FDA WARNING_LETTER - SANA Group LLC - February 19, 2021

The FDA issued a Warning Letter to Mr. Harris after reviewing the website www.sleepsana.com in December 2020, determining that the "Sleep Drops" and "Sleep Shots" products are marketed with claims establishing them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), as they are intended for disease treatment. These products are considered "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 these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act. Furthermore, the products are misbranded under section 502(f)(1) of the Act because they fail to bear adequate directions for use, as their intended purposes are not amenable to self-diagnosis or treatment by a layperson. The introduction of these misbranded drugs into interstate commerce also violates section 301(a) of the Act. The firm is required to take prompt action to address these violations and notify the FDA in writing within fifteen working days, detailing corrective steps, recurrence prevention measures, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction.