FDA WARNING_LETTER - Innovative Medicine LLC - November 02, 2020

The FDA and FTC issued a Warning Letter on November 17, 2020, to Innovative Medicine, citing violations related to unapproved and misbranded products marketed for COVID-19. The FDA reviewed the websites https://innovativemedicine.com/ and https://nadovim.com/ on September 15 and November 2, 2020, respectively, and the social media site http://www.instagram.com/nadovim/.

The product "Nadovim" is offered for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19, making it an unapproved new drug under section 505(a) and a misbranded drug under section 502 of the FD&C Act. Its introduction into interstate commerce is prohibited by sections 301(a) and (d).

Additionally, Innovative Medicine participates in the Amazon Associates program, promoting "Amazon associate products" with similar COVID-19 claims on https://innovativemedicine.com/. These claims cause the Amazon associate products to be unapproved new drugs and misbranded drugs, violating sections 505(a) and 502, and their introduction into interstate commerce is prohibited by sections 301(a) and (d). Doing any act that results in a drug being misbranded while held for sale after interstate shipment is also prohibited under section 301(k).