Natural Products Insider

MAR-APR 2018

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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40 INSIDER March/April 2018 Sports Nutrition Another Olympics has come and gone. In its wake, it is easy to refl ect on the booming sports nutrition market. Supplements don't create champions overnight. The only way for athletes to reach the next level and shatter personal records is through hard work and dedication, paired with a healthy lifestyle. Supplements complement these efforts and are only a piece of the puzzle. Unfortunately, for years, unscrupulous companies eager to make a buck have preyed on the vulnerability of hopeful athletes who may be willing to do anything to get results. Anything but sportsmanlike, these companies make crazy claims, sell products containing illegal ingredients and create a bad name for an otherwise responsible, law-abiding industry. FDA identifi ed bodybuilding and weight loss supplements as high-risk for adulteration, and is cracking down on enforcing regulations and policing the market. Looking for products containing illicit ingredients, such as selective androgen receptor modulators (SARMs) and 1,3-dimethylamylamine (DMAA), the agency is targeting bad actors illegally marketing these dangerous substances as dietary supplements. Here are fi ve rules for companies that sell sports nutrition products and value the safety and confi dence of their consumers: 1 Use known dietary ingredients. If brands don't want to end up on FDA's watch list, they should use only ingredients that meet the defi nition of a dietary ingredient. This means an ingredient must be an old dietary ingredient (ODI) or a new dietary ingredient (NDI) that has been notifi ed to FDA or is exempt from notifi cation. Companies looking to go the extra mile to protect their consumers and reduce regulatory risk should consider hiring a knowledgeable regulatory consultant to thoroughly research the regulatory status of every ingredient going into their products. 2 Abide by cGMPs (current good manufacturing practices) and other best practices. Follow cGMPs to ensure products are safe, consistent and unadulterated. Cutting corners or trying to outsmart regulators is a surefi re way to have products removed from the market. Brands should work only with trusted ingredient suppliers, carefully monitor their supply chains and regularly test for the presence of illegal ingredients. 3 Ensure all claims are substantiated by credible scientifi c evidence. Bad actors have no problem making outlandish claims to attract consumers to their products, while responsible companies work hard to stay on the right side of the law by conducting competitive, enticing—but not-misleading—marketing campaigns. Product claims must be backed by credible scientifi c evidence. Before marketing the "latest and greatest" product, brands should consider a third-party review of the evidence supporting their claims and submit all structure/function claims to FDA within 30 days of going to market. 4 Regularly review FDA's website for the agency's position on ingredients. Good brands stay on top of FDA consumer alerts, enforcement reports and ingredient status updates to ensure their products abide by the agency's latest positions and regulatory guidance. If a brand suspects an FDA public announcement may impact its products, it should review labels with a legal or regulatory expert. 5 Remember responsible industry's top priority: consumer safety. Health and nutrition products are intended to help people live healthier lives and reach their wellness goals. When a consumer purchases a product, he or she denotes trust in the company. If a brand chooses to ignore regulations and operates unlawfully, it betrays that trust and, potentially, puts lives at risk. Consumer safety comes fi rst. Companies who believe otherwise have no place in the market. Duffy MacKay, N.D., is the senior vice president, scientifi c and regulatory affairs, for the Council for Responsible Nutrition (CRN,, a trade association for the dietary supplement and functional food industry. Five Ways to Play Fair in Sports Nutrition by Duffy MacKay, N.D. NOW ON DEMAND Premium Series W E B I N A R SPEAKERS ROBERT RODOPHELE Attorney Ferriter Scobbo & Rodophele PC RICHARD B. KREIDER, PH.D., FACSM, FISSN, FACN, FNAK Professor & Executive Director, Human Clinical Research Facility Texas A&M University RICK COLLINS ESQ., CSCS Collins Gann McCloskey & Barry PLLC TIM N. ZIEGENFUSS, PH.D., CSCS, FISSN CEO The Center for Applied Health Sciences MODERATOR DOUGLAS "DUFFY" MACKAY, N.D. Senior Vice President, Scientific & Regulatory Affairs CRN Sports Nutrition: Playing by the Rules to Win Fairly in the Supplement Space CO-SPONSORED BY: To watch, visit

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