FDA WARNING_LETTER - Natural Sprout Co. LLC - September 30, 2020

The FDA issued a Warning Letter to Mr. Aton on October 29, 2020, following a September 2020 review of the websites www.natsprout.com and https://stmarcusorganics.com. The letter states that products sold, including various sprout powders and capsules (e.g., Alfalfa, Barley, Broccoli, Fenugreek, Mung Bean, Oat, Soy, Spelt, High Antioxidant Blend), are promoted with claims establishing them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. These claims indicate the products are intended for disease cure, mitigation, treatment, or prevention.

The FDA asserts these products are "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their intended uses. Introducing or delivering new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act.

Furthermore, several products (Alfalfa, Barley, Broccoli, Buckwheat, High Antioxidant Blend, Mung Bean, Oat, Soy Sprout Powders and Capsules) are deemed misbranded under section 502(f)(1) of the Act [