Last week, the Office of Information and Regulatory Affairs released the spring 2025 edition of the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). This semiannual publication outlines the regulatory priorities of federal agencies and provides insight into upcoming rulemaking efforts across federal agencies.
Among the notable items listed in this edition is a Notice of Proposed Rulemaking (NPRM) from the U.S. Food and Drug Administration (FDA) concerning substances that are Generally Recognized As Safe (GRAS) for use in human and animal food—Unified Agenda Entry RIN 0910-AJ02. The proposed rule, if finalized, would amend the existing GRAS framework codified at 21 C.F.R. Parts 170 and 570 by requiring the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS.
Currently, submission of GRAS notices to the FDA is voluntary, and many manufacturers self-determine the GRAS status of substances without notifying the agency. Under the proposed changes, however, companies would be legally obligated to notify the FDA before marketing any food or feed substance under the GRAS designation.
Analysis of FDA's Statutory Authority for Mandatory GRAS Notifications
The statutory provisions cited in the NPRM, 21 U.S.C. § 321, § 342, § 348, and § 371, raise questions regarding FDA's legal authority to mandate GRAS notification requirements. It does not appear that these provisions, either alone or in combination, provide FDA with such authority. Rather, each provision serves a distinct function within the overall GRAS regulatory framework.
1. 21 U.S.C. § 321 (FDCA § 201): "Definitions"
Section 201 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) establishes key definitions, including definitions for "food additive" and "generally recognized as safe." As a definitional provision, it establishes that GRAS substances are those "generally recognized among experts" as safe. This section creates the statutory framework for the GRAS exemption rather than providing independent rulemaking authority to modify that exemption. To state it differently, it creates a safe harbor for ingredients that are added to food that experts would agree are safe.
2. 21 U.S.C. § 342 (FDCA § 402): "Adulterated Food"
Section 402 defines when food becomes "adulterated," including when it contains unapproved food additives. Specifically, § 402 causes a food to be adulterated if it contains an unapproved food additive. However, GRAS substances are not food additives. So, in essence, this section reinforces the existing GRAS framework rather than expanding regulatory authority over GRAS substances if they are not filed with FDA. Notably, § 402 does not establish that the failure to notify FDA of a GRAS determination renders the substance adulterated as a matter of law. Indeed, only new dietary ingredients that FDA is notified of are deemed adulterated as a matter of law under FD&C Act § 413(a), provided they were not previously used as food in a chemically unaltered form.
3. 21 U.S.C. § 348 (FDCA § 408): "Food Additives"
Section 408 establishes FDA's food additive approval process and authorizes regulations for substances meeting the statutory definition of "food additive." Since GRAS substances are specifically excluded from the food additive definition in § 201(s), this provision's regulatory scope is limited to non-GRAS substances requiring premarket approval. Thus, the basis for FDA's reliance on this section as a source of legal authority is unclear.
4. 21 U.S.C. § 371 (FDCA § 701): "General Rulemaking Authority"
Section 701(a) provides FDA with general authority to "prescribe regulations for the efficient enforcement" of the FD&C Act. However, under established principles of statutory construction, general rulemaking provisions typically cannot override specific statutory exemptions without clear congressional intent. The relationship between general enforcement authority and specific exemptions requires careful analysis of congressional intent and statutory structure.
Considerations Moving Forward
The interplay between these provisions and the GRAS exemption presents complex questions of statutory interpretation that may benefit from further legal analysis. FDA possesses various enforcement tools under current law, including the ability to challenge GRAS determinations through warning letters and judicial proceedings when safety concerns arise.
Rather than pursuing potentially controversial regulatory changes that may not withstand a court challenge, the agency may be better served to consider whether existing enforcement mechanisms adequately address safety concerns while maintaining the integrity of the regulatory system.
This approach would avoid potential legal challenges over FDA rulemaking authority while ensuring appropriate oversight of food ingredient safety. Any final determination regarding FDA's authority would ultimately rest with the courts, which would analyze these provisions using established principles of statutory construction, particularly in light of recent developments in administrative law jurisprudence, which signals that FDA's proposed action would have a difficult time surviving a court challenge.
FDA is expected to publish the proposed rule next month. Stakeholders, and other interested parties, will have the opportunity to submit comments once the proposed rule is officially published in the Federal Register. Given the complexities surrounding GRAS determinations, the forthcoming rule is likely to prompt substantial public and industry comment.
We are monitoring developments closely and will provide updates once the proposed rule is published. Companies making GRAS determinations should begin reviewing their procedures now to evaluate how potential changes could affect their business. Contact Venable's Food and Drug Law team with any questions.