FDA’s Unified Regulatory Agenda: Key Updates for Food, Dietary Supplements, and Cosmetics

In September 2025, the U.S. Food and Drug Administration (FDA) published its Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda), which contains regulations that the FDA is currently developing. 

This list provides insight into the FDA’s top regulatory priorities and includes some key developments in the food and beverage, dietary supplement, and cosmetics industries. The Unified Regulatory Agenda has a wide range across the FDA. Key agenda items include, but are not limited to: 

• A final rule on front-of-package (FOP) nutrition labeling;
• A proposed rule on substances generally recognized as safe (GRAS);
• A proposed rule regarding an as-yet unnamed ingredient that is not excluded from the definition of “dietary supplement”; and
• A proposed rule on the disclosure of fragrance allergens in cosmetic labeling. 

Additional information on each is below. 

Front-of-Package Nutrition Labeling

The FDA announced its intention to finalize a proposed rule first promulgated in January 2025 regarding FOP nutrition labeling. If finalized, the rule would require many packaged food products to display certain nutrition information on the principal display panel. Specifically, the FOP nutrition label would provide per serving values for saturated fat, sodium, and added sugars. The rule outlines how these nutrients should be described as “Low,” “Med,” or “High” and specifies the box’s required format, contents, and placement. Businesses with $10 million or more in annual food sales would have three years to comply after the rule takes effect, while smaller businesses would have four years. 

Substances Generally Recognized as Safe

This proposed rule, if finalized, would require companies to submit notices for all food substances—both ingredients and those added indirectly, such as through packaging—that are claimed to be GRAS for use in human and animal food. Substances already listed or affirmed as GRAS by regulation or those for which the FDA has previously issued a “no questions” letter would be exempt from this requirement. The proposed rule also clarifies that the FDA will maintain and regularly update a public inventory of all GRAS notices submitted under these new requirements, making information about the safety of food substances more accessible. Additionally, the rule would clarify the process by which the FDA determines that a substance is not considered GRAS for its intended use.

An As-Yet Unnamed Ingredient Is Not Excluded From the Definition of “Dietary Supplement”

This proposed rule, if finalized, would clarify that a specific ingredient will not be excluded from the definition of a dietary supplement. This means that products containing this ingredient could be lawfully marketed as dietary supplements, as long as they meet the requirements outlined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and do not otherwise violate the FD&C Act. At this time, the FDA has not identified which specific ingredient the rule will address, and the proposed rule is scheduled for publication in January 2026.

Disclosure of Fragrance Allergens in Cosmetic Labeling 

The FDA intends to propose a rule identifying certain substances as fragrance allergens and require that these allergens be disclosed on the labels of cosmetic products. The Modernization of Cosmetics Regulation Act (MoCRA), a 2022 statute, amended the Federal Food, Drug, and Cosmetic Act to require fragrance allergen labeling among other changes to cosmetic regulations. Under MoCRA, this rulemaking was required within 18 months of MoCRA’s enactment, or June 29, 2024. The agency has not yet issued a proposed fragrance allergen rule.

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We will continue to monitor these evolving regulatory developments and provide updates as new information becomes available. For further information or specific inquiries, please contact the firm’s Food & Beverage Industry regulatory team.