FDA WARNING_LETTER - Double Wood LLC - July 29, 2020

The FDA issued a Warning Letter to Mr. Wood after reviewing websites (https://doublewoodsupplements.com/products/dycetin-box and https://www.dycetin.com/) in June 2020, where the product Dycetin was offered for sale. The agency determined that claims made on these websites establish Dycetin as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], due to its intended use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims include preventing hangovers, protecting the liver and brain from alcohol damage, and reducing alcohol intoxication. The FDA explicitly states that a hangover is a sign or symptom of alcohol intoxication, which is classified as a disease. Consequently, Dycetin is deemed a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for these uses. Introducing or delivering an unapproved new drug into interstate commerce violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. The firm is required to take prompt action to correct these violations and notify the FDA in writing within fifteen working days, detailing corrective steps and providing documentation. Failure to comply may lead to legal action, including product seizure and injunction.