FDA Food Ingredient Approvals Slow Innovation | 2022-10-25


Is an algae-based food additive that can significantly reduce methane emissions considered a food ingredient or an animal drug? What about a pet food ingredient that could actually reduce the risk of salmonella? Under current Food and Drug Administration policy, the answer is an animal drug, which adds years and additional costs to obtaining FDA approval.

But the FDA’s Center for Veterinary Medicine recently hosted a virtual listening session on whether the regulation of foods of animal origin with certain types of claims – on environmental benefits, production (including milk production and feed efficiency) and effects on the animal microbiome – may fall under the less restrictive animal feed classification.

Agriculture Secretary Tom Vilsack has repeatedly explained how food additives can provide environmental benefits, including reducing methane emissions from animals, but the FDA must allow additives to be marketed using these claims.

Acting Secretary Tom Vilsack

“There’s political pressure now, based on the administration’s real focus on climate change, and I think that’s kind of brought the issue more to the forefront,” said Dave Fairfield, vice president. head of animal feed at the National Grain and Feed Association, who testified at the listening session.

“And it’s clear that there are feed ingredients that can produce environmental benefits, and bringing them to market as animal feed rather than animal medicine helps achieve environmental goals.”

Bovaer, a product developed by Royal DSM that the company says consistently reduces emissions by 30%, has received European Union approval but is under review at the FDA as an animal drug. The agency has consistently declined to comment on the status of his candidacy.

In April, US company Elanco Animal Health and Royal DSM announced a strategic alliance under which Elanco was granted exclusive US licensing rights to develop, manufacture and market Bovaer for beef cattle and dairy cows.

In the language of the report accompanying the fiscal year 2022 appropriations bill, Congress directed the CVM to study pet food claims policy to facilitate the process for new food additives.

Kristi Smedley, owner and director of the Center for Regulatory Services, said the FDA’s request was simple: update its policy to enable innovation based on scientific understanding that did not exist when the policy was created in 1998.

Smedley testified that simple corrections and clarifications to CVM’s Policy and Procedures Manual guide 1240.3605 would make more efficient use of animal feed, improve animal health and make human food safer, in addition to providing environmental benefits. And all could be done within the limits of the existing Federal Food, Drug and Cosmetic Act and Policy Manual.

“We’re asking for policy change, not regulatory change or law change,” Smedley said.

Louise Calderwood, director of regulatory affairs for the American Feed Industry Association, told FDA officials that animal nutrition plays a vital role in improving the health of livestock, poultry, pets and pets. fish, and that companies are pushing for innovative solutions.

“Our members are constantly researching how existing ingredients can further support animal production and health, in addition to public and environmental health, and animal welfare,” Calderwood said. “They regularly develop new pet food ingredients that go beyond the typical taste, aroma and nutritional value historically associated with pet foods and develop breakthrough solutions that work only on or in the digestive tract of animals. .”

Elizabeth Lewis, science and regulatory adviser for NutraSteward, which helps companies submit food and feed claims in the United States, Canada and the European Union, said the EU allows a class of additives that may have data to support its benefits on animal welfare, animal performance and the environment. In the United States, one would have to go through the regulatory route for animal drugs, which takes seven to eight years, compared to two to three years for a food ingredient.

Elizabeth LewisElizabeth Lewis, Nutra Steward

“The flow is global. When a company designs a product, they want to bring that product to more than one market,” Lewis said. “While the regulatory systems always have differences, I think some harmonization effort in terms of basic understanding of this boundary between animal feed and animal medicine is really important.

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In the United States, companies cannot make any production performance claims on a label. “I think the FDA is hindering innovation,” Lewis said. And for a country with a strong base of research leadership and the importance of the domestic livestock and poultry sector, “it just doesn’t make sense,” she said.

The United States is one of many countries that have signed the Global Methane Commitment to reduce methane emissions by 30% by 2030. However, some of the animal feed additives that could be put on the market and proven to reduce enteric emissions are regulated as an animal drug, rather than a food ingredient.

Calderwood said the FDA needs to act quickly if it wants to help American companies stay competitive, as well as address the many complex challenges that have power solutions in the pipeline.

“In order to meet that commitment by 2030, that means we have to get these products to market no later than 2029. We know it takes the FDA about three years to review these products, and that’s s “They have enough staff and if they believe the data that has been submitted is adequate for the claim the company wants to make. That takes us back to 2026.

“The clock is ticking, and it’s ticking fast,” Calderwood said.

Calderwood said that based on conversations with the FDA, the agency could have a policy change proposal ready in a few months. The FDA should then consider public comments and may update its policy within the next year. “Then we look at three to four years to really bring the products to market,” she said.

A public comment period on the issue is open until November 17.

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