FDA WARNING_LETTER - Lotus Herbal Supplements - July 01, 2020

On July 6, 2020, the FDA and FTC issued a Warning Letter to Pingxiu Leard of Shijiazhuang Yiling Pharmaceutical Agent US, LLC, regarding the sale of an unapproved and misbranded traditional Chinese medicine (TCM) product on www.lotusherbalsupplements.com. The product is marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19, which the FDA deems an unapproved new drug under section 505(a) and a misbranded drug under section 502 of the FD&C Act.

The letter emphasizes that there are no FDA-approved products for COVID-19 and that the company's claims are misleading. The introduction of this product into interstate commerce violates sections 301(a) and (d) of the FD&C Act. The FTC also noted that the company lacks competent and reliable scientific evidence, including well-controlled human clinical studies, to substantiate its COVID-19 related claims, violating the FTC Act.

The company is required to take immediate action to cease the sale of these products and correct all violations. Within 48 hours, they must email COVID-19-Task-Force-CDER@fda.hhs.gov and rcleland@ftc.gov, detailing corrective steps, recurrence prevention, and supporting documentation. Failure to comply may result in legal action, including seizure, injunction