New York Nutrition Company
FDA issued a warning letter to New York Nutrition Company (American Metabolix) regarding its dietary supplement products 'Lean Muscle For Her' and 'Lean Muscle,' which were found to contain 5-alpha-hydroxy-laxogenin, a substance that does not qualify as a dietary ingredient under the FD&C Act. Because this substance is neither GRAS nor approved as a food additive, the products are deemed adulterated under section 402(a)(2)(C)(i) of the FD&C Act. The company was directed to respond within 15 working days with corrective steps, and FDA warned that failure to comply 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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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