FDA WARNING_LETTER - Griffo Botanicals - October 01, 2020

On October 7, 2020, the FDA and FTC issued a Warning Letter to Griffo Botanicals regarding unapproved and misbranded herbal tincture products marketed for COVID-19. The agencies reviewed the company's websites (griffobotanicals.com, facebook.com/griffobotanicals, instagram.com/griffobotanicals) on September 15 and October 1, 2020.

The FDA determined that the products are unapproved new drugs under Section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) because they are intended to mitigate, prevent, treat, diagnose, or cure COVID-19. They are also misbranded drugs under Section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by Sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FTC found that claims of preventing, treating, or curing COVID-19 lack competent and reliable scientific evidence, violating the FTC Act (15 U.S.C. 41 et seq.).

Griffo Botanicals must immediately cease selling these unapproved products and remove all COVID-19-related claims. Within 48 hours,