Baker's Best Health Products, Inc. – FDA Warning Letter, Dec 20, 2017

On December 13-20, 2017, an FDA inspection of Baker's Best Health Products, Inc. identified serious violations of the Federal Food, Drug, and Cosmetic Act. The company's products, including Colon Formula, Eterni-D, Triple Action Joint Formula, and Apple Cider Vinegar+, are marketed with claims on their website and in pamphlets that establish them as unapproved new drugs under Section 201(g)(1)(B) of the Act, as they are intended for disease treatment or prevention. These products are not generally recognized as safe and effective for their claimed uses, making them "new drugs" under Section 201(p), requiring prior FDA approval.

Furthermore, Eterni-D and Apple Cider Vinegar+ are misbranded under Section 502(f)(1) because they lack adequate directions for layperson use, as they address conditions requiring professional supervision. The introduction of these misbranded drugs into interstate commerce violates Section 301(a).

Additionally, several products are misbranded dietary supplements under Section 403. Eterni-D's pamphlet falsely claims manufacturing in an "FDA-approved lab." Mind and Memory Formula is misbranded under Section 403(u) for using "ginseng" for an ingredient not from the Panax genus. Eterni-D's label fails to declare common or usual names for all ingredients (e.g., "