A recent decision by FDA to reject a company’s citizen petition to classify homotaurine as a dietary ingredient may have far-reaching implications for the sports nutrition supplement industry.
Homotaurine was previously studied by a pharmaceutical company as an investigational new drug to treat Alzheimer’s disease. When the results proved disappointing for a viable pharmaceutical, the compound was withdrawn from clinical trials. But homotaurine showed enough promise for the company to form a subsidiary called OVOS Natural Health, Inc., which submitted a citizen petition to FDA in June 2009 requesting the promulgation of a regulation permitting the marketing of the New Dietary Ingredient (NDI) “homotaurine” for use in dietary supplements. Permission from FDA is required when a company is seeking to market a NDI that was previously investigated as a new drug. The company intended to market homotaurine not as a drug, but as a dietary supplement for memory protection. OVOS simultaneously submitted the required 75-day pre-market notification to FDA that it would be marketing the compound (under the brand name Vivimind).
In February 2011, after 15 months, FDA finally issued a letter responding to OVO’s requests with a thumbs’ down on Vivimind, stating that homotaurine was not a dietary ingredient because it was not, as required under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)(1)), a “vitamin”, “mineral”, “herb or other botanical”, “amino acid”, “dietary substance for use by man to supplement the diet by increasing the total dietary intake” or a “concentration, metabolite, constituent, extract, or combination of” any of the above categories.
OVOS had claimed homotaurine was a dietary ingredient because it is an amino acid, but FDA countered that the term “amino acid” must be taken in the nutrition science context regarding supplements, not the organic chemistry context. Thus, because homotaurine is a gamma-amino sulfonic acid, not an alpha-amino carboxylic acid (the kind in proteins), FDA said it wasn’t a dietary ingredient.
More interestingly, FDA said that homotaurine failed to fit into any of the other categories for a dietary ingredient (e.g., a botanical) because although homotaurine is naturally found in seaweed (kelp), the homotaurine in Vivimind is made synthetically, not extracted from a plant. This is a key point for the sports nutrition market, because when a chemical that is found in miniscule concentrations in a plant, but is synthetically produced to put into a supplement, is determined not to be a dietary ingredient under the law, then it’s an adulterated/misbranded drug … and introducing it into interstate commerce is a federal crime.
You won’t find Vivimind marketed in America. But what about similar type “botanical” ingredients in sports nutrition products – ingredients found in uncommonly eaten plants but synthetically replicated for supplement products? Manufacturers, distributors and retailers (and their principals) bear the risk of prosecution, especially if, unlike OVOS, they simply introduced the products to market without notifying FDA.
As counsel within the sports nutrition category, the lawyers at Collins, McDonald & Gann have long suggested to the industry at large to make sure that everything contained in your products meets the definition of a dietary ingredient. It’s the best way to protect consumers, minimize the risk of civil or criminal litigation, and keep the market healthy. An industry thrives when everyone plays by the rules. When some companies push the envelope with illegal products, the others may be competitively disadvantaged. Tougher regulations on everyone also naturally flow.