FDA WARNING_LETTER - Bioactive C60/FullerLifeC60 LLC - March 27, 2020

On March 30, 2020, the FDA and FTC issued a Warning Letter to Bioactive C60 regarding their product "FullerLifeC60," sold on www.bioactivec60.com. The agencies reviewed the website on March 19 and March 27, 2020.

The FDA determined that "FullerLifeC60" is marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. This renders the product an unapproved new drug under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and a misbranded drug under section 502 (21 U.S.C. § 352). The introduction of such products into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).

The letter cites the public health emergency declared on January 31, 2020, and the national emergency declared on March 13, 2020, related to COVID-19, as context for urgent measures against unapproved products.

Bioactive C60 is required to immediately cease selling these unapproved and unauthorized products for COVID-19 related