FDA WARNING_LETTER - Ironmag Labs - May 09, 2022

The FDA issued a Warning Letter to IronMagLabs concerning their products CBD Gummies, Ephedra Stack, Lean Fuel V2, and Stimulate, labeled as dietary supplements. The FDA determined these products are unapproved new drugs and, in the case of CBD Gummies, also a misbranded drug, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Ephedra Stack, Lean Fuel V2, and Stimulate products are deemed adulterated dietary supplements because they contain higenamine and hordenine, which are "new dietary ingredients" not lawfully marketed before October 15, 1994, and for which no new dietary ingredient notifications were submitted to the FDA. Furthermore, the FDA found no evidence establishing their safety as dietary ingredients.

The CBD Gummies product cannot be a dietary supplement because CBD is excluded from the dietary supplement definition under the FD&C Act, as it is an active ingredient in an approved drug product or authorized for new drug investigation.

All four products (CBD Gummies, Ephedra Stack, Lean Fuel V2, and Stimulate) are considered unapproved new drugs due to therapeutic claims on the company's website, such as "pain relief," "decreases anxiety & depression," and "anti-inflammatory," indicating their intended use in the cure, mitigation, treatment, or prevention of disease. These products are not generally recognized as safe and effective for these uses.

Additionally, CBD Gummies are misbranded because they lack