The American Feed Industry Association (AFIA) and the National Grain and Feed Association (NGFA) have urged the Food and Drug Administration’s Center for Veterinary Medicine (CVM) to keep pace with advances in animal nutrition by modernizing its regulatory policy that currently limits feed ingredients with environmental or production claims from making it to market in a timely way.
Both groups submitted formal comments to the agency in response to its federal docket (FDA-2022-N-2015), stating that these products should be regulated as feeds, not drugs, and that the agency has the authority to make that change.
“The FDA is long overdue in allowing U.S. farmers, ranchers and pet owners to access novel animal food products with environmental, production, animal well-being and pre-harvest food safety benefits claims, which is central to improving the health of animals, incentivizing innovation and competing in a global marketplace," said AFIA’s President and CEO Constance Cullman.
"If we are serious about helping the United States meet its ambitious 2030 methane reduction goals of 30% below 2020 levels, then these products need to be in the CVM’s review process by 2024, so that they can be approved and make a difference on farms by that deadline. The clock is ticking, and the time to fix this issue is now.”
AFIA’s letter outlines several points for the CVM to consider, including:
- Animal foods with certain environmental claims are a key component in addressing global climate change.
Feed ingredients with known efficacy to reduce enteric methane emissions in cattle cannot be sold with marketing claims for methane reduction in the United States due to current CVM policy, whereas farmers and ranchers around the world can knowingly and legally use them for their environmental benefits, putting U.S. farmers at a competitive disadvantage.
In addition, the European Food Safety Authority recognizes that animal food ingredients constitute an important group of pre-harvest food safety measures across all livestock and poultry types. Many administration officials, including Secretary of Agriculture Tom Vilsack, congressional leaders and animal industry stakeholders have called for the CVM to modernize its outdated approach so that these products can come to market with accurate label claims.
- Current CVM policy is challenging and narrow.
AFIA members are regularly developing new animal food ingredients that go beyond the typical taste, aroma and nutritive value historically associated with animal food, and they are developing game-changing solutions that act solely on or in the digestive tract of animals. Current CVM policy requires that these products be regulated as animal drugs instead of feed ingredients, however, a costly and cumbersome process, when these products are clearly feed ingredients and should be regulated as such. AFIA members have products approved in dozens of other countries that they cannot, or are unwilling to, submit for review at the FDA because of its narrow policy interpretations.
- The CVM has the means to make this change.
The AFIA is urging the CVM to adopt a modernized, science-based policy that utilizes the food additive petition, the generally recognized as safe (GRAS) process and Association of American Feed Control Officials’ ingredient definition pathways to support industry innovation in safe animal food ingredients that will address existing and emerging issues in the production, use and legally compliant labeling of animal food.
The AFIA believes this can be accomplished using these existing regulatory pathways and that the CVM has the existing statutory authority to regulate animal food ingredients that work within the gastrointestinal tract and provide public and environmental health benefits or promote animal growth, feed efficiency and well-being as foods instead of animal drugs, as current policy dictates.
For more information, read AFIA’s full letter here.
In its comments submitted to the FDA, NGFA said the current statutory definitions of “food” and “drug” provide FDA with the regulatory flexibility to modify its current policy and allow animal food with claims related to environmental benefits, production efficiency, modifying the digestive tract and changes to the microbiome to be classified as animal food, rather than animal drugs.
Animal food manufacturers can use existing animal food review pathways to demonstrate the safety of products and substantiate truthful production and environmental claims, NGFA said.
“Providing a more efficient regulatory framework to bring these products to market with such claims will benefit the well-being of animals, farmers and ranchers, consumers and the public at large,” NGFA said during a listening session conducted by FDA on October18.
“FDA’s characterization of these products as animal food will allow new technologies and innovation to reach the market sooner, resulting in increased efficiencies within U.S. animal agriculture, enhanced safety of animal-derived foods, and reduced greenhouse gas emissions and other environmental benefits.”
NGFA concluded its statement by urging the CVM to modernize its guide to allow animal food manufacturers to make truthful, non-misleading production, environmental and well-being claims for animal foods that have been substantiated to provide such benefits.
"We believe CVM has existing regulatory authority to modify its current policy, and that revisions may be made without amending the Federal Food, Drug, and Cosmetic Act or current regulations," it noted.