FDA WARNING_LETTER - Beeyoutiful.com, LLC - May 31, 2021

The FDA issued a Warning Letter to Mr. Tallent of Beeyoutiful.com on July 12, 2021, following a review of their website in April and May 2021. The FDA determined that numerous products sold on www.beeyoutiful.com, including Vitex w/ Dong Quai, Berry Well, Colostrum Transfer Factor, and others, are marketed with claims that establish them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)], as they are intended for the cure, mitigation, treatment, or prevention of disease.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their claimed uses and lack prior FDA approval. Introducing or delivering these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)].

Furthermore, many of these products, such as Vitex w/ Dong Quai, Berry Well, and Colostrum Transfer Factor, are intended for