Herbs of Kedem – FDA Warning Letter, Apr 9, 2020
On April 10, 2020, the FDA and FTC issued a Warning Letter to Kedemnatural.com after reviewing their website on March 31 and April 9, 2020. The FDA observed the website offering herbal products for sale in the U.S. with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.
These products are deemed unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. § 355(a), and misbranded drugs under section 502, 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.
Kedemnatural.com must immediately cease selling these unapproved and unauthorized products for COVID-19 related uses. The company is required to 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 legal action, including seizure and injunction. The firm will be added to
ID · 666eae6f-ad32-4f51-ad2a-de2647c8f392
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