Plum Dragon Herbs, Inc. – FDA Warning Letter, May 1, 2020
On May 8, 2020, the FDA issued a Warning Letter to Plum Dragon Herbs after reviewing their website, www.plumdragonherbs.com, on May 1, 2020. The FDA observed that Plum Dragon Herbs was offering traditional Chinese medicine (TCM) products for sale in the U.S. that were intended to mitigate, prevent, treat, diagnose, or cure COVID-19.
The FDA determined these products are unapproved new drugs, sold in violation of section 505(a) of the FD&C Act, and misbranded drugs under section 502 of the FD&C Act. The introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act.
Examples of claims cited include "Wen Bing Defense formula, Huang Qin Extract and Wildcrafted Osha Root Extract may continue to provide beneficial support against COVID-19" and "Shanghan Lun Defense liquid extract formula...intended for use for those who become exposed or infected to support immunity and overall health."
Plum Dragon Herbs was instructed to immediately cease the sale of these unapproved and unauthorized products for COVID-19. They 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
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