DSEO LLC – FDA Warning Letter

On April 24, 2015, the FDA issued a Warning Letter to DSEO LLC regarding its dietary supplement products, HybriLean and PREAMP. The letter states that these products are adulterated because they contain DMBA (1,3 Dimethylbutylamine), a new dietary ingredient, without the required notification under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6.

The FDA asserts there is no evidence DMBA was lawfully marketed as a dietary ingredient before October 15, 1994, or present in the food supply as an unaltered food article. Furthermore, the FDA states there is no history of use or other safety evidence establishing that DMBA is reasonably expected to be safe. The letter also notes that synthetically produced DMBA is not considered a "dietary ingredient" under section 201(ff)(1) of the Act, as it is not a vitamin, mineral, amino acid, herb, botanical, or a derivative thereof, nor is it commonly used as human food or drink.

DSEO LLC was requested to take prompt action to correct these violations for HybriLean, PREAMP, and any other products containing DMBA. Failure to cease distribution could result in enforcement actions, including product seizure and injunction. A written