FDA WARNING_LETTER - Cathay Natural, LLC - April 03, 2020

On April 6, 2020, the FDA and FTC issued a Warning Letter to Cathay Herbs regarding their website, www.cathayherbs.com. The agencies reviewed the website on March 27, 2020, and April 3, 2020, respectively.

The FDA observed that Cathay Herbs offers herbal products for sale in the United States, claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs, violating section 505(a) of the FD&C Act, 21 U.S.C. § 355(a), and misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).

The letter emphasizes the public health emergency declared for COVID-19. Cathay Herbs is required to immediately cease selling these unapproved and unauthorized products. The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions and providing supporting documentation. Failure to comply may result in legal