FDA WARNING_LETTER - Dominant Nutrition LLC formerly 8 Weeks Out Labs - October 21, 2021

The FDA issued a Warning Letter to Dominant Nutrition on October 21, 2021, following a September 2021 review of their website, dominant-nutrition.com. The letter identifies serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to their products ADIPROPEN ULTRA, SUPERJOINTS, OPTIMUM-CLA, and LipogenX.

The product LipogenX is deemed an adulterated dietary supplement because it contains Hordenine, a "new dietary ingredient" under section 413(d) of the FD&C Act, for which no new dietary ingredient notification was submitted to the FDA. Furthermore, there is no evidence Hordenine was lawfully marketed before October 15, 1994, or has a history of safe use as a food ingredient. This violates sections 402(f)(1)(B) and 413(a) of the FD&C Act.

Additionally, ADIPROPEN ULTRA, SUPERJOINTS, and OPTIMUM-CLA are considered unapproved new drugs under section 201(p) of the FD&C Act because their website claims indicate they are intended for disease treatment, cure, mitigation, or prevention. These products are not generally recognized as safe and effective for such uses and lack FDA approval, violating sections 301(d) and 505(a) of