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The agency sent a warning letter to Chloroquineonline.com for selling unapproved products for the treatment of COVID-19.
Another warning letter has gone out to a company offering “treatments” for COVID-19. The agency sent the letter, dated May 18, 2020, to Chloroquineonline.com after reviewing the company’s website and finding products reporting to prevent COVID-19, including chloroquine phosphate marketed as "Generic Aralen".
“Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d),” the letter states.
The letter goes on to state that FDA-approved versions of chloroquine on the market are approved by prescription for the treatment of malaria and extraintestinal amebiasis and “no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19”. FDA also stated that there are no approved drug applications in effect for the products listed on the company’s website.
The agency gave the company 48 hours to email the COVID-19 taskforce with steps the company intends to take to correct the violations. “Failure to immediately correct the violations cited in this letter may result in legal action, including, without limitation, seizure and injunction,” the agency stated.