Muscle Sport Products LLC – FDA Warning Letter, Sep 27, 2022
The FDA issued a Warning Letter to MuscleSport, LLC, following reviews of their websites (www.musclesport.com, www.purgesports.com, www.musclemilitia.com, www.kodiaksupps.com) and social media (https://www.facebook.com/OptituneNutrition/) in May and September 2022. The FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act.
The products CardioBurn For Her Powder, Rhino Rampage Capsules™, Joint Revolution™ Capsules, STRESS B-COMPLEX, IMMUNITY + Powder, Apple Cider Vinegar Capsules, THERMX™ Powder, HYPEX Powder, RECOMP Capsules, Attack™ Pre-Workout Powder, and Coma™ Sleep & Recovery Activator Lemon Drop Powder are deemed unapproved new drugs under section 201(g)(1)(B) and 201(p) of the Act because their website claims indicate they are intended for use in the cure, mitigation, treatment, or prevention of disease. Specifically, IMMUNITY + Powder is cited for COVID-19 related claims. Introducing these products into interstate commerce without FDA approval violates sections 301(d) and 505(a) of the Act.
Furthermore, CardioBurn For Her Powder, IMMUNITY + Powder, and HYPEX Powder are misbranded under section 502(f)(1) of the Act
ID · 5236087a-0794-41d0-9f48-de755a2bb677
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