Could Self-GRAS Determinations Be Eliminated?
HHS Secretary Robert F. Kennedy, Jr., Moves to Revise FDA Food Safety Regulations
Department of Health & Human Services (HHS) Secretary Robert F. Kennedy, Jr., announced on March 10, 2025, that he is directing the U.S. Food & Drug Administration (FDA) “to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.” The press release announcing the directive points to the goal of this potential rulemaking as “eliminating the self-affirmation process would require companies to publicly notify the FDA of their intended use of [GRAS] ingredients, along with underlying safety data, before they are introduced in the food supply.”
In addition to this envisioned “rulemaking” path, the press release commits HHS to work “with Congress to explore ways legislation can completely close the GRAS loophole.”
The stated rationale for directing FDA to consider potential rulemaking to eliminate self-GRAS affirmations is to “enhance FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers” about what ingredients are in the nation’s food supply, with Secretary Kennedy reproaching “ingredient manufacturers and sponsors” for having “exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public.”
The press release does not address, however, the difficulties that FDA may encounter in trying to achieve the stated goal of eliminating self-GRAS affirmations in light of current statutory provisions.
FDA Jurisdiction over GRAS Substances
The GRAS self-affirmation (or determination) process stems from the 1958 Food Additive Amendments, through which Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) to require premarket authorization or clearance by FDA for “food additives.”
Food additives are defined in pertinent part, under section 201(s) of the FDCA,[1] as “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.” Thus, food additives may include ingredients added directly to food and substances used to process, package, transport, or hold food that are reasonably expected to become components of food under their intended conditions of use.
The definition, however, excludes any substance that is “generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures . . . or experience based on common use in food to be safe under the conditions of its intended use.” Thus, GRAS substances are distinguished from food additives, which is important in consideration of FDA’s authority over food additives.
Under Section 409 of the Act,[2] a food additive is considered “unsafe” unless it is used in accordance with a food additive regulation promulgated by FDA or, as well, in the case of a food additive used as a food contact substance, in accordance with an effective food contact notification. As GRAS substances are excluded from the definition of food additive, they are likewise excluded from the requirement of being the subject of a regulatory clearance issued by FDA prior to use. In other words, a self-affirmation that a substance is GRAS is sufficient to market the product under the FDCA. FDA premarket clearance is not required.
FDA regulations describe the criteria relevant to determining whether a substance qualifies as GRAS.[3] First and foremost, a substance cannot be classified as GRAS under the conditions of its intended use if the available data do not satisfy the same safety standard as is applicable for a food additive under the Act. Further, as set forth in its regulation describing eligibility requirements for GRAS substances:
- General recognition of safety requires common knowledge, throughout the expert scientific community knowledgeable about the safety of substances directly or indirectly added to food, that there is a reasonable certainty that the substance is not harmful under the conditions of its intended use;
- This “common knowledge” can be based on either “scientific procedures” or on experience based on common use of a substance in food prior to January 1, 1958;
- General recognition of safety through scientific procedures must be based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.
After the passage of the Food Additives Amendment in 1958, FDA published in the Code of Federal Regulations a list of substances it recognized as GRAS,[4] to which FDA continued to add substances until 1972, when it established through rulemaking a voluntary GRAS affirmation petition process.[5] Under this regulation, an individual or company could petition FDA to review and affirm its determination of the GRAS status of a substance. FDA would then publish a notice of the filing in the Federal Register, request comments, conduct a comprehensive review, and then—if the Agency agreed with the petition—publish a final rule in the Federal Register, in which it affirmed that status.
By the 1990s, petition backlogs led the Agency to shift toward a voluntary notification system. In 1997, FDA proposed a rule to replace the GRAS affirmation process with a notification procedure.[6] Under that procedure, a notice could be submitted for a substance that a submitter considered GRAS. After its evaluation of the basis for the GRAS determination by the notifier and the accompanying data, if FDA had no questions concerning the determination, it would inform the submitter that FDA does not question the basis for the GRAS determination.
On the other hand, if FDA found the submission deficient, it would advise the notifier that the submission lacked a sufficient basis for a GRAS determination and explain the reasons. If the issues raised by the Agency could be satisfactorily answered, then FDA would respond by saying it had no questions. FDA may also issue a letter indicating that it has ceased review of the GRAS notice at the submitter’s request.
Although the proposed rule was not final, FDA invited submissions and considered them in accordance with its proposal. In February 2014, the Center for Food Safety (CFS) filed a lawsuit to vacate the 1997 proposed notification rule, and, under a Consent Decree issued by the U.S. District Court for the District of Columbia, FDA agreed to issue a final rule on the GRAS review program by the end of August 2016, which the Agency did by formally replacing the GRAS affirmation petition process with a voluntary notification procedure (GRASN) in a final rule issued on August 17, 2016.[7]
Under the final rule, a party is permitted, but is not required, to notify the Agency of its conclusion that a substance may be used in or with food as GRAS under specified conditions of use. In addition, the final rule details the process for submitting a GRAS notice, the information that should be included in it, and FDA's response to it. In this regard, the rule addresses the scientific evidence that should be submitted to demonstrate safety as well as the manner in which a party can demonstrate that the scientific evidence used to establish safety is generally available to the relevant expert scientific community and accepted by that community as demonstrating a reasonable certainty of no harm.
(For further detail on the history of the GRAS program, see the Packaginglaw.com article, The Final GRAS Regulation: Putting the Voluntary Notification Procedure in Place.)
Legal and Practical Considerations in Revising the GRAS Regulation
The HHS directive raises several legal and procedural questions as to how FDA would carry out its mission. Top of mind is how FDA will go about implementing a rulemaking on such a significant and potentially controversial subject if terminations of personnel in the FDA Human Foods Program continue apace. In addition to normal employee attrition and staff cuts recommended by the Department of Government Efficiency (DOGE), HHS announced a program to offer early buyouts of up to $25,000 to many of its 80,000 employees, including FDA personnel. If the staff is not there to do the job, the job won’t get done, or at least not effectively.
Second, there is a significant question as to what, if any, authority FDA has “to eliminate the self-affirmed GRAS pathway” as described in the press release, without amendment of the FDCA. The current law, as noted above, provides FDA with jurisdiction to authorize only food additives, as defined by the Act, to be used in food. However, the definition of food additive excludes, among others, substances that are “generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures . . . to be safe under the conditions of its intended use.” That does not give FDA much room to regulate these substances.
In 2021, FDA prevailed in a federal lawsuit brought by the Center for Food Safety (CFS) and the Environmental Defense Fund (EDF) challenging FDA’s final GRAS rule.[8] The lawsuit claimed that FDA’s final GRAS rule violated the Administrative Procedures Act (APA) and the FDCA because the statute unambiguously requires food manufacturers to disclose all GRAS determinations. The court held that the FDCA does not require mandatory disclosures of GRAS determinations and, in fact, signals that such a requirement does not exist as the FDCA exempts GRAS substances from the more rigorous statutory scheme for approving food additives.[9]
CFS and EDF also argued that, to the extent the FDCA is unclear on whether industry is required to disclose all GRAS determinations to FDA, the Agency impermissibly construed the statute to allow for a voluntary disclosure program. The court found in FDA’s favor, concluding that the Agency reasonably interpreted the FDCA to allow for a voluntary program and adequately explained the grounds upon which its decision was made.[10]
If FDA were able to reverse course at this point and conjure up the authority to require premarket notification and review of GRAS determinations, or if such authority were delegated to it by Congress, how the program would operate in practice is a good question. For example, would businesses, which rely on GRAS status for specified ingredients, be required retroactively to seek FDA clearance, and what would be the status of the substances while that process is being undertaken?
Additionally, the question arises as to whether an amendment to require FDA premarket review would have a time limit on FDA review, or whether the process could take literally years to complete as is the case now with Agency consideration of Food Additive Petitions. Further, what liability would lie for a downstream user of a product who is not aware that the product contains a GRAS substance that has not gone through this ex post facto clearance process?
This does not even account for other considerations advanced to federal agencies in President Trump’s Executive Orders on assessing the economic impact of new regulations on its stakeholders and the requirement to trim ten regulations from its books for every new regulation issued.
Legislative and State-Level Actions on GRAS
As to the HHS commitment to work “with Congress to explore ways legislation can completely close the GRAS loophole,” several legislative attempts have been made in the last few years to modify the GRAS program. In 2022, Senators Markey (D-Mass.), Blumenthal (D.-Conn.), and Warren (D-Mass.) introduced the “Ensuring Safe and Toxic-Free Foods Act of 2022,” which proposed to prohibit manufacturers from making GRAS self-determinations without first providing notice of the determination and supporting safety data to the Secretary of Health and Human Services. Portions of the Senate bill matched the proposed “Toxic Free Food Act of 2021,” which was introduced by Rep. Rosa DeLauro and failed to advance in the House.
Meanwhile, individual states are considering or have proposed laws that would mandate disclosure of GRAS self-determinations. Bills are pending in the New York Assembly and New York Senate that would require companies to provide information to the state on the use of any substance used in or in contact with food for which a self-determination has been made. A similar bill in New Jersey requiring notification to the state is also pending.[11]
Whether we see more states following suit, or Congress advance legislation such as that most recently (re)introduced in September 2024 by Rep. DeLauro to “close the GRAS loophole,” is an unknown. The legislation again failed to pass in the last Congress, but may be introduced in the new congressional session.
What’s Next?
While neither federal nor state efforts have gained much traction to date, it remains to be seen if this may change with this renewed attention on the issue by a Cabinet Secretary of a Republican administration, which could lend bipartisan support to the effort. Congress may give serious consideration to amending the FDCA. However, whether such legislation would be successful without the backing and agreement of the food industries and food safety advocacy groups is questionable.
The most important takeaway for now, though, is that Secretary Kennedy’s announcement has no legal effect on the status of ingredients currently marketed as GRAS and will not until the day that FDA completes its task of exploring regulatory pathways to end self-GRAS determinations with promulgation of a final rule, or Congress intervenes to act on the matter through legislation. In the meantime, industry stakeholders should closely monitor legislative and regulatory developments, as potential changes could reshape the future of food safety compliance in the United States.
Keller and Heckman will assist in this regard by continuing to track these developments and to provide updates as they unfold.
[1] See 21 U.S.C. § 321(s) et seq. The definition also specifically includes “any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use.”
[2] See 21 U.S.C. § 348(a) et seq.
[3] 21 C.F.R. § 170.30, “Eligibility for classification as Generally Recognized as Safe (GRAS).”
[4] 21 C.F.R. Part 182, “Substances Generally Recognized as Safe.”
[5] 21 C.F.R. Part 184, “Direct Food Substances Affirmed as Generally Recognized as Safe,” and 21 C.F.R. Part 186, “Indirect Food Substances Affirmed as Generally Recognized as Safe.”
[6] See 62 FR 18937 (April 17, 1997).
[7] See 81 FR 54960 (August 17, 2016).
[8] See Ctr. for Food Safety v. Becerra, 565 F.Supp.3d 519 (S.D.N.Y. 2021).
[9] Id. at 538-39.
[10] Id. at 539.