AFIA Welcomes FDA's Move Toward Modern Claims Regulations, But Says Legislation Still Needed

February 2, 2024

Contact Victoria Broehm

The American Feed Industry Association applauds the Food and Drug Administration Center for Veterinary Medicine’s (CVM) decision to revoke an outdated regulatory policy spanning almost three decades, which has deterred animal food ingredient manufacturers from investing in the U.S. marketplace. This move could catalyze significant enhancements in livestock, poultry and aquaculture production, as well as advancements in food safety, environmental sustainability and animal well-being by allowing feed additives to be reviewed through the appropriate ingredient review processes versus the CVM’s animal drug review process.

AFIA’s President and CEO Constance Cullman issued the following statement:

“The AFIA welcomes the CVM’s intention to withdraw its nearly 30-year-old regulatory policy, which shows its commitment to partnering with animal food innovators. This action signifies progress toward fixing a broken process and will allow our industry to start providing innovations for animal production, but the need does not end here. Congress, now it's your turn to act by swiftly passing the bipartisan Innovative Feed Enhancement and Economic Development (Innovative FEED) Act (H.R.6687 and S. 1842), providing the FDA with the tools it needs to codify a regulatory pathway and support. American animal food manufacturers."

Over recent years, the FDA's 1998 Program Policy and Procedures Manual Guide 1240.3605 has faced criticism, particularly from the AFIA, animal producers, lawmakers and federal officials, who argue that it hindered timely and cost-effective introduction of animal food ingredients with beneficial properties. The CVM's strict interpretation categorized these products as animal drugs. This categorization subjects them to lengthy drug review procedures rather than more suitable ingredient review processes, needlessly prolongs the evaluation period and, in many cases, stops companies from seeking product approval in the United States. The Innovative FEED Act, endorsed by nearly 190 stakeholders, would codify a regulatory review pathway that demonstrates safety and effectiveness for animal food ingredients impacting the microbiome of animals, food safety or the environment.