Our late Rottweiler mix, Lucy, was diagnosed with chronic hip dysplasia when she was only 4 years old. After researching ways to help her I learned that joint supplements containing the ingredients chondroitin and glucosamine seem to help some dogs with joint issues. Following a discussion with my veterinarian, I started Lucy on two pills a day. I dont know if they helped her, but she joined us on walks and hikes until we finally lost her at age 15.

Now we think that our 10-year-old border collie mix, Jason, is showing signs of arthritis. Once the vet confirms this, well ask if we should put him on the same supplements we used for Lucy? Were not alone in considering the use of pet supplements. According to market researcher Packaged Facts, projected retail sales for pet supplements and nutraceutical treats in the U.S. are expected to grow through 2017, to an estimated $1.6 billion.

The National Animal Supplement Council (NASC) describes pet supplements as products that are intended to complement the diet and help support and maintain a normal biological function. Products range from multivitamins for overall health to targeted formulas that claim to alleviate joint problems or canine cognitive dysfunction.

The most commonly used pet supplements are multivitamins, joint supplements and fatty acids. Veterinary experts agree that glucosamine/chondroitin supplements if they are of good quality, may have modest benefits in some animals with arthritis. And fish oil supplements may be beneficial for pets with certain medical conditions, such as heart disease, kidney disease and cancer. However, even these common supplements have potential side effects and are not right for every dog and cat with these conditions. As for multivitamin supplements, veterinary experts say that pets do not need these unless they are on a nutritionally unbalanced diet.

A healthy dog and cat on a well-regulated commercial pet food that has been carefully designed by a board-certified veterinary nutritionist will be getting all the vitamins and minerals they need, said Laura Eirmann, a veterinary nutritionist at Oradell Animal Hospital. Complete and balanced pet foods are made to give pets the right amount of nutrients and adding more could be harmful to your pet Eirmann said. For example, giving too much calcium to a large breed puppy can lead to skeletal diseases.

Eirmann advises that pet owners always speak with their primary care veterinarian before adding a supplement to their pets diet. This is especially important because unlike drugs, the Food and Drug Administration (FDA) does not review supplements for efficacy, safety or quality before they are put on the market. Drug manufacturers must prove that a drug is safe and effective before it can be sold to consumers. However, in the case of pet supplements, the FDA has to prove that they are unsafe before they can be pulled off of the market.

Because pet supplements are not regulated its a buyer beware area, Eirmann said.

Dogs and cats handle food items differently than we do. Just because a supplement is advertised as natural, that doesnt mean it is safe for our pets.

In her article Dietary Supplements for Pets: Harmful or Helpful? Lisa M. Freeman, a veterinary nutritionist, and professor at Tufts University Cummings Veterinary Medical Center wrote that pets can get sick or even die as a result of dietary supplements. She writes:

Even if the supplement by itself is safe, its use in combination with medications an animal may be taking can cause dangerous interactions. In addition, numerous studies have shown that many supplements have terrible quality control. This means that if you buy a supplement that is supposed to contain 500 mg per tablet, it may contain 500 mg but it also may contain 1000 mg or nothing at all! Some supplements may be contaminated with mercury, lead, or other substances. That doesnt even get into the issues of supplement tablets that dont dissolve appropriately (which means they wont get absorbed).

Eirmann said there is evidence that some supplements can help pets. In fact, her 15 -year-old golden retriever, Sprocket, is taking a supplement that contains SAMe and Silybin, proven to support certain types of liver disease. In addition to speaking with a veterinarian, Eirmanns advice to anyone interested in adding supplements to their pets diet is to do extensive research. Find out if the company manufacturing the supplements has done any studies and if those studies are applicable to your particular pet.

If youre doing the research online, dont rely solely on testimonials or company marketing materials, Eirmann said. You want to know if a product is safe and if it is effective. Your veterinarian is the expert so ask before making a final decision on using a product.

Source: Laura Eirmann, a veterinary nutritionist at Oradell Animal Hospital

Photo Credit:Thinkstock

Disclaimer: The views expressed above are solely those of the author and may not reflect those of Care2, Inc., its employees or advertisers.

Originally posted here:

Do Our Pets Really Benefit From Supplements? Here's What the Experts Have to Say - Care2.com

Exposure to pyrrolizidine alkaloids in food, in particular for frequent and high consumers of tea and herbal infusions, is a possible long-term concern for human health due to their potential carcinogenicity, say EFSAs experts.

The consumption of food supplements based on pyrrolizidine alkaloid-producing plants could also result in exposure levels causing short-term toxicity resulting in adverse health effects.

EFSA has updated its 2011 advice on the risks for human and animal health from pyrrolizidine alkaloids, a large group of toxins produced by different plant species that can unintentionally enter the food chain.

The European Commission requested the updated risk assessment, which takes account of exposure estimates using more recent data on the levels of these toxins in honey, tea, herbal infusions and food supplements.

In 2011 EFSA concluded there were possible long-term health concerns for toddlers and children who are high consumers of honey, the only food category for which sufficient data were then available.

EFSAs experts identified 17 pyrrolizidine alkaloids in food and feed that should continue to be monitored and recommended further studies on the toxicity and carcinogenicity of those most commonly found in food.

See the article here:

Pyrrolizidine alkaloids in tea, herbal infusions and food supplements - EU News

Tips and tricks for those looking for a healthy boost

Health food isnt just a trend, its the new norm. As mainstream grocery stores incorporate organic sections into their floorplans, its becoming clearer that were in the midst of an organic revolution.

Audrey McDonough, supplement manager at the Better Health Store in Frandor Shopping Center, shared some popular healthy foods, a few personal favorites and unique perspectives on a few mainstays for the health conscience consumer.

Healthy fats The health food community is all about fat right now, and Im all about it too. Coconut oil, MCT oil, grass fed butter, grass fed ghee and olive oil can be really healthy for you and can make your body actually burn fat and calories more often.

Coconut water Coconut water the perfect sports drink. It has all your electrolytes and no added sugars. Its a great way for someone like an athlete to move over to something thats natural, and away who from those crappy, electrolyte drinks that are full of sugars and dye. They make flavored coconut water now if you dont like the way it tastes.

Kombucha Kombucha is fermented green or black tea full of probiotic bacteria essential to your gut health and can help your brain and immune system. The probiotic culture ferments the tea and makes it fizzy, bubbly and yummy. Its a great alternative for people who want to stop drinking pop and have slightly adventurous taste buds.

Turmeric Turmeric is probably one of our most popular supplements because everyone needs some sort of anti-inflammatory. It works best when its paired with black pepper which allows it to stay in the bloodstream a lot longer and do its work.

Apple cider vinegar Apple cider vinegar is awesome. It can help alkalize the body and if you take it after meals it will minimize the increase in your blood sugar and help you burn fat.

I hear a lot of people brag they can drink it straight, which isnt good dilute apple cider vinegar when youre ingesting it because its full of acetic acid which is bad for your tooth enamel. One teaspoon to 8 ounces of water is a good ratio.

Gluten Free

If you have to go gluten free, I suggest cutting out the groups that contain gluten. You shouldnt have a huge portion of your diet made up of gluten free food because a lot of the main ingredients in the gluten free versions are made of starches like rice flower and potato starch that turn into sugar, or contain a lot of sugar.

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How-to health food guide - City Pulse

Not all vitamin D is created equal. Thats what a new study found, and the results may have significant implications for public health strategies seeking to boost levels of the important vitamin.

The study, appearing in the American Journal of Clinical Nutrition, found that food supplements containing one type of the vitamin D3 were far more effective at raising vitamin levels in the body compared to supplements containing another form, vitamin D2.

Our findings show that vitamin D3 is twice as effective as D2 in raising vitamin D levels in the body, which turns current thinking about the two types of vitamin D on its head, said lead authorDr. Laura Tripkovicfrom the University of Surrey.

Both substances are found naturally, but they come from different sources. Vitamin D3 derives from animal products, while D2 comes from plants.

For the study, researchers assessed total vitamin D levels in 335 women over a two-year span. To gauge the effectiveness of the different vitamins, they had one group of women consume juice or eat a biscuit containing D3 and the other group do the same with D2. The experiment lasted over the course of two winters.

Related:Vitamin D May Ease Sunburns by Reducing Skin Damage

After the trial ended, the women who consumed D3 had about a 75 percent increase in circulating levels of vitamin D in their bodies, compared to a 34 percent boost among those who consumed D2.

The study may overturn current dietary guidelines, which consider both forms of vitamin D to have equal health benefits.

This is a very exciting discovery which will revolutionize how the health and retail sector views vitamin D, said professor Susan Lanham-New, Head of theDepartment of Nutritional Sciencesat the University of Surrey.

In regions where sunlight is scarce, such as parts of North America and the United Kingdom, people rely on vitamin D supplements to ensure healthy levels of the vital nutrient. Healthy vitamin D levels are linked to disease-fighting prowess, bone health and other important factors.

People may want to reconsider their dietary choices in light of the new findings.

Those who consume D3 through fish, eggs or vitamin D3 containing supplements are twice as more likely to raise their vitamin D status than when consuming vitamin D2-rich foods, such as mushrooms, vitamin D2 fortified bread or vitamin D2 containing supplements, helping to improve their long term health, said Tripkovic.

Related:Vitamin D Deficiency May Cause Early Menopause

Vitamin D deficiency is a serious matter, but this will help people make a more informed choice about what they can eat or drink to raise their levels through their diet, said Lanham-New.

The difference in vitamin D fortification is particularly important for pregnant women, notes a previous study from the University of Surrey.

The importance of vitamin D sufficiency should not be underestimated. It is well-known to be good for our musculoskeletal systems, but our research shows that if levels are low in expectant mothers, it can affect the development of their children in their early years of life, said Dr. Andrea Darling, who led a separate study on vitamin D and health outcomes related to pregnancy.

Vitamin D is found in oily fish (e.g. salmon, sardines, mackerel and fresh tuna) and in small amounts of red meat, eggs, fortified fat spreads and some breakfast cereals. However, unless a large portion of oily fish (100g) is eaten daily it is difficult to get the recommended daily intake of 10 micrograms per day from food alone, said Darling.

Richard Scott is a health care reporter focusing on health policy and public health. Richard keeps tabs on national health trends from his Philadelphia location and is an active member of the Association of Health Care Journalists.

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Are You Consuming the Right Kind of Vitamin D? - Vital Updates

Dietary supplements in a variety of forms, including as vitamins, herbs or energy drinks, are often marketed to consumers as a simple solution to boost energy, induce weight loss and improve overall mood.

But new researchpublished Monday in the Journal of Medical Toxicology highlights the potential dangers of dietary supplements, which are not regulated by the Food and Drug Administration.

In fact, researchers found that the rate of supplement-related calls to poison control centers increased by 49.3 percent between 2005 and 2012.

According to data from the National Poison Data System, there were 274,998 dietary supplement exposures called in to U.S. poison control centers thats about one call every 24 minutes.

And of those exposures, 70 percent were in children ages six and under, nearly all unintentional and accidental.

Sometimes, parents don't think of keeping dietary supplements away from their kids, because they're not medicines prescribed by the doctor. People think of them as natural, Henry Spiller, lead author of the study and director of Central Ohio Poison Control,told CNN. "But they need to be treated as if they were a medicine. Don't leave them out on the counter. Keep them out of reach."

Approximately 4.5 percent of the cases (more than 12,300) led to serious medical complications.

Most dangerous supplements

While the majority of the cases didnt require treatment at a medical facility, authors of the study warn exposures to dietary supplements yohimbe (herbal supplement promoted as male sexual performance enhancer) and energy products are considerably toxic.

Overall, the most dangerous supplements, according to the study, are yohimbe, homeopathic agents marketed to help with conditions like asthma or migraines, energy drinks and ma huang, a stimulant with ephedra that was outlawed by the FDA in 2004 after it was linked to multiple deaths.

Authors plea for FDA regulation

Because dietary supplements are not regulated by the FDA, there are not robust studies done to ensure that they are efficacious or have a reliable safety profile, Jeannette Trella, managing director of the Poison Control Center at the Childrens Hospital of Philadelphia and not involved with the study,told CNN. We're often going down a path of unknowns, and for possibly no benefit at all.

But the Council for Responsible Nutrition, which leads trade for the dietary supplement industry, said it is invested in providing safe products for the more than 170 million Americans who take these supplements each year.

We recommend that consumers store dietary supplement products in safe places, out of a child's reach. In addition, we recommend that consumers talk with their doctor or pediatrician about their family's supplement use, the Council said in a statement.

Still, the authors of the study call on the FDA to consider the regulation of yohimbe and energy products as the administration did for ma huang, which helped dramatically plummet calls to poison centers in2004.

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The truth about the dangers of dietary supplements - Atlanta Journal Constitution

WASHINGTON The Council for Responsible Nutrition on Tuesday announced the addition of 11 new companies to the associations membership roster.

These companies include voting members Before Brands, Biova, Life Line Foods, Natrol, Nutrawise, Pharma Tech Industries, Shanghai Freemen and Trident Brands and associate members Michael Schaeffer, LLC, Natural Partners and SRQ-Bio.

Before Brands is a consumer product company that will soon launch an innovative line of dietary supplements enabling young families to take a proactive approach with nutrition and food allergens. Biova markets water-soluble egg membrane ingredients. And Life Line Foods specializes in the manufacturing of liquid minerals, liquid vitamins and liquid specialty nutrient formulas through Buried Treasure, their nutraceutical division.

Natrol has been a leading manufacturer of vitamins, minerals, and supplements for more than 35 years and is dedicated to empowering consumers to Own Your Health with the help of their top-selling products: melatonin, 5-HTP and biotin. Nutrawise is a leading manufacturer of health and wellness supplements including the line of youtheory products. Pharma Tech Industries is a family-owned-and-operated pharmaceutical contract manufacturing organization.

Shanghai Freemen offers ingredients and solutions to enhance the performance, taste and nutritional benefits of some of the world's most celebrated brands. And Trident Brands is a U.S. public company specializing in the functional food, supplement and active nutrition categories with an exclusive license to manufacture Everlast branded active nutrition products and supplements in North America.

New associate members include Michael Schaeffer, which provides consultation, professional and technical services for the natural products industry with an emphasis in dietary supplement label review, product formulation, international product registration and overall support to companies which market or distribute dietary supplements. Natural Partners is a resource for health care practitioners who strive to improve patient wellness by providing education and professional-grade products. And SRQ-Bio is a Florida-based research organization equipped to support ingredient/product integrity and safety with qualitative and quantitative identity testing, and screening for GMO and pesticides.

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CRN announces addition of 11 new companies to membership roster - Drug Store News

GETTY

According to the NHS, it helps to turn the food we eat into energy, and ensures that parathyroid glands - which produce hormones essential for bone health - work normally.

The mineral is also important for maintaining heart health and blood sugar control.

Its present in many foods, such as green leafy vegetables, nuts, brown rice, fish, wholegrain bread, meat, dairy, peanut butter and soy milk.

However, many people dont consume enough through dietary sources.

GETTY

According to the NHS, the amount of magnesium you need a day if youre between 19 and 64 years includes 300mg for men and 270mg for women.

For example, its estimated that 80 per cent of Americans are deficient.

Signs of this include inability to sleep, sensitivity to noise, anxiety, muscle soreness and infertility.

It means that many people need to rely on magnesium supplements to top up adequately.

According to the NHS, the amount of magnesium you need a day if youre between 19 and 64 years includes 300mg for men and 270mg for women.

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A-Z of vitamins and minerals

GETTY

This is less than in the US where the National Institutes of Healths Office of Dietary Supplements recommend 400 to 420mg for men and 310 to 320mg for women.

Sometimes doctors may prescribe more to pregnant women or others with a particular condition.

However, just like vitamin C, it is possible to consume too much.

The NHS state: Taking high doses of magnesium - more than 400mg - for a short time can cause diarrhoea.

GETTY

If you take magnesium supplements, don't take too much as this could be harmful.

The Office for Dietary Supplements highlights another health issue too much magnesium can cause.

Technically known as hypermagnesemia, it occurs when theres too much magnesium in the blood.

Its rare because the kidneys usually work to get rid of excess magnesium, however people with kidney disease, heart disease and gastrointestinal disorders are at a higher risk.

It can cause nausea and vomiting, lethargy, muscle weakness, irregular heartbeat, low blood pressure, urine retention, respiratory distress and cardiac arrest, according to the Office for Dietary Supplements.

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Magnesium warning: Too much of the supplement could trigger cardiac arrest - Express.co.uk

A new study found calls to poison control centers in the U.S. due to exposures to dietary supplements rose by nearly 50 percent between 2005 and 2012, and that a majority of those calls involved children being exposed to supplements.

The report, published Friday in the Journal of Medical Toxicology, called for an increase in regulation by the Food and Drug Administration for certain supplements that were associated with high amounts of toxicity.

Researchers combed through all calls that were made to poison control centers in the U.S. related to dietary supplement exposure between 2000 to 2012, and also found that the majority of supplement exposure calls (70 percent) involved children 6 years old and under.

Dr. Jennifer Ashton, ABC News' Chief Women's Health Correspondent shared some tips on "Good Morning America" today to help keep your children safe from accidental exposures to dietary supplements, advising parents to treat supplements like prescription medicines, and keep them far away from children.

She adds that you should never assume that just because something is "natural" that it is safe.

Ashton recommends keeping a poison control center phone number handy in your home, and if you do suspect your child has accidentally ingested supplements, to never induce vomiting without speaking to poison control authorities first.

Link:

Study finds a major uptick in calls to poison control centers over dietary supplements - ABC News

New U.S. Patent Allowance Granted to Mastix LLC for a New Chewing Gum Manufacturing Method Incorporating Cannabinoids

Allows Unique Manufacturing Process for Chewing Gum Products Used to Deliver Active Ingredients Including CBD and THC

Hunt Valley, MD: Mastix LLC, a leading developer and manufacturer of innovative functional food and dietary supplement products, today announces that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application 14/732,072, a utility patent that claims a new manufacturing method for functional chewing gum that covers all forms of powder and oil-based active ingredients, including cannabidiol (CBD) and tetrahydrocannabinol (THC). A Notice of Allowance is issued after the USPTO has determined that a patent will be granted from an application. This platform patent technology covers the inclusion of a wide range of food and supplement active ingredients, including cannabinoids (both naturally extracted and synthetically derived), which is a market currently experiencing explosive growth.

This is the first patent granted to Mastix LLC for its unique chewing gum manufacturing method. Mastix has filed several additional patent applications with the USPTO in this platform technology for the inclusion of cannabinoids into its gum delivery system.

The granting of this notice of allowance for our novel chewing gum dosage form validates the innovative nature of our platform technology and positions us well to offer our customers and consumers an alternative delivery system to pills, capsules and beverages that is widely acceptable and very familiar.

We have the unique ability to incorporate either a single active ingredient, or multiple active ingredients, into the gum tablets we make to provide our customers with truly custom chewing gum products that will now be patent protected.

Consumers are actively seeking alternative delivery vehicles for the many pharmaceutical and supplement products they currently take as pills or capsules. Chewing gum is a convenient and discrete way for consumers to quickly and efficiently deliver the benefits they expect from the products they use to improve their health and wellness. The extensive clinical studies the US Military performed on our caffeine gum proved that gum delivered through the oral mucosa is up to five times faster than swallowing pills or capsules while also maintaining high bioavailability of the active.

In addition to its proprietary MedCBDX gum (www.medcbdx.com), Mastix offers custom product development, contract manufacturing and private label services for its chewing gum, lozenge and chewable tablet product formats. Mastix has developed many tableted products in a wide range of active ingredients including dietary supplements, herbal extracts, probiotics and cannabinoids, and is best known as the supplier of caffeine chewing gum that the US Military packed into its ration kits. Mastix has recently developed several One-of-a-Kind chewing gum products that its contract customers will be introducing to their respective markets very soon.

About Mastix LLC

Mastix LLC develops, manufactures and markets niche functional food and dietary supplement products in chewing gum, chewable tablet and lozenge dosage formats. Mastix manufactures its products in full compliance with FDA GMP (good manufacturing practice) regulations.

FOOD AND DRUG ADMINISTRATION (FDA) DISCLOSURE

The statements presented in this press release have not been evaluated by the FDA and are not intended to diagnose, treat, cure or prevent any disease.

LEGAL DISCLOSURE Mastix LLC does not develop, manufacture, sell or distribute any products that are in violation of the United States Controlled Substances Act (US.CSA).

CONTACT:

Robert Estey Chief Executive Officer Mastix LLC P. 410-316-1080 x100 restey@mastixllc.com http://www.mastixmedica.com

Source: Company

The NCV Newswire by New Cannabis Ventures aims to curate high quality content and information about leading cannabis companies to help our readers filter out the noise and to stay on top of the most important cannabis business news. The NCV Newswire is hand-curated by an editor and not automated in anyway. For questions contact us.

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Mastix Secures Functional Chewing Gum Patent Covering CBD and THC - New Cannabis Ventures (blog)

U.S. Poison Control Centers receive a call every 24 minutes, on average, regarding dietary supplement exposures, according to a new study from the Center for Injury Research and Policy and the Central Ohio Poison Center, both at Nationwide Childrens Hospital.

The study, published online today in the Journal of Medical Toxicology, found the rate of calls regarding dietary supplement exposures increased (46.1%) during 2000 to 2002, decreased (8.8%) during 2002 to 2005 and increased again (49.3%) from 2005 to 2012. The decrease from 2002 to 2005 most likely resulted from the U.S. Food and Drug Administrations (FDA) ban of the botanical stimulant ma huang previously found in some dietary supplements.

Seventy percent of dietary supplement exposure calls occurred among children younger than six years old and the majority of these were unintentional. Most exposures (97.3%) occurred at home, and in more than 97 percent of the cases, the child swallowed the substance. Serious medical outcomes accounted for 4.5 percent of exposures and the most serious outcomes (95.0%) occurred among children six years and older.

"Many consumers believe dietary supplements are held to the same safety and efficacy standards as over-the-counter medications," said Gary Smith, MD, DrPH, senior author of the study and director of the Center of Injury Research and Policy at Nationwide Childrens. "However, dietary supplements are not considered drugs, thus they are not required to undergo clinical trials or obtain approval from the FDA prior to sale, unless the product is labeled as intended for therapeutic use."

Miscellaneous substances found in commonly used dietary supplements accounted for the majority of exposure calls (43.9%). Other substances involved in exposures included botanicals (31.9%), hormonal products (15.1%), and other supplements (5.1%). Amino acids, cultural medicines and energy products each account for less than (2.0%) of exposures.

The dietary supplements with the highest proportion of serious medical outcomes were energy products, botanical and cultural medicines. Within the botanical category, yohimbe accounted for the largest proportion of serious medical outcomes (28.2%).

Nearly 30 percent of yohimbe exposure calls resulted in moderate or major effects. Yohimbe can cause heart beat rhythm changes, kidney failure, seizures, heart attack, and death.

Energy products, including drinks, advertised to increase energy and mental performance, can cause bad clinical effects as well. Many energy product exposures were unintentional and occurred among young children, causing heart and breathing problems, seizures, and other clinical problems. Findings support the need for improved energy product regulation, child-resistant packaging, and caregiver information, according to the study authors.

"Lack of federal oversight has led to inconsistencies in the quality of dietary supplements, product mislabeling and contamination with other substances," said Henry Spiller, MS, D.ABAT, a co-author of the study and director of the Central Ohio Poison Center at Nationwide Childrens. "Although the majority of these exposure calls did not result in serious medical outcomes, exposures to yohimbe and energy products can be dangerous, suggesting the need for child-resistant packaging, caregiver education and FDA regulation of these substances."

Data for this study were obtained from the National Poison Data System, which is maintained by the American Association of Poison Control Centers (AAPCC). The AAPCC receives data on calls to participating poison control centers that serve the US and its territories. Poison control centers receive phone calls through the Poison Help Line and document information about the product, route of exposure, individual exposed, exposure scenario, and other data.

Continue reading here:

Dietary supplements lead to calls for help every 24 minutes - 10TV

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.

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Laws and Policies Governing Performance Enhancing Supplements - Gurdon Times

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.

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Laws and Policies Governing Performance Enhancing Supplements - Heber Springs Sun-Times

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 - WholeFoods Magazine

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."

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

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 Natural Food Products - WhaTech

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.

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Beginner's guide to using protein - Republica

The European Commission has threatened to take Spain to the European Court of Justice to ensure free movement of food supplements.

A reasoned opinion has been sent to Spain, urging it to remove discriminatory practices that affect the marketing of food supplements.

According to Spanish law, when a company first places a food supplement on the market, companies based in Spain must notify the local authorities. However, companies from other EU countries must apply to the Spanish Agency for Food Safety and Nutrition (AECOSAN), which leads to higher costs.

According to European food and nutrition law expert Luca Bucchini of Hylobates Consulting, notifications by EU-based companies to the central AECOSAN agency cost more than 900 per product, while a Spanish firm notifying local authorities would generally pay a maximum of 200 though often local notifications are free.

For example, an Irish business needs to spend 18,000 to register and sell 20 food supplements in Spain; a Spanish business may have to spend zero to do the same thing, Bucchini told us. This is a significant competitive advantage, and against single market rules.

According to the European Commission press memo , Spain has two months to notify it of new measures that remedy the current discriminatory situation.

The Commission thus considers that the Spanish requirements restrict the free movement of goods (Article 34TFEU ) as these discriminate against businesses based in another EU country, said the Commission in a press release memo.

If new measures are not implemented, the EC may decide to refer the case to the Court of Justice of the EU, it said.

Bucchini told us that Spain has shown resistance to previous calls asking it to change the system, as they claim it is a result of their regional set-up.

But it would be easy for Spain to allow EU-based companies to register products with the regional authority where they first sell, so they would be an equal footing with Spanish competitors, he suggested.

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EC urges Spain to remove 'discriminatory' practices for imported food supplements - NutraIngredients.com