Written by: Louise Calderwood | October 13, 2021
This blog is part of our policy priority series.
The use of animal food ingredients to address animal wellness, food safety and production efficiency is bursting forward worldwide with the development of innovative products demonstrating proven efficacy and safety. Across continents and animal management systems, animal food additives are making their mark by fostering improvements for animal care and environmental protection.
In many countries, animal food additives can be marketed for their benefits to animals by increasing performance, improving feed conversion and boosting the intestinal presence of immunoglobulins for mucosal health. The international market for feed additives is expanding and some industry reports predict that the market will grow 6.1% between 2020 and 2027, reaching a value of $56.22 billion by 2027.
But there is one notable gap on the globe with a large piece of unpainted canvas in the vibrant picture of opportunities provided by animal food additives. And that white spot hovers right over the United States.
As the rest of the world marches forward to adopt the benefits afforded by animal food additives, U.S. farmers and ranchers lag, hampered by black-and-white regulations and limited access to new developments. It is time for the United States to fill in our spot on the palette of animal food additives.
Since 1998, the Food and Drug Administration’s Center for Veterinary Medicine (CVM) has used a very narrow definition of what is considered a “food” and what is a “drug” when reviewing new animal food products, which can legally be considered both. Guide 1240.3605 in the CVM Program Policy and Procedures Manual is less than a full five pages long, but it packs a wallop in limiting permissible marketing claims for animal food ingredient labels. Guides 1240.3605 states:
“…while the guidance is intended to assist in consistent or uniform regulation, it is not intended to be inflexible but is to be regarded as guidance to be followed in most instances for uniformity.”
It is time to broaden the regulatory roadway for animal food marketing claims to accommodate the expanded understanding of the physiology of the gastrointestinal tract. The CVM is long overdue in revisiting its narrow path for regulatory approval of animal food ingredients, and the public and food companies are starting to take notice.
Speaking in September at the Ag Outlook Forum organized by the Agricultural Business Council of Kansas City, Agriculture Secretary Tom Vilsack commented on the developing openness of the FDA to think differently and broadly about its regulatory process for emerging technology. Vilsack frequently references the merits of animal food additives as essential elements to meeting national climate change goals. His recent remarks reflected the current era in agriculture, and our association joins him in encouraging the FDA to maintain this nascent momentum in the adoption of a new regulatory approach to animal food additives. Secretary Vilsack said:
“I think FDA is now open, MORE open, than they have been to conversations and hopefully that leads to not only the speeding up their current process but encouraging them to think differently and to think broadly.”
Congress has also taken notice and has inquired about the CVM’s policy. For example, in June, U.S. Senator Tammy Baldwin, D-Wis., before the Senate Committee on Appropriations subcommittee said:
“Other countries will be using this emissions-reduction technology four or five years earlier than we will be able to in the United States, materially disadvantaging U.S. farmers and ranchers in terms of export markets for beef and dairy products.”
Worldwide, feed products that improve animal production and well-being, address preharvest food safety and reduce the environmental impacts of livestock production are regulated as food, but in the U.S., many are regulated as animal drugs. Globally, many countries embrace the functionality of animal food ingredients and allow properly substantiated claims for the benefit of animals, producers, consumers and the environment.
Modernizing a two-plus decades-old policy to reflect advances in public and environmental health and animal well-being is a top priority for the American Feed Industry Association and can be implemented without amending the Federal Food Drug and Cosmetic Act or FDA regulations. By updating the Guide 1240.3605, the CVM can modernize its approach toward regulating claims for animal food ingredients and keep pace with science and the international community.
It is time to complete the picture and add the United States to the global palette of animal food additives.