HHS Explores Stronger FDA Oversight for Food Ingredients

U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced on March 10, 2025, that he directed the acting commissioner of the U.S. Food and Drug Administration (FDA) to explore potential rulemaking opportunities to tighten or eliminate current pathways that allow ingredients to be used in food products without premarket approval by the FDA.

The statement highlighted two targets for additional scrutiny: a final rule issued by the FDA on Aug. 17, 2016, that clarified long-standing rules regarding when substances may be considered "generally recognized as safe" (GRAS), as well as the related "self-affirmed" pathway companies may use to independently conclude whether a substance is GRAS.

Status of GRAS Today

Under Section 201(s) and Section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), any substance that is intentionally added to food is a "food additive." Food additives are subject to premarket review and approval by FDA; however, a food manufacturer can add a food additive to food without FDA's premarket review or approval if the substance is generally recognized by qualified experts to be safe under the conditions of its intended use. Certain substances added to food do not require premarket approval because they have a long history of safe use. Otherwise, there are currently two mechanisms for establishing GRAS status for a food additive:

• Self-Affirmation. Manufacturers (and/or ingredient suppliers) independently conclude that a substance is GRAS without notifying the FDA, based on their assessment of available scientific data.
• FDA Notification. Companies voluntarily submit a GRAS notice to the FDA, including evidence that supports the safety of the substance. The FDA reviews the notice and, if it agrees with the conclusion, issues a "no questions" letter.

Though the FDA encourages companies to submit voluntary notices outlining the safety of the ingredients used in the products they manufacture, this notice is not required. Many companies instead opt to utilize the self-affirm GRAS option.

The Trump Administration is challenging the FDA's historic position on the topic, which has previously been subject to criticism from public health advocates. The administration's position is that the self-affirmed process allows for new ingredients to be introduced to the U.S. market without appropriate oversight by the agency. On the other hand, there is pushback from the industry, anticipating that stricter preapprovals could stifle innovation pipelines and, thus, the ability to get new and improved products to the market quickly.

What Comes Next?

Efforts to revisit the GRAS standard and self-affirmation process through rulemaking are supported by Secretary Kennedy and Dr. Martin Makary, President Donald Trump's nominee for FDA commissioner. The two highlighted similar concerns during their respective confirmation hearings about lax regulatory standards for food products and ingredients in the U.S. such as additives, including food dyes.

Secretary Kennedy said he wants to bring U.S. food ingredient standards on par with European nations and criticized the GRAS standard as one that "looks at any new chemical [as] innocent until proven guilty." Similarly, Dr. Makary highlighted the need to revisit the GRAS standard to ensure products that have been on the market for decades continue to be safe and potentially require new additive ingredients to meet a higher regulatory threshold of safety before being marketed in the U.S.

Though Secretary Kennedy's directive urges the acting commissioner of the FDA to identify only potential rulemaking opportunities to address the GRAS standard and self-affirmation process, healthcare leaders are aligned on prioritizing oversight of the U.S. food industry. Regulatory action may be swift, and stakeholders should be prepared for a proposed rule to be issued as soon as within the next few months. This timeline could accelerate if Dr. Makary is confirmed by the U.S. Senate as FDA commissioner, which could happen within the next two weeks.

In addition, as the acting FDA commissioner begins working on Secretary Kennedy's directive in absence of a Senate-confirmed FDA commissioner, Secretary Kennedy is likely to consider publicly advocating for changes to regulatory standards for food products and ingredients. During a March 11, 2025, meeting, Secretary Kennedy urged senior executives to remove from their products "the worst ingredients," such as artificial dyes by "the time he leaves" federal office.

This announcement marks a pivotal step toward enhancing food safety and transparency.

For more information or questions, please contact the authors. 

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