Reddy Naturals, LLC – FDA Warning Letter, Dec 18, 2020

The FDA issued a Warning Letter to Reddy Naturals on December 18, 2020, following a review of their websites (www.reddynaturals.com and www.facebook.com/ReddyNaturals) in December 2020. The letter addresses the marketing of ten products: “Glycostasis,” “Glucosamine Curcumin,” “Turmeric 50,” “Turmeric Curcumin,” “Cetyl Curcumin,” “Ashwagandha,” “Huruli,” “Black Seed Oil,” “Curcumin Turmerone,” and “Ashwagandha Honey.” The FDA determined that claims made on the company's websites establish these products 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)] because they are intended for the cure, mitigation, treatment, or prevention of disease. Specifically, the products are not generally recognized as safe and effective for their claimed uses, rendering them "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)]. Introducing these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. Furthermore, the products are deemed misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] because they fail to bear adequate directions for use, as their intended disease treatments are not amenable to self-diagnosis or treatment by a layperson. The introduction of these misbranded drugs into interstate commerce violates section 301(a) of the Act [21 U.S.C. 331(a)]. Reddy Naturals is required to take prompt corrective action and respond in writing within fifteen working days, detailing steps taken to correct violations and prevent recurrence, or face potential legal action including seizure and injunction.