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FDA Letter to Industry: Industry Encouraged to Contact FDA Regarding Novel Animal Foods with Drug Claims

Update, May 20, 2024: After thoroughly reviewing Program Policy and Procedures Manual (PPM) Guide 1240.3605, Regulating Animal Foods with Drug Claims, and carefully considering stakeholder feedback, the FDA has determined the PPM, originally published in 1998, no longer reflects the agency’s current thinking. Therefore, the FDA has withdrawn the PPM

Firms interested in marketing an animal food substance that would have been subject to the withdrawn PPM are encouraged to email animalfood-premarket@fda.hhs.gov.  

Dear Stakeholder,

The U.S. Food and Drug Administration is aware that the animal feed industry is interested in bringing to market animal food substances that act solely within the gut of the affected animal with scientifically substantiated claims related to animal production, animal well-being, food safety, and environmental benefits, as animal food. FDA encourages firms with these novel products for animals to contact the agency early in the product development process.

To facilitate animal and veterinary product advancement, and to encourage the development of safe, novel products and products for unmet human and animal needs, FDA’s Center for Veterinary Medicine (CVM) intends to withdraw Policy & Procedures Manual (PPM) 1240.3605, Regulating Animal Foods with Drug Claims

Additionally, FDA is working with Congress in seeking new legislative authority for a clear regulatory pathway for substances added to animal food or drinking water that function in the gut of an animal in one of three ways. These substances may affect the microbiome of the animal, affect the byproducts of the digestive process, or reduce pathogens in food products made from the animal.  

These efforts align with FDA’s Animal and Veterinary Innovation Agenda, released on September 15th, 2023, which outlines FDA current and intended actions to foster novel animal and veterinary product development and implement smart, risk-based approaches to regulating these modern products.  FDA continues to actively talk with stakeholders and consider modernization of our approach to animal food additive regulation and its policies more broadly.  

To contact FDA-CVM about an animal food substance intended to have the effects described above, please email animalfood-premarket@fda.hhs.gov.

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