East Fork Cultivars – FDA Warning Letter, Dec 26, 2023

The FDA issued a Warning Letter to East Fork Hemp, LLC on December 22, 2023, following a September 2023 review of their websites (https://eastforkcultivars.com/, https://eastforkhemp.com/) and social media (Facebook, Instagram). The FDA determined that the company promotes and sells various cannabidiol (CBD) products, including Rescue Rub CBD, CBD Oil, and Peak CBD Solution tinctures, with claims establishing them as unapproved new drugs and misbranded drugs.

The FDA cited violations of sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)) for introducing unapproved new drugs into interstate commerce. Examples of drug claims included statements related to preventing infection, reducing inflammation, and treating COVID-19. The products are considered "new drugs" under section 201(p) (21 U.S.C. 321(p)) because they are not generally recognized as safe and effective for their intended uses and lack FDA approval.

Additionally, the products are misbranded under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) because their labeling fails to bear adequate directions for use,