDA also approved Qualified Health Claims (QHCs) for various health conditions for calcium, selenium and chromium picolinate.[18] QHCs are supported by scientific evidence, but do not meet the more rigorous significant scientific agreement standard required for an authorized health claim. If dietary supplement companies choose to make such a claim then the FDA stipulates the exact wording of the QHC to be used on labels and in marketing materials. The wording can be onerous: "One study suggests that selenium intake may reduce the risk of bladder cancer in women. However, one smaller study showed no reduction in risk. Based on these studies, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of bladder cancer in women."[19]

Protein-containing supplements, either ready-to-drink or as powders to be mixed into water, are marketed as aids to people recovering from illness or injury, those hoping to thwart the sarcopenia of old age,[20][21] to athletes who believe that strenuous physical activity increases protein requirements,[22] to people hoping to lose weight while minimizing muscle loss, i.e., conducting a protein-sparing modified fast,[23] and to people who want to increase muscle size for performance and appearance. Whey protein is a popular ingredient,[21][24][25] but products may also incorporate casein, soy, pea, hemp or rice protein.

According to US & Canadian Dietary Reference Intake guidelines, the protein Recommended Dietary Allowance (RDA) for adults is based on 0.8 grams protein per kilogram body weight. The recommendation is for sedentary and lightly active people.[26][27][28] Scientific reviews can conclude that a high protein diet, when combined with exercise, will increase muscle mass and strength,[29][30][31] or conclude the opposite.[32] The International Olympic Committee recommends protein intake targets for both strength and endurance athletes at about 1.2-1.8 g/kg body mass per day.[22] One review proposed a maximum daily protein intake of approximately 25% of energy requirements, i.e., approximately 2.0 to 2.5 g/kg.[27]

The same protein ingredients marketed as dietary supplements can be incorporated into meal replacement and medical food products, but those are regulated and labeled differently from supplements. In the United States, "meal replacement" products are foods and are labeled as such. These typically contain protein, carbohydrates, fats, vitamins and minerals. There may be content claims such as "good source of protein", "low fat" or "lactose free."[33] Medical foods, also nutritionally complete, are designed to be used while a person is under the care of a physician or other licensed healthcare professional.[34][35] Liquid medical food products - example Ensure - are available in regular and high protein versions.

Proteins are chains of amino acids. Nine of these proteinogenic amino acids are considered essential for humans because they cannot be produced from other compounds by the human body and so must be taken in as food. Recommended intakes, expressed as milligrams per kilogram of body weight per day, have been established.[26] Other amino acids may be conditionally essential for certain ages or medical conditions. Amino acids, individually and in combinations, are sold as dietary supplements. The claim for supplementing with the branched chain amino acids leucine, valine and isoleucine is for stimulating muscle protein synthesis. A review of the literature concluded this claim was unwarranted.[36] In elderly people, supplementation with just leucine resulted in a modest (0.99kg) increase in lean body mass.[37] The non-essential amino acid arginine, consumed in sufficient amounts, is thought to act as a donor for the synthesis of nitric oxide, a vasodilator. A review confirmed blood pressure lowering.[38] Taurine, a popular dietary supplement ingredient with claims made for sports performance, is technically not an amino acid. It is synthesized in the body from the amino acid cysteine.[39]

Bodybuilding supplements are dietary supplements commonly used by those involved in bodybuilding, weightlifting, mixed martial arts, and athletics for the purpose of facilitating an increase in lean body mass. The intent is to increase muscle, increase body weight, improve athletic performance, and for some sports, to simultaneously decrease percent body fat so as to create better muscle definition. Among the most widely used are high protein drinks, branched-chain amino acids (BCAA), glutamine, arginine, essential fatty acids, creatine, HMB,[40] and weight loss products.[41] Supplements are sold either as single ingredient preparations or in the form of "stacks" proprietary blends of various supplements marketed as offering synergistic advantages. While many bodybuilding supplements are also consumed by the general public the frequency of use will differ when used specifically by bodybuilders. One meta-analysis concluded that for athletes participating in resistance exercise training and consuming protein supplements for an average of 13weeks, total protein intake up to 1.6g/kg of body weight per day would result in an increase in strength and fat-free mass, i.e. muscle, but that higher intakes would not further contribute.[30] The muscle mass increase was statistically significant but modest - averaging 0.3kg for all trials and 1.02.0kg, for protein intake 1.6g/kg/day.[30]

As of 2010,[update] annual sales of sport nutrition products in the United States was over US$2.7billion according to a publication by Consumer Reports.[42]

Fish oil is a commonly used fatty acid supplement because it is a source of omega-3 fatty acids.[43] Fatty acids are strings of carbon atoms, having a range of lengths. If links are all single (C-C), then the fatty acid is called saturated; with one double bond (C=C), it is called monounsaturated; if there are two or more double bonds (C=C=C), it is called polyunsaturated. Only two fatty acids, both polyunsaturated, are considered essential to be obtained from the diet, as the others are synthesized in the body. The "essential" fatty acids are alpha-linolenic acid (ALA), an omega-3 fatty acid, and linoleic acid (LA), an omega-6 fatty acid.[43][44] ALA can be elongated in the body to create other omega-3 fatty acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

Plant oils, particularly seed and nut oils, contain ALA.[43] Food sources of EPA and DHA are oceanic fish, whereas dietary supplement sources include fish oil, krill oil and marine algae extracts. The European Food Safety Authority (EFSA) identifies 250mg/day for a combined total of EPA and DHA as Adequate Intake, with a recommendation that women pregnant or lactating consume an additional 100 to 200mg/day of DHA.[45] In the United States and Canada are Adequate Intakes for ALA and LA over various stages of life, but there are no intake levels specified for EPA and/or DHA.[46]

Supplementation with EPA and/or DHA does not appear to affect the risk of death, cancer or heart disease.[47][48] Furthermore, studies of fish oil supplements have failed to support claims of preventing heart attacks or strokes.[49] In 2017, the American Heart Association issued a science advisory stating that it could not recommend use of omega-3 fish oil supplements for primary prevention of cardiovascular disease or stroke, although it reaffirmed supplementation for people who have a history of coronary heart disease.[50]

Dietary supplements can be manufactured using intact sources or extracts from plants, animals, algae, fungi or lichens, including such examples as ginkgo biloba, curcumin, cranberry, St. Johns wort, ginseng, resveratrol, glucosamine and collagen.[51][52][53] Products bearing promotional claims of health benefits are sold without requiring a prescription in pharmacies, supermarkets, specialist shops, military commissaries, buyers clubs, direct selling organizations, and the internet.[52] While most of these products have a long history of use in herbalism and various forms of traditional medicine, concerns exist about their actual efficacy, safety and consistency of quality.[54][55][56] Canada has published a manufacturer and consumer guide describing quality, licensing, standards, identities, and common contaminants of natural products.[57] In 2016, sales of herbal supplements just in the United States were $7.5 billion, with the market growing at about 8% per year.[52] Italy, Germany and Eastern European countries were leading consumers of botanical supplements in 2016, with European Union market growth forecast to be $8.7 billion by 2020.[58]

In humans, the large intestine is host to more than 1,000 species of microorganisms, mostly bacteria, numbering in the tens of trillions.[59] "Probiotic" in the context of dietary supplements is the theory that by orally consuming specific live bacteria (or yeast) species, it is possible to influence the large intestine microbiota, with consequent health benefits. Although there are numerous claimed benefits of using probiotic supplements, such as maintaining gastrointestinal health, in part by lowering risk of and severity of constipation or diarrhea, and improving immune health, including lower risk of and severity of acute upper respiratory tract infections, i.e., the common cold, such claims are not all supported by sufficient clinical evidence.[60][61][62] A review based on interviews with dozens of experts in microbiome research expressed concern about "...how biomedical research is co-opted by commercial entities that place profit over health."[62] The concern is timely, as through 2021, probiotic supplements are expected to be the fastest growing segment of the dietary supplement market worldwide, while at the same time, the global health benefits market for probiotic-containing yogurt (a food, not a dietary supplement) is declining.[63][64]

As with all dietary supplements, in the United States inappropriate label health claims such as preventing or treating disease are opposed by the FDA and deceptive advertisements by the Federal Trade Commission. Probiotic foods and dietary supplements are allowed to make claims using Structure:Function vocabulary as long as human trial evidence is adequate. In 2005, the FDA issued a Warning Letter to UAS Laboratories for disease treatment claims (colds, flu, ulcers, elevated blood cholesterol, colon cancer...). The company revised label and website content and continued to sell the product.[65] In 2011 the company was found to have resumed the label and website claims, and the FDA seized product and stopped production.[66] In 2010 a FTC action was brought against a probiotic food company for exaggerated health claims, resulting in a multimillion-dollar fine and revisions to future advertising.[67] In the European Union a more restrictive approach has been taken by the EFSA. All proposed health claims were rejected on the grounds that the science was not sufficient, and no health claims are permitted. Foods with live microorganisms (yogurt, kefir) can be sold, but without claims.[60][63]

Probiotic supplements are generally regarded as safe. The greatest concern, evidenced by reviews reporting on case studies, is that for people with compromised gut wall integrity there may be a risk of systemic infection. For this reason, probiotic research is expected to exclude bacteria species that are antibiotic resistant.[68][69]

In 2015, the American market for dietary supplements was valued at $37 billion,[4] with the economic impact in the United States for 2016 estimated at $122 billion, including employment wages and taxes.[70] One 2016 analysis estimated the total market for dietary supplements could reach $278 billion worldwide by 2024.[71]

Over the period 2008 to 2011, the Government Accountability Office (GAO) of the United States received 6,307 reports of health problems (identified as adverse events) from use of dietary supplements containing a combination of ingredients in manufactured vitamins, minerals or other supplement products,[72] with 92% of tested herbal supplements containing lead and 80% containing other chemical contaminants.[73] Using undercover staff, the GAO also found that supplement retailers intentionally engaged in "unequivocal deception" to sell products advertised with baseless health claims, particularly to elderly consumers.[73] Consumer Reports also reported unsafe levels of arsenic, cadmium, lead and mercury in several protein powder products.[74] The Canadian Broadcasting Corporation (CBC) reported that protein spiking, i.e., the addition of amino acids to manipulate protein content analysis, was common.[75] Many of the companies involved challenged CBC's claim.[76]

A 2013 study on herbal supplements found that many products were of low quality, one third did not contain the active ingredient(s) claimed, and one third contained unlisted substances.[77] In a genetic analysis of herbal supplements, 78% of samples contained animal DNA that was not identified as an ingredient on the product labels.[55] In some botanical products, undeclared ingredients were used to increase the bulk of the product and reduce its cost of manufacturing, while potentially violating certain religious and/or cultural limitations on consuming animal ingredients, such as cow, buffalo or deer.[55] In 2015, the New York Attorney General identified four major retailers with dietary supplement products that contained fraudulent and potentially dangerous ingredients, requiring the companies to remove the products from retail stores.[78]

A study of dietary supplements sold between 2007 and 2016 identified 776 that contained unlisted pharmaceutical drugs, many of which could interact with other medications and lead to hospitalization.[79] 86% of the adulterated supplements were marketed for weight loss and sexual performance, with many containing prescription erectile dysfunction medication. Muscle building supplements were contaminated with anabolic steroids, and multiple products contained antidepressants and antihistamines. Despite these findings, fewer than half of the adulterated supplements were recalled.[79]

The European Commission has published harmonized rules on supplement products to assure consumers have minimal health risks from using dietary supplements and are not misled by advertising.[80]

The United States Food and Drug Administration (FDA Office of Inspections, Compliance, Enforcement, and Criminal Investigations) monitors supplement products for accuracy in advertising and labeling. Dietary supplements are regulated by the FDA as food products subject to compliance with current Good Manufacturing Practices (CGMP) and labeling with science-based ingredient descriptions and advertising.[81][82] When finding CGMP or advertising violations, FDA warning letters are used to notify manufacturers of impending enforcement action, including search and seizure, injunction, and financial penalties.[83] Examples between 2016 and 2018 of CGMP and advertising violations by dietary supplement manufacturers included several with illegal compositions or advertising of vitamins and minerals.[84][85][86]

The United States Federal Trade Commission, which litigates against deceptive advertising in marketed products,[67] established a consumer center to assist reports of false health claims in product advertising for dietary supplements.[87] In 2017, the FTC successfully sued nine manufacturers for deceptive advertising of dietary supplements.[88]

In the United States, manufacturers of dietary supplements are required to demonstrate safety of their products before approval is granted for commerce.[89] Despite this caution, numerous adverse effects have been reported,[72] including muscle cramps, hair loss, joint pain, liver disease, and allergic reactions, with 29% of the adverse effects resulting in hospitalization, and 20% in serious injuries or illnesses.[72] By more than five-fold, the highest incidence of health problems derived from "combination products", whereas supplements for vitamins and minerals, lipid products, and herbal products were less likely to cause adverse effects.[72]

Among general reasons for the possible harmful effects of dietary supplements are: a) absorption in a short time, b) manufacturing quality and contamination, and c) enhancing both positive and negative effects at the same time.[56] The incidence of liver injury from herbal and dietary supplements is about 1620% of all supplement products causing injury, with the occurrence growing globally over the early 21st century.[41] The most common liver injuries from weight loss and bodybuilding supplements involve hepatocellular damage with resulting jaundice, and the most common supplement ingredients attributed to these injuries are green tea catechins, anabolic steroids, and the herbal extract, aegeline.[41] Weight loss supplements have also had adverse psychiatric effects.[90]

Work done by scientists in the early 20th century on identifying individual nutrients in food and developing ways to manufacture them raised hopes that optimal health could be achieved and diseases prevented by adding them to food and providing people with dietary supplements; while there were successes in preventing vitamin deficiencies, and preventing conditions like neural tube defects by supplementation and food fortification with folic acid, no targeted supplementation or fortification strategies to prevent major diseases like cancer or cardiovascular diseases have proved successful.[91]

For example, while increased consumption of fruits and vegetables are related to decreases in mortality, cardiovascular diseases and cancers, supplementation with key factors found in fruits and vegetable, like antioxidants, vitamins, or minerals, do not help and some have been found to be harmful in some cases.[92][93] In general as of 2016, robust clinical data is lacking, that shows that any kind of dietary supplementation does more good than harm for people who are healthy and eating a reasonable diet but there is clear data showing that dietary pattern and lifestyle choices are associated with health outcomes.[94][95]

As a result of the lack of good data for supplementation and the strong data for dietary pattern, public health recommendations for healthy eating urge people to eat a plant-based diet of whole foods, minimizing processed food, salt and sugar and to get exercise daily, and to abandon Western pattern diets and a sedentary lifestyle.[96][97]:10

The regulation of food and dietary supplements by the U.S. Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act ("the Act") and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.

Substances which the FDA regulates as food are subdivided into various categories, including foods, food additives, added substances (man-made substances which are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. The specific standards which the FDA exercises differ from one category to the next. Furthermore, the FDA has been granted a variety of means by which it can address violations of the standards for a given category of substances.

Dietary supplement manufacture is required to comply with the good manufacturing practices established in 2007. The FDA can visit manufacturing facilities, send Warning Letters[85] if not in compliance with GMPs, stop production, and if there is a health risk, require that the company conduct a recall.[98]

The European Union's (EU) Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in dosages and in purity.[99] Only those supplements that have been proven to be safe may be sold in the EU without prescription. As a category of food, food supplements cannot be labeled with drug claims but can bear health claims and nutrition claims.[100]

The dietary supplements industry in the United Kingdom (UK), one of the 28 countries in the bloc, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and various doctors and scientists, had signed petitions by 2005 against what are viewed by the petitioners as unjustified restrictions of consumer choice.[101] In 2004, along with two British trade associations, the Alliance for Natural Health (ANH) had a legal challenge to the Food Supplements Directive[102] referred to the European Court of Justice by the High Court in London.[103]

Although the European Court of Justice's Advocate General subsequently said that the bloc's plan to tighten rules on the sale of vitamins and food supplements should be scrapped,[104] he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting public health. ANH, however, interpreted the ban as applying only to synthetically produced supplements, and not to vitamins and minerals normally found in or consumed as part of the diet.[105] Nevertheless, the European judges acknowledged the Advocate General's concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add the product to the list must be open to challenge in the courts.[106]

Examples of ongoing government research organizations to better understand the potential health properties and safety of dietary supplements are the European Food Safety Authority,[3] the Office of Dietary Supplements of the United States National Institutes of Health,[7][107] the Natural and Non-prescription Health Products Directorate of Canada,[108] and the Therapeutic Goods Administration of Australia.[109] Together with public and private research groups, these agencies construct databases on supplement properties, perform research on quality, safety, and population trends of supplement use, and evaluate the potential clinical efficacy of supplements for maintaining health or lowering disease risk.[107]

As continual research on the properties of supplements accumulates, databases or fact sheets for various supplements are updated regularly, including the Dietary Supplement Label Database,[5] Dietary Supplement Ingredient Database,[110] and Dietary Supplement Facts Sheets of the United States.[111] In Canada where a license is issued when a supplement product has been proven by the manufacturer and government to be safe, effective and of sufficient quality for its recommended use, an eight-digit Natural Product Number is assigned and recorded in a Licensed Natural Health Products Database.[112] The European Food Safety Authority maintains a compendium of botanical ingredients used in manufacturing of dietary supplements.[113]

In 2015, the Australian Government's Department of Health published the results of a review of herbal supplements to determine if any were suitable for coverage by health insurance.[114] Establishing guidelines to assess safety and efficacy of botanical supplement products, the European Medicines Agency provided criteria for evaluating and grading the quality of clinical research in preparing monographs about herbal supplements.[115] In the United States, the National Center for Complementary and Integrative Health of the National Institutes of Health provides fact sheets evaluating the safety, potential effectiveness and side effects of many botanical products.[116]

To assure supplements have sufficient quality, standardization, and safety for public consumption, research efforts have focused on development of reference materials for supplement manufacturing and monitoring.[117][113] High-dose products have received research attention,[107][118] especially for emergency situations such as vitamin A deficiency in malnutrition of children,[119] and for women taking folate supplements to reduce the risk of breast cancer.[120]

In the United States, the National Health and Nutrition Examination Survey (NHANES) has investigated habits of using dietary supplements in context of total nutrient intakes from the diet in adults and children.[107] Over the period of 1999 to 2012, use of multivitamins decreased, and there was wide variability in the use of individual supplements among subgroups by age, sex, race/ethnicity, and educational status.[121] Particular attention has been given to use of folate supplements by young women to reduce the risk of fetal neural tube defects.[122][123]

Research initiatives to improve knowledge of the possible health benefits of supplementing with essential nutrients to lower disease risk have been extensive. As examples, just in 2017 were reviews on

A 2017 review indicated a rising incidence of liver injury from use of herbal and dietary supplements, particularly those with steroids, green tea extract, or multiple ingredients.[128]

The potential benefit of using essential nutrient dietary supplements to lower the risk of diseases has been refuted by findings of no effect or weak evidence in numerous clinical reviews, such as for cardiovascular diseases,[127] cancer,[127] HIV,[129] or tuberculosis.[130]

A review of clinical trials registered at clinicaltrials.gov, which would include both drugs and supplements, reported that nearly half of completed trials were sponsored wholly or partially by industry.[131] This does not automatically imply bias, but there is evidence that because of selective non-reporting, results in support of a potential drug or supplement ingredient are more likely to be published than results that do not demonstrate a statistically significant benefit.[131][132] One review reported that fewer than half of the registered clinical trials resulted in publication in peer-reviewed journals.[133]

Improving public information about use of dietary supplements involves investments in professional training programs, further studies of population and nutrient needs, expanding the database information, enhancing collaborations between governments and universities, and translating dietary supplement research into useful information for consumers, health professionals, scientists, and policymakers.[134] Future demonstration of efficacy from use of dietary supplements requires high-quality clinical research using rigorously-qualified products and compliance with established guidelines for reporting of clinical trial results (e.g., CONSORT guidelines).[107]

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Dietary supplement - Wikipedia

Dietary supplement – Wikipedia

"Food supplement" redirects here. For food additions that alter the flavor, color or longevity of food, see Food additive.

A dietary supplement is a manufactured product intended to supplement the diet when taken by mouth as a pill, capsule, tablet, or liquid.[2] A supplement can provide nutrients either extracted from food sources or synthetic, individually or in combination, in order to increase the quantity of their consumption. The class of nutrient compounds includes vitamins, minerals, fiber, fatty acids and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, as for example collagen from chickens or fish. These are also sold individually and in combination, and may be combined with nutrient ingredients. In the United States and Canada, dietary supplements are considered a subset of foods, and are regulated accordingly. The European Commission has also established harmonized rules to help insure that food supplements are safe and properly labeled.[3]

Creating an industry estimated to have a 2015 value of $37 billion,[4] there are more than 50,000 dietary supplement products marketed just in the United States,[5] where about 50% of the American adult population consumes dietary supplements. Multivitamins are the most commonly used product.[6] For those who fail to consume a balanced diet, the United States National Institutes of Health states that certain supplements "may have value."[7]

In the United States, it is against federal regulations for supplement manufacturers to claim that these products prevent or treat any disease. Companies are allowed to use what is referred to as "Structure/Function" wording if there is substantiation of scientific evidence for a supplement providing a potential health effect.[8] An example would be "_____ helps maintain healthy joints", but the label must bear a disclaimer that the Food and Drug Administration (FDA) "has not evaluated the claim and that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.[8] The FDA enforces these regulations, and also prohibits the sale of supplements and supplement ingredients that are dangerous, or supplements not made according to standardized good manufacturing practices (GMPs).

In the United States, the Dietary Supplement Health and Education Act of 1994 provides this description: "The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines the term dietary supplement to mean a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients. Furthermore, a dietary supplement must be labeled as a dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a sole item of a meal or of the diet. In addition, a dietary supplement cannot be approved or authorized for investigation as a new drug, antibiotic, or biologic, unless it was marketed as a food or a dietary supplement before such approval or authorization. Under DSHEA, dietary supplements are deemed to be food, except for purposes of the drug definition."[9]

Per DSHEA, dietary supplements are consumed orally, and are mainly defined by what they are not: conventional foods (including meal replacements), medical foods,[10] preservatives or pharmaceutical drugs. Products intended for use as a nasal spray, or topically, as a lotion applied to the skin, do not qualify. FDA-approved drugs cannot be ingredients in dietary supplements. Supplement products are or contain vitamins, nutritionally essential minerals, amino acids, essential fatty acids and non-nutrient substances extracted from plants or animals or fungi or bacteria, or in the instance of probiotics, are live bacteria. Dietary supplement ingredients may also be synthetic copies of naturally occurring substances (example: melatonin). All products with these ingredients are required to be labeled as dietary supplements.[11] Like foods and unlike drugs, no government approval is required to make or sell dietary supplements; the manufacturer confirms the safety of dietary supplements but the government does not; and rather than requiring riskbenefit analysis to prove that the product can be sold like a drug, such assessment is only used by the FDA to decide that a dietary supplement is unsafe and should be removed from market.[11]

A vitamin is an organic compound required by an organism as a vital nutrient in limited amounts.[12] An organic chemical compound (or related set of compounds) is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. The term is conditional both on the circumstances and on the particular organism. For example, ascorbic acid (vitamin C) is a vitamin for anthropoid primates, humans, guinea pigs and bats, but not for other mammals. Vitamin D is not an essential nutrient for people who get sufficient exposure to ultraviolet light, either from the sun or an artificial source, as then they synthesize vitamin D in skin.[13] Humans require thirteen vitamins in their diet, most of which are actually groups of related molecules, "vitamers", (e.g. vitamin E includes tocopherols and tocotrienols, vitamin K includes vitamin K1 and K2). The list: vitamins A, C, D, E, K, Thiamine (B1), Riboflavin (B2), Niacin (B3), Pantothenic Acid (B5), Vitamin B6, Biotin (B7), Folate (B9) and Vitamin B12. Vitamin intake below recommended amounts can result in signs and symptoms associated with vitamin deficiency. There is little evidence of benefit when consumed as a dietary supplement by those who are healthy and consuming a nutritionally adequate diet.[14]

The U.S. Institute of Medicine sets Tolerable upper intake levels (ULs) for some of the vitamins. This does not prevent dietary supplement companies from selling products with content per serving higher than the ULs. For example, the UL for vitamin D is 100g (4,000 IU),[15] but products are available without prescription at 10,000 IU.

Minerals are the exogenous chemical elements indispensable for life. Four minerals: carbon, hydrogen, oxygen, and nitrogen, are essential for life but are so ubiquitous in food and drink that these are not considered nutrients and there are no recommended intakes for these as minerals. The need for nitrogen is addressed by requirements set for protein, which is composed of nitrogen-containing amino acids. Sulfur is essential, but for humans, not identified as having a recommended intake per se. Instead, recommended intakes are identified for the sulfur-containing amino acids methionine and cysteine. There are dietary supplements which provide sulfur, such as taurine and methylsulfonylmethane.

The essential nutrient minerals for humans, listed in order by weight needed to be at the Recommended Dietary Allowance or Adequate Intake are potassium, chlorine, sodium, calcium, phosphorus, magnesium, iron, zinc, manganese, copper, iodine, chromium, molybdenum, selenium and cobalt (the last as a component of vitamin B12). There are other minerals which are essential for some plants and animals, but may or may not be essential for humans, such as boron and silicon. Essential and purportedly essential minerals are marketed as dietary supplements, individually and in combination with vitamins and other minerals.

Although as a general rule, dietary supplement labeling and marketing are not allowed to make disease prevention or treatment claims, the U.S. FDA has for some foods and dietary supplements reviewed the science, concluded that there is significant scientific agreement, and published specifically worded allowed health claims. An initial ruling allowing a health claim for calcium dietary supplements and osteoporosis was later amended to include calcium supplements with or without vitamin D, effective January 1, 2010. Examples of allowed wording are shown below. In order to qualify for the calcium health claim, a dietary supplement much contain at least 20% of the Reference Dietary Intake, which for calcium means at least 260mg/serving.[16]

In the same year, the European Food Safety Authority also approved a dietary supplement health claim for calcium and vitamin D and the reduction of the risk of osteoporotic fractures by reducing bone loss.[17]The U.S. FDA also approved Qualified Health Claims (QHCs) for various health conditions for calcium, selenium and chromium picolinate.[18] QHCs are supported by scientific evidence, but do not meet the more rigorous significant scientific agreement standard required for an authorized health claim. If dietary supplement companies choose to make such a claim then the FDA stipulates the exact wording of the QHC to be used on labels and in marketing materials. The wording can be onerous: "One study suggests that selenium intake may reduce the risk of bladder cancer in women. However, one smaller study showed no reduction in risk. Based on these studies, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of bladder cancer in women."[19]

Protein-containing supplements, either ready-to-drink or as powders to be mixed into water, are marketed as aids to people recovering from illness or injury, those hoping to thwart the sarcopenia of old age,[20][21] to athletes who believe that strenuous physical activity increases protein requirements,[22] to people hoping to lose weight while minimizing muscle loss, i.e., conducting a protein-sparing modified fast,[23] and to people who want to increase muscle size for performance and appearance. Whey protein is a popular ingredient,[21][24][25] but products may also incorporate casein, soy, pea, hemp or rice protein.

According to US & Canadian Dietary Reference Intake guidelines, the protein Recommended Dietary Allowance (RDA) for adults is based on 0.8 grams protein per kilogram body weight. The recommendation is for sedentary and lightly active people.[26][27][28] Scientific reviews can conclude that a high protein diet, when combined with exercise, will increase muscle mass and strength,[29][30][31] or conclude the opposite.[32] The International Olympic Committee recommends protein intake targets for both strength and endurance athletes at about 1.2-1.8 g/kg body mass per day.[22] One review proposed a maximum daily protein intake of approximately 25% of energy requirements, i.e., approximately 2.0 to 2.5 g/kg.[27]

The same protein ingredients marketed as dietary supplements can be incorporated into meal replacement and medical food products, but those are regulated and labeled differently from supplements. In the United States, "meal replacement" products are foods and are labeled as such. These typically contain protein, carbohydrates, fats, vitamins and minerals. There may be content claims such as "good source of protein", "low fat" or "lactose free."[33] Medical foods, also nutritionally complete, are designed to be used while a person is under the care of a physician or other licensed healthcare professional.[34][35] Liquid medical food products - example Ensure - are available in regular and high protein versions.

Proteins are chains of amino acids. Nine of these proteinogenic amino acids are considered essential for humans because they cannot be produced from other compounds by the human body and so must be taken in as food. Recommended intakes, expressed as milligrams per kilogram of body weight per day, have been established.[26] Other amino acids may be conditionally essential for certain ages or medical conditions. Amino acids, individually and in combinations, are sold as dietary supplements. The claim for supplementing with the branched chain amino acids leucine, valine and isoleucine is for stimulating muscle protein synthesis. A review of the literature concluded this claim was unwarranted.[36] In elderly people, supplementation with just leucine resulted in a modest (0.99kg) increase in lean body mass.[37] The non-essential amino acid arginine, consumed in sufficient amounts, is thought to act as a donor for the synthesis of nitric oxide, a vasodilator. A review confirmed blood pressure lowering.[38] Taurine, a popular dietary supplement ingredient with claims made for sports performance, is technically not an amino acid. It is synthesized in the body from the amino acid cysteine.[39]

Bodybuilding supplements are dietary supplements commonly used by those involved in bodybuilding, weightlifting, mixed martial arts, and athletics for the purpose of facilitating an increase in lean body mass. The intent is to increase muscle, increase body weight, improve athletic performance, and for some sports, to simultaneously decrease percent body fat so as to create better muscle definition. Among the most widely used are high protein drinks, branched-chain amino acids (BCAA), glutamine, arginine, essential fatty acids, creatine, HMB,[40] and weight loss products.[41] Supplements are sold either as single ingredient preparations or in the form of "stacks" proprietary blends of various supplements marketed as offering synergistic advantages. While many bodybuilding supplements are also consumed by the general public the frequency of use will differ when used specifically by bodybuilders. One meta-analysis concluded that for athletes participating in resistance exercise training and consuming protein supplements for an average of 13weeks, total protein intake up to 1.6g/kg of body weight per day would result in an increase in strength and fat-free mass, i.e. muscle, but that higher intakes would not further contribute.[30] The muscle mass increase was statistically significant but modest - averaging 0.3kg for all trials and 1.02.0kg, for protein intake 1.6g/kg/day.[30]

As of 2010,[update] annual sales of sport nutrition products in the United States was over US$2.7billion according to a publication by Consumer Reports.[42]

Fish oil is a commonly used fatty acid supplement because it is a source of omega-3 fatty acids.[43] Fatty acids are strings of carbon atoms, having a range of lengths. If links are all single (C-C), then the fatty acid is called saturated; with one double bond (C=C), it is called monounsaturated; if there are two or more double bonds (C=C=C), it is called polyunsaturated. Only two fatty acids, both polyunsaturated, are considered essential to be obtained from the diet, as the others are synthesized in the body. The "essential" fatty acids are alpha-linolenic acid (ALA), an omega-3 fatty acid, and linoleic acid (LA), an omega-6 fatty acid.[43][44] ALA can be elongated in the body to create other omega-3 fatty acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

Plant oils, particularly seed and nut oils, contain ALA.[43] Food sources of EPA and DHA are oceanic fish, whereas dietary supplement sources include fish oil, krill oil and marine algae extracts. The European Food Safety Authority (EFSA) identifies 250mg/day for a combined total of EPA and DHA as Adequate Intake, with a recommendation that women pregnant or lactating consume an additional 100 to 200mg/day of DHA.[45] In the United States and Canada are Adequate Intakes for ALA and LA over various stages of life, but there are no intake levels specified for EPA and/or DHA.[46]

Supplementation with EPA and/or DHA does not appear to affect the risk of death, cancer or heart disease.[47][48] Furthermore, studies of fish oil supplements have failed to support claims of preventing heart attacks or strokes.[49] In 2017, the American Heart Association issued a science advisory stating that it could not recommend use of omega-3 fish oil supplements for primary prevention of cardiovascular disease or stroke, although it reaffirmed supplementation for people who have a history of coronary heart disease.[50]

Dietary supplements can be manufactured using intact sources or extracts from plants, animals, algae, fungi or lichens, including such examples as ginkgo biloba, curcumin, cranberry, St. Johns wort, ginseng, resveratrol, glucosamine and collagen.[51][52][53] Products bearing promotional claims of health benefits are sold without requiring a prescription in pharmacies, supermarkets, specialist shops, military commissaries, buyers clubs, direct selling organizations, and the internet.[52] While most of these products have a long history of use in herbalism and various forms of traditional medicine, concerns exist about their actual efficacy, safety and consistency of quality.[54][55][56] Canada has published a manufacturer and consumer guide describing quality, licensing, standards, identities, and common contaminants of natural products.[57] In 2016, sales of herbal supplements just in the United States were $7.5 billion, with the market growing at about 8% per year.[52] Italy, Germany and Eastern European countries were leading consumers of botanical supplements in 2016, with European Union market growth forecast to be $8.7 billion by 2020.[58]

In humans, the large intestine is host to more than 1,000 species of microorganisms, mostly bacteria, numbering in the tens of trillions.[59] "Probiotic" in the context of dietary supplements is the theory that by orally consuming specific live bacteria (or yeast) species, it is possible to influence the large intestine microbiota, with consequent health benefits. Although there are numerous claimed benefits of using probiotic supplements, such as maintaining gastrointestinal health, in part by lowering risk of and severity of constipation or diarrhea, and improving immune health, including lower risk of and severity of acute upper respiratory tract infections, i.e., the common cold, such claims are not all supported by sufficient clinical evidence.[60][61][62] A review based on interviews with dozens of experts in microbiome research expressed concern about "...how biomedical research is co-opted by commercial entities that place profit over health."[62] The concern is timely, as through 2021, probiotic supplements are expected to be the fastest growing segment of the dietary supplement market worldwide, while at the same time, the global health benefits market for probiotic-containing yogurt (a food, not a dietary supplement) is declining.[63][64]

As with all dietary supplements, in the United States inappropriate label health claims such as preventing or treating disease are opposed by the FDA and deceptive advertisements by the Federal Trade Commission. Probiotic foods and dietary supplements are allowed to make claims using Structure:Function vocabulary as long as human trial evidence is adequate. In 2005, the FDA issued a Warning Letter to UAS Laboratories for disease treatment claims (colds, flu, ulcers, elevated blood cholesterol, colon cancer...). The company revised label and website content and continued to sell the product.[65] In 2011 the company was found to have resumed the label and website claims, and the FDA seized product and stopped production.[66] In 2010 a FTC action was brought against a probiotic food company for exaggerated health claims, resulting in a multimillion-dollar fine and revisions to future advertising.[67] In the European Union a more restrictive approach has been taken by the EFSA. All proposed health claims were rejected on the grounds that the science was not sufficient, and no health claims are permitted. Foods with live microorganisms (yogurt, kefir) can be sold, but without claims.[60][63]

Probiotic supplements are generally regarded as safe. The greatest concern, evidenced by reviews reporting on case studies, is that for people with compromised gut wall integrity there may be a risk of systemic infection. For this reason, probiotic research is expected to exclude bacteria species that are antibiotic resistant.[68][69]

In 2015, the American market for dietary supplements was valued at $37 billion,[4] with the economic impact in the United States for 2016 estimated at $122 billion, including employment wages and taxes.[70] One 2016 analysis estimated the total market for dietary supplements could reach $278 billion worldwide by 2024.[71]

Over the period 2008 to 2011, the Government Accountability Office (GAO) of the United States received 6,307 reports of health problems (identified as adverse events) from use of dietary supplements containing a combination of ingredients in manufactured vitamins, minerals or other supplement products,[72] with 92% of tested herbal supplements containing lead and 80% containing other chemical contaminants.[73] Using undercover staff, the GAO also found that supplement retailers intentionally engaged in "unequivocal deception" to sell products advertised with baseless health claims, particularly to elderly consumers.[73] Consumer Reports also reported unsafe levels of arsenic, cadmium, lead and mercury in several protein powder products.[74] The Canadian Broadcasting Corporation (CBC) reported that protein spiking, i.e., the addition of amino acids to manipulate protein content analysis, was common.[75] Many of the companies involved challenged CBC's claim.[76]

A 2013 study on herbal supplements found that many products were of low quality, one third did not contain the active ingredient(s) claimed, and one third contained unlisted substances.[77] In a genetic analysis of herbal supplements, 78% of samples contained animal DNA that was not identified as an ingredient on the product labels.[55] In some botanical products, undeclared ingredients were used to increase the bulk of the product and reduce its cost of manufacturing, while potentially violating certain religious and/or cultural limitations on consuming animal ingredients, such as cow, buffalo or deer.[55] In 2015, the New York Attorney General identified four major retailers with dietary supplement products that contained fraudulent and potentially dangerous ingredients, requiring the companies to remove the products from retail stores.[78]

A study of dietary supplements sold between 2007 and 2016 identified 776 that contained unlisted pharmaceutical drugs, many of which could interact with other medications and lead to hospitalization.[79] 86% of the adulterated supplements were marketed for weight loss and sexual performance, with many containing prescription erectile dysfunction medication. Muscle building supplements were contaminated with anabolic steroids, and multiple products contained antidepressants and antihistamines. Despite these findings, fewer than half of the adulterated supplements were recalled.[79]

The European Commission has published harmonized rules on supplement products to assure consumers have minimal health risks from using dietary supplements and are not misled by advertising.[80]

The United States Food and Drug Administration (FDA Office of Inspections, Compliance, Enforcement, and Criminal Investigations) monitors supplement products for accuracy in advertising and labeling. Dietary supplements are regulated by the FDA as food products subject to compliance with current Good Manufacturing Practices (CGMP) and labeling with science-based ingredient descriptions and advertising.[81][82] When finding CGMP or advertising violations, FDA warning letters are used to notify manufacturers of impending enforcement action, including search and seizure, injunction, and financial penalties.[83] Examples between 2016 and 2018 of CGMP and advertising violations by dietary supplement manufacturers included several with illegal compositions or advertising of vitamins and minerals.[84][85][86]

The United States Federal Trade Commission, which litigates against deceptive advertising in marketed products,[67] established a consumer center to assist reports of false health claims in product advertising for dietary supplements.[87] In 2017, the FTC successfully sued nine manufacturers for deceptive advertising of dietary supplements.[88]

In the United States, manufacturers of dietary supplements are required to demonstrate safety of their products before approval is granted for commerce.[89] Despite this caution, numerous adverse effects have been reported,[72] including muscle cramps, hair loss, joint pain, liver disease, and allergic reactions, with 29% of the adverse effects resulting in hospitalization, and 20% in serious injuries or illnesses.[72] By more than five-fold, the highest incidence of health problems derived from "combination products", whereas supplements for vitamins and minerals, lipid products, and herbal products were less likely to cause adverse effects.[72]

Among general reasons for the possible harmful effects of dietary supplements are: a) absorption in a short time, b) manufacturing quality and contamination, and c) enhancing both positive and negative effects at the same time.[56] The incidence of liver injury from herbal and dietary supplements is about 1620% of all supplement products causing injury, with the occurrence growing globally over the early 21st century.[41] The most common liver injuries from weight loss and bodybuilding supplements involve hepatocellular damage with resulting jaundice, and the most common supplement ingredients attributed to these injuries are green tea catechins, anabolic steroids, and the herbal extract, aegeline.[41] Weight loss supplements have also had adverse psychiatric effects.[90]

Work done by scientists in the early 20th century on identifying individual nutrients in food and developing ways to manufacture them raised hopes that optimal health could be achieved and diseases prevented by adding them to food and providing people with dietary supplements; while there were successes in preventing vitamin deficiencies, and preventing conditions like neural tube defects by supplementation and food fortification with folic acid, no targeted supplementation or fortification strategies to prevent major diseases like cancer or cardiovascular diseases have proved successful.[91]

For example, while increased consumption of fruits and vegetables are related to decreases in mortality, cardiovascular diseases and cancers, supplementation with key factors found in fruits and vegetable, like antioxidants, vitamins, or minerals, do not help and some have been found to be harmful in some cases.[92][93] In general as of 2016, robust clinical data is lacking, that shows that any kind of dietary supplementation does more good than harm for people who are healthy and eating a reasonable diet but there is clear data showing that dietary pattern and lifestyle choices are associated with health outcomes.[94][95]

As a result of the lack of good data for supplementation and the strong data for dietary pattern, public health recommendations for healthy eating urge people to eat a plant-based diet of whole foods, minimizing processed food, salt and sugar and to get exercise daily, and to abandon Western pattern diets and a sedentary lifestyle.[96][97]:10

The regulation of food and dietary supplements by the U.S. Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act ("the Act") and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.

Substances which the FDA regulates as food are subdivided into various categories, including foods, food additives, added substances (man-made substances which are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. The specific standards which the FDA exercises differ from one category to the next. Furthermore, the FDA has been granted a variety of means by which it can address violations of the standards for a given category of substances.

Dietary supplement manufacture is required to comply with the good manufacturing practices established in 2007. The FDA can visit manufacturing facilities, send Warning Letters[85] if not in compliance with GMPs, stop production, and if there is a health risk, require that the company conduct a recall.[98]

The European Union's (EU) Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in dosages and in purity.[99] Only those supplements that have been proven to be safe may be sold in the EU without prescription. As a category of food, food supplements cannot be labeled with drug claims but can bear health claims and nutrition claims.[100]

The dietary supplements industry in the United Kingdom (UK), one of the 28 countries in the bloc, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and various doctors and scientists, had signed petitions by 2005 against what are viewed by the petitioners as unjustified restrictions of consumer choice.[101] In 2004, along with two British trade associations, the Alliance for Natural Health (ANH) had a legal challenge to the Food Supplements Directive[102] referred to the European Court of Justice by the High Court in London.[103]

Although the European Court of Justice's Advocate General subsequently said that the bloc's plan to tighten rules on the sale of vitamins and food supplements should be scrapped,[104] he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting public health. ANH, however, interpreted the ban as applying only to synthetically produced supplements, and not to vitamins and minerals normally found in or consumed as part of the diet.[105] Nevertheless, the European judges acknowledged the Advocate General's concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add the product to the list must be open to challenge in the courts.[106]

Examples of ongoing government research organizations to better understand the potential health properties and safety of dietary supplements are the European Food Safety Authority,[3] the Office of Dietary Supplements of the United States National Institutes of Health,[7][107] the Natural and Non-prescription Health Products Directorate of Canada,[108] and the Therapeutic Goods Administration of Australia.[109] Together with public and private research groups, these agencies construct databases on supplement properties, perform research on quality, safety, and population trends of supplement use, and evaluate the potential clinical efficacy of supplements for maintaining health or lowering disease risk.[107]

As continual research on the properties of supplements accumulates, databases or fact sheets for various supplements are updated regularly, including the Dietary Supplement Label Database,[5] Dietary Supplement Ingredient Database,[110] and Dietary Supplement Facts Sheets of the United States.[111] In Canada where a license is issued when a supplement product has been proven by the manufacturer and government to be safe, effective and of sufficient quality for its recommended use, an eight-digit Natural Product Number is assigned and recorded in a Licensed Natural Health Products Database.[112] The European Food Safety Authority maintains a compendium of botanical ingredients used in manufacturing of dietary supplements.[113]

In 2015, the Australian Government's Department of Health published the results of a review of herbal supplements to determine if any were suitable for coverage by health insurance.[114] Establishing guidelines to assess safety and efficacy of botanical supplement products, the European Medicines Agency provided criteria for evaluating and grading the quality of clinical research in preparing monographs about herbal supplements.[115] In the United States, the National Center for Complementary and Integrative Health of the National Institutes of Health provides fact sheets evaluating the safety, potential effectiveness and side effects of many botanical products.[116]

To assure supplements have sufficient quality, standardization, and safety for public consumption, research efforts have focused on development of reference materials for supplement manufacturing and monitoring.[117][113] High-dose products have received research attention,[107][118] especially for emergency situations such as vitamin A deficiency in malnutrition of children,[119] and for women taking folate supplements to reduce the risk of breast cancer.[120]

In the United States, the National Health and Nutrition Examination Survey (NHANES) has investigated habits of using dietary supplements in context of total nutrient intakes from the diet in adults and children.[107] Over the period of 1999 to 2012, use of multivitamins decreased, and there was wide variability in the use of individual supplements among subgroups by age, sex, race/ethnicity, and educational status.[121] Particular attention has been given to use of folate supplements by young women to reduce the risk of fetal neural tube defects.[122][123]

Research initiatives to improve knowledge of the possible health benefits of supplementing with essential nutrients to lower disease risk have been extensive. As examples, just in 2017 were reviews on

A 2017 review indicated a rising incidence of liver injury from use of herbal and dietary supplements, particularly those with steroids, green tea extract, or multiple ingredients.[128]

The potential benefit of using essential nutrient dietary supplements to lower the risk of diseases has been refuted by findings of no effect or weak evidence in numerous clinical reviews, such as for cardiovascular diseases,[127] cancer,[127] HIV,[129] or tuberculosis.[130]

A review of clinical trials registered at clinicaltrials.gov, which would include both drugs and supplements, reported that nearly half of completed trials were sponsored wholly or partially by industry.[131] This does not automatically imply bias, but there is evidence that because of selective non-reporting, results in support of a potential drug or supplement ingredient are more likely to be published than results that do not demonstrate a statistically significant benefit.[131][132] One review reported that fewer than half of the registered clinical trials resulted in publication in peer-reviewed journals.[133]

Improving public information about use of dietary supplements involves investments in professional training programs, further studies of population and nutrient needs, expanding the database information, enhancing collaborations between governments and universities, and translating dietary supplement research into useful information for consumers, health professionals, scientists, and policymakers.[134] Future demonstration of efficacy from use of dietary supplements requires high-quality clinical research using rigorously-qualified products and compliance with established guidelines for reporting of clinical trial results (e.g., CONSORT guidelines).[107]

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Dietary supplement - Wikipedia

Food Supplements Europe

Food Supplements Europe has been created to represent the interests of the European food supplement sector. Its membership includes national associations and companies committed to ensuring that future EU legislation and policy reflects the important role that this sector plays in the health of consumers.

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Food Supplements Europe

Health & Food Supplements Information Service

gMicrogram a measurement of weight equal to one millionth of a gram (or one thousandth of a milligram). Microgram (g or mcg) is used for a number of nutrients found in food supplements.Amino AcidThe building blocks of protein, there are eight essential amino acids which cannot be synthesised within the body and therefore must come from the diet. These are: isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine. In addition arginine and histidine are amino acids required by infants and young children which supports their rapid growth.AntioxidantA substance or nutrient which helps to protect our cells from damage caused by free radicals, damaging molecules which are found in pollution and tobacco smoke. Our bodies also produce free radicals as part of the normal biochemistry of living.DeficiencyA lack of essential macronutrients or micronutrients which results in malnutrition and or disease. This may be the result of inadequate intakes or absorption issues associated with gastrointestinal disease. There are a number of recognised deficiency diseases including (but not exclusively): scurvy (vitamin C deficiency); rickets (vitamin D deficiency); anaemia (iron deficiency, but also deficiencies in B12 and folic acid) and Kwashiorkor (protein deficiency).DHThe Department of Health is a UK Government department. It has responsibility for nutrition legislation and sets health policy for nutrition.DHADocosahexaenoic acid; one of the key omega-3 fats that provides health benefitsDietitianAn individual qualified in nutrition and dietetics who can assess, diagnose and treat health issues associated with nutrition and diet. Dietitians are governed by law with a statutory code of practice; they often work within the health service although increasing numbers are also working in a freelance capacity.EFAEssential fatty acids (omega 3 and omega 6) cannot be synthesised by the body and must be derived from the diet. EFAs do not provide fuel for energy production and are required for vital biological processes which support growth, development and health.EFSAEuropean Food Safety Authority; the European Union food risk management agency which scientifically evaluates safety across all areas of food.EPAEicosapentaenoic acid; one of the key omega-3 fats that provides health benefits.Fat soluble vitaminThe fat soluble vitamins are vitamins A, D, E and K. Because they are fat soluble these substances can accumulate in the body, often being stored in fat cells, or in the liver. This can create health issues, particularly if intakes have been high for a prolonged period of time. For example, long term high intakes of vitamin D may lead to the laying down of calcium in tissues such as liver and kidneys which can cause nausea and vomiting.Food supplementA food supplement is a concentrated source of vitamins, minerals or other substances with a nutritional or physiological effect which is sold in small, measured unit doses.FSAThe Food Standards Agency is a non-ministerial UK Government department responsible for food safety and food hygiene.GLAGamma-linoleic acid is an omega-6 fatty acid (an essential fatty acid considered to be necessary for human health which must be derived from the diet). GLA is most commonly found in evening primrose oil (EPO), borage or starflower oil and blackcurrant seed oil.Health claimA health claim is any claim which states, or implies, that consumption of a specific food will have a beneficial effect on health. Claims may be written, verbal or pictorial.Herbal medicine (herbal remedy)A product is considered to be a herbal medicine if the main active ingredient/s are only herbal substances or preparations. Not all herbal products are medicines, some may be food supplements and some may be cosmetics. What determines if a product is, or is not a medicine is complex but generally rests with how the product is presented (i.e. does it make medicinal claims to treat, prevent or cure any disease) and what it does (i.e. does it have a physiological impact on, or alter, any body functions).MacronutrientDietary constituents which are needed in significant amounts, generally protein, fat, carbohydrate, fibre and water.MalnutritionMalnutrition is a state in which the deficiency of nutrients such as energy, protein, vitamins or minerals results in measurable adverse effects on the body. Malnutrition may refer to insufficient intake of protein, carbohydrate and fats (macronutrients) which can result in overly low BMI. It may also be insufficient intake of vitamins, minerals and other micronutrients, which can impact on overall health and could include obese individuals with poor diets.MgMilligram is a measurement of weight equal to one thousandth of a gram. Mg is used for a number of nutrients found in food supplements.MicronutrientA substance derived from food which is needed in extremely small amounts for the normal growth and development of living beings. Micronutrients are vitamins, minerals and essential fatty acids (omega-3 fats)MineralInorganic micronutrient essential to health and wellbeing. Minerals are absorbed from soil by plants which are in turn eaten by animals or humans. Minerals may be split into minerals which are needed in relatively high amounts (calcium, phosphorus, magnesium, sodium, chloride and potassium) and trace elements (iron, zinc, cobalt, copper, chromium, fluoride, iodine, manganese, molybdenum, boron and selenium) which are needed in very small quantities.MultivitaminA product which contains more than one vitamin, often multivitamins will contain all 13 vitamins although some may contain only the eight B vitamins, or a combination of some of the vitamins and some additional minerals.NDNSThe UK National Diet and Nutrition Survey is a continuous rolling survey of the dietary habits and nutritional status of adults and children in the UK. The results are used to assess whether intakes of food and nutrients are adequate across different ages and population groups.NRVNutrient Reference Value is the amount set by the European Food Safety Authority (EFSA), primarily to support food labelling, which the majority of the population requires to maintain health. Previously known as RDANutrientA substance derived from food which provides nourishment to the body and is essential for the maintenance of life and for growth and development.NutritionistNutritionists generally work for public bodies or governments, although some do work with private clients. They tend to look at large populations to determine risk factors and make dietary recommendations that are applied at population levels. For example, evidence on the incidence of type II Diabetes led public health nutritionists to determine that some populations are more at risk of developing this disease, and to make recommendations for dietary changes to either reduce the risk or manage the disease. However, public health nutritionists do not practice with individual patients.Omega-3 fatsEssential fatty acids which cannot be synthesised by the body and must be derived from the diet. Primary sources for omega-3 fats are oily fish and fish oil supplements with some also coming from enriched eggs and fortified foods. There are a number of scientifically proven health benefits for omega-3 fats including supporting the health of the eyes, brain and heart, maintaining an appropriate balance of triglycerides in the blood and reducing blood pressure.Omega-6 fatsEssential fatty acids which cannot be synthesised by the body and must be derived from the diet. Primary sources for omega-6 are vegetable oils such as sunflower and corn oils as well as nuts and seeds. There are a number of health benefits associated with omega-6 fatty acids; they are thought to be beneficial in the management of premenstrual syndrome and in some skin conditions including eczema and psoriasis.PAGBProprietary Association of Great Britain (PAGB) is the UK trade association which represents the manufacturers of branded over-the-counter medicines, self care medical devices and food supplements.PrebioticsFoods which promote the growth of probiotics, the beneficial bacteria that inhabit our gut. Prebiotics are generally fibres such as inulin, which our bodies cannot digest and absorb but which provide a food source for probiotics.ProbioticsLive bacteria (and some yeasts) which inhabit the digestive tract which are viewed as being beneficial to human health. There are thousands of different bacterial strains; some are resident in specific areas of the digestive tract whilst others are transient, simply passing through.Public Health England (PHE)Public Health England is an agency of the Department of Health responsible for improving public health. They work with local government, the NHS and non-governmental organisations as well as communicating public health messages to the general public.PUFAPolyunsaturated fatty acids (PUFA) are found in nuts, seeds, fish (and fish oil), krill and some algae, small amounts are also found in leafy greens. The omega-3 and omega 6 fats are PUFAs, which are generally associated with health.RDARecommended Daily Amount; previously used terminology for the amount set, primarily to support food labelling, which the majority of the population require to maintain health. Now described using nutrient reference value (NRV)SULSafe Upper Levels of vitamins and minerals were established by the Expert Group on Vitamins and Minerals who published a report in 2003 (https://cot.food.gov.uk/sites/default/files/cot/vitmin2003.pdf). The UK food supplements industry works to the levels set in this report.VitaminOrganic micronutrient essential to health and wellbeing. Vitamins cannot be synthesised in sufficient amounts by the animal or human body and must therefore be obtained from the diet. Plants manufacture vitamins which move up the food chain as the plants are consumed by animals or humans. Vitamins can be divided into fat soluble (vitamins A, D, E and K) and water soluble (vitamins B1, B2, B3, B5, B6, B12, biotin, folic acid and vitamin C).Water soluble vitaminThe B vitamins and vitamin C are water soluble. They are not stored in any significant quantities within the body and are generally either utilised or excreted in the urine. As they are not stored in the body, they tend to have low toxicity and are needed on a daily basis.

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Health & Food Supplements Information Service

Whole Food vs. Synthetic Supplements | Melissa Wood, ND

Ive already discussed the importance of taking natural supplements to support your body and immune system. But which supplements do you take, and how do you know which supplements are the best ones? Americans spend billions of dollars every year on supplements, and its very important to understand that not all supplements are created equal. Sometimes, there are vast differences between products.

So lets talk about the difference between whole food supplements and synthetic supplements a.k.a. isolated or fractionated supplements.

A great example would be just to simply look at almost any multivitamin. When you scan the nutritional content fact and ingredientlabel, youll see quite an assortment of vitamins (Vitamin A, Vitamin C, Vitamin E, etc.).Here is a portion of a label for a common multivitamin:

There are a lot more vitamins listed on this label than I had room for, but I think you get the idea. Look at the items listed under Ingredients.Those are what we call Isolated vitamins and other chemicals.There are no foods or herbal ingredients listed, only partial vitamins and other chemicals.

Nature intended for us to consume food in its WHOLE form because all the vitamins, minerals, antioxidants and enzymes are bound together in one package and work synergistically to deliver the nutrition your body needs.

Synthetic supplements give you isolated or fractionated pieces of the whole. It is simply not the same youre not getting the full benefit nature intended. The other problem is, by taking isolated vitamins, sometimes we are getting massive doses of some vitamins, but not enough of others.This imbalance this can cause health problems too. Arent we trying to get healthier rather than cause more problems?

Whole-Food based supplements are different, as those will, typically, list the foods the supplement was made from. What follows is a partial example of what to look for when searching for a Whole-Food based product.Notice that under the supplemental facts, you still see all the vitamins listed, but theres a huge difference in the ingredients.

What a difference this second product will make in your body vs. the first product!Youll actually be gaining benefits from the WHOLE food and all of the vitamins, minerals, antioxidants and enzymes that occur naturally in the food or plant.

Another way that might make sense is to look at the source.When Vitamin C is listed on a multivitamin label, look for any natural sources, like citrus fruits, papaya or bell peppers.If you see a listing for Ascorbic Acid, that means it is an Isolated product, so you must keep searching for ones that list whole foods.

In summary, be sure you read your labels!It is important to educate yourself about what youll be putting into your body and supplements are no different than anything else.

Its important to read food labels so you know what youre eating. But its just as important, if not moreso, to be sure youre reading all of your supplement labels too!You want to be consuming supplements that have actual whole foods, plants or herbs listed on the label. That way you know it is as close to natural as possible!

And lastly,understand that no supplement alone will help you achieve the level of health you desire. You will have to make lifestyle and behavior changes as well as taking supplements to achieve ultimate health.

Originally posted here:

Whole Food vs. Synthetic Supplements | Melissa Wood, ND

Dietary supplement – Wikipedia

"Food supplement" redirects here. For food additions that alter the flavor, color or longevity of food, see Food additive.

A dietary supplement is a manufactured product intended to supplement the diet when taken by mouth as a pill, capsule, tablet, or liquid.[2] A supplement can provide nutrients either extracted from food sources or synthetic, individually or in combination, in order to increase the quantity of their consumption. The class of nutrient compounds includes vitamins, minerals, fiber, fatty acids and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, as for example collagen from chickens or fish. These are also sold individually and in combination, and may be combined with nutrient ingredients. In the United States and Canada, dietary supplements are considered a subset of foods, and are regulated accordingly. The European Commission has also established harmonized rules to help insure that food supplements are safe and properly labeled.[3]

Creating an industry estimated to have a 2015 value of $37 billion,[4] there are more than 50,000 dietary supplement products marketed just in the United States,[5] where about 50% of the American adult population consumes dietary supplements. Multivitamins are the most commonly used product.[6] For those who fail to consume a balanced diet, the United States National Institutes of Health states that certain supplements "may have value."[7]

In the United States, it is against federal regulations for supplement manufacturers to claim that these products prevent or treat any disease. Companies are allowed to use what is referred to as "Structure/Function" wording if there is substantiation of scientific evidence for a supplement providing a potential health effect.[8] An example would be "_____ helps maintain healthy joints", but the label must bear a disclaimer that the Food and Drug Administration (FDA) "has not evaluated the claim and that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.[8] The FDA enforces these regulations, and also prohibits the sale of supplements and supplement ingredients that are dangerous, or supplements not made according to standardized good manufacturing practices (GMPs).

In the United States, the Dietary Supplement Health and Education Act of 1994 provides this description: "The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines the term dietary supplement to mean a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients. Furthermore, a dietary supplement must be labeled as a dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a sole item of a meal or of the diet. In addition, a dietary supplement cannot be approved or authorized for investigation as a new drug, antibiotic, or biologic, unless it was marketed as a food or a dietary supplement before such approval or authorization. Under DSHEA, dietary supplements are deemed to be food, except for purposes of the drug definition."[9]

Per DSHEA, dietary supplements are consumed orally, and are mainly defined by what they are not: conventional foods (including meal replacements), medical foods,[10] preservatives or pharmaceutical drugs. Products intended for use as a nasal spray, or topically, as a lotion applied to the skin, do not qualify. FDA-approved drugs cannot be ingredients in dietary supplements. Supplement products are or contain vitamins, nutritionally essential minerals, amino acids, essential fatty acids and non-nutrient substances extracted from plants or animals or fungi or bacteria, or in the instance of probiotics, are live bacteria. Dietary supplement ingredients may also be synthetic copies of naturally occurring substances (example: melatonin). All products with these ingredients are required to be labeled as dietary supplements.[11] Like foods and unlike drugs, no government approval is required to make or sell dietary supplements; the manufacturer confirms the safety of dietary supplements but the government does not; and rather than requiring riskbenefit analysis to prove that the product can be sold like a drug, such assessment is only used by the FDA to decide that a dietary supplement is unsafe and should be removed from market.[11]

A vitamin is an organic compound required by an organism as a vital nutrient in limited amounts.[12] An organic chemical compound (or related set of compounds) is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. The term is conditional both on the circumstances and on the particular organism. For example, ascorbic acid (vitamin C) is a vitamin for anthropoid primates, humans, guinea pigs and bats, but not for other mammals. Vitamin D is not an essential nutrient for people who get sufficient exposure to ultraviolet light, either from the sun or an artificial source, as then they synthesize vitamin D in skin.[13] Humans require thirteen vitamins in their diet, most of which are actually groups of related molecules, "vitamers", (e.g. vitamin E includes tocopherols and tocotrienols, vitamin K includes vitamin K1 and K2). The list: vitamins A, C, D, E, K, Thiamine (B1), Riboflavin (B2), Niacin (B3), Pantothenic Acid (B5), Vitamin B6, Biotin (B7), Folate (B9) and Vitamin B12. Vitamin intake below recommended amounts can result in signs and symptoms associated with vitamin deficiency. There is little evidence of benefit when consumed as a dietary supplement by those who are healthy and consuming a nutritionally adequate diet.[14]

The U.S. Institute of Medicine sets Tolerable upper intake levels (ULs) for some of the vitamins. This does not prevent dietary supplement companies from selling products with content per serving higher than the ULs. For example, the UL for vitamin D is 100g (4,000 IU),[15] but products are available without prescription at 10,000 IU.

Minerals are the exogenous chemical elements indispensable for life. Four minerals: carbon, hydrogen, oxygen, and nitrogen, are essential for life but are so ubiquitous in food and drink that these are not considered nutrients and there are no recommended intakes for these as minerals. The need for nitrogen is addressed by requirements set for protein, which is composed of nitrogen-containing amino acids. Sulfur is essential, but for humans, not identified as having a recommended intake per se. Instead, recommended intakes are identified for the sulfur-containing amino acids methionine and cysteine. There are dietary supplements which provide sulfur, such as taurine and methylsulfonylmethane.

The essential nutrient minerals for humans, listed in order by weight needed to be at the Recommended Dietary Allowance or Adequate Intake are potassium, chlorine, sodium, calcium, phosphorus, magnesium, iron, zinc, manganese, copper, iodine, chromium, molybdenum, selenium and cobalt (the last as a component of vitamin B12). There are other minerals which are essential for some plants and animals, but may or may not be essential for humans, such as boron and silicon. Essential and purportedly essential minerals are marketed as dietary supplements, individually and in combination with vitamins and other minerals.

Although as a general rule, dietary supplement labeling and marketing are not allowed to make disease prevention or treatment claims, the U.S. FDA has for some foods and dietary supplements reviewed the science, concluded that there is significant scientific agreement, and published specifically worded allowed health claims. An initial ruling allowing a health claim for calcium dietary supplements and osteoporosis was later amended to include calcium supplements with or without vitamin D, effective January 1, 2010. Examples of allowed wording are shown below. In order to qualify for the calcium health claim, a dietary supplement much contain at least 20% of the Reference Dietary Intake, which for calcium means at least 260mg/serving.[16]

In the same year, the European Food Safety Authority also approved a dietary supplement health claim for calcium and vitamin D and the reduction of the risk of osteoporotic fractures by reducing bone loss.[17]The U.S. FDA also approved Qualified Health Claims (QHCs) for various health conditions for calcium, selenium and chromium picolinate.[18] QHCs are supported by scientific evidence, but do not meet the more rigorous significant scientific agreement standard required for an authorized health claim. If dietary supplement companies choose to make such a claim then the FDA stipulates the exact wording of the QHC to be used on labels and in marketing materials. The wording can be onerous: "One study suggests that selenium intake may reduce the risk of bladder cancer in women. However, one smaller study showed no reduction in risk. Based on these studies, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of bladder cancer in women."[19]

Protein-containing supplements, either ready-to-drink or as powders to be mixed into water, are marketed as aids to people recovering from illness or injury, those hoping to thwart the sarcopenia of old age,[20][21] to athletes who believe that strenuous physical activity increases protein requirements,[22] to people hoping to lose weight while minimizing muscle loss, i.e., conducting a protein-sparing modified fast,[23] and to people who want to increase muscle size for performance and appearance. Whey protein is a popular ingredient,[21][24][25] but products may also incorporate casein, soy, pea, hemp or rice protein.

According to US & Canadian Dietary Reference Intake guidelines, the protein Recommended Dietary Allowance (RDA) for adults is based on 0.8 grams protein per kilogram body weight. The recommendation is for sedentary and lightly active people.[26][27][28] Scientific reviews can conclude that a high protein diet, when combined with exercise, will increase muscle mass and strength,[29][30][31] or conclude the opposite.[32] The International Olympic Committee recommends protein intake targets for both strength and endurance athletes at about 1.2-1.8 g/kg body mass per day.[22] One review proposed a maximum daily protein intake of approximately 25% of energy requirements, i.e., approximately 2.0 to 2.5 g/kg.[27]

The same protein ingredients marketed as dietary supplements can be incorporated into meal replacement and medical food products, but those are regulated and labeled differently from supplements. In the United States, "meal replacement" products are foods and are labeled as such. These typically contain protein, carbohydrates, fats, vitamins and minerals. There may be content claims such as "good source of protein", "low fat" or "lactose free."[33] Medical foods, also nutritionally complete, are designed to be used while a person is under the care of a physician or other licensed healthcare professional.[34][35] Liquid medical food products - example Ensure - are available in regular and high protein versions.

Proteins are chains of amino acids. Nine of these proteinogenic amino acids are considered essential for humans because they cannot be produced from other compounds by the human body and so must be taken in as food. Recommended intakes, expressed as milligrams per kilogram of body weight per day, have been established.[26] Other amino acids may be conditionally essential for certain ages or medical conditions. Amino acids, individually and in combinations, are sold as dietary supplements. The claim for supplementing with the branched chain amino acids leucine, valine and isoleucine is for stimulating muscle protein synthesis. A review of the literature concluded this claim was unwarranted.[36] In elderly people, supplementation with just leucine resulted in a modest (0.99kg) increase in lean body mass.[37] The non-essential amino acid arginine, consumed in sufficient amounts, is thought to act as a donor for the synthesis of nitric oxide, a vasodilator. A review confirmed blood pressure lowering.[38] Taurine, a popular dietary supplement ingredient with claims made for sports performance, is technically not an amino acid. It is synthesized in the body from the amino acid cysteine.[39]

Bodybuilding supplements are dietary supplements commonly used by those involved in bodybuilding, weightlifting, mixed martial arts, and athletics for the purpose of facilitating an increase in lean body mass. The intent is to increase muscle, increase body weight, improve athletic performance, and for some sports, to simultaneously decrease percent body fat so as to create better muscle definition. Among the most widely used are high protein drinks, branched-chain amino acids (BCAA), glutamine, arginine, essential fatty acids, creatine, HMB,[40] and weight loss products.[41] Supplements are sold either as single ingredient preparations or in the form of "stacks" proprietary blends of various supplements marketed as offering synergistic advantages. While many bodybuilding supplements are also consumed by the general public the frequency of use will differ when used specifically by bodybuilders. One meta-analysis concluded that for athletes participating in resistance exercise training and consuming protein supplements for an average of 13weeks, total protein intake up to 1.6g/kg of body weight per day would result in an increase in strength and fat-free mass, i.e. muscle, but that higher intakes would not further contribute.[30] The muscle mass increase was statistically significant but modest - averaging 0.3kg for all trials and 1.02.0kg, for protein intake 1.6g/kg/day.[30]

As of 2010,[update] annual sales of sport nutrition products in the United States was over US$2.7billion according to a publication by Consumer Reports.[42]

Fish oil is a commonly used fatty acid supplement because it is a source of omega-3 fatty acids.[43] Fatty acids are strings of carbon atoms, having a range of lengths. If links are all single (C-C), then the fatty acid is called saturated; with one double bond (C=C), it is called monounsaturated; if there are two or more double bonds (C=C=C), it is called polyunsaturated. Only two fatty acids, both polyunsaturated, are considered essential to be obtained from the diet, as the others are synthesized in the body. The "essential" fatty acids are alpha-linolenic acid (ALA), an omega-3 fatty acid, and linoleic acid (LA), an omega-6 fatty acid.[43][44] ALA can be elongated in the body to create other omega-3 fatty acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

Plant oils, particularly seed and nut oils, contain ALA.[43] Food sources of EPA and DHA are oceanic fish, whereas dietary supplement sources include fish oil, krill oil and marine algae extracts. The European Food Safety Authority (EFSA) identifies 250mg/day for a combined total of EPA and DHA as Adequate Intake, with a recommendation that women pregnant or lactating consume an additional 100 to 200mg/day of DHA.[45] In the United States and Canada are Adequate Intakes for ALA and LA over various stages of life, but there are no intake levels specified for EPA and/or DHA.[46]

Supplementation with EPA and/or DHA does not appear to affect the risk of death, cancer or heart disease.[47][48] Furthermore, studies of fish oil supplements have failed to support claims of preventing heart attacks or strokes.[49] In 2017, the American Heart Association issued a science advisory stating that it could not recommend use of omega-3 fish oil supplements for primary prevention of cardiovascular disease or stroke, although it reaffirmed supplementation for people who have a history of coronary heart disease.[50]

Dietary supplements can be manufactured using intact sources or extracts from plants, animals, algae, fungi or lichens, including such examples as ginkgo biloba, curcumin, cranberry, St. Johns wort, ginseng, resveratrol, glucosamine and collagen.[51][52][53] Products bearing promotional claims of health benefits are sold without requiring a prescription in pharmacies, supermarkets, specialist shops, military commissaries, buyers clubs, direct selling organizations, and the internet.[52] While most of these products have a long history of use in herbalism and various forms of traditional medicine, concerns exist about their actual efficacy, safety and consistency of quality.[54][55][56] Canada has published a manufacturer and consumer guide describing quality, licensing, standards, identities, and common contaminants of natural products.[57] In 2016, sales of herbal supplements just in the United States were $7.5 billion, with the market growing at about 8% per year.[52] Italy, Germany and Eastern European countries were leading consumers of botanical supplements in 2016, with European Union market growth forecast to be $8.7 billion by 2020.[58]

In humans, the large intestine is host to more than 1,000 species of microorganisms, mostly bacteria, numbering in the tens of trillions.[59] "Probiotic" in the context of dietary supplements is the theory that by orally consuming specific live bacteria (or yeast) species, it is possible to influence the large intestine microbiota, with consequent health benefits. Although there are numerous claimed benefits of using probiotic supplements, such as maintaining gastrointestinal health, in part by lowering risk of and severity of constipation or diarrhea, and improving immune health, including lower risk of and severity of acute upper respiratory tract infections, i.e., the common cold, such claims are not all supported by sufficient clinical evidence.[60][61][62] A review based on interviews with dozens of experts in microbiome research expressed concern about "...how biomedical research is co-opted by commercial entities that place profit over health."[62] The concern is timely, as through 2021, probiotic supplements are expected to be the fastest growing segment of the dietary supplement market worldwide, while at the same time, the global health benefits market for probiotic-containing yogurt (a food, not a dietary supplement) is declining.[63][64]

As with all dietary supplements, in the United States inappropriate label health claims such as preventing or treating disease are opposed by the FDA and deceptive advertisements by the Federal Trade Commission. Probiotic foods and dietary supplements are allowed to make claims using Structure:Function vocabulary as long as human trial evidence is adequate. In 2005, the FDA issued a Warning Letter to UAS Laboratories for disease treatment claims (colds, flu, ulcers, elevated blood cholesterol, colon cancer...). The company revised label and website content and continued to sell the product.[65] In 2011 the company was found to have resumed the label and website claims, and the FDA seized product and stopped production.[66] In 2010 a FTC action was brought against a probiotic food company for exaggerated health claims, resulting in a multimillion-dollar fine and revisions to future advertising.[67] In the European Union a more restrictive approach has been taken by the EFSA. All proposed health claims were rejected on the grounds that the science was not sufficient, and no health claims are permitted. Foods with live microorganisms (yogurt, kefir) can be sold, but without claims.[60][63]

Probiotic supplements are generally regarded as safe. The greatest concern, evidenced by reviews reporting on case studies, is that for people with compromised gut wall integrity there may be a risk of systemic infection. For this reason, probiotic research is expected to exclude bacteria species that are antibiotic resistant.[68][69]

In 2015, the American market for dietary supplements was valued at $37 billion,[4] with the economic impact in the United States for 2016 estimated at $122 billion, including employment wages and taxes.[70] One 2016 analysis estimated the total market for dietary supplements could reach $278 billion worldwide by 2024.[71]

Over the period 2008 to 2011, the Government Accountability Office (GAO) of the United States received 6,307 reports of health problems (identified as adverse events) from use of dietary supplements containing a combination of ingredients in manufactured vitamins, minerals or other supplement products,[72] with 92% of tested herbal supplements containing lead and 80% containing other chemical contaminants.[73] Using undercover staff, the GAO also found that supplement retailers intentionally engaged in "unequivocal deception" to sell products advertised with baseless health claims, particularly to elderly consumers.[73] Consumer Reports also reported unsafe levels of arsenic, cadmium, lead and mercury in several protein powder products.[74] The Canadian Broadcasting Corporation (CBC) reported that protein spiking, i.e., the addition of amino acids to manipulate protein content analysis, was common.[75] Many of the companies involved challenged CBC's claim.[76]

A 2013 study on herbal supplements found that many products were of low quality, one third did not contain the active ingredient(s) claimed, and one third contained unlisted substances.[77] In a genetic analysis of herbal supplements, 78% of samples contained animal DNA that was not identified as an ingredient on the product labels.[55] In some botanical products, undeclared ingredients were used to increase the bulk of the product and reduce its cost of manufacturing, while potentially violating certain religious and/or cultural limitations on consuming animal ingredients, such as cow, buffalo or deer.[55] In 2015, the New York Attorney General identified four major retailers with dietary supplement products that contained fraudulent and potentially dangerous ingredients, requiring the companies to remove the products from retail stores.[78]

A study of dietary supplements sold between 2007 and 2016 identified 776 that contained unlisted pharmaceutical drugs, many of which could interact with other medications and lead to hospitalization.[79] 86% of the adulterated supplements were marketed for weight loss and sexual performance, with many containing prescription erectile dysfunction medication. Muscle building supplements were contaminated with anabolic steroids, and multiple products contained antidepressants and antihistamines. Despite these findings, fewer than half of the adulterated supplements were recalled.[79]

The European Commission has published harmonized rules on supplement products to assure consumers have minimal health risks from using dietary supplements and are not misled by advertising.[80]

The United States Food and Drug Administration (FDA Office of Inspections, Compliance, Enforcement, and Criminal Investigations) monitors supplement products for accuracy in advertising and labeling. Dietary supplements are regulated by the FDA as food products subject to compliance with current Good Manufacturing Practices (CGMP) and labeling with science-based ingredient descriptions and advertising.[81][82] When finding CGMP or advertising violations, FDA warning letters are used to notify manufacturers of impending enforcement action, including search and seizure, injunction, and financial penalties.[83] Examples between 2016 and 2018 of CGMP and advertising violations by dietary supplement manufacturers included several with illegal compositions or advertising of vitamins and minerals.[84][85][86]

The United States Federal Trade Commission, which litigates against deceptive advertising in marketed products,[67] established a consumer center to assist reports of false health claims in product advertising for dietary supplements.[87] In 2017, the FTC successfully sued nine manufacturers for deceptive advertising of dietary supplements.[88]

In the United States, manufacturers of dietary supplements are required to demonstrate safety of their products before approval is granted for commerce.[89] Despite this caution, numerous adverse effects have been reported,[72] including muscle cramps, hair loss, joint pain, liver disease, and allergic reactions, with 29% of the adverse effects resulting in hospitalization, and 20% in serious injuries or illnesses.[72] By more than five-fold, the highest incidence of health problems derived from "combination products", whereas supplements for vitamins and minerals, lipid products, and herbal products were less likely to cause adverse effects.[72]

Among general reasons for the possible harmful effects of dietary supplements are: a) absorption in a short time, b) manufacturing quality and contamination, and c) enhancing both positive and negative effects at the same time.[56] The incidence of liver injury from herbal and dietary supplements is about 1620% of all supplement products causing injury, with the occurrence growing globally over the early 21st century.[41] The most common liver injuries from weight loss and bodybuilding supplements involve hepatocellular damage with resulting jaundice, and the most common supplement ingredients attributed to these injuries are green tea catechins, anabolic steroids, and the herbal extract, aegeline.[41] Weight loss supplements have also had adverse psychiatric effects.[90]

Work done by scientists in the early 20th century on identifying individual nutrients in food and developing ways to manufacture them raised hopes that optimal health could be achieved and diseases prevented by adding them to food and providing people with dietary supplements; while there were successes in preventing vitamin deficiencies, and preventing conditions like neural tube defects by supplementation and food fortification with folic acid, no targeted supplementation or fortification strategies to prevent major diseases like cancer or cardiovascular diseases have proved successful.[91]

For example, while increased consumption of fruits and vegetables are related to decreases in mortality, cardiovascular diseases and cancers, supplementation with key factors found in fruits and vegetable, like antioxidants, vitamins, or minerals, do not help and some have been found to be harmful in some cases.[92][93] In general as of 2016, robust clinical data is lacking, that shows that any kind of dietary supplementation does more good than harm for people who are healthy and eating a reasonable diet but there is clear data showing that dietary pattern and lifestyle choices are associated with health outcomes.[94][95]

As a result of the lack of good data for supplementation and the strong data for dietary pattern, public health recommendations for healthy eating urge people to eat a plant-based diet of whole foods, minimizing processed food, salt and sugar and to get exercise daily, and to abandon Western pattern diets and a sedentary lifestyle.[96][97]:10

The regulation of food and dietary supplements by the U.S. Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act ("the Act") and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.

Substances which the FDA regulates as food are subdivided into various categories, including foods, food additives, added substances (man-made substances which are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. The specific standards which the FDA exercises differ from one category to the next. Furthermore, the FDA has been granted a variety of means by which it can address violations of the standards for a given category of substances.

Dietary supplement manufacture is required to comply with the good manufacturing practices established in 2007. The FDA can visit manufacturing facilities, send Warning Letters[85] if not in compliance with GMPs, stop production, and if there is a health risk, require that the company conduct a recall.[98]

The European Union's (EU) Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in dosages and in purity.[99] Only those supplements that have been proven to be safe may be sold in the EU without prescription. As a category of food, food supplements cannot be labeled with drug claims but can bear health claims and nutrition claims.[100]

The dietary supplements industry in the United Kingdom (UK), one of the 28 countries in the bloc, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and various doctors and scientists, had signed petitions by 2005 against what are viewed by the petitioners as unjustified restrictions of consumer choice.[101] In 2004, along with two British trade associations, the Alliance for Natural Health (ANH) had a legal challenge to the Food Supplements Directive[102] referred to the European Court of Justice by the High Court in London.[103]

Although the European Court of Justice's Advocate General subsequently said that the bloc's plan to tighten rules on the sale of vitamins and food supplements should be scrapped,[104] he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting public health. ANH, however, interpreted the ban as applying only to synthetically produced supplements, and not to vitamins and minerals normally found in or consumed as part of the diet.[105] Nevertheless, the European judges acknowledged the Advocate General's concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add the product to the list must be open to challenge in the courts.[106]

Examples of ongoing government research organizations to better understand the potential health properties and safety of dietary supplements are the European Food Safety Authority,[3] the Office of Dietary Supplements of the United States National Institutes of Health,[7][107] the Natural and Non-prescription Health Products Directorate of Canada,[108] and the Therapeutic Goods Administration of Australia.[109] Together with public and private research groups, these agencies construct databases on supplement properties, perform research on quality, safety, and population trends of supplement use, and evaluate the potential clinical efficacy of supplements for maintaining health or lowering disease risk.[107]

As continual research on the properties of supplements accumulates, databases or fact sheets for various supplements are updated regularly, including the Dietary Supplement Label Database,[5] Dietary Supplement Ingredient Database,[110] and Dietary Supplement Facts Sheets of the United States.[111] In Canada where a license is issued when a supplement product has been proven by the manufacturer and government to be safe, effective and of sufficient quality for its recommended use, an eight-digit Natural Product Number is assigned and recorded in a Licensed Natural Health Products Database.[112] The European Food Safety Authority maintains a compendium of botanical ingredients used in manufacturing of dietary supplements.[113]

In 2015, the Australian Government's Department of Health published the results of a review of herbal supplements to determine if any were suitable for coverage by health insurance.[114] Establishing guidelines to assess safety and efficacy of botanical supplement products, the European Medicines Agency provided criteria for evaluating and grading the quality of clinical research in preparing monographs about herbal supplements.[115] In the United States, the National Center for Complementary and Integrative Health of the National Institutes of Health provides fact sheets evaluating the safety, potential effectiveness and side effects of many botanical products.[116]

To assure supplements have sufficient quality, standardization, and safety for public consumption, research efforts have focused on development of reference materials for supplement manufacturing and monitoring.[117][113] High-dose products have received research attention,[107][118] especially for emergency situations such as vitamin A deficiency in malnutrition of children,[119] and for women taking folate supplements to reduce the risk of breast cancer.[120]

In the United States, the National Health and Nutrition Examination Survey (NHANES) has investigated habits of using dietary supplements in context of total nutrient intakes from the diet in adults and children.[107] Over the period of 1999 to 2012, use of multivitamins decreased, and there was wide variability in the use of individual supplements among subgroups by age, sex, race/ethnicity, and educational status.[121] Particular attention has been given to use of folate supplements by young women to reduce the risk of fetal neural tube defects.[122][123]

Research initiatives to improve knowledge of the possible health benefits of supplementing with essential nutrients to lower disease risk have been extensive. As examples, just in 2017 were reviews on

A 2017 review indicated a rising incidence of liver injury from use of herbal and dietary supplements, particularly those with steroids, green tea extract, or multiple ingredients.[128]

The potential benefit of using essential nutrient dietary supplements to lower the risk of diseases has been refuted by findings of no effect or weak evidence in numerous clinical reviews, such as for cardiovascular diseases,[127] cancer,[127] HIV,[129] or tuberculosis.[130]

A review of clinical trials registered at clinicaltrials.gov, which would include both drugs and supplements, reported that nearly half of completed trials were sponsored wholly or partially by industry.[131] This does not automatically imply bias, but there is evidence that because of selective non-reporting, results in support of a potential drug or supplement ingredient are more likely to be published than results that do not demonstrate a statistically significant benefit.[131][132] One review reported that fewer than half of the registered clinical trials resulted in publication in peer-reviewed journals.[133]

Improving public information about use of dietary supplements involves investments in professional training programs, further studies of population and nutrient needs, expanding the database information, enhancing collaborations between governments and universities, and translating dietary supplement research into useful information for consumers, health professionals, scientists, and policymakers.[134] Future demonstration of efficacy from use of dietary supplements requires high-quality clinical research using rigorously-qualified products and compliance with established guidelines for reporting of clinical trial results (e.g., CONSORT guidelines).[107]

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Dietary supplement - Wikipedia

Food Supplements Europe

Food Supplements Europe has been created to represent the interests of the European food supplement sector. Its membership includes national associations and companies committed to ensuring that future EU legislation and policy reflects the important role that this sector plays in the health of consumers.

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Food Supplements Europe

Publications and Guidelines | Food Supplements Europe

The aim of this document is to produce guidelines which address the specific needs of the food supplement industry in relation to good manufacturing practice, with special attention paid to the requirements of EU food legislation. It covers the complete cycle of production and quality control of a food supplement, from the acquisition of all materials through all stages of subsequent processing, packaging and storage to the distribution or release of the finished product. As such, relevant sections of the document apply also to food supplement companies whose products are contract manufactured and also to those who aresolelydistributors of products.

Download the publication

A questionnaire is also available to assist companies with assessing their current GMP status and to highlight any areas where further efforts to raise the GMP standard may be required. If no external GMP assessment is undertaken, annual self-assessment of GMP is recommended, as a minimum.

Download the self-assessment questionnaire PDF

Read more:

Publications and Guidelines | Food Supplements Europe

Food Supplements Europe

Food Supplements Europe has been created to represent the interests of the European food supplement sector. Its membership includes national associations and companies committed to ensuring that future EU legislation and policy reflects the important role that this sector plays in the health of consumers.

Read more:

Food Supplements Europe

Publications and Guidelines | Food Supplements Europe

The aim of this document is to produce guidelines which address the specific needs of the food supplement industry in relation to good manufacturing practice, with special attention paid to the requirements of EU food legislation. It covers the complete cycle of production and quality control of a food supplement, from the acquisition of all materials through all stages of subsequent processing, packaging and storage to the distribution or release of the finished product. As such, relevant sections of the document apply also to food supplement companies whose products are contract manufactured and also to those who aresolelydistributors of products.

Download the publication

A questionnaire is also available to assist companies with assessing their current GMP status and to highlight any areas where further efforts to raise the GMP standard may be required. If no external GMP assessment is undertaken, annual self-assessment of GMP is recommended, as a minimum.

Download the self-assessment questionnaire PDF

Excerpt from:

Publications and Guidelines | Food Supplements Europe

Whole Food vs. Synthetic Supplements | Melissa Wood, ND

Ive already discussed the importance of taking natural supplements to support your body and immune system. But which supplements do you take, and how do you know which supplements are the best ones? Americans spend billions of dollars every year on supplements, and its very important to understand that not all supplements are created equal. Sometimes, there are vast differences between products.

So lets talk about the difference between whole food supplements and synthetic supplements a.k.a. isolated or fractionated supplements.

A great example would be just to simply look at almost any multivitamin. When you scan the nutritional content fact and ingredientlabel, youll see quite an assortment of vitamins (Vitamin A, Vitamin C, Vitamin E, etc.).Here is a portion of a label for a common multivitamin:

There are a lot more vitamins listed on this label than I had room for, but I think you get the idea. Look at the items listed under Ingredients.Those are what we call Isolated vitamins and other chemicals.There are no foods or herbal ingredients listed, only partial vitamins and other chemicals.

Nature intended for us to consume food in its WHOLE form because all the vitamins, minerals, antioxidants and enzymes are bound together in one package and work synergistically to deliver the nutrition your body needs.

Synthetic supplements give you isolated or fractionated pieces of the whole. It is simply not the same youre not getting the full benefit nature intended. The other problem is, by taking isolated vitamins, sometimes we are getting massive doses of some vitamins, but not enough of others.This imbalance this can cause health problems too. Arent we trying to get healthier rather than cause more problems?

Whole-Food based supplements are different, as those will, typically, list the foods the supplement was made from. What follows is a partial example of what to look for when searching for a Whole-Food based product.Notice that under the supplemental facts, you still see all the vitamins listed, but theres a huge difference in the ingredients.

What a difference this second product will make in your body vs. the first product!Youll actually be gaining benefits from the WHOLE food and all of the vitamins, minerals, antioxidants and enzymes that occur naturally in the food or plant.

Another way that might make sense is to look at the source.When Vitamin C is listed on a multivitamin label, look for any natural sources, like citrus fruits, papaya or bell peppers.If you see a listing for Ascorbic Acid, that means it is an Isolated product, so you must keep searching for ones that list whole foods.

In summary, be sure you read your labels!It is important to educate yourself about what youll be putting into your body and supplements are no different than anything else.

Its important to read food labels so you know what youre eating. But its just as important, if not moreso, to be sure youre reading all of your supplement labels too!You want to be consuming supplements that have actual whole foods, plants or herbs listed on the label. That way you know it is as close to natural as possible!

And lastly,understand that no supplement alone will help you achieve the level of health you desire. You will have to make lifestyle and behavior changes as well as taking supplements to achieve ultimate health.

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Whole Food vs. Synthetic Supplements | Melissa Wood, ND

Food fortification – Wikipedia

Food fortification or enrichment is the process of adding micronutrients (essential trace elements and vitamins) to food. Sometimes it's a purely commercial choice to provide extra nutrients in a food, while other times it is a public health policy which aims to reduce the number of people with dietary deficiencies within a population. Staple foods of a region can lack particular nutrients due to the soil of the region or from inherent inadequacy of a normal diet. Addition of micronutrients to staples and condiments can prevent large-scale deficiency diseases in these cases.[1]

As defined by the World Health Organization (WHO) and the Food and Agricultural Organization of the United Nations (FAO), fortification refers to "the practice of deliberately increasing the content of an essential micronutrient, ie. vitamins and minerals (including trace elements) in a food irrespective of whether the nutrients were originally in the food before processing or not, so as to improve the nutritional quality of the food supply and to provide a public health benefit with minimal risk to health", whereas enrichment is defined as "synonymous with fortification and refers to the addition of micronutrients to a food which are lost during processing".[2]

Food fortification was identified as the second strategy of four by the WHO and FAO to begin decreasing the incidence of nutrient deficiencies at the global level.[2] As outlined by the FAO, the most common fortified foods are cereals (and cereal based products), milk (and milk products), fats and oils, accessory food items, tea and other beverages, and infant formulas.[3] Undernutrition and nutrient deficiency is estimated globally to cause between 3 and 5 million deaths per year.[1]

Main methods of food fortification:

The WHO and FAO, among many other nationally recognized organizations, have recognized that there are over 2 billion people worldwide who suffer from a variety of micronutrient deficiencies. In 1992, 159 countries pledged at the FAO/WHO International Conference on Nutrition to make efforts to help combat these issues of micronutrient deficiencies, highlighting the importance of decreasing the number of those with iodine, vitamin A, and iron deficiencies.[2] A significant statistic that led to these efforts was the discovery that approximately 1 in 3 people worldwide were at risk for either an iodine, vitamin A, or iron deficiency.[5] Although it is recognized that food fortification alone will not combat this deficiency, it is a step towards reducing the prevalence of these deficiencies and their associated health conditions.[6]

In Canada, the Food and Drug Regulations have outlined specific criterion which justifies food fortification:

There are also several advantages to approaching nutrient deficiencies among populations via food fortification as opposed to other methods. These may include, but are not limited to: treating a population without specific dietary interventions therefore not requiring a change in dietary patterns, continuous delivery of the nutrient, does not require individual compliance, and potential to maintain nutrient stores more efficiently if consumed on a regular basis.[4]

Several organizations such as the WHO, FAO, Health Canada, and Nestl Research acknowledge that there are limitations to food fortification. Within the discussion of nutrient deficiencies the topic of nutrient toxicities can also be immediately questioned. Fortification of nutrients in foods may deliver toxic amounts of nutrients to an individual and also cause its associated side effects. As seen with the case of excessive fluoride intakes below, the result can be irreversible staining to the teeth. Although this may be a minor toxic effect to health, there are several that are more severe.[8]

The WHO states that limitations to food fortification may include: human rights issues indicating that consumers have the right to choose if they want fortified products or not, the potential for insufficient demand of the fortified product, increased production costs leading to increased retail costs, the potential that the fortified products will still not be a solution to nutrient deficiencies amongst low income populations who may not be able to afford the new product, and children who may not be able to consume adequate amounts thereof.[2]

Food safety worries led to legislation in Denmark in 2004 restricting foods fortified with extra vitamins or minerals. Products banned include: Rice Crispies, Shreddies, Horlicks, Ovaltine and Marmite.[9]

One factor that limits the benefits of food fortification is that isolated nutrients added back into a processed food that has had many of its nutrients removed, does not always result in the added nutrients being as bioavailable as they would be in the original, whole food. An example is skim milk that has had the fat removed, and then had vitamin A and vitamin D added back. Vitamins A and D are both fat-soluble and non-water-soluble, so a person consuming skim milk in the absence of fats may not be able to absorb as much of these vitamins as one would be able to absorb from drinking whole milk. On the other hand, the nutrient added as a fortificant may have a higher bioavailability than from foods, which is the case with folic acid used to increase folate intakes.[10]

Phytochemicals such as phytic acid in cereal grains can also impact nutrient absorption, limiting the bioavailability of intrinsic and additional nutrients, and reducing the effectiveness of fortification programs.

Ecological studies have shown that increased B vitamin fortification is correlated with the prevalence of obesity and diabetes.[11] Daily consumption of iron per capita in the United States has dramatically surged since World War II and nearly doubled over the past century due to increases in iron fortification and increased consumption of meat.[12] Existing evidence suggests that excess iron intake may play a role in the development of obesity, cardiovascular disease, diabetes and cancer.[13]

Fortification of foods with folic acid has been mandated in many countries solely to improve the folate status of pregnant women to prevent neural tube defectsa birth defect which affected 0.5% (1 out of 200) US births before fortification began.[14][15] However, when fortification is introduced, several hundred thousand people are exposed to an increased intake of folic acid for each neural tube defect pregnancy that is prevented.[16] In humans, increased folic acid intake leads to elevated blood concentrations of naturally occurring folates and of unmetabolized folic acid. High blood concentrations of folic acid may decrease natural killer cell cytotoxicity, and high folate status may reduce the response to drugs used to treat malaria, rheumatoid arthritis, psoriasis, and cancer.[16] A combination of high folate levels and low vitamin B-12 status may be associated with an increased risk of cognitive impairment and anemia in the elderly and, in pregnant women, with an increased risk of insulin resistance and obesity in their children.[16] Folate has a dual effect on cancer, protecting against cancer initiation but facilitating progression and growth of preneoplastic cells and subclinical cancers.[16] Furthermore, intake of folic acid from fortification have turned out to be significantly greater than originally modeled in pre mandate predictions.[17] Therefore, a high folic acid intake due to fortification may be harmful for more people than the policy is designed to help.[15][16][18][19]

There is a concern that micronutrients are legally defined in such a way that does not distinguish between different forms, and that fortified foods often have nutrients in a balance that would not occur naturally. For example, in the U.S., food is fortified with folic acid, which is one of the many naturally-occurring forms of folate, and which only contributes a minor amount to the folates occurring in natural foods.[20] In many cases, such as with folate, it is an open question of whether or not there are any benefits or risks to consuming folic acid in this form.

In many cases, the micronutrients added to foods in fortification are synthetic.

In some cases, certain forms of micronutrients can be actively toxic in a sufficiently high dose, even if other forms are safe at the same or much higher doses. There are examples of such toxicity in both synthetic and naturally-occurring forms of vitamins. Retinol, the active form of Vitamin A, is toxic in a much lower dose than other forms, such as beta carotene. Menadione, a phased-out synthetic form of Vitamin K, is also known to be toxic.

There are several main groups of food supplements like:

Many foods and beverages worldwide have been fortified, whether a voluntary action by the product developers or by law. Although some may view these additions as strategic marketing schemes to sell their product, there is a lot of work that must go into a product before simply fortifying it. In order to fortify a product, it must first be proven that the addition of this vitamin or mineral is beneficial to health, safe, and an effective method of delivery. The addition must also abide by all food and labeling regulations and support nutritional rationale. From a food developer's point of view, they also need to consider the costs associated with this new product and whether or not there will be a market to support the change.[21]

Examples of foods and beverages that have been fortified and shown to have positive health effects:

"Iodine deficiency disorder (IDD) is the single greatest cause of preventable mental retardation. Severe deficiencies cause cretinism, stillbirth and miscarriage. But even mild deficiency can significantly affect the learning ability of populations. [] Today over 1 billion people in the world suffer from iodine deficiency, and 38 million babies born every year are not protected from brain damage due to IDD."Kul Gautam, Deputy Executive Director, UNICEF, October 2007[22]

Iodised salt has been used in the United States since before World War II. It was discovered in 1821 that goiters could be treated by the use of iodized salts. However, it was not until 1916 that the use of iodized salts could be tested in a research trial as a preventative measure against goiters. By 1924, it became readily available in the US.[23] Currently in Canada and the US, the RDA for iodine is as low as 90g/day for children (48 years) and as high as 290g/day for breast-feeding mothers.

Diseases that are associated with an iodine deficiency include: mental retardation, hypothyroidism, and goiter. There is also a risk of various other growth and developmental abnormalities.

Folic acid (also known as folate) functions in reducing blood homocysteine levels, forming red blood cells, proper growth and division of cells, and preventing neural tube defects (NTDs).[24] In many industrialized countries, the addition of folic acid to flour has prevented a significant number of NTDs in infants. Two common types of NTDs, spina bifida and anencephaly, affect approximately 2500-3000 infants born in the US annually. Research trials have shown the ability to reduce the incidence of NTDs by supplementing pregnant mothers with folic acid by 72%.[25]

The RDA for folic acid ranges from as low as 150g/day for children aged 13 years old, to 400g/day for males and females over the age of 19, and 600g/day during pregnancy.[26] Diseases associated with folic acid deficiency include: megaloblastic or macrocytic anemia, cardiovascular disease, certain types of cancer, and NTDs in infants.

Niacin has been added to bread in the USA since 1938 (when voluntary addition started), a programme which substantially reduced the incidence of pellagra.[27] As early as 1755, pellagra was recognized by doctors as being a niacin deficiency disease. Although not officially receiving its name of pellagra until 1771.[28] Pellagra was seen amongst poor families who used corn as their main dietary staple. Although corn itself does contain niacin, it is not a bioavailable form unless it undergoes nixtamalization (treatment with alkali, traditional in Native American cultures) and therefore was not contributing to the overall intake of niacin.

The RDA for niacin is 2mg NE(niacin equivalents)/day (AI) for infants aged 06 months, 16mg NE/day for males, and 14mg NE/day for females who are over the age of 19.

Diseases associated with niacin deficiency include: Pellagra which consisted of signs and symptoms called the 3D's-"Dermatitis, dementia, and diarrhea. Others may include vascular or gastrointestinal diseases.[28] Common diseases which present a high frequency of niacin deficiency: alcoholism, anorexia nervosa, HIV infection, gastrectomy, malabsorptive disorders, certain cancers and their associated treatments.[28]

Since Vitamin D is a fat-soluble vitamin, it cannot be added to a wide variety of foods. Foods that it is commonly added to are margarine, vegetable oils and dairy products.[29] During the late 1800s, after the discovery of curing conditions of scurvy and beriberi had occurred, researchers were aiming to see if the disease, later known as rickets, could also be cured by food. Their results showed that sunlight exposure and cod liver oil were the cure. It was not until the 1930s that vitamin D was actually linked to curing rickets.[30] This discovery led to the fortification of common foods such as milk, margarine, and breakfast cereals. This took the astonishing statistics of approximately 8090% of children showing varying degrees of bone deformations due to vitamin D deficiency to being a very rare condition.[31]

The current RDA for infants aged 06 months is 10g (400 International Units (IU))/day and for adults over 19 years of age it is 15g (600 IU)/day.

Diseases associated with a vitamin D deficiency include rickets, osteoporosis, and certain types of cancer (breast, prostate, colon and ovaries). It has also been associated with increased risks for fractures, heart disease, type 2 diabetes, autoimmune and infectious diseases, asthma and other wheezing disorders, myocardial infarction, hypertension, congestive heart failure, and peripheral vascular disease.[31]

Although fluoride is not considered an essential mineral, it is useful in prevention of tooth decay and maintaining adequate dental health.[32][33] In the mid-1900s it was discovered that towns with a high level of fluoride in their water supply was causing the residents' teeth to have both brown spotting and a strange resistance to dental caries. This led to the fortification of water supplies with fluoride in safe amounts (or reduction of naturally-occurring levels) to retain the properties of resistance to dental caries but avoid the staining cause by fluorosis (a condition caused by excessive fluoride intake).[34]The tolerable upper intake level (UL) set for fluoride ranges from 0.7mg/day for infants aged 06 months and 10mg/day for adults over the age of 19.

Conditions commonly associated with fluoride deficiency are dental caries and osteoporosis.

Some other examples of fortified foods:

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Food fortification - Wikipedia


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