As a cattle producer, you have many things to worry about on any given day, one of which is ensuring the feed you are receiving from your feed manufacturer is safe and high quality and provides the nutritional value it guarantees. You are not likely to think about what it takes to get the ingredients in that feed approved as safe for the intended use. The regulatory process can be cumbersome and slow, but work is being done to address this problem to ensure cattle producers can use innovative products to support healthy, productive animals.
The FDA’s Center for Veterinary Medicine (CVM) and the Association of American Feed Control Officials (AAFCO) are the responsible authorities that oversee the review and approval of new animal food ingredients in the U.S. Under federal law, any substance added to or expected to become a component of animal food must be an approved food additive (published in the Code of Federal Regulations) unless it is generally recognized as safe (GRAS) for that intended use.
AAFCO, an association of state and federal feed control officials, plays a role in animal food ingredient reviews by establishing ingredient definitions, which are published in the AAFCO Official Publication. Though they are not approved food additives under federal law, the FDA generally accepts these AAFCO-defined ingredients for use in the U.S., provided there are no safety concerns. To ensure there are no safety concerns, the CVM acts as the reviewer for AAFCO to determine that any new AAFCO-defined ingredient is safe for its intended use.
Over the past decade, these review processes have become slow and very difficult for bringing new products to the marketplace. The American Feed Industry Association (AFIA) has focused its policy activities on improving the efficiency and effectiveness of the ingredient review processes at the FDA and AAFCO. It has become quicker and more affordable to get ingredients approved in other countries than here at home. The AFIA is working hard to fix several issues with the aim of getting the American system back on track and continuing our country’s role as the world leader in nutrition innovation.
Boosting FDA’s resources
Part of the slowness of ingredient reviews stems from a lack of focus and resources at the CVM for animal food ingredient reviews. Over the past 15 years, budgets have tightened within the agency, making it difficult to hire or fill vacancies when staff moved to new positions or retired. Also, during this time, the CVM staff have been pulled away for competing higher-priority issues (i.e., writing and implementing the Food Safety Modernization Act regulations). Couple this tightening of resources with the fact that the CVM has taken broad, and sometimes excessive, interpretations of its policies, has led to significant delays in approvals for new animal food ingredients, resulting in a logjam for new ingredient reviews.
The AFIA has sought to address these issues with the FDA and Congress, and in the past three years, a total of $6 million in new money has been appropriated to the CVM as a result of these advocacy efforts. This money has allowed the agency to hire 12 full-time staff to fill vacancies and provide expertise in new scientific areas, such as microbiology and biotechnology, to fill knowledge gaps in the division. These individuals have been onboarded for two years, and the industry is starting to see a faster turnaround speed for food additive petitions and AAFCO definitions, which is much appreciated. This is one area where growth in government can help animal agriculture in the long run.
The CVM also went through a reorganization in 2022, which separated its pre-approval areas of work (i.e., animal food ingredient reviews) from its compliance efforts. This means the staff within the newly named Division of Animal Food Ingredients could better concentrate on their responsibilities for reviewing new animal food ingredients and not get called over into other regulatory or enforcement efforts within the agency.
Updating FDA policy on label claims
Since 1998, the CVM has used a narrow definition of what is considered a “food” and what is a “drug” when reviewing new animal food products. Currently, any animal food ingredient that aims to provide anything other than taste, nutrition or aroma is classified as a drug and needs to proceed through that regulatory review process. In September 2020, the AFIA asked the CVM to modernize the policy interpretation to allow products that work within the gastrointestinal tract or on the digesta to be regulated as “feeds” instead of “drugs.” We hope this requested change will soon allow animal food additives to make accurate label claims for animal production, animal well-being, food safety and the environment.
Last fall, stakeholders provided feedback to the CVM about this process. In a listening session and in written comments, the CVM heard overwhelming support across animal agriculture for this policy change and a desire for a quick decision in order to equip producers with these important tools, especially related to the environment. AFIA’s legal opinion is that such a change can be implemented without amending the Federal Food Drug and Cosmetic Act or FDA regulations, and these products can be reviewed through the existing review pathways – food additive petition, GRAS and AAFCO.
Without this policy change, our country will continue to lag behind most of the world – including the European Union, Canada, Brazil, Australia and others – in approving safe and effective feed ingredients with animal production, as well as environmental and other benefits. This delay is not only preventing U.S. cattle producers from accessing these technologies but is limiting the U.S. in making progress on its climate and food security goals.
Cattle producers and the beef industry chain have enough to worry about and need to be confident that their feed ingredients have a reliable regulatory review pathway that determines the products are safe for animals and the humans who eat their food products, and that the products do what they say they will do. Cattle producers deserve those assurances, and the animal food industry needs these assurances to properly bring to and market these products in the marketplace.
The AFIA anticipates that in 2023 the CVM will make progress in modernizing its policy interpretation. We will continue collaborating with state feed control officials, Congress and the administration to ensure that the regulatory agency has the necessary resources to handle this new workload and for policies to be in place to allow farmers and producers to get access to these ingredients in a timely way, so they can remain competitive in an ever-changing global market.
