FDA WARNING_LETTER - Bailey’s Wellness, LLC dba Bailey’s CBD - April 29, 2025

The FDA issued a Warning Letter to John V. O’Keefe III and Aaron A. Argueta after reviewing their website, baileyscbd.com, and social media, which promote and sell various cannabidiol (CBD)-containing products for both animals and humans. The agency determined that the CBD-containing products for animals, including Hemp Pellets for Horses and Livestock, CBD Oil for Dogs, and Calming CBD Yummies, are unapproved new animal drugs, unsafe under 21 U.S.C. 360b(a), and adulterated under 21 U.S.C. 351(a)(5). Their introduction into interstate commerce is prohibited under 21 U.S.C. 331(a). A significant concern was the marketing of CBD products for food-producing animals, raising safety issues regarding residues in human food. Furthermore, adding CBD to animal foods like Hemp Pellets and CBD Yummies constitutes a prohibited act under 21 U.S.C. 331(ll), as CBD is a drug with substantial clinical investigations. CBD is also considered an unapproved food additive in animal products, rendering them adulterated under 21 U.S.C. 342(a)(2)(C)(i) because it is not generally recognized as safe (GRAS) for animal use. For human products, including Elevar Wellness Focus Plus 1:1 CBD & CBG Oil and HeyerPower Wellness CBD Oil Trio, the FDA found them to be unapproved new drugs, marketed in violation of 21 U.S.C. 355(a) and 331(d). The company is required to immediately cease the sale of any unapproved CBD products for food-producing animals and respond within fifteen working days, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction.