Todos Medical Ltd aka Todos Medical USA Inc – FDA Warning Letter, Jun 23, 2022
On November 7, 2022, the FDA issued a Warning Letter to Todos Medical regarding the unapproved and misbranded product Tollovid 3CL Protease Inhibitor Delayed Release (Tollovid). The FDA reviewed the company's websites (todosmedical.com, mytollovid.com, tollovid.myshopify.com), social media (Facebook, YouTube), and Amazon storefront on June 23, 2022.
The FDA found that Tollovid is offered for sale in the U.S. and is intended to mitigate, prevent, treat, diagnose, or cure COVID-19. This product is an unapproved new drug, violating section 505(a) of the FD&C Act, and is misbranded under section 502. The introduction of this product into interstate commerce is prohibited by sections 301(a) and (d).
The letter cites specific claims from the company's websites and social media, such as "3CL Protease Inhibitors: The Potential Key to Combating the SARS-CoV-2 Virus Life Cycle" and "Tollovir,™ a highly potent 3CL protease inhibitor as a COVID-10 antiviral." Testimonials on mytollovid.com also indicate intended use for COVID-19 treatment and prevention.
Todos Medical is required to take immediate action to cease the sale of all unapproved and unauthorized
ID · 67ffaac3-97a1-4c97-b560-acae31bf37cc
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