Bee Healthy Farms LLC – FDA Warning Letter, Jul 11, 2023

The FDA issued a Warning Letter to Bee Healthy Farms on May 3, 2023, following website reviews in September-October 2022 and March-April 2023. The FDA determined that products sold on www.beehealthyfarms.com, including Bee Healthy Farms Bee Propolis Capsules (1000 mg), Bee Healthy Farms Royal Jelly Capsules, Bee Healthy Farms Organic Clover Honey Sticks, Propolis Mint Chewing Gum, Kontak Organic Children’s Propolis Extract 20%, and Propolit Propol Caps, are unapproved new drugs and misbranded drugs.

The claims on the website, such as "treat early signs of a sore throat," "antibacterial," "antiviral," "antitumor," "anti-inflammatory," "enhances the effects of prescribed antibiotics," "sped up the healing of bone fractures," and "increase the success of chemotherapy," establish the products' intent for disease treatment or prevention. These claims render the products drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

Since these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) of the Act. Introducing or delivering new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act