Dear NASC Members & Affiliates,

We want to bring to your attention FDA Warning Letters recently issued to three pet product companies for the marketing and sale of unapproved new animal drug products containing CBD and mushroom-based supplements for animals.

The letters were posted by the FDA on April 7, 2025.

As noted by legal counsel during the panel at the NASC Annual Conference, the FDA is stepping up inspections and other actions from compliance and surveillance.

Below is a summary of the companies cited:

• NOTE: Two different brands—House of Alchemy, LLC (dba CBD Dog Health); Hamet Love, LLC (dba MycoDog) – FDA Warning Letter issued for marketing unapproved new animal drugs containing CBD and mushroom-based products intended to treat various animal diseases.
• Bailey’s Wellness, LLC (dba Bailey’s CBD) – FDA Warning Letter issued for marketing unapproved new animal drugs containing CBD products intended to treat various animal diseases.
• Holista, LLC (dba HolistaPet) – FDA Warning Letter issued for marketing unapproved new animal drugs containing CBD products intended to treat various animal diseases.

The FDA’s review of their websites and social media channels identified claims indicating that these companies’ products are intended to diagnose, cure, mitigate, treat, or prevent disease in animals, classifying them as new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

As new animal drugs, they are required to have an approved new animal drug application, conditional approval, or index listing to be legally marketed, which they do not.

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.

Due to the lack of research on residue formation and human safety, the FDA highlighted concerns about food safety, especially regarding products marketed for food-producing animals.

NASC remains committed to ensuring compliance with and responsible marketing of animal supplements within the allowable regulatory framework.

We encourage all members companies to review these warning letters carefully and ensure that your product claims align with FDA regulations.

Companies with out-of-bounds claims and labeling like these cast a disparaging shadow on our industry and make it difficult for those of us who are trying to define appropriate and responsible paths forward.

Please feel free to make others, including retailers, aware of this information.

• Click here for FDA’s searchable database of all FDA Warning Letters.
• Click here for FDA Warning Letters for cannabis-derived products.

Sincerely,
Bill Bookout, NASC President