FDA WARNING_LETTER - Heavenly Natural Products - November 10, 2020

On December 2, 2020, the FDA and FTC issued a Warning Letter to Heavenly Natural Products regarding unapproved and misbranded products related to COVID-19. The FDA reviewed the company's website and social media on September 11 and November 10, 2020, finding that C60 (Carbon 60) and colloidal silver products, including "AVOCADO C60 ANTI-VIRAL COMBO – VIRUS PREVENTION," were offered for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are cited as unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded drugs under section 502 (21 U.S.C. § 352). The introduction into interstate commerce of these products is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). Examples of violative claims include statements from blog posts and social media linking C60 and colloidal silver to antiviral activity, immune support, and prevention/treatment of COVID-19.

Heavenly Natural Products is required to immediately cease the sale of these unapproved products. Within 48 hours, the company must email COVID-