FDA WARNING_LETTER - Beta Labs

The FDA issued a Warning Letter to Beta Labs regarding their product, Oxyphen XR Amp’d?, labeled as a dietary supplement. The product's Supplement Facts panel declares 4-AMP (4-Amino methylpentane citrate), also known as DMBA, as a dietary ingredient.

The FDA states that DMBA is a "new dietary ingredient" for which a notification is required under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR 190.6. To the best of FDA's knowledge, DMBA was not lawfully marketed as a dietary ingredient in the U.S. before October 15, 1994, nor has it been present in the food supply as an unchemically altered food. Since the required notification was not submitted, Oxyphen XR Amp’d? is deemed adulterated under sections 402(f)(1)(B) and 413(a) of the Act.

Furthermore, the FDA indicates there is no evidence establishing DMBA's safety when used as a dietary ingredient, rendering the product adulterated under the same sections due to inadequate safety information. The letter also notes that synthetically produced DMBA is not considered a "dietary ingredient" as defined in section 201(ff)(1) of the Act.

Beta Labs is requested to take prompt action to correct