FDA WARNING_LETTER - Smoky Mountain Naturals, LLC - December 15, 2020

On December 2, 2020, the FDA issued Warning Letter No. 609235 to Mr. Jetton, regarding products sold on www.smnutrition.com. An FDA review in November 2020 found that "Evening Primrose Oil" and "Beta Glucan" products are marketed with claims establishing them as drugs under section 201(g)(1)(B) of the FD&C Act, intended for disease treatment, cure, mitigation, or prevention.

Specific claims cited include "Evening Primrose Oil" for Psoriasis, Eczema, Inflammation-related Acne, and High Blood Pressure, and "Beta Glucan" for "Immune Boosting." These products are deemed "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their claimed uses. Introducing or delivering these new drugs into interstate commerce without FDA approval violates sections 301(d) and 505(a) of the Act.

Furthermore, the products are misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson. As they are intended for conditions not amenable to self-diagnosis or treatment, they require supervision by a licensed practitioner, making it impossible to provide adequate directions for lay use. The introduction of these misbranded drugs into interstate commerce violates section 301(