3RD Day Nutraceuticals, LLC – FDA Warning Letter, Aug 10, 2021

The FDA issued a Warning Letter to 3rd Day Nutra after reviewing its website in April 2021, identifying products Immune Booster, Allergy Support, Inflammatory Response Support, and Revive & Recover. The FDA determined that claims made on the website establish these products as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act, as they are intended for disease treatment or prevention. Consequently, introducing these products into interstate commerce violates the Act. Furthermore, the products are considered "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their intended uses. New drugs require prior FDA approval before interstate commerce introduction, as per sections 301(d) and 505(a). The products are also deemed misbranded under section 502(f)(1) because they fail to bear adequate directions for use, as their intended purposes are not amenable to self-diagnosis or treatment by a layperson without professional supervision (21 CFR 201.5). The introduction of these misbranded drugs into interstate commerce violates section 301(a). The firm is required to notify the FDA in writing within 15 working days of the specific steps taken to address these violations and prevent recurrence, with failure to comply potentially leading to legal action, including seizure and injunction.