Sponsors (52)
The bill enables use and clearer approval/labeling of feed additives that may reduce foodborne pathogens and improve market information, but it raises compliance costs, regulatory uncertainty, enforcement risk, and potential animal-health concerns from reduced veterinary oversight.
Farmers and consumers: allowing use of substances specifically approved to reduce foodborne pathogens can lower contamination risk in the food supply.
Manufacturers and small businesses: the bill creates a clearer regulatory pathway and defined data/labeling requirements for novel feed additives, giving firms more predictable approval criteria and regulatory expectations.
Buyers and producers: manufacturers may label intended non-therapeutic effects on animal GI structure/function, helping purchasers make more informed product choices.
Farmers and manufacturers: the petition requirements for full investigation reports and efficacy data raise testing, documentation, and compliance costs, which can be burdensome for small businesses and producers.
Manufacturers and small businesses: mandatory disease-disclaimer labeling and misbranding penalties increase compliance burden and heighten the risk of enforcement actions.
Manufacturers: narrow statutory exclusions plus agency rulemaking discretion create uncertainty about which products qualify, potentially delaying market entry and investment.
Based on analysis of 2 sections of legislative text.
Creates a new FDA regulatory category and section 409 premarket pathway for certain non‑therapeutic gut‑acting feed/water additives and adds labeling and data requirements.
Official title: To amend the Federal Food, Drug, and Cosmetic Act with respect to the regulation of zootechnical animal food substances.
Introduced March 18, 2025 by Nicholas A. Langworthy · Last progress March 18, 2025
Creates a new regulatory category for certain non‑therapeutic substances added to animal feed or drinking water — called “zootechnical animal food substances” — and requires those substances to be regulated as food additives under the Federal Food, Drug, and Cosmetic Act before being introduced into interstate commerce. The bill sets definition boundaries, excludes drugs and other categories, adds data and petition requirements, establishes labeling language warning the substance is not for diagnosing or treating animal disease, makes omission of that label a misbranding violation, and forbids the FDA from mandating their use.