U.S- The U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine has announced its intention to withdraw a policy that has hindered ingredient manufacturers from investing in the U.S. marketplace. 

The policy, outlined in the FDA’s 1998 Program Policy and Procedures Manual Guide 1240.3605, has long been criticized by industry stakeholders, including the American Feed Industry Association (AFIA) and animal producers, for its restrictive interpretation of categorizing certain products as animal drugs. 

This categorization subjected them to prolonged drug review procedures rather than more suitable ingredient review processes, causing unnecessary delays in evaluation and hindering product approval in the United States.

In response to these concerns, the FDA aims to withdraw the policy and collaborate with Congress to seek 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 specific ways. 

These substances may affect the animal’s microbiome, alter digestive byproducts, or reduce pathogens in food products derived from the animal.

In a statement released on February 2, the FDA acknowledged the animal feed industry’s interest in introducing substances that specifically target the gut of the affected animal, supported by scientific evidence related to animal production, well-being, food safety, and environmental benefits. 

The FDA encourages companies with innovative products to collaborate with the agency early in the product development process.

Industry groups, such as the National Grain and Feed Association (NGFA) and AFIA, welcomed the FDA’s decision as a positive step toward promoting innovation in the development of safe and beneficial feed ingredients. 

David Fairfield, NGFA’s Senior Vice President of Feed, emphasized the significance of the FDA’s move in facilitating the introduction of innovative animal food products that offer production benefits, thereby enhancing the competitiveness of American agriculture on a global scale. 

Fairfield noted that outdated FDA policies have hindered American animal food manufacturers from making substantiated production claims on their product labels. This contrasts with more progressive policies in other regions.

Constance Cullman, President and CEO of AFIA, echoed similar sentiments, emphasizing the need for legislative action to support the FDA in establishing a regulatory pathway for innovative feed ingredients. 

Cullman urged Congress to swiftly pass the bipartisan Innovative Feed Enhancement and Economic Development (Innovative FEED) Act, which would provide the FDA with the necessary tools to establish a regulatory pathway and support American animal food manufacturers in bringing innovative products to market.

Endorsed by nearly 190 stakeholders, the Innovative FEED Act aims to establish a regulatory review process that demonstrates the safety and effectiveness of animal food ingredients, particularly those that impact animal microbiomes, food safety, or the environment.

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