Bioactive C60/FullerLifeC60 LLC – FDA Warning Letter, Mar 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
ID · 46069005-a770-4117-951a-1612519fafcd
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.