SinoTradition.com – FDA Warning Letter, Jul 1, 2020

On July 6, 2020, the FDA and FTC issued a Warning Letter to Sinotradition.com for selling unapproved and misbranded traditional Chinese medicine (TCM) products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA reviewed the website on June 12, 2020, and July 1, 2020, finding the products to be unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act. The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d).

The letter emphasizes the ongoing public health emergency declared for COVID-19. Sinotradition.com is required to immediately cease selling these unapproved products. The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, including steps to prevent recurrence, and providing supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The firm will be added to FDA's public list of companies selling fraudulent COVID-19 products.

The FTC also stated that advertising products to prevent, treat, or cure human disease without competent and reliable scientific evidence, such as well-controlled human clinical studies, violates the FTC Act, 15 U.S.