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 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. Recently, however, FDA has again set its sights on the supplement industry. Its actions against supplements containing ephedra (recently overturned by a federal judge) and androstenedione, and its efforts to more clearly define "new dietary ingredients", suggest a 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 exempting the popular anti-aging supplement DHEA (dehydroepiandrosterone) from the new anti-steroid law, perhaps not understanding 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 continue 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. California state senator Jackie Speier, for example, has been a staunch advocate against both steroids and supplements (see
Jim Schmaltz's criticism of her bills).
A satirical piece comparing hardcore bodybuilders to the vilified mutants of "X-Men" may have more than a kernal of truth.
The law firm of Collins, McDonald & Gann (CMG) is positioned at the forefront of sports and fitness supplement issues. When FDA pronounced last year that dietary supplement products containing androstenedione were adulterated new dietary ingredients under DSHEA, CMG 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. Mr. Collins 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, Mr. Collins gave a presentation entitled “Ephedra, Prohormones ... What's Next? -- How the Federal Government Regulates the Dietary Supplement Industry" at the 2nd Annual ISSN Conference in New Orleans. Also, the new court decision on ephedra has many industry insiders debating its implications. "Ephedra: Interpreting the New Court Ruling" offers some basic considerations. (Feel free to contact CMG for specific advice.)
Call 516-294-0300 or email info@cmgesq.com if you have any legal questions about sports and fitness nutrition supplements. The lawyers of CMG regularly counsel companies in the dietary supplement industry, and uphold a long-standing commitment to strength, health, and consumer freedom to choose safe supplements.