FDA WARNING_LETTER - Mind, Body & Coal LLC - July 29, 2020

The FDA issued a Warning Letter to Ms. Smith after reviewing the website miracoal.com and Amazon.com in June 2020, where the product Miracoal – Ultimate Hangover Relief and Total Body Detox is sold. The FDA determined that claims made for the product, such as "Ultimate Hangover Relief" and "PUT YOUR HANGOVER TO BED," establish its intended use in the cure, mitigation, treatment, or prevention of disease. This classifies Miracoal as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 321(g)(1)(B)], as a hangover is considered a symptom of alcohol intoxication, a disease. Furthermore, the product is deemed an unapproved "new drug" under section 201(p) [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its claimed uses. Introducing such 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 FDA requires prompt corrective action, with a written response detailing steps taken to correct violations and prevent recurrence due within fifteen working days. Failure to comply may result in legal action, including seizure and injunction.