Written by: AFIA Editor | October 19, 2022
On Tuesday, the American Feed Industry Association’s Louise Calderwood participated in a listening session at the Food and Drug Administration’s Center for Veterinary Medicine on the regulation of animal foods with certain claims. This issue is one the AFIA has been following for quite some time (see related blog posts here and here), given its hindrance to getting products to the marketplace that would help the U.S. get one step closer to meeting its food security and climate goals.
Calderwood’s full remarks are below.
Hello, I’m Louise Calderwood, director of regulatory affairs for the American Feed Industry Association, the world’s largest organization devoted exclusively to representing the business, legislative and regulatory interests of the U.S. animal food industry and its suppliers. Thank you to the Food and Drug Administration for providing this opportunity to present our thoughts on the Regulation of Animal Foods with Certain Types of Claims.
Founded in 1909, the AFIA serves as the voice for everyone involved in the manufacture of commercial and integrated feed and pet food, from ingredient suppliers to equipment manufacturers. We are also founding members of the International Feed Industry Federation, where we strive for global harmonization and science-based regulation of our industry.
I am here today to explain how the animal food industry in the U.S. lags behind most of the world including the EU and Canada and even behind Brazil, Chile, Colombia, Australia and Thailand, in approving safe and effective feed ingredients with animal production, environmental and other benefits, and how that delay is not only preventing farmers and pet owners from accessing these technologies, but is limiting the United States in making progress on its climate and food security goals.
We believe our country does not have time to waste. Our farmers and ranchers are prepared to do their part, and it is time for the Food and Drug Administration to recalibrate the clock and move ahead with long needed changes to its policy.
As mentioned by several speakers today, animal nutrition plays a vital role in improving and promoting the health of our livestock, poultry, pets and fish. Our members are continuously researching how existing ingredients can further support animal production and health, in addition to public and environmental health, and animal well-being. They 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.
These gut-based technologies are proven to:
By harnessing the power of the GI tract, animal food additives can help producers and pet owners boost their animals’ quality of life. In countries where they are approved these technologies help farmers be more efficient in their use of land, water and feed, therefore supporting sustainability efforts to feed a growing global population.
Unfortunately, in the United States, the animal food industry and our customers, cannot use these technologies due to the policy interpretation laid out in the FDA Center for Veterinary Medicine Program Policy and Procedures Manual Guide 1240.3605. This policy requires that these products be regulated as animal drugs instead of feed ingredients. Sure, these ingredients could be put through the regulatory review process as a new animal drug, but they should not have to. They are clearly feed ingredients and should be regulated as such. Our members tell us they have products approved in dozens of other countries that they cannot submit for review at the FDA because of policy limitations.
The AFIA urges the CVM to address this limitation by modernizing its guide to keep pace with scientific advances in animal nutrition, paving the way for animal food ingredients with production, animal safety, food safety and environmental claims to be regulated as foods, not as animal drugs.
Legally, animal foods with such claims may be considered either as a food in title 21 of the U.S. code, section 321(f), or as a drug, in title 21 section 321(g). We urge the agency to adopt a science-based approach, regulate these products as food and allow these game-changing innovations to be used safely and with accurate, compliant labeling. We believe the science surrounding the functionality of new animal food ingredients has advanced to the point that production claims can be properly substantiated and can be truthful and not misleading, and that the CVM should recognize substantiated structure/function and other well-being and resiliency claims for animal foods and animal food ingredients.
This modern approach and transparent policy would promote industry innovation and provide clear direction to state feed control officials, who are currently reluctant to register or provide certificates of free sale for animal feeds and ingredients bearing certain claims.
As you’ve heard today and will likely hear even more during the written comment period, we are not alone in this request for needing these changes. The Secretary of Agriculture Tom Vilsack has spoken numerous times about the role feed ingredients can play in reducing greenhouse gas emissions and has urged the FDA to modernize its approach. He believes the FDA is now more open to conversations about needed changes and has expressed hope that the agency is ready to think differently and broadly. We have confidence he is correct and this is, indeed, the case.
Even Congress in its fiscal 2022 appropriations bill directed the CVM to study this old policy on animal food claims and make this change.
The AFIA is not asking the FDA to create a new regulatory pathway. Rather, we are asking it to update its policy to support industry innovation in safe animal food ingredients that address current and emerging issues in animal food production using the existing ingredient review pathways. The food additive petition, the generally recognized as safe (or GRAS) process and the ingredient review process of the Association of American Feed Control Officials (or AAFCO) all review ingredients for safety to the animal being fed the product, safety of the resulting meat, milk or eggs being consumed by humans, and the utility of the product – that the product does what its label claims it does.
We believe these requested actions are in the interest of public and environmental health and animal well-being and can be implemented without amending the Federal Food Drug and Cosmetic Act or FDA regulations. Moreover, we believe that the FFDCA and the First Amendment allow manufacturers and sellers to assert truthful, substantiated structure/function and other well-being and resiliency claims pertaining to animal food.
By making this change, the agency will strengthen its mandate of ensuring public health through human and animal health by giving these products a regulatory review pathway that will be utilized by our industry. The CVM will also be helping the United States get closer to meeting its climate and food security goals.
It is often said that time is our enemy, and with the challenges before us of ensuring all Americans can breathe easier and have access to safe food, we do not have time to waste. Let us make this moment count and not let another day go by without recognizing the important role the FDA can play in solving this challenge.
As a responsible stakeholder, we appreciate this opportunity to encourage the CVM to explore potential solutions to its current policy.
Thank you for considering this important issue. Our industry stands ready to work with you in the future.