FDA WARNING_LETTER - Carbon Fire, LLC - May 14, 2024

The FDA issued a Warning Letter to David Woods regarding the product "213° Metabolism Boosting Complex," labeled as a dietary supplement. The letter, dated March 1, 2024, states that the product is adulterated under the Federal Food, Drug, and Cosmetic Act (the Act) because it contains N-Methyltyramine, a new dietary ingredient (NDI).

N-Methyltyramine is considered an NDI as there is no information demonstrating its lawful marketing as a dietary ingredient in the U.S. before October 15, 1994, nor its presence in the food supply as an unchemically altered food article. Therefore, it is subject to the NDI notification requirement under section 413(a)(2) of the Act and 21 CFR 190.6. The FDA has not received any NDI notifications for N-Methyltyramine.

Introducing or delivering this product into interstate commerce is prohibited under sections 301(a) and (v) of the Act because it is an adulterated dietary supplement. The letter requires a written response within fifteen working days detailing specific corrective actions taken, an explanation of steps to prevent recurrence, and supporting documentation. If corrective actions cannot be completed within this timeframe, the reason for delay and a timeline must be provided. Failure to adequately address the violations may result in legal action, including seizure and injunction.