FDA WARNING_LETTER - Shen Clinic, LLC - June 25, 2020

On July 6, 2020, the FDA and FTC issued a Warning Letter to Shen Clinic regarding unapproved and misbranded Traditional Chinese Medicine (TCM) products advertised on their website, shenclinic.com, on June 11 and June 25, 2020. The products are marketed to mitigate, prevent, treat, diagnose, or cure COVID-19, making them unapproved new drugs under 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 letter emphasizes the public health emergency declared for COVID-19 and the urgent need to protect consumers from unauthorized products. Shen Clinic is required to immediately cease selling these products. 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 to comply may result in legal action, including seizure and injunction. Shen Clinic will be added to the FDA's public list of firms selling fraudulent COVID-1