On June 26, 2020, the FDA issued a warning letter to SuperHealthGuard and Loyal Great International Ltd. for selling traditional Chinese medicine products with unsupported claims that they can treat coronavirus (COVID-19).
The company was promoting the product Lianhua Qingwen capsule with statements such as, "Traditional Chinese medicine Lianhua Qingwen capsule has been proven effective for the treatment of COVID-19. China's top respiratory expert Zhong Nanshan said... 'It's the first time in the world that we have enough evidence to prove Lianhua Qingwen capsule is effective and can help patients recover'" and "...after taking the capsule, patients' symptoms improve quickly..."
The FDA has previously stated: "There currently are no vaccines, pills, potions, lotions, lozenges or other prescription or over-the-counter products available to treat or cure coronavirus disease 2019 (COVID-19)."
The agency instructed the companies to send an email to COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours of receipt of the warning, describing the specific steps they have taken to correct these violations.
For other Recalls and Warnings click HERE.For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.
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