Carbon Fire, LLC
FDA issued a warning letter to Carbon Fire, LLC (Saint Louis, MO) regarding its dietary supplement product '213° Metabolism Boosting Complex,' which contains N-Methyltyramine, a new dietary ingredient (NDI) not marketed in the U.S. before October 15, 1994. FDA determined the product is adulterated under the Federal Food, Drug, and Cosmetic Act because no NDI notification was submitted to FDA as required under section 413(a)(2) and 21 CFR 190.6. The agency warned that failure to address the violations may result in seizure or injunction, and required a written response within fifteen working days.
Flagged claims (1)
213° Metabolism Boosting Complex
Required actions (2)
Within fifteen working days of receipt of this letter, please notify FDA 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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