Episode 3: DMHA and Phenibut - Warning Letters

Performax Labs

The FDA has sent 11 companies (so far) for marketing dietary supplements that don’t meet its "guidelines".

The agency issued warnings to three companies for marketing dietary supplements containing phenibut, which is sometimes sold as a sleep aid or to treat anxiety. It said that phenibut doesn’t meet the statutory definition of a dietary ingredient, which is generally a vitamin, herb or other natural substance used to supplement the diet.
These products are considered adulterated because the FDA has determined that DMHA is either a “new dietary ingredient” for which the FDA has not received the required New Dietary Ingredient notification or that DMHA is an unsafe food additive.

But is it REALLY?