FDA WARNING_LETTER - Atomixx - April 16, 2019

This FDA Warning Letter, dated April 10, 2019, was issued to Atomixx, specifically addressing their product "Limitless," sold in liquid and capsule forms as a dietary supplement. The core violation identified is that the product labeling lists β-phenyl-γ-aminobutyric acid (phenibut) as a dietary ingredient.

The FDA asserts that phenibut does not fit any of the dietary ingredient categories defined under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)]. These categories include vitamins, minerals, herbs or other botanicals, amino acids, dietary substances for supplementing the diet, or concentrates/metabolites/constituents/extracts/combinations thereof.

Consequently, declaring phenibut as a dietary ingredient causes "Limitless" to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], as its labeling is false or misleading. The letter clarifies that it does not address whether phenibut could be lawfully marketed as a non-dietary ingredient (which would require compliance with food additive regulations or GRAS status).

Atomixx is required to take prompt action to correct this violation. They must notify the FDA in writing within fifteen working days of receiving the letter