FDA WARNING_LETTER - Lianhuaqingwencaps.com - July 01, 2020

On July 6, 2020, the FDA and FTC issued a Warning Letter to the operator of lianhuaqingwencaps.com for selling unapproved and misbranded products related to COVID-19. The website, reviewed on June 15 and July 1, 2020, offered a traditional Chinese medicine product claiming to mitigate, prevent, treat, diagnose, or cure COVID-19.

This product is an unapproved new drug under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and a misbranded drug under section 502 (21 U.S.C. § 352). Its introduction into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FDA emphasized urgent measures to protect consumers during the COVID-19 public health emergency declared on January 31, 2020, and the national emergency declared on March 13, 2020.

The letter demands immediate cessation of sales for these unapproved and unauthorized 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