Companies received warning letters from FDA for unapproved CBD products

The FDA's Center for Veterinary Medicine announced that it has issued warning letters to Bailey’s Wellness, Holista, and House of Alchemy/Hamet & Love, accusing them of selling unapproved cannabis-derived products, The letters were issued to the companies in question on April 7, 2025, stating that they are marketing and promoting their cannabidiol (CBD) products for uses that are not deemed safe or effective for their intended use under the federal Food, Drug, and Cosmetic Act.1

“Under the federal Food, Drug, and Cosmetic Act, products for which therapeutic claims are made must be approved by the FDA to be legally manufactured and marketed. The FDA approval process is how the safety and efficacy of such products [are] demonstrated. Assurance regarding the efficacy and safety of products is obviously important to veterinarians who are considering whether to use them in the treatment of their patients,” the American Veterinary Medical Association explains on its Cannabis Use and Pets resource page.2

The letters each addressed the marketing the companies have been doing for a variety of products, including chews, oils, and pellets that suggest unproven benefits across websites and social media platforms. Particularly, the FDA expressed concerns over the selling of unapproved CBD products for food-producing animals.

“In addition to raising potential concerns regarding safety for the animals themselves, CBD products for food-producing animals raise concerns regarding the safety of the human food [meat, milk, and eggs] derived from those animals,” the FDA stated in its letter to Bailey’s Wellness.3

“There is currently a lack of data on the formation of residues in edible products of food-producing animals in association with the consumption of CBD products by those animals and on safe levels of any potential residues for the human consumer. We request that you take immediate action to cease the sale of any unapproved CBD products for food-producing animals,” the letter continued.

Holista, which sells products under the name HollistaPet, and House of Alchemy, which sells products under CBD Dog Health, Hamet & Love, and MycoDog, shared similar concerns from the FDA as Bailey’s Wellness.

Within 15 days after receiving the letters, each company is required to notify the FDA in writing of their specific steps to address any violations, including an explanation of each step the companies are taking to prevent recurrence of violations and copies of related documents. If they could not complete corrective actions within the 15 days, they must provide a reason for the delay and when they will be able to submit the needed materials. Any of the companies in question that believe they are not in violation of the act were required to list their reasoning and supporting information for the FDA to take into consideration.

When receiving a warning letter from the FDA, failure to adequately address the matter can result in legal actions, including, without limitation, seizure and injunction.

References

1. FDA issues warning letters to companies selling unapproved CBD products. News release. American Veterinary Medical Association. June 23, 2025. Accessed June 23, 2025. https://www.avma.org/news/fda-issues-warning-letters-companies-selling-unapproved-cbd-products\
2. Cannabis use and pets. American Veterinary Medical Association. Accessed June 23, 2025. https://www.avma.org/resources-tools/animal-health-and-welfare/animal-health/cannabis-use-and-pets
3. Food and Drug Administration. Warning Letter to Bailey’s Wellness, LLC dba Bailey’s CBD. April 7, 2025. June 23, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/baileys-wellness-llc-dba-baileys-cbd-701066-04072025