In 1994, the Dietary Supplement Health and Education Act (DSHEA) was passed with the unanimous consent of Congress.
The law was the legislative response to the perceived anti-supplement tactics of the Food and Drug Administration (FDA), which provoked a groundswell of public criticism and consumer outrage. The law had a chilling effect on FDA’s regulatory activism for a decade. In more recent years, however, FDA has again set its sights on the supplement industry. Its early actions against supplements containing ephedra and androstenedione, and its more recent efforts to more clearly define “new dietary ingredients,” have suggested a major shift in policy toward more aggressive policing of the supplement industry, particularly the sports and fitness nutrition segment. The line between anabolic steroids and dietary supplements has become less clear since the criminal scheduling of numerous over-the-counter “prohormone” (steroid precursor) products. Some journalists and “consumer advocacy” groups are even criticizing Congress for maintaining the exemption for the popular anti-aging supplement DHEA (dehydroepiandrosterone) in the 2014 amendment to the federal anti-steroid law (The Designer Anabolic Steroid Control Act of 2014), either not understanding or not caring that adding it to the list would subject health-conscious baby boomers to arrest and federal prosecution as drug offenders.
An ongoing barrage of negative media reports continues to misinform the public on the topic of performance-enhancing dietary supplements. Stories about anabolic steroids often blur the line by including references to creatine monohydrate and other popular dietary supplement products. A story in the Saratogian (4/30/05) about a lecture from a politician and a former athlete at a local high school falsely described the dietary supplement creatine as “one of the steroid precursors.” The anti-supplement leanings of the mainstream press and many members of Congress may ultimately have a serious adverse effect upon those seeking better and health and physical development through diet, exercise, and nutritional supplementation. A satirical piece comparing hardcore bodybuilders to the vilified mutants of “X-Men” (while dated, as the law has since been amended) may have more than a kernel of truth.
Rick Collins, Esq., an internationally recognized authority on sports nutrition, is positioned at the forefront of sports and fitness supplement issues. When FDA pronounced that dietary supplement products containing androstenedione were adulterated new dietary ingredients under DSHEA, CGMB analyzed the legal grounds and standards upon which FDA acted in “Adulterated Androstenedione: What FDA’s Action Against Andro Means for Industry,” published in the Sports Nutrition Review Journal, 1(1):52-60, 2004. The article, authored by Rick Collins, Esq., and Alan Feldstein, Esq., suggests what might be done to ameliorate the escalating problem of lack of communication and cooperation between FDA and industry. Rick also presented on “The Future of Sports Nutrition after Ephedra and the Steroid Scandal” at the FitExpo in Pasadena, CA, in 2004, and gave an “Insider’s Update on the Regulatory Issues Surrounding Sports Supplements” at the International Society of Sports Nutrition 2004 Annual Conference in Las Vegas. Mr. Collins and Mr. Feldstein also recently co-authored “Comments on FDA’s Pre-market Notification for New Dietary Ingredients” which Mr. Feldstein presented to the Food and Drug Administration in Washington, DC. More recently, Rick gave a presentation entitled “Nutrition Law Every Fitness Professional Should Know” at the 12th Annual International Society of Sports Nutrition Conference and Expo in Austin, TX. For recent presentations, see his curriculum vitae here. Rick also writes frequently on issues relating to dietary supplements, and has co-authored chapters in two textbooks: ESSENTIALS OF SPORTS NUTRITION AND SUPPLEMENTS, J. Antonio, D. Kalman, et al., editors (Humana Press; 2008), Chapter 24, “Regulatory Aspects of the Sports Nutrition Industry,” and NUTRITIONAL SUPPLEMENTS IN SPORT AND EXERCISE, M. Greenwood, et al., editors (Humana Press, 2008), the chapter, “The Effect of Government Regulation on the Evolution of Sports Nutrition.”
Call 516-294-0300 or email [email protected] if you have any legal questions about sports and fitness nutrition supplements. Rick and his team of bicoastal lawyers maintain an informative blog at www.supplementcounsel.com dedicated to keeping dietary supplement industry and supplement consumers informed of the latest legislative and regulatory developments.