The FDA has issued warning letters to three pet product companies for marketing unapproved animal drug products containing CBD and mushroom-based supplements, according to an announcement from the National Animal Supplement Council (NASC).
The warning letters, posted by the FDA on April 7, 2025, indicate an increase in regulatory inspection and surveillance activities, as previously highlighted by legal counsel at the NASC Annual Conference.
Companies receiving FDA warning letters include:
- House of Alchemy, LLC (operating as CBD Dog Health) and Hamet Love, LLC (operating as MycoDog) for marketing unapproved new animal drugs containing CBD and mushroom-based products
- Bailey's Wellness, LLC (operating as Bailey's CBD) for marketing unapproved new animal drugs containing CBD products
- Holista, LLC (operating as HolistaPet) for marketing unapproved new animal drugs containing CBD products
According to NASC, the FDA's review of these companies' websites and social media channels revealed claims indicating their products were intended to diagnose, cure, mitigate, treat or prevent disease in animals. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), such claims classify these products as new animal drugs.
To be legally marketed, these products would require an approved new animal drug application, conditional approval, or index listing, which they do not possess. Additionally, certain products marketed as edible CBD treats for dogs were deemed adulterated under the FD&C Act due to the presence of CBD, which is not approved for use in animal food.
The FDA expressed particular concern about food safety, especially regarding products marketed for food-producing animals, citing a lack of research on residue formation and human safety.
NASC, a nonprofit organization operating since 2001 with the mission of protecting and enhancing companion animal and horse health throughout the U.S, stated it remains committed to ensuring compliance with and responsible marketing of animal supplements within the allowable regulatory framework.
The organization encouraged all member companies to review these warning letters carefully and ensure their product claims align with FDA regulations, noting that non-compliant claims and labeling "cast a disparaging shadow on our industry."
