Unlimited Nutritions Dietary Ingredients Raise FDA Concerns

GRAHAM, N.C.Unlimited Nutrition received a warning letter from FDA in late August, questioning the marketing of several dietary supplement products, including two items containing piracetam (a cyclic derivative of GABA) and other sports nutrition items.

FDA cited concerns about Smart Powders Piracetam and Primaforce Piracetam, specifically stating the products, marketed as dietary supplements, do not contain any dietary ingredients" approved for sale in the United States, meaning the products do not qualify as dietary supplements. While Unlimited Nutrition did submit a new dietary ingredient notification (NDIN) in 2003 for piracetam, FDA responded in 2004 that it did not consider piracetam to be a dietary ingredient. If the products are not dietary supplements, the agency determined certain structure/function claims made on the products relating to support of memory, cardiovascular health, and reduction of stress and fatigue position the products as unapproved drugs.

In the sports nutrition arena, FDA stated Unlimited Nutritions products Advanced Muscle Science Arom-X, Advanced Muscle Science 4-AD UTT, G.E.T. ArimaDex, iForce Nutrition Reversitol and Fizogen Off Cycle II Hardcore are all unapproved and misbranded drugs. The agency stated all the products cite ingredients that are synonyms for ATD," an aromatase inhibitor that is not recognized as a dietary ingredient allowed for use in dietary supplements. As with the previous products, because these items would therefore not qualify as dietary supplements, the structure/function statements used in marketing position the products as unapproved new drugs. FDA added it was concerned about possible toxicity or potential harm if the products were used without supervision of a practitioner, particularly as labeling fails to carry adequate directions for use" as required of prescription drugs.