Daily Archives: July 22, 2017

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 ... - Charleston Express

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

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