FDA WARNING_LETTER - MusclMasster, LLC - May 12, 2017

The FDA issued a Warning Letter to MusclMasster, LLC following inspections from February 15-23, 2017, and March 30-May 12, 2017, at their Wheat Ridge, CO facility. The letter identifies serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.

**Key Violations:**

1. **Adulterated Dietary Supplement (AL-ER-G):** Laboratory analysis confirmed the presence of ephedrine alkaloids in the "AL-ER-G" product, rendering it adulterated under section 402(f)(1)(A)(ii) of the Act, as it presents a significant or unreasonable risk of illness or injury. The firm voluntarily destroyed Ephedra-containing ingredients and issued a nationwide recall for AL-ER-G.

2. **Unapproved New Drugs/Misbranded Drugs:** Products like Vas-Q-Lar, Vir-L IV, and Nu Woman are marketed with claims on their website and labels indicating intended use for curing, mitigating, treating, or preventing disease (e.g., diabetes, acid reflux, stroke, hypertension, cancer, depression). These claims classify them as "new drugs" under section 201(p)(1) of the Act, requiring FDA approval before interstate commerce. Additionally, Vas-Q-Lar and Vir-L IV are misbranded under section 5