Category Archives: Food Supplements

It is a shame that we even have to write about this subject, but it seems that we aging amateurs are frequently targets of scam artists. I am especially interested in health scams, but there are plenty of other types out there, too.

It turns out that there are probably several reasons that those of us who are experienced taxpayers are more likely to be taken in.

A study several years ago led by UCLA psychologist Shelley Taylor found that older individuals were less likely to recognize untrustworthy facial cues than younger adults (a smile in the mouth, but not in the eye, an averted gaze or a backward lean). In a follow-up study using brain imaging, Taylor found that older adults appear to have less activity in the area of the brain that processes risk and subtle danger. She hypothesizes that this may be part of an effort to make life more positive (those rose-colored glasses) as we age.

Whatever the reason (or reasons) that make us more likely to fall for them, we are exposed to scams on a daily basis, whether we read magazines, newspapers, junk mail," surf the web or watch most television channels.

What are the most common health scams?

Treatments for diseases that are difficult or very complicated to take care of or require significant lifestyle changes for successful management like many cancers, diabetes or obesity. These scams are potentially dangerous and may cause harmful delays in getting proper diagnosis and appropriate therapy.

Treatments for illnesses that we lack highly effective medications or other interventions for like dementia or aging itself. In addition to potentially delaying diagnosis of treatable or reversible causes of decreased mental acuity or illnesses that may mimic standard aging, costs for many treatments are substantial.

Treatments for diseases that wax and wane in severity for reasons that are often difficult to understand or predict such as multiple sclerosis, many forms of arthritis and even low back pain. Since the symptoms come and go, treatments like magnets, copper bracelets, special diets, dietary supplements and electronic devices may appear to work, and many people spend many dollars with very limited benefits.

Dietary supplements are an element in all of the health scams listed above. While they are intended to ensure that a person gets enough essential nutrients, they are often promoted to do much more than this.

They are not regulated as drugs and may not claim to diagnose, treat, prevent or cure diseases (except the appropriate use of vitamins folic acid, for example, prevents neural tube defects when given to pregnant women).

The Food and Drug Administration (FDA) does not have the authority to review dietary supplement products for safety or effectiveness before they are marketed. So it is buyer beware when using these products.

Why are supplements potentially risky products? Many supplements contain ingredients that have biological effects in the body that could lead to harmful consequences: when several supplements are combined, when supplements and prescription medications are used together, when supplements are used instead of prescription medications, or when supplements are used in larger doses than recommended.

So, if you take dietary supplements, use them as directed and be sure that your health care provider knows what products you are using and how much. It will be helpful to bring your supplements with you to your appointments.

The FDA has a list of Tip-Offs to Rip-Offs

1. Be suspicious of these red flag claims and others like them: quick fix," all natural, miracle cure," one product does it all," scientific breakthrough," new discovery," what your doctor doesnt want you to know," secret ingredient," shrinks tumors," lowers blood sugar," or lose weight without diet or exercise.

2. Be wary of personal testimonials by real people or doctors claiming amazing results. Testimonials are not a substitute for scientific proof.

3. Be careful. If a product claims to cure a wide range of unrelated diseases, its probably a scam.

Scams are out there, dont let yourself or your family members fall victim to one of them.

Bert Keller and Bill Simpson write the occasional column, Aging for Amateurs. Simpson, a retired physician, wrote this installment. Comments, questions and suggestions are welcome atagingforamateurs@gmail.com.

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Aging for Amateurs: Too good to be true? Health scams are out there - Charleston Post Courier

Jacque Martin

Editors Note: This is the second in a series of articles regarding the use of supplements in high school football programs.

The FDA exists to protect the public health by regulating human/animal drugs and biologics, medical devices, tobacco products, food, cosmetics, and electronic products that emit radiation. FDA enforcement usually occurs after a product is already on the market and safety issues become apparent. The FDA doesnt review the effectiveness or safety of dietary supplements unless a supplement may contain a new ingredient not marketed in the United States. A notification must be filed with the FDA 75 days prior to the marketing of the ingredient and include information that the manufacturer or distributor of the new ingredient is reasonably safe. If safety issues occur with the new ingredient, then the FDA evaluates product safety through research and adverse event monitoring. FDA regulations require that food labels be present on most foods, including dietary supplements. Any claims on food products are required to be truthful and not misleading. Manufacturers must list the serving size and the nutrients contained in each serving in the Nutrition Panel or the Supplement Facts for dietary supplements. Nor does the FDA approve structure-function claims on dietary supplements and other foods. An example of a structure-function claim is the statement, Protein builds muscle mass. Dietary supplements must provide a disclaimer regarding structure-function claims that the claim hasnt been reviewed by the FDA. The product label must also state that the product isnt intended to diagnose, treat, cure, or prevent any disease. The Arkansas School Board Association (ASBA) provides updated school policies that are generated from educational laws passed by the Arkansas General Assembly after every legislative session so that policies are consistent across the state. School districts are required by law to electronically post all school district policies and student handbooks or to make them available in a hard copy format. Heber Springs School District Policy 4.35 Student Medications states, Unless authorized to self-administer, students are not allowed to carry any medications including over-the-counter medications or any perceived health remedy not regulated by the US Food and Drug Administration while at school. This statement occurs on page 54 of the student handbook. Last December a girls volleyball coach, Deborah Clark, resigned her position from the Westside Consolidated School District when she learned that Superintendent Scott Guantt recommended termination because she sent a group text to volleyball players instructing them to mix C4 in a water bottle and consume it before the game without the knowledge of the head coach or consent from the parents. C4 contains caffeine. The documents that the Bryant News obtained from the school district state that some of the players felt shaky, unwell, and jittery and even reported their vision was effected by the drink not to mention crashing as the caffeine wore off. C4 is banned by the National Federation of State High Schools Association (NFHS) and the Arkansas Athletics Association (AAA). According to a DHS investigative report provided to The Sun Times, Dusty Combs admitted to providing a non-FDA regulated product, BCAA EnergyTM, to a student. Like C4, BCAA EnergyTM contains caffeine, a substance banned not only by the NFSHSA and AAA, but also by the NCAA and the NFL. Coach Combs was recommended by Superintendent Alan Stauffacher for promotion to Junior High Head Football Coach and Senior Assistant Football Coach. The School Board approved the promotion 4 to 1 with the one opposing vote coming from Judy Crowder. All members of the school board knew that DHS was investigating the allegations against Combs. In the same DHS report, the investigator wrote, Brad Reese stated that the coaches were selling the supplementsIt would appear that the school is providing work out supplements without consent of the childrens parents based on these statements. Calls were placed and messages left for Brad Reese and Dusty Combs requesting interviews and to give them an opportunity to explain the school district football program. There was no return phone call from either as of the publishing of this article. The Arkansas Athletics Association website links to the NFHS position statement on dietary supplements, which states, The NFHS SMAC strongly opposes the use of supplements by high school athletes for performance enhancement, due to the lack of published, reproducible scientific research documenting the benefits of their use and confirming no potential long-term adverse health effects with their use, particularly in the adolescent age groupIn order to discourage dietary supplement use for athletic performance: school personnel, coaches, and parents should allow for open discussion about dietary supplement use, and strongly encourage obtaining optimal nutrition through a well-balanced diet; remind athletes that no supplement is harmless or free from consequences and that there are no short cuts to improve athletic performance; and, because they are not strictly regulated, dietary supplements may contain impurities and banned substances not listed on the label. The NCAA Nutritional/Dietary Supplements Warning states: Before consuming any nutritional/dietary supplement product, review the product with the appropriate or designated athletics department staff! Dietary supplements, including vitamins and minerals, are not well regulated and may cause a positive drug test result. Student-athletes have tested positive and lost their eligibility using dietary supplements. Many dietary supplements are contaminated with banned drugs not listed on the label. Any product containing a dietary supplement ingredient is taken at your own risk [in bold]. The NFL Policy on Performance-Enhancing Substances, Appendix D, Use of Supplements, states: Over the past several years, we have made a special effort to educate and warn Players about the risks involved in the use of nutritional supplements. Despite these efforts, several Players have been suspended though their positive test result may have been due to the use of a supplementAs the Policy clearly warns, supplements are not regulated or monitored by the government. This means that, even if they are bought over-the-counter from a known establishment, there is currently no way to be sure that they: (a) contain the ingredients listed on the packaging; (b) have not been tainted with prohibited substances; or (c) have the properties or effects claimed by the manufacturer or salesperson.For your own health and success in the League, we strongly encourage you to avoid the use of supplements altogether, or at the very least to be extremely careful about what you choose to take. States are beginning to regulate and ban performance enhancing drugs and supplements in the public-school systems as well. Michigan was the first to initiate this legislation in 1999 when Act 187 prohibited public school employees and volunteers from promoting or supplying dietary supplements which carry claims of enhanced athletic performance. In October 2005, then Governor Arnold Schwarzenegger signed into law SB37, which required any person interested in competing in high school sports to sign a pledge that they would not use performance enhancing supplements. It also banned any supplement manufacturer from sponsoring any school events. The bill established the high school coach education and training program as well as prohibiting the marketing, sale and distribution of prohibited dietary substances. Michigan passed Act 216 in 2006 in which the law requires all public school districts and academies to include in their local codes of conduct that possession or use of any National Collegiate Athletic Association banned drug is not permitted. Any student found with banned substances suffer the same penalties established by Michigan school districts for the possession/use of tobacco, alcoholic beverages and illegal drugs. In July 2007, Governor Rick Perry of Texas signed into law a bill that required random steroid testing of public school athletes. Any athlete who tested positive for anabolic steroids could be suspended and permanently banned from participating in athletics. Besides Texas, New Jersey and Florida also mandate steroid testing. Eight other states have passed laws for testing, but didnt mandate it, and seventeen other states have testing policies at the state or local level. There is no law in Arkansas mandating anabolic steroid testing. As the NCAA and the NFL performance enhancing policies have warned, dietary supplements may be contaminated with banned substances, putting athletes health and sports eligibility at risk.

Read more:

Laws and Policies Governing Performance Enhancing Supplements - Paris Express

With the excess amounts of information available to us now via the internet and a variety of other sources, there is a deluge of news regarding supplements. Any given day a new story can be published regarding supplements that leads to questions. These questions may be about whether supplements are beneficial or harmful, which ones are most effective or not effective at all, and whether or not they should even be ingested. Here are a few ways to help determine whether or not what is published is legitimate.

Sources The source of the information can be vital in determining if the information you are acquiring is legitimate or not. Gathering information from an unbiased source that isnt directly involved with the sales of a product or wouldnt benefit from an article whether it is positive or negative is ideal. When searching for supplements on the internet, use noncommercial sites (e.g. NIH, FDA, USDA) rather than depending on information from sellers, advises the U.S. Food and Drug Administration (FDA) (1). These sites, especially those based in science, will typically offer cold hard facts that can be utilized as a starting point towards your research into supplement news.

However, many of us will have our go-to publications and news sources that we rely on. These often distill scientific information in easily digestible ways that help us draw conclusions more easily. Big news sources such as newspapers and magazines have fact-checkers that verify information or will cite their sources. Citations are helpful because they allow you to explore another source of information. They are particularly important when coming across a website that is unfamiliar. Checking these sources can be the litmus test for how reliable the information is. Students may remember being told time and again by teachers not to trust Wikipedia, for example, because the sources may be unreliable. Be sure to check multiple sources for confirmation of information you have obtained.

As with many industries, those working in it perceive a bias against it, particularly from mainstream media outlets because they typically focus on reporting negative topics such as recalls and clinical trials that may contradict established information. Skeptics of dietary supplements may view these reports as proof while believers view them as an aberration. Indeed, not all studies are well designed and industry advocates will say so, easing the concerns of dietary supplement users.

We dont encourage anyone to validate only their personal world view, but to try to get both sides of the story and decide for themselves. For example, a few years ago, when negative press came out questioning fish oils effectiveness for supporting heart health, it caused a decline in sales and anxiety in the industry. However, in science, one study cannot refute an abundant amount of research.

Noncommercial sites that are primarily informational are ideal, though sites for specific product manufacturers can sometimes provide helpful information. It should however, be taken with a grain of salt and more due diligence should be conducted from outside sources. This is particularly true if one manufacturer is disparaging anothers product.

Claims Be wary of products making generous claims. If claims sound too good to be true, they probably are. Be mindful of product claims such as works better than [a prescription drug], totally safe, or has no side effects, advises FDA (1). Supplements do not require the same level of scrutiny as drugs, so FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed, unless it is a new dietary ingredient. However, this means that supplement manufacturers cannot make disease claims that over-the-counter and prescription drugs are authorized to make.

Unlike drugs, which must be approved by the FDA before they can be marketed, dietary supplements do not require premarket review or approval by the FDA. While the supplement company is responsible for having evidence that their products are safe and that label claims are truthful and not misleading, they do not have to provide that evidence to the FDA before the product is marketed, explains the National Institutes of Health (2).

Knowing the manufacturer of the supplement and their history can be helpful in this regard. Enforcement actions are made public by FDA and can be easily found on their sites. Most dietary supplement manufacturers and suppliers follow the letter of the law closely, but some go too far, either pushing the envelope with the claims theyre allowed to make or even marketing products with dangerous and illegal ingredients. The latter is particularly important to watch because their irresponsibility can harm consumers and unfortunately reflects negatively on the industry as a whole. It is important to keep in mind that on the whole, dietary supplement companies manufacture and sell products responsibly.

Varying conflicting reports about supplements can make being informed difficult. Knowing the correct way to verify information found concerning supplements is important in weighing decisions regarding the validity of news being reported about them. Regardless of facts and opinions involving supplement information, one fact remains the same, supplements are not there to cure or treat disease, and with any changes to diet, always check with a physician before starting a dietary supplement regimen. This is particularly important if one takes prescription drugs, in order to avoid interactions (3). WF

References

Published in WholeFoods Magazine August 2017

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Interpreting Supplement News | Whole Foods Magazine - WholeFoods Magazine

Jacque Martin

Editors Note: This is the second in a series of articles regarding the use of supplements in high school football programs.

The FDA exists to protect the public health by regulating human/animal drugs and biologics, medical devices, tobacco products, food, cosmetics, and electronic products that emit radiation. FDA enforcement usually occurs after a product is already on the market and safety issues become apparent. The FDA doesnt review the effectiveness or safety of dietary supplements unless a supplement may contain a new ingredient not marketed in the United States. A notification must be filed with the FDA 75 days prior to the marketing of the ingredient and include information that the manufacturer or distributor of the new ingredient is reasonably safe. If safety issues occur with the new ingredient, then the FDA evaluates product safety through research and adverse event monitoring. FDA regulations require that food labels be present on most foods, including dietary supplements. Any claims on food products are required to be truthful and not misleading. Manufacturers must list the serving size and the nutrients contained in each serving in the Nutrition Panel or the Supplement Facts for dietary supplements. Nor does the FDA approve structure-function claims on dietary supplements and other foods. An example of a structure-function claim is the statement, Protein builds muscle mass. Dietary supplements must provide a disclaimer regarding structure-function claims that the claim hasnt been reviewed by the FDA. The product label must also state that the product isnt intended to diagnose, treat, cure, or prevent any disease. The Arkansas School Board Association (ASBA) provides updated school policies that are generated from educational laws passed by the Arkansas General Assembly after every legislative session so that policies are consistent across the state. School districts are required by law to electronically post all school district policies and student handbooks or to make them available in a hard copy format. Heber Springs School District Policy 4.35 Student Medications states, Unless authorized to self-administer, students are not allowed to carry any medications including over-the-counter medications or any perceived health remedy not regulated by the US Food and Drug Administration while at school. This statement occurs on page 54 of the student handbook. Last December a girls volleyball coach, Deborah Clark, resigned her position from the Westside Consolidated School District when she learned that Superintendent Scott Guantt recommended termination because she sent a group text to volleyball players instructing them to mix C4 in a water bottle and consume it before the game without the knowledge of the head coach or consent from the parents. C4 contains caffeine. The documents that the Bryant News obtained from the school district state that some of the players felt shaky, unwell, and jittery and even reported their vision was effected by the drink not to mention crashing as the caffeine wore off. C4 is banned by the National Federation of State High Schools Association (NFHS) and the Arkansas Athletics Association (AAA). According to a DHS investigative report provided to The Sun Times, Dusty Combs admitted to providing a non-FDA regulated product, BCAA EnergyTM, to a student. Like C4, BCAA EnergyTM contains caffeine, a substance banned not only by the NFSHSA and AAA, but also by the NCAA and the NFL. Coach Combs was recommended by Superintendent Alan Stauffacher for promotion to Junior High Head Football Coach and Senior Assistant Football Coach. The School Board approved the promotion 4 to 1 with the one opposing vote coming from Judy Crowder. All members of the school board knew that DHS was investigating the allegations against Combs. In the same DHS report, the investigator wrote, Brad Reese stated that the coaches were selling the supplementsIt would appear that the school is providing work out supplements without consent of the childrens parents based on these statements. Calls were placed and messages left for Brad Reese and Dusty Combs requesting interviews and to give them an opportunity to explain the school district football program. There was no return phone call from either as of the publishing of this article. The Arkansas Athletics Association website links to the NFHS position statement on dietary supplements, which states, The NFHS SMAC strongly opposes the use of supplements by high school athletes for performance enhancement, due to the lack of published, reproducible scientific research documenting the benefits of their use and confirming no potential long-term adverse health effects with their use, particularly in the adolescent age groupIn order to discourage dietary supplement use for athletic performance: school personnel, coaches, and parents should allow for open discussion about dietary supplement use, and strongly encourage obtaining optimal nutrition through a well-balanced diet; remind athletes that no supplement is harmless or free from consequences and that there are no short cuts to improve athletic performance; and, because they are not strictly regulated, dietary supplements may contain impurities and banned substances not listed on the label. The NCAA Nutritional/Dietary Supplements Warning states: Before consuming any nutritional/dietary supplement product, review the product with the appropriate or designated athletics department staff! Dietary supplements, including vitamins and minerals, are not well regulated and may cause a positive drug test result. Student-athletes have tested positive and lost their eligibility using dietary supplements. Many dietary supplements are contaminated with banned drugs not listed on the label. Any product containing a dietary supplement ingredient is taken at your own risk [in bold]. The NFL Policy on Performance-Enhancing Substances, Appendix D, Use of Supplements, states: Over the past several years, we have made a special effort to educate and warn Players about the risks involved in the use of nutritional supplements. Despite these efforts, several Players have been suspended though their positive test result may have been due to the use of a supplementAs the Policy clearly warns, supplements are not regulated or monitored by the government. This means that, even if they are bought over-the-counter from a known establishment, there is currently no way to be sure that they: (a) contain the ingredients listed on the packaging; (b) have not been tainted with prohibited substances; or (c) have the properties or effects claimed by the manufacturer or salesperson.For your own health and success in the League, we strongly encourage you to avoid the use of supplements altogether, or at the very least to be extremely careful about what you choose to take. States are beginning to regulate and ban performance enhancing drugs and supplements in the public-school systems as well. Michigan was the first to initiate this legislation in 1999 when Act 187 prohibited public school employees and volunteers from promoting or supplying dietary supplements which carry claims of enhanced athletic performance. In October 2005, then Governor Arnold Schwarzenegger signed into law SB37, which required any person interested in competing in high school sports to sign a pledge that they would not use performance enhancing supplements. It also banned any supplement manufacturer from sponsoring any school events. The bill established the high school coach education and training program as well as prohibiting the marketing, sale and distribution of prohibited dietary substances. Michigan passed Act 216 in 2006 in which the law requires all public school districts and academies to include in their local codes of conduct that possession or use of any National Collegiate Athletic Association banned drug is not permitted. Any student found with banned substances suffer the same penalties established by Michigan school districts for the possession/use of tobacco, alcoholic beverages and illegal drugs. In July 2007, Governor Rick Perry of Texas signed into law a bill that required random steroid testing of public school athletes. Any athlete who tested positive for anabolic steroids could be suspended and permanently banned from participating in athletics. Besides Texas, New Jersey and Florida also mandate steroid testing. Eight other states have passed laws for testing, but didnt mandate it, and seventeen other states have testing policies at the state or local level. There is no law in Arkansas mandating anabolic steroid testing. As the NCAA and the NFL performance enhancing policies have warned, dietary supplements may be contaminated with banned substances, putting athletes health and sports eligibility at risk.

See more here:

Laws and Policies Governing Performance Enhancing Supplements ... - Charleston Express

As FDA seeks to move forward on its draft guidance for new dietary ingredients (NDIs), one expert reports that the agency could reach out as soon as this fall to encourage further dialogue with the dietary supplements industry on a number of key issues related to the draft guidance. The last public move the agency made on the NDI draft guidance was officially closing the comment period last December on its August 2016 version of the draft guidance. Attorney Scott Bass, who helped draft the Dietary Supplement Health and Education Act of 1994 (DSHEA), says that the most important issue industry needs to get addressed relates to FDAs interpretation of the term dietary substance within the draft guidance. According to Bass, the agencys misinterpretation that dietary substances must be nutritional substances is incorrectly causing the agency to exclude non-nutritional ingredients, such as synthetic botanicals and probiotics, from its definition of a dietary ingredientand potentially putting those ingredients out of the running for use in dietary supplements.

In an interview this week with Nutritional Outlook, Bass, a partner at law firm Sidley Austin LLP, reiterated concerns that he had expressed in public comments that he had helped draft on behalf of the Consumer Healthcare Products Association (CHPA; Washington, DC) to FDA last December. In the CHPA comments, Bass and his coauthors wrote that FDA must correct its continued misreading of Section 201 (ff)(1)(e) of the Federal Food Drug and Cosmetic Act (FFDCA). The authors pointed out that in FDAs draft guidance discussion of synthetic botanicals, the agency stated that it considers dietary substances to be those that are food or food components that humans eat as part of their usual diet and that have been used as a lawfully marketed ingredient in the conventional food supply. FDA also clarified in the draft guidance that synthetic vitamins, minerals, and amino acids, for instance, are recognized as dietary ingredients because a vitamin, mineral, or amino acid is defined by its nutrition function (its ability to provide nutrients to the human body), not by its state of matter like a botanical.

By contrast, the agency said, synthetic botanicals do not qualify as dietary ingredients. As Bass and his coauthors wrote in CHPAs comments back in December: As part of its discussion of synthetic herbs, FDA reiterates a position that it had internally rejected in 2003: that the DSHEA definition of dietary ingredient in Section 201(ff)(1)(E)dietary substanceonly means substances that are already present in food or food components that humans eat as part of their usual diet and that have been used as a lawfully marketed ingredient in the conventional food supply.

For FDA, they wrote, this section acts a de facto exclusion of new synthetic versions of botanical ingredients and other new synthetic ingredients intended to supplement the diet.

FDAs interpretation of the term dietary substance is incorrect, Bass says. According to Bass, who participated in drafting the DSHEA statute, lawmakers at the time purposely chose not to define a dietary ingredient as one that is nutritional, meaning that dietary substances are not restricted to those that are consumed for nutritional purposes. Rather, he says, lawmakers used the term dietary ingredient instead of nutritional ingredient so that ingredients like synthetic CoQ10 or synthetic conjugated linoleic acidor even probiotics or synthetic botanicalswould be considered dietary ingredients even if they are not consumed strictly for their nutritional value.

Originally, what Congress first said was nutritional substance, but they took that word out and made it dietary substance so that it wouldnt be bound by any definition of nutrients, and so that the law would not limit innovation and progress in the supplements industry, Bass tells Nutritional Outlook.

The point of Congress insertion of a separate definition for non-food ingredients was to anticipate expansion and innovation in dietary supplement development, wrote Bass and his colleagues back in December. Section 201(ff)(1)(e) should instead open the door to innovative dietary supplements, including synthetic ingredients and probiotics, concluding that The Congressional intent is clear: there is no rationale for FDA to take the position that Section 201(ff)(1)(E) of the FFDCA precludes synthetics or probiotics as dietary ingredients.

By contrast, Bass says, in FDAs draft guidance, the agency is interpreting it to mean only things with recognized nutritional value. Its the opposite of what the statute says, he says. And if this incorrect interpretation precludes ingredients like synthetic botanicals and probioticsand, in fact, any ingredient that has gone obviously synthetic or changes to traditional productsfrom being considered dietary ingredients, the effect would be to stymie innovation in the dietary supplement industry. As Bass and his colleagues wrote in their CHPA comments, there are also proposals in [FDAs draft guidance] that may impede product/ingredient innovation by responsible companies and make it difficult to introduce new products. Some of the 2016 draft guidance content thus runs counter to the essence and intent of the Dietary Supplement Health and Education Act (DSHEA).

They continued, FDA should withdraw its effort to eliminate all innovative products, including synthetics and probiotics, that are not traditional vitamins, minerals or herbs under section 201(ff)(1)(e) of the FFDCA. Other dietary substance[s] does not mean other nutritional substances. Congress made that clear. This provision in FDAs 2016 draft guidance will all but eliminate innovation.

Bass says that FDAs misreading has implications across everything, not just synthetic herbs. It has implications for [ital] all dietary supplements and dietary ingredients. So far, he says, this issue has not received much attentionalthough, he says, it is on FDAs radar now because CHPA included discussion on the topic in its public comments. Still, he says, I think thats the biggest issue that everyones missing, because industry is based on innovation, and FDAs misreading will prevent certain innovative ingredients from moving forward as supplement ingredients.

Could FDA change its interpretation? Its possible. Bass says that this year the agency has been very receptive to dialoguing with industry as it prepares to move forward on the draft guidance. (Some originally predicted that the agency could issue a final version of its draft guidance by the end of 2017.)

Bass speaks from experience. Just this June, he and Cara Welch, PhD, FDAs senior advisor at FDAs Office of Dietary Supplement Programs were co-presenters at a conference titled, The Revised FDA Draft NDI Guidance: Assessments, Interpretations, and Ambiguities. Bass says he has heard FDA said it plans to reach out to industry this fall to further discussion. They will be discussing how to deal with the whole NDI process from the standpoint of master files and other things, he says. So I think FDA is really showing a lot of willingness to move forward and to move forward with the proper input from industry.

In general, he says, I think theres a new attitude at FDA. Theyre much more willing to engage with industry and try to figure out a path that works. Whether this includes amending the agencys interpretation of a dietary substance remains to be seen.

Read more of Nutritional Outlook's extensive reporting on FDA's NDI draft guidance.

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DSHEA Expert Says FDA's Misreading of the Term Dietary Substance in NDI Draft Guidance Is Biggest Hurdle for ... - Nutritional Outlook

Dr Joe Kosterich explains how to make your immune system as strong as possible this winter, through a combination of food, supplements and antioxidants.

When it comes to health, we tend to make it difficult for ourselves. The reality is, getting healthy, and staying healthy, is simple. All it takes is dedication and attention to eight important health pillars. Sound daunting? Dont worry! Each pillar is simple to strengthen, and once youve aligned all eight, youll find that youre happier and healthier than ever before.

During winter, its tempting to stay warm and cozy indoors. Yet, this behaviour may be affecting your immunity and causing you to be more susceptible to colds. Being outdoors in the fresh air has been proven to not only boost your immune system, but is also good for your overall mood, a blessing for those who suffer from Seasonal Affective Disorder (SAD).

Fresh, seasonal ingredients are natures medicine cabinet for what ails us, especially during cold and flu season. If youre suffering from repetitive illnesses, or you need a healthy boost, then add these immune boosting foods to your shopping list: lean meats, such as chicken, beef and pork; leafy green vegetables such as spinach, kale, rocket; blueberries, raspberries, kiwi fruit, oranges, and legumes. Eggs, milk and cheese are also an important addition to a healthy, well-balanced diet. Experiment with different recipes: hearty winter soups are an easy way to include many different ingredients in one healthy hit.

Around one in three of us are sleep-deprived, a lack of which can weaken your immunity. One study found that men who slept just four hours a night for one week, produced half the amount of flu-fighting antibodies in their blood, compared to those who regularly achieved 7 1/2 to 8 1/2 hours a night.

If your water consumption dips during winter, its time to refill that water bottle. Aim to drink at least eight glasses of water a day, and if you do have a cold, ensure youre keeping your fluids topped up with hot lemon and honey, chicken soup, and filtered water.

Life is busy, and sometimes we think we dont have time to fall ill. Which is usually when our body shows us differently. Taking time every day to just sit in one place, and meditate on your day, your thoughts, and then nothing at all, can help lower your stress levels and boost your immunity.

Cold weather may turn us all into couch potatoes, but our health (not to mention our waistlines), will suffer. A brisk walk, jog or bike ride in the winter sun will ensure your body stays strong and increases its ability to fight against illness.

Finding out what you want to do with your life can be tricky, but worth the search. Taking up a hobby can help boost your immunity, and widen your social circle, which means youll have more reasons to get out and about.

However healthy your diet and lifestyle may be, during winter your immune system can be under the pump. This is where a quality multivitamin supplement can help shore up the foundations of your health. Consider including antioxidants, vitamin C and vitamin E (or take them separately), as well as the energy boosting vitamin B supplements. Take them every morning with a healthy green smoothie to start your day in the best way possible.

Ask your health professional what supplements are right for you. Vitamin supplements should not replace a balanced diet. Always read the label. Use only as directed.

This article was written by Joe Kosterich

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Eight ways to boost your immune system this winter - Starts at 60

A judge sentenced the president of a dietary supplement company to serve 18 months in prison for introducing misbranded food into interstate commerce, the U.S. Justice Department announced this week.

Derek Vest of Gentech Pharmaceutical authorized the use of an amphetamine derivative, DMAA (1,3-Dimethylamine), in various supplements, but he failed to disclose the presence of DMAA on the product labeling for the tablets, according to a July 18 press release from the U.S. Attorneys Office for the Middle District of Florida.

David Goldberg, an attorney representing Vest, and Lexium International, formerly known as Gentech, did not immediately respond to requests for comment.

FDA for years has maintained DMAA is an illegal ingredient in dietary supplements, and a federal judge sided in April with the public health agency in an unrelated case that is likely to be reviewed by a federal appeals court in Atlanta.

In March, the 52-year-old Vest of Fort Myers, Florida accepted a plea deal following a federal grand jury investigation into his companys manufacturing, marketing and sales of dietary supplements containing unlabeled DMAA.

Formed in 2010, Gentech developed and sold supplement products for cognitive function, weight loss and sleep aid," according to a 2016 filing with federal regulators by Lexium. Gentech later changed its name to Lexium, and Vest sold his interest in Lexium in 2015, the filing noted.

The conduct targeted by federal prosecutors covered April 2013 to November 2014 while Vest oversaw the manufacture, marketing and sale of purported dietary supplements as president of Gentech.

During the above period, Vests company sold more than 2 million misbranded tablets that were shipped to consumers, the U.S. Attorneys Office said. Vest must forfeit US$2.5 million as part of his plea deal and the sentence imposed by the court.

Daniel Williams, a spokesman for the U.S. Attorneys Office in Tampa, Florida, declined a request to interview the prosecutor in the case, Yolande Viacava, regarding Vests sentence. However, he said the offense to which Vest pleaded guilty carried a maximum statutory penalty of three years in prison, and the government recommended a sentence at the low end of the advisory guideline range.

Ultimately, it was the court that determined the sentence that was sufficient, but not greater than necessary, and imposed a sentence of 18 months imprisonment," Williams said in an emailed statement.

Marc Ullman, a lawyer in New York whoadvises dietary supplement companies on FDA regulations,said the prosecution against Vest should serve as a reminder that violations of the Federal Food, Drug and Cosmetic Act are all potentially criminal offenses.

While FDA is often very slow in bringing prosecutions like this, companies need to realize that this is a public health law and that ignoring FDA warnings can come with very severe consequences," said Ullman, Of Counsel to Rivkin Radler LLP, in an emailed statement.

In an unrelated case, a federal judge in April rejected a dietary supplement manufacturers argument that DMAA qualifies as a dietary ingredient. Jared Wheat, the owner of Hi-Tech Pharmaceuticals Inc., which has sold supplements containing DMAA for several years, has vowed to file an appeal.

Our position on DMAA has been constant," Steven Tave, director of FDAs Office of Dietary Supplement Programs (ODSP), told INSIDER in a phone interview earlier this year. Its an illegal ingredient. It shouldnt be in dietary supplements.

Tave suggested other companies selling DMAA are on FDAs radar for enforcement action.

When we see it, we take action," he said, but action isnt necessarily instantaneous, so whether its a warning letter, whether its judicial action, just because you havent seen something happen doesnt mean that were not working on it."

See the original post:

Executive Sold DMAA Supplements, Sentenced to Prison - Natural Products INSIDER (blog)

When it comes to building muscle quickly, shrinking your recovery time and even losing some fat, protein supplements have been known to help us in our quest. However, consuming them isnt as simple as purchasing a tub of protein at your closest fitness store. Folks at Diet Nepal in Naxal have been around supplying protein supplements for years now and they can vouch for it. Here, Laxmi Timalsina from the Diet Nepal store helps

The Week get our facts right about protein supplements battling all the misconceptions she has heard from customers over the years.

Insisting on getting started with protein shakes on day one of the gym

Though there is no serious harm to this, wed recommend people to wait out, access their physical capacity at the gym and then accordingly choose the supplements and their amount. For instance, if somebody wants to take protein to gain weight, observe the changes that your body and daily diet bring about for two weeks to a month. Later with that knowledge you can add the required protein supplements. This will help bring about more significant changes. Thus, its always best if you realize your body power and requirements first.

Seeking cheaper protein supplements

When it comes to protein powder, theres no such thing as cheap. Protein powders dont have many side effects. The side effects we hear about are some disturbance in sleeping pattern because of too much consumption of some caffeinated products or constipation because they havent been drinking sufficient amount of water. Other than that there isnt anything to worry about, but that is only if you are using quality products. Gym goers really need to be wary of fake or low quality protein shakes. If your shake contains a concentrate powder with a suspiciously low price and a long shelf life then it possibly means you are paying for something packed with fat and carbs as well. So, dont try to scrimp and save on proteins.

Relying on protein for lunch and dinner

Many people falsely assume that they can make a proper meal out of protein shakes. Thats not true. Protein shakes come in handy when you dont have the time to prepare full course nutrient packed meals or your hectic schedule doesnt allow you to eat on time, however, they cant replace whole food. They dont have as many nutrients as a proper meal; the reason why they are called supplements, not food. So dont be that guy or girl who is chugging down shakes for their meals. In fact nutritionists note that eating proper food will also help with your fitness plan because a full course means your body has to work harder to break down the food so you use up more calories in the digestion process. Focus on things like fish and chicken and make an effort to treat your body to proper meals.

Not reading the labels and neglecting the importance of the mix

We have so many guys coming in and, right off the bat, they ask for Whey, nothing more. They think that a tub of it will be enough. But Whey is only protein and sometimes we can tell some customers will need more to reach their desired body goals. So in these instances, knowledge on these matters is crucial. Familiarize yourself with words like BCAA, amino acids, creatinine, leucine and so on.

Read the labels and see the nutrients that are already present in your tub of protein and consult about the ones you might have to add later on as well. For instance, BCAAs (branched-chain amino acids) are very popular among athletes who are searching for ways to increase lean mass and performance. Leucine is considered the key acid that stimulates muscle protein synthesis and growth. Creatinine is also very popular among body builders since it helps with the energy supply of muscles among other things. So it is best if you educate yourself on these things.

At Diet Nepal, they even have small jars of other minerals to help rest and ease muscles, melatonin to recover sleeping patterns, and fiber to make the body building process more effective and hassle free. If you require some guidance, always ask for it.

Timing it wrong

It isnt enough to have protein in your system. When it comes to supplements working when to take them can be just as important as what youre taking. So discuss this issue with your trainer.

We have supplements for the pre-workout phase, things like Animo energy that will help with boosting your energy for activities like weight lifting. Then there are minerals like BCAA that are recommended for after workout for muscle recovery and tightening. There are also products that can be consumed while you are working out as well. So you might want to plan these things as per your requirement.

If protein is being taken after the workout, most experts suggest that you consume it within an hour after your workout. This way you can help your muscles with the repair and recovery process. Indeed, rules like these need to be taken into account as well while using protein.

Continue reading here:

Beginner's guide to using protein - Republica

Synthetic food technology is implied by certain companies such as New Wave Foods, Memphis Meat etc. to produce laboratory prepared food items that are sustainable and environmental friendly. Animal protein derived from animal meat and fish can be prepared in labs using any other components other than animal flesh and the end product will carry the similar texture, taste and valuable nutrition which you get from eating actual animal meat or fish. This is a sustainable process that seeks to feed continuously the ever=growing population. Even if there is food scarcity, there will be alternative food items to sustain life.

Have you pondered what the future of earth will look like??

Well! It is time for all the countries to seriously pool together their resources and start rethinking on various strategies to prepare the near future which is already displaying a very scary picture. The world population is increasing exponentially, along with, the depletion of fossil fuels and other natural resources, our insatiable hunger for animal meat, rise in pollution and global warming etc. The issues are multiplying yet all we do is engage in petty warfare.

What are we going to explain our future generation?? They will not have any natural resources and food supplements left to support their existence.

However, not every single human being is insensible. This point has been proven by a Californian Biotech company named New Wave Foodswhose main objective is to familiarize consumers on more sustainable alternative such as synthetic technology for food supplements and is acquiring funds to commercialize algae-based prawns and shrimps.

Allow me to take you further into this topic, citing the example of New Wave Foods.

So, what do you actually mean by Synthetic food supplements??

Synthetic or artificial food products, laboratory prepared, imitate naturalfoodsupplements in appearance, taste, and odor and are derived from chemically synthesizedfoodsubstances. This synthetic technology imbibed food items carrying all the life-supporting vitamins, proteins and minerals.

What is the reason behind the advent of such a unique concept??

The ever increasing human population is responsible for many environmental issues and one of the major issues is the disposal of waste materials, where major of the human disposals get dumped every day into our water bodies. The non-biodegradable waste disposals such as plastics are causing damaging health hazards. Seafood eaters are at greater risk of consuming 11000 tiny pieces of plastic every year. Experts say that there are more than five trillion pieces of micro plastic in the world's oceans and by 2050 that will increase to four trucks every minute.

Also, countries such as United Kingdom are losing out on their choicest fish species such as cod, flounder, haddock etc. due to the recurring problem of temperature rise in the North Sea. Experts fear that by the year of 2048, there will be no fish available to consume.

Bad News for fish eaters eh??

Moreover, the prawn fishing industry has been the center of environmental controversies for ages. Prawn agriculture carried out in countries like India, Vietnam and Brazil resulted in widespread mangrove destruction and deforestation.

The reasons are wide and really alarming and the worst part is, the issues are multiplying by it to the extent that the future will definitely be a dangerous time to dwell in. In fact we are slowly poisoning our life supporting resources.

Do you see some relevance with the Mother Earth as portrayed in the Sci-fi film of Will Smith named After Earth?? Well!! I do and so did the founders of New Wave Foods and many others in the market.

What is New Wave Foods, all about??

It is a start-up venture founded by Dominique Barnes and Michelle Wolf, who have successfully produced fake shrimps from a combination of many plant and algae ingredients that give a similar shrimp like taste when you consume it. The best part is you will get all the life supporting nutrition that your body needs. Moreover, the shell fish allergy component that affects some eaters has been eliminated in the artificial product.

The company has launched its products in California and Nevada and expects them to be available in the food retail sector by 2018. Presently, they are selling the synthetic shrimps to food-service operators catering to colleges, universities, restaurants, resorts, food trucks, Kosher caterers and many more.

Who are the other key players involved with the synthetic food technology??

New Wave Foods is not the only company who is socially responsible. There are other key players who display how biotechnology has broken its backbone to get a solution that can meet the food crisis anytime in the distant future. Some of the names you are pretty much familiar with. Let us see who these other key players are:

Summing Up

These companies have taken the giant step towards sustainability, exploiting the field of bio-technology to come up with multiple food supplements or alternatives that will continue to feed the hungry millions even when the natural food sources cease to exist. They have shown you the way. So if you are as responsible as them, then start getting adapted to these viable alternatives and spare a few useful and natural substances for your future generation.technology for synthetic food is the apt answer to this rising crisis of food scarcity.

Continued here:

Synthetic Food Technology Supplements: The Viable Alternative to ... - WhaTech

Good Food

by Well+Good Editors, July 19, 2017

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Summer is officially the season of fresh, juicy foods (as proven by all thetongue-out emojis on your Instagram feed).But what if you could take all your healthy favesand upgrade them?

With nutrient-rich add-ins from HUM Nutrition, you can dial upthe health factor of all yourhot-weather treats. From blendingin the signatureRaw Beautypowder (which manages to pack flavor without that chalky aftertaste), to hacking your vitamins into mixable ingredients, the full HUM lineup helpsyou tackle outer beautyfrom within. Plus, theyre clinically proven to deliver results and are free of parabens, sulfates, artificial colors, and preservatives.

We tapped HUM Nutritions Alex Caspero, RDto share her tips for supercharging your summer snacks,so you canhave your probiotic-boosted popsicles, and eat them, too.

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Popsicles that reduce bloat? Believe it. This healthy version of your favorite old-schoolsnackis packed with probiotics and digestive enzymes to help promotegut health, with an assist from mouth-watering flavors like pineapple, mango, coconut, andRaw Beauty Tropical Infusion.

Plus, Raw Beautysunique antioxidant blend of acai powder, gogi berry powder, and moringa make these cool desserts a surprising source of energy and complexion-clearing goodness.

Tropical Chia Popsicle

Yields 6 popsicles

Ingredients1/2 can (8 oz.) lite coconut milk or 1 cup vanilla almond milk1/3 cup coconut water3 Tbsp chia seeds3 kiwis, peeled and sliced1 fresh mango, diced3 scoopsHUM Raw Beauty Coconut & Pineapple Tropical Infusion

1. Mix the almond or coconut milk until smooth, and then add in chia seeds and Raw Beauty powder. Set aside.

2. In a blender, blend the mango and coconut water until pureed.

3. In a popsicle mold, press twokiwis slices into each mold. Pour the mango puree on top until each is 2/3 filled, and layer with the Raw Beauty blend until full. Freeze for three hours or until solid, then snack away!

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For that time of the month when all you want to do is indulge, consider this smoothie your ally. Cherries (which are rich in beta carotene and vitamin C), coconut milk, and bananas combine for a heart-healthy sip that could help treat PMS symptoms.

But the real genius is whats hidden inside: capsules of HUM Moody Bird, broken open to add in Vitex (a berry tree extract) and Dong quai (a Chinese herb), which areknown for their powers to relieve cramps and irritability.

I love showing people that you can add in capsule supplements to foods, especially smoothies, Casperosays. For people who dont enjoy taking pills, breaking them open and adding to smoothies (or other foods) is a great alternative. Drink it daily in the week leading up to your period for maximum results.

Bliss Beauty Smoothie

Ingredients1/2 cup frozen cherries1 banana1 cup ice1 Tbsp almond butter1 cup coconut milk2 capsules HUM Moody Bird,broken open

1. Add cherries, banana, almond butter, coconut milk, and ice to a blender.

2. Pull aparttwo capsules of HUM Moody Bird and pour the powder into the blender.

3. Pulse until smooth, and enjoy!

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Overnight oats never get boringand with HUMs Raw Beauty packets as your secret weapon, you can transform them intoa seriously high-vibe healthy breakfast.

Loaded withantioxidants, adaptogens (ashwaganda FTW!), and probiotics plus detoxifying greens like chlorella and spirulina, the superfood powderprovides a natural energy and metabolism boostwith major glowy-complexion benefits.

Bonus: Youll stay full until lunch thanks to the healthy fats from nut butter and chia seedsand score a dose of omega-3s for healthy skin and hair.

Raw Beauty Overnight Oats

Yields 1 serving

Ingredients1 cup gluten-free oats2 Tbspnut butter1 packetHUM Raw Beauty To Go in Mint Chocolate Chip Infusion2 Tbspchia seeds1 cup vanilla almond milkCinnamon, to taste

1. Combine all ingredients in a cup or bowl and mix well.

2. Put in the refrigerator over night andvoila: Youve got a healthy,ready-to-go breakfast.

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This anti-inflammatorypowerhouse goes down more like a milkshake than a health beverage (trust us on this one.) Natural antioxidants from blueberries and spinach are joinedbyRaw Beauty Vanilla BerryInfusion, which contains digestive enzymes to help maximize absorption of the fresh fruits and veggieshelping give you a more youthful complexion.

P.S. You can sub your farm-grown blueberries for wild ones for an even more potent dose of antioxidants, and swap out the banana for avocado for a lower sugar option, Casperonotes.

Beauty Boosting Berry Smoothie

Ingredients1 cup spinach1/2 frozen banana2 Tbspfrozen blueberries1 Tbspalmond butter1 scoop HUM Raw Beauty Tahitian Vanilla & Berry Infusion1 cup vanilla almond milk

1. Combine all ingredients in a blender and pulse for about one minute or until smooth. Then sipor gulp.

Psst: Score samples and 20 percent off HUM Nutrition supplements with code WGSUMMER!

In partnership with HUM Nutrition

Top photo: Stocksy/Pixel Stories

Original post:

How to sneakily use supplements in all your go-to summer recipes - Well+Good