FDA WARNING_LETTER - Mountain Peak Nutritionals - February 19, 2021

The FDA reviewed Mountain Peak Nutritionals' website in December 2020 and determined that their "Mood Support" product is marketed with claims establishing it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], due to its intended use in the cure, mitigation, treatment, or prevention of disease.

The product is deemed a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its referenced uses. Introducing or delivering this product into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)].

Furthermore, "Mood Support" is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] as it lacks adequate directions for use. Since it's intended for diseases not amenable to self-diagnosis or treatment, adequate directions for a layperson cannot be provided, making it a misbranded drug. The introduction of misbranded drugs