HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

The Federal Food, Drug, and Cosmetic Act (FFDCA) has recognized since 1958 that GRAS ingredients are exempt from the food additive definition and can lawfully be marketed without first seeking FDA authorization when there are published data supporting their GRAS status on the basis of common use in foods prior to 1958 or scientific procedures. Since 1997, FDA has also run a voluntary GRAS notification program, which has been successful on many fronts; it is an efficiently run and public program, with FDA completing evaluations generally in well under a year and posting notifications on the agency’s website. The GRAS process, however, has been criticized because establishments can review the published data, conclude an ingredient is GRAS, and market the ingredient without first seeking FDA authorization to do so. 

It remains to be seen whether Secretary Kennedy will try to reform the GRAS process administratively or seek Congressional action for amendments to the FFDCA that would establish a process for mandatory filing of GRAS notifications. The announcement raises many questions about how GRAS reform could unfold and what impact it would have for industry and consumers.  

Background on GRAS Framework

Under the 1958 Food Additives Amendment to the FFDCA, any “food additive” is considered unsafe, rendering the finished food legally adulterated, unless the specific use for which it is added to the food has been authorized by FDA pursuant to a food additive regulation.¹

Under this provision, “food additive” is defined broadly to include, in relevant part, “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 (including 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

This statutory definition of a “food additive” expressly excludes 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 (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.”³ In other words, an ingredient for which a food additive regulation has not been issued may be used in foods if the user can determine it is generally recognized as safe (GRAS) for its intended use. 

Shortly after the Food Additives Amendment, FDA published in the Code of Federal Regulations (CFR) a list of food ingredients considered GRAS by FDA at that time. When issuing the regulation, the agency noted: 

It is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, vinegar, baking powder, and monosodium glutamate as safe for their intended use.⁴

Years after publishing the initial list of GRAS ingredients, FDA worked with the Select Committee on GRAS Substances (SCOGS) to assess the safety of many of the listed substances, ultimately affirming many substances as GRAS through the rulemaking process and placing them on the list of GRAS affirmed ingredients in 21 CFR Part 184 for food ingredients added directly to foods and 21 CFR Part 186 for indirectly added food ingredients. The GRAS listed ingredients that did not go through the GRAS affirmation process continue be listed at 21 CFR Part 182.  

Until 1997, interested parties could voluntarily petition the agency to issue a GRAS affirmation regulation for a substance. In 1997, FDA proposed to replace the GRAS affirmation petition process with a voluntary GRAS notification system, which it began implementing under an interim pilot program.⁵ Under this program, which was formally implemented in 2016 as discussed below, a company may voluntarily notify the agency of its independent conclusion that the use of a substance is GRAS. This GRAS notification process, including submission requirements, is defined by regulation.⁶ Once a GRAS notification is submitted, FDA will review the materials and issue a response letter. A “no questions” letter states that FDA does not question the basis for the notifier’s independent GRAS conclusion.⁷ FDA makes available to the public an online inventory of all GRAS notifications and FDA responses, which is updated on a continuous basis.⁸

In 2016, FDA issued a final rule formally establishing the new voluntary GRAS notification program and clarifying the criteria for a substance to be considered GRAS.⁹ The agency clarified in the preamble to the final rule that companies maintain the option to make an independent conclusion of the GRAS status of an ingredient and may lawfully use an ingredient without notification to the agency provided the GRAS criteria are satisfied.

In 2017, a group of NGOs sued FDA, seeking declaratory judgment that this GRAS final rule, in relevant part, exceeded FDA’s statutory authority and was arbitrary and capricious under the Administrative Procedure Act.¹⁰ The plaintiffs argued, in part, that the GRAS rule improperly delegated FDA’s duty to evaluate the safety of food additives to industry and that the FFDCA mandates disclosure of independent GRAS conclusions to FDA. In 2021, a judge for the Southern District of New York granted FDA’s motion to dismiss the case, concluding, in relevant part, that FDA had not improperly delegated any duty to industry because the agency retained its authority to challenge independent conclusions of GRAS status and that, contrary to the plaintiffs’ arguments, “it remains unclear under the [FFDCA] whether FDA even has the authority to make GRAS notifications mandatory.”  

HHS Directive to FDA

Secretary Kennedy’s directive to FDA marks an initial step in the exploration of potential GRAS reform. The secretary directed the agency to “take steps 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.”¹¹ In a press release, Secretary Kennedy stated, “[f]or far too long, ingredient manufacturers and sponsors have 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 . . . Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”¹²

Assessment

Secretary Kennedy’s directive to FDA leaves open many questions about how potential GRAS reform could unfold. 

It is challenging to predict how this administration would approach GRAS reform. Historically, FDA would choose rulemaking and would develop arguments as part of the rulemaking in support of the agency’s determination that GRAS notifications should be mandatory. While there is no clear statutory provision authorizing mandatory filing of GRAS notices, the agency could point to those provisions of the FFDCA that provide FDA with the discretion to issue regulations that will support the efficient enforcement of the law. Such  arguments, however, could be susceptible to challenge given the lack of clear statutory authority. A conclusion that the statute does grant the agency this authority is susceptible to challenge following the 2024 U.S. Supreme Court decision in Loper Bright Enterprises v. Raimondo, which substantially curtailed the longstanding deference afforded to agencies in statutory interpretation.¹³ FDA could also pursue other options that could be implemented more quickly such as an Executive Order that would provide a legal basis for arguing self-GRAS determinations lack the public availability element of the “general recognition” standard and therefore cannot serve as the basis for a GRAS determination. The administration could pursue these and other arguments to support a position that it will no longer accept self-GRAS determinations and is prepared to take action against companies that are utilizing this approach. It remains to be seen whether such an approach in an Executive Order would withstand judicial scrutiny given the absence of any clear statutory language mandating the filing of GRAS notices.  

The administration, therefore, may opt to pursue statutory changes. The GRAS exemption from the food additive definition is a statutory designation, so Congressional action is one way to establish a mandatory notification program. Indeed, HHS concluded its press release with discussion of possible legislation in this area: “HHS also is committed to working with Congress to explore ways legislation can completely close the GRAS loophole. Such legislation, in tandem with potential future rulemaking, are crucial steps necessary to Make America Healthy Again.”¹⁴

Other open questions are: how quickly potential rulemaking or legislation amending the GRAS framework would or could proceed; whether and how changes to the GRAS framework would impact foods already on the market; and how potential rulemaking activities might fit into the Trump Administration’s recent executive order directing agency heads to identify at least ten existing regulations to be repealed for every one new regulation proposed.¹⁵

Finally, interested parties might also consider how potential GRAS reform could impact state regulation of food ingredients. Many state ingredient bans and proposals to date have focused on specific food and color additives, with a limited number of bills focusing on the GRAS process. A mandatory GRAS notification program implemented through an Executive Order or notice and comment rulemaking would not have clear preemptive effect and it is unclear if the courts would find preemption because the FFDCA does not expressly preempt FDA authorized food ingredients.  Legislation amending the GRAS process could be written in a way to create express preemption.    

Next Steps

Industry should continue to monitor FDA’s exploration of potential changes to the GRAS framework and remain engaged throughout the process, including by participating in any notice and comment rulemaking activities or stakeholder meetings. 

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We will continue to monitor developments in this area. Please contact us if you have any questions.

Authored by: Martin Hahn, Elizabeth Fawell, and Rachel Buff.