Honey Feast, Inc. – FDA Warning Letter, Mar 17, 2022

The FDA issued a Warning Letter to Honeyfeast following a review of their website (honeyfeast.com) in February through March 2022. The agency determined that the company's products, including Raw Honeycomb, Tupelo Honey Raw, and Superfood Honey with Royal Jelly, Bee Pollen, Propolis, are marketed with disease claims, establishing them as unapproved new drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. These products are not generally recognized as safe and effective, making them "new drugs" under section 201(p) [21 U.S.C. 321(p)], which require prior FDA approval for interstate commerce (sections 301(d) and 505(a)). Furthermore, the products are deemed misbranded under section 502(f)(1) [21 U.S.C. 352(f)(1)] because they lack adequate directions for use, as their intended purposes are not amenable to self-diagnosis or treatment by a layperson. The introduction of these unapproved new drugs and misbranded drugs into interstate commerce violates sections 301(d), 505(a), and 301(a) of the Act. Honeyfeast must respond in writing within 15 working days, detailing corrective actions, prevention measures, and supporting documentation, or face potential legal action, including seizure and injunction.