March 6, 2018
Another Olympics has come and gone.
In its wake, it is easy to reflect on the booming sports nutrition market. Companies are constantly introducing innovative products to meet the demand for the evolving needs and preferences of their customers, who themselves are looking to meet their fitness goals.
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 identified 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 five rules for companies that sell sports nutrition products that value the safety and confidence of their consumers:
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 definition of a dietary ingredient. This means an ingredient must be an old dietary ingredient (ODI) or a new dietary ingredient (NDI) that has been notified to FDA or is exempt from notification. 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.
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 sure-fire 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.
Ensure all claims are substantiated by credible scientific 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 scientific 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.
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.
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 first. Companies who believe otherwise have no place in the market.
Register for the "Sports Nutrition: Playing by the Rules to Win Fairly in the Supplement Space" webinar being offered Wednesday, March 14 at 2 p.m. EST, to dive deeper into the rules of playing fair in sports nutrition.
Duffy MacKay, N.D., is the senior vice president, scientific and regulatory affairs, for the Council for Responsible Nutrition (CRN, crnusa.org), a trade association for the dietary supplement and functional food industry.
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