FDA WARNING_LETTER - Ivermectin24h.com - March 15, 2022

On February 25, 2022, the FDA issued a Warning Letter to www.ivermectin24h.com following a website review on December 13, 2021. The FDA observed the website offering drug products, including "Hydroxychloroquine," for sale in the U.S., claiming to mitigate, prevent, treat, diagnose, or cure COVID-19 and other diseases like malaria, lupus erythematosus, and rheumatoid arthritis.

The FDA determined these products are misbranded drugs under section 503(b) of the FD&C Act [21 U.S.C. § 353(b)]. Specifically, hydroxychloroquine is a prescription drug under section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)] due to its toxicity and potential for harmful effects, requiring supervision by a licensed practitioner. The website offers this drug without requiring a prescription, violating section 503(b)(1) and section 301(k) of the FD&C Act [21 U.S.C. § 331(k)]. Furthermore, offering these drugs for sale to U.S. consumers causes the introduction of misbranded drugs into interstate commerce, violating section 301(a) of the FD&C Act [21