The FDA’s Center for Veterinary Medicine (CVM) announced that it will host a virtual listening session on October 18 regarding the Agency’s regulation of animal foods with certain types of claims, such as claims about environmental benefits (e.g., reduced greenhouse emissions), production (e.g., growth promotion, feed efficiency), and effects on the animal microbiome. The FDA is specifically interested in receiving comments on its existing policy, PPM 1240.3605 “Regulating Animal Foods with Drug Claims,” to address the following questions:

1. How could the FDA modernize or improve this policy?

2. What challenges are presented by this policy?

3. What additional types of claims or ingredients should the FDA consider in its review of this policy?

As background, PPM 1240.3605 states that the FDA will usually regulate nutritional ingredients or products with claims describing an intended effect on the structure or function of an animal’s body as animal food, whereas nutritional ingredients or products with production claims and non-nutritive ingredients or products with structure/function claims are usually regulated as animal drugs. The FDA wants to review this policy to evaluate how it could be updated, and changes to the FDA’s existing policy could potentially allow these products to be regulated as animal food while maintaining safety and consistency with current laws and regulations.

The listening session will be an opportunity for stakeholders to share feedback on how the FDA regulates animal foods with certain claims. Stakeholders interested in attending the session must register no later than 11:59pm ET on October 11. On the registration form, stakeholders may request to present during the listening session, but all presentation requests must be made by September 20. The FDA is also accepting electronic or written comments until November 17 on www.regulations.gov (FDA Docket # FDA-2022-N-2015).