The FDA has proposed to mandate that manufacturers of feed notify about the additives used.

Economics

The proposed amendments, published under number FDA-2025-N-3262, concern two sections of federal regulations: part 170 (human food) and part 570 (animal feed). Since 1958, companies have had the right to independently classify ingredients as "Generally Recognized as Safe" (GRAS) and market them without prior notification to the regulator. Under the new rule, manufacturers will be required to submit relevant notifications to the FDA.

Agency data show a significant reporting gap: since the launch of the pilot project, the regulator has received more than 1,200 GRAS notifications, yet the FDA's Center for Veterinary Medicine had registered only 75 applications concerning animal feed by March 2025. Given that this industry supplies the livestock sector and pets with feed, the actual volume of substances used in the market without registration remains unknown.

The regulator emphasizes the interconnectedness between the markets: standards for feed additives take into account that when using substances for productive animals, it is necessary to consider the consumption history of their derived products by humans. For feed additives, the draft contains requirements similar to the rules for human food, with some exceptions. In particular, for substances intended for livestock, it will be necessary to provide data on potential residual amounts of components in the edible tissues of animals.

The proposed measures are not a pre-approval system: substances may be marketed before the agency reviews the notification. The absence of an entry in the registry will not be considered an automatic violation of the law, but it will become a criterion for priority post-market monitoring. The initiative's goal is to form a complete database of ingredients entering the food supply chain.

At the moment, the initiative is a draft rule, not a law. For ingredients already in use on the market, the agency plans to introduce a one-year window for submitting information under a simplified procedure. Public comment on the document will continue until December 9, 2026, after which the FDA will be required to issue the final version of the rules.