Carbon Fire, LLC Warning Letter Details

Summary

Carbon Fire, LLC was cited for marketing 213° Metabolism Boosting Complex, a dietary supplement containing N-Methyltyramine, which the FDA classified as a new dietary ingredient not marketed in the U.S. before October 15, 1994. The company failed to demonstrate either that the ingredient had been present in the food supply in unaltered form or that it had submitted safety evidence to FDA at least 75 days before introducing the product into interstate commerce, as required under section 413(a) of the Federal Food, Drug, and Cosmetic Act. This omission rendered the product adulterated and unlawful for distribution.