H.R. 2203 — Innovative FEED Act of 2025

This section establishes a definition of "zootechnical animal food substance" in section 201 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)—i.e., a substance added to animal food or water intended to affect digestive byproducts, reduce certain foodborne pathogens, or manipulate the animal's gastrointestinal microbiome (acting solely within the gastrointestinal tract and excluding hormones, ionophores, new animal drugs, disease treatments, or other substances as specified or per future rulemaking)—and deems such substances food additives under FD&C Act section 201(s) (regulated via section 409 petitions) that are not drugs under section 201(g)(1)(C) solely due to their intended effects. (Thus, these substances, such as certain microbiome modifiers, avoid new animal drug approval requirements.) The section further amends FD&C Act section 409 (food additives) to (1) require petitions for zootechnical animal food substances to include data on intended effects, quantities, and investigations; (2) direct the Secretary of Health and Human Services, upon approval, to specify conditions achieving the intended effect; (3) allow denial if the substance fails to achieve its intended effect; and (4) mandate labeling with the statement "Not for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals" while permitting claims on structure/function effects. Additionally, the section amends FD&C Act section 403 to deem a zootechnical animal food substance misbranded if its labeling lacks the required statement and includes a rule of construction clarifying that it does not authorize the Secretary to require use of such substances.