FDA WARNING_LETTER - PharmaCanna - January 03, 2023

On January 5, 2023, the FDA and FTC issued a Warning Letter to Pharmacanna regarding unapproved and misbranded products related to COVID-19. The agencies reviewed Pharmacanna's website (https://www.pharmacanna.com) on November 30, 2022, and January 3, 2023, and social media (Facebook, YouTube) where the company directs consumers to purchase cannabinoid products, including "CBDefense 2000."

The FDA determined that "CBDefense 2000" is offered for sale in the U.S. and is intended to mitigate, prevent, treat, diagnose, or cure COVID-19. This product is an unapproved new drug, violating 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). Its introduction into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)).

The letter cites the ongoing COVID-19 public health emergency and national emergency declarations as reasons for urgent action. Pharmacanna is required to immediately cease selling all unapproved and unauthorized products claiming to mitigate, prevent,