FDA WARNING_LETTER - Greenway Herbal Products LLC - March 22, 2022
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On March 28, 2022, the FDA and FTC issued a Warning Letter to GreenWay Herbal Products, LLC (d/b/a Tanasi) regarding unapproved and misbranded CBD products related to COVID-19. The FDA reviewed Tanasi's website (tanasi.com) on February 18, 2022, and the FTC reviewed it on March 22, 2022, also noting their Facebook page.
The FDA found that Tanasi's CBD products were marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19, making them 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 of these 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)).
Examples of violative claims included blog posts and social media content suggesting CBD defends against COVID-19, curbs cell infections, prevents coronavirus from entering cells, and helps with recovery and inflammation.
Tanasi must immediately cease selling unapproved and unauthorized COVID-19 related products
ID · 446f8a26-1e10-43b6-9e4a-26c2038994d8
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