On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized as Safe) final rule.
Secretary Kennedy’s intent is to reform the self-affirmed GRAS pathway, as the first step in his personal mission to enhance FDA oversight and raise consumer awareness of ultra-processed foods.
Such a directive, if implemented, would require companies to notify FDA and provide safety data before they are permitted to introduce a new food ingredient into the food supply. That approach stands in contrast to the current system through which companies can self-affirm an ingredient as GRAS without notifying FDA.
Currently, FDA maintains a GRAS notification program that includes a public inventory of GRAS notices. However, the program does not account for all food ingredients that enter the market through the self-affirmation process — the GRAS “loophole.” As we previously discussed, the current GRAS system allows food manufacturers substantial leeway to bring new food additives to market without significant regulatory oversight.
Under this system, companies are responsible for determining whether a substance is GRAS or, instead, requires premarket submission to the agency as a food additive. Companies must also conduct their own safety review to establish GRAS status for new substances. If a manufacturer fails to conduct the necessary scientific review required to establish a substance as GRAS or does not submit a non-GRAS substance to FDA for review as a new food additive, then the substance is considered an unlawful food additive subject to enforcement action.
To eliminate this so-called loophole, the agency would have to undergo formal rulemaking to amend 21 CFR 170.30. However, this may be challenging because, as we previously discussed, President Donald Trump issued an executive order that requires 10 regulations or guidance documents to be withdrawn for every one new regulation or guidance published. Additionally, Secretary Kennedy recently changed the policy for when the Department of Health and Human Services (HHS) will engage in notice-and-comment rulemaking.
While we expect FDA to engage in standard rulemaking processes to pursue GRAS reform, the Trump administration’s deregulation initiative may complicate this effort. HHS also has indicated its intention to work with Congress to address the GRAS process.
Tightening the standards for GRAS designation and subjecting more additives to the premarket review process would increase oversight for new food additives. We do not yet know if FDA will recommend a retrospective review of food additives that have already been marketed as GRAS or only implement changes prospectively. However, FDA previously undertook a 30-year comprehensive review of all GRAS food substances and, in 1997, concluded that the agency could not continue to sustain the review due to time and resource constraints.
A major reform of GRAS that requires premarket review of the majority of food ingredients — rather than the small minority currently subject to premarket review — or that requires retrospective review of already marketed food additives would likely overwhelm FDA’s resources, as occurred in the prior GRAS review. This is particularly notable as one of the main reasons cited by the previous deputy commissioner for human foods for his resignation was the elimination of many of the scientists in charge of studying food additives. To achieve any degree of widespread GRAS reform, FDA will likely need to hire additional food scientists to support a premarket review program.
On the same day Secretary Kennedy announced his intent to reform GRAS, he also met with food industry leaders, where he stated that a top priority is eliminating artificial food dyes.
FDA has already banned Red Dye No. 3 and brominated vegetable oil. In addition, California has banned certain food additives like potassium bromate and propylparaben, and at least a dozen other states including West Virginia and New York are instituting similar bans. These state-level bans can act as de facto national bans, and states have historically been faster at the rulemaking process than FDA.
Both FDA’s proposal for reforming GRAS and the impending report from the Make America Healthy Again Commission are poised to reshape much of the food industry in the United States. We will continue to monitor these issues as they develop.
This memorandum is provided by Skadden, Arps, Slate, Meagher & Flom LLP and its affiliates for educational and informational purposes only and is not intended and should not be construed as legal advice. This memorandum is considered advertising under applicable state laws.
For further information, please contact:
Avia M. Dunn, Partner, Skadden
avia.dunn@skadden.com
