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The agency sent warning letters to three more companies for selling unapproved products claiming to treat COVID-19.
On April 14, 2020, FDA announced the agency and the Federal Trade Commission (FTC) have sent three warning letters to companies marketing unapproved products claiming to treat or prevent COVID-19. According to the agency, there are no FDA-approved products currently available to treat or prevent COVID-19, and FDA is exercising its authority to protect consumers.
The first letter, dated April 10, 2020, was sent to Herbs of Kedem, who’s website sells herbal products “intended to mitigate, prevent, treat, diagnose, or cure COVID-19.” FDA considers these products unapproved and in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a) and “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 second letter was sent to The GBS dba Alpha Arogya India Pvt Ltd on April 13, 2020 for promoting ayurvedic products the company claims can prevent and treat COVID-19. In the letter, FDA cites language on the company’s website that claims its products can clear the infection, help protect from coughing and breathing problems, and even prevent infection.
Gaia Arise Farms Apothecary received the third letter, dated April 13, 2020. According to the FDA warning letter, the company’s website claim its products are the “best defense” against “whatever virus you encounter”. Other products claim to inhibit and block coronavirus.
“[…] it is unlawful under the FTC Act [Federal Trade Commission Act], 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the product identified above. Thus, any coronavirus-related prevention or treatment claims regarding such product are not supported by competent and reliable scientific evidence,” FDA stated in the letters.
FDA is giving the companies 48 hours to respond to the letters and provide FDA with plans for resolving 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 in the warning letters.