This article comes is reprinted from NGFA's April 28th newsletter.

The U.S. Food and Drug Administration (FDA) has proposed legislative language that would establish a new category of “zootechnical animal food substances” within the federal Food Drug and Cosmetic Act (FFDCA) and allow such substances to be reviewed under FDA’s food additive petition process, rather than the new animal drug application process.

FDA’s proposal follows the virtual listening session conducted on Oct. 18, 2022, during which the agency solicited public and stakeholder input on how FDA regulates animal foods with certain types of claims, such as claims about environmental benefits (e.g., reduced greenhouse emissions), production (e.g., growth promotion, feed efficiency), and effects on the animal microbiome.

NGFA comments made during the session and subsequently submitted to the docket urged FDA to modernize its policies to allow animal food manufacturers to make truthful, non-misleading production, environmental and well-being claims for animal foods that have been substantiated to provide such benefits in a more efficient manner.

NGFA said that in doing so FDA would enable innovative products to reach farmers and ranchers, allow U.S. agriculture to compete in global markets, support the United States in achieving climate and food security goals, and advance improvements in food safety.

The proposal to establish “zootechnical animal food substances” is one aspect of the approach FDA has chosen to modernize its policies related to environmental and health benefit claims for animal food.

The proposal is intended for substances that FDA deems to be “non-nutritive” and would provide clearer legal authority for the agency to allow non-nutritive animal food substances to make such claims by gaining approval through the food additive petition process.

In contrast, FDA’s current policy characterizes such substances as animal drugs, which requires approval through the burdensome new animal drug application process.

The second aspect of FDA’s approach to modernize its policies is to develop and issue guidance – likely during the first six months of 2024 – to provide a framework through which nutritional animal food substances could make production claims.

FDA when developing guidance intends to create a definition for “nutritive value,” which will be key in establishing the scope of animal food substances that would be allowed to make production claims.

This approach differs from current FDA policy in that the agency has traditionally reserved claims for improving animal production to drugs and has not permitted such claims for nutritional animal foods.

In response to inquiries from staff associated with the Senate Committee on Health, Education, Labor and Pensions about FDA’s proposed legislative language, NGFA has provided perspectives on the proposal, including:

• FDA has yet to propose a definition for “nutritive value” so the scope of substances that would be classified as “zootechnical animal food substances” is unknown.

• FDA previously in some circumstances has characterized substances that are a source of viable microorganisms as “animal food” and NGFA in general believes that sources of viable microorganisms do provide nutritive value and should not arbitrarily be classified as a zootechnical animal food substance.

• NGFA believes a company that desires to make a new claim for a substance that is already approved or recognized should not be required to submit the substance through the food additive petition process again. Instead, FDA should initiate a process whereby the company can submit data to support the new claim without subjecting the substance to the entire food additive petition process.

• The FFDCA contains a provision that allows substances that are generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, to be excluded from the definition of a food additive and therefore excluded from the food additive petition process. NGFA believes this so-called “generally recognized as safe” (GRAS) provision should also extend to zootechnical animal food substances.

• FDA proposes to require that labels of zootechnical animal food substances include the statement “Not for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals.” However, no other labels of animal foods currently are required to include such a statement, and it is a violation of existing misbranding provisions of the FFDCA for foods to make drug claims. NGFA does not understand FDA’s rationale for why this statement is necessary and does not support the proposed requirement.

FDA’s proposed legislation potentially could be added to the reauthorization of the Animal Drug User Fee Act (ADUFA), which is set to expire on Sept. 30, 2023.

NGFA will continue to address this issue and provide additional updates as new information becomes available.