Performax Labs Inc
FDA's Center for Food Safety and Applied Nutrition issued a warning letter to Performax Labs Inc. (Torrance, CA) regarding two products — Brute BCAA and Predator Pro — labeled as dietary supplements. Both products declare 5-alpha-hydroxy-laxogenin as a dietary ingredient; however, FDA determined this substance does not qualify as a dietary ingredient under the FD&C Act and is not GRAS, making it an unapproved food additive. As a result, both products are deemed adulterated under section 402(a)(2)(C)(i) of the FD&C Act, and FDA warned that failure to address the violations may result in seizure or injunction.
Flagged claims (1)
5a-Hydroxy-Laxogenin
Required actions (2)
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction
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