FDA WARNING_LETTER - Lecheek Nutrition Inc dba Insane Labz

The FDA issued a Warning Letter to Lecheek Nutrition concerning their dietary supplement products, AMPilean and AMPitropin, which declare AMP citrate (DMBA) as a dietary ingredient. The FDA states that DMBA is a "new dietary ingredient" as defined by section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR 190.6, requiring a notification to the FDA. To the FDA's knowledge, DMBA was not lawfully marketed as a dietary ingredient before October 15, 1994, nor has it been present in the food supply as an unchemically altered food.

Consequently, since the required notification was not submitted, AMPilean and AMPitropin are deemed adulterated under sections 402(f)(1)(B) and 413(a) of the Act. Furthermore, the FDA states there is no evidence establishing DMBA's safety when used as a dietary ingredient, leading to further adulteration under the same sections due to inadequate safety information. The letter also notes that synthetically produced DMBA is not considered a "dietary ingredient" under section 201(ff)(1) of the Act.

Lecheek Nutrition is requested to promptly correct these violations and any others related to their products containing DMBA. Failure to cease distribution could result in enforcement actions, including product seizure and injunction.