CVM Holds Virtual Listening Session to Gather Stakeholder Input on Regulation of Animal Foods with Certain Types of Claims

On Tuesday, October 18, 2022, the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) held a virtual listening session on the regulation of animal foods with certain types of claims, including claims about environmental benefits (e.g., reduced greenhouse emissions), production (e.g., growth promotion, feed efficiency, and increased milk production) and effects on the animal microbiome. The purpose of this session was to provide stakeholders with an opportunity to share their views and other information on this topic, in connection with CVM’s review and potential update of its existing policy, CVM Policy and Procedures Manual (PPM) 1240.3605, Regulating Animal Foods with Drug Claims.

Dr. Steven Solomon, Director of CVM, opened the meeting by noting the widespread interest this topic has received across various stakeholder sectors, affirming CVM’s commitment to the One Health approach, and acknowledging the importance of aligning regulatory policies with current science. Following Dr. Solomon’s remarks, Dr. Timothy Schell, Director of CVM’s Office of Surveillance and Compliance, provided an overview of CVM’s existing policy for the regulatory classification of animal foods that are intended to affect the structure or function of an animal’s body, in accordance with PPM 1240.3605. Key points Dr. Schell raised include:

• Under the Federal Food, Drug, and Cosmetic Act (the Act), a “food” is defined to include “articles used for food or drink for man or other animals,” as well as components of such articles.[1] The term “drug” is defined to include “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals,” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”[2]
• Whether an article is regulated as a food or a drug is determined by its intended use, which can be shown, for example, by labeling claims, advertising materials, and oral or written statements.[3] To be commercialized, a new animal food ingredient must be generally recognized as safe, subject to a prior sanction, or the subject of a food additive regulation authorizing its use.[4] Products determined to be new animal drugs generally must follow the new animal drug approval process.
• Based on a 1983 decision from the U.S. Court of Appeals for the Seventh Circuit, Nutrilab v. Schweiker[5], FDA interprets the “other than food” exception within the “drug” definition to apply to articles consumed primarily for taste, aroma, or nutritive value. Accordingly, CVM limits structure/function claims for animal foods to those that describe effects that derive from these "food properties." Under CVM's PPM 1240.3605, an ingredient that bears a production claim will be regulated as an animal drug.
• Under this framework, animal products that bear claims for environmental benefits or effects on the animal microbiome may also be regulated as animal drugs.

CVM is currently reviewing PPM 1240.3605 to evaluate how this policy could be updated to reflect evolving scientific knowledge and promote innovation, while continuing to ensure human and animal safety and consistency with current laws and regulations. In particular, CVM is considering changes that could potentially allow products with certain claims that are currently regulated as animal drugs to be regulated as animal foods. CVM solicited comments on the following questions, focusing on animal foods with claims for environmental benefits, production, and effects on the animal microbiome:

• How could the FDA modernize or improve this policy?
• What challenges does the policy present?
• What additional types of claims or ingredients should the FDA consider in its review of this policy?

The over twenty participants who delivered oral presentations included pet food and feed manufacturers, microbial and other ingredient manufacturers, industry trade groups, other advocacy groups, and a state agency. Most commenters, although not all, expressed support for amending PPM 1240.3605 to clarify and expand the scope of claims that can be permissible structure/function claims for animal food. The comments also urged CVM to consider:

• The importance of adopting science-based policies that promote innovation;
• The number of foreign jurisdictions (e.g., Canada, European Union, United Kingdom, Brazil) that permit certain claims for animal foods that, in the U.S., would cause the products to be regulated as animal drugs, and the disadvantages U.S. manufacturers consequently face;
• The need for CVM to adopt an interpretation of “nutritive value” that is more consistent with the interpretation FDA’s Center for Food Safety and Applied Nutrition (CFSAN) implemented; [6] and
• The critical role that certain new products can have for meeting sustainability goals and the need to facilitate their pathways to market.

Interested stakeholders have until November 17, 2022 to submit comments.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Animal Food and Drug practice.