FDA WARNING_LETTER - The Art Of Cure - April 13, 2020

On April 15, 2020, the FDA and FTC issued a Warning Letter to The Art of Cure regarding unapproved and misbranded homeopathic drug products marketed for COVID-19. The agencies reviewed the company's websites, theartofcure.net and facebook.com/TheArtOfCure/, on April 1 and April 13, 2020.

The FDA found that the products are unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FTC determined that claims of preventing, treating, or curing COVID-19 lacked competent and reliable scientific evidence, violating the FTC Act (15 U.S.C. 41 et seq.).

The letter demands immediate cessation of sales of these unapproved products for COVID-19. The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure