NGFA during a listening session conducted by the U.S. Food and Drug Administration (FDA) on Oct. 18 urged the agency to modernize its existing policies so that animal foods with demonstrated production, health and environmental benefits can be brought to market in a more efficient manner.
The listening session was conducted by FDA as part of the agency’s review of the Center for Veterinary Medicine (CVM) Policy and Procedures Manual (PPM) 1240.3605, Regulating Animal Foods with Drug Claims. Based on the current PPM, FDA traditionally has reserved claims for improving animal production (production claims), such as increased milk production, increased leanness, and improved growth and efficiency of gain, to animal drugs.
FDA requires such animal foods with production claims to gain premarket approval through its animal drug approval process, a process that is very complex, time-consuming and expensive.
During comments made during the meeting, NGFA stated that 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.
“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.
“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.”
FDA is accepting electronic or written comments related to its policies through Nov. 17. To electronically submit comments to the docket, visit regulations.gov and type “FDA-2022-N-2015” in the search box.