FDA WARNING_LETTER - Unlimited Nutrition - February 17, 2010

On February 16-17, 2010, the FDA inspected Unlimited Nutrition Scivation, Inc. and reviewed its website, www.smartpowders.com. The FDA found that the firm was marketing products in violation of the Federal Food, Drug, and Cosmetic Act.

The "Smart Powders Piracetam" and "Primaforce Piracetam" products were marketed as dietary supplements but were excluded from this definition because piracetam is not a dietary ingredient. Claims like "supports memory and concentration" indicate these products are intended to affect body function, classifying them as unapproved new drugs under sections 201(g)(1)(C) and 201(p) of the Act. Their sale without FDA-approved applications violates sections 301(d) and 505(a).

Additionally, "Advanced Muscle Science Arom-X," "Advanced Muscle Science 4-AD UTT," "G.E.T ArimaDex," "iForce Nutrition Reversitol," and "Fizogen Off Cycle II Hardcore" were marketed as dietary supplements but contain ATD, which is not a dietary ingredient. Claims such as "Anti-estrogen complex" and "Natural testosterone booster" classify these as unapproved new drugs under sections 201(g)(1)(C) and 201(p), violating sections 301(d) and 505