Half Hill Farm Inc – FDA Warning Letter, Aug 31, 2020

The FDA reviewed Halfhill Farm's website, www.halfhillfarm.com, in August 2020 and determined that products including Reuma-Art X-Strength, Turkey Tail Mushroom Dual Extract, Cordyceps Mushroom Dual Extract, Lion’s Mane Mushroom Dual Extract, Chaga Mushroom Dual Extract, Red Reishi Mushroom Dual Extract, and Propolis Extract are marketed with claims establishing them as drugs under section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)]. These claims, such as "anti-inflammatory" properties for Reuma-Art X-Strength ingredients and scientific citations for Turkey Tail Mushroom Dual Extract, indicate intended use for disease cure, mitigation, treatment, or prevention.

These products are considered "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for their referenced uses. Introducing new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. 331(d), 355(a)].

Furthermore, these products are misbranded under section 502(f)(1) of