Kennedy’s FDA Mandates GRAS Notifications and Proposes First Federal ‘Ultra-Processed’ Definition

What Kennedy’s Twin Food Policy Reforms Actually Change

The U.S. Department of Health and Human Services announced two significant food policy changes on August 10, 2026. The Food and Drug Administration issued a proposed rule that would, for the first time, require manufacturers to notify the agency whenever they determine a substance added to human or animal food is Generally Recognized as Safe. Separately, HHS and the U.S. Department of Agriculture submitted the federal government’s first proposed definition of ultra-processed foods for final review.

The moves are part of the Trump administration’s Make America Healthy Again strategy, led by HHS Secretary Robert F. Kennedy Jr. They aim to close a decades-old regulatory gap: since 1958, companies have been permitted to make their own GRAS determinations without informing the FDA, relying on a voluntary notification program that left many substances unreviewed. The new proposal would make those notifications mandatory and create a public inventory of submissions, while also establishing a time-limited pathway for manufacturers to submit information on existing self-determined GRAS uses.

The proposed UPF definition is designed to standardize how federal agencies classify and research these foods, which currently account for nearly 60% of the American diet. Research has linked high UPF consumption to type 2 diabetes, heart disease and other chronic conditions, but the absence of a common definition has hindered consistent research and policy. The definition was developed with feedback from thousands of stakeholders, including industry, consumer groups and researchers.

The administration also encouraged Congress to build on the proposals with legislation that further strengthens food safety oversight. Kennedy framed the actions as a direct response to the chronic disease epidemic, highlighting that childhood obesity now affects more than one in five American children.

Where the GRAS Overhaul and UPF Definition Leave the Food Industry

Kennedy’s Regulatory Philosophy Takes Shape

Secretary Kennedy has long criticized the food industry’s influence on dietary health, and these twin actions translate his rhetoric into enforceable policy. By targeting both the ingredients that enter the food supply and the definitional framework for processed food, the administration is constructing a two-pronged regulatory infrastructure. The GRAS rule changes the oversight of individual substances; the UPF definition lays the groundwork for future labeling, dietary guidance and potentially taxation or marketing restrictions. Together they signal a much more interventionist federal stance on food than the industry has faced in decades.

GRAS Mandate: Closing the Self-Certification Loophole

Under the current voluntary system, many food additives have entered the market without any FDA review. Mandatory GRAS notification gives the agency far greater visibility and a chance to question safety determinations. The proposed rule doesn’t eliminate the GRAS pathway itself, but it eliminates the ability of manufacturers to operate in the shadows. The time-limited streamlined submission for existing self-GRAS substances is a pragmatic compromise—it allows legacy ingredients to be registered without forcing full new safety dossiers immediately, while still giving FDA a curated list for priority post-market evaluations. Companies with a heavy reliance on undisclosed GRAS ingredients face immediate operational and documentation costs, as well as potential reputational exposure if substances now come under scrutiny.

The UPF Definition: A Foundation for Future Regulation

A standard federal definition of ultra-processed foods may seem academic, but it is a necessary precursor to nearly any downstream policy. Without it, a national UPF warning label, a reformulation target, or nutritional standards tied to processing level cannot be coherently designed or enforced. The definition itself does not impose restrictions, but it will immediately influence how federal research funds are allocated and may be used by the Dietary Guidelines advisory committees, school meal programs and procurement standards. International experience—particularly in Brazil and some European countries—shows that a UPF classification framework often becomes the backbone of marketing restrictions and front-of-pack labeling schemes, even if those are not yet proposed in the U.S.

Winners and Losers in the Industry

The clearest winners are companies that have already invested in clean-label product lines, organic or minimally processed portfolios, and transparent supply chains. They now have a regulatory tailwind that reinforces their premium positioning. Ingredient suppliers with well-documented safety dossiers and GRAS notifications on file face a lower marginal burden. On the losing side are large manufacturers of highly processed snacks, frozen meals, soft drinks and reconstituted meat products whose product mix scores poorly on the emerging UPF spectrum. The mandatory GRAS rule also raises costs for small and mid-sized food businesses that may have relied on self-determination without the legal and scientific resources to quickly compile formal submissions. Private equity and venture capital investors in food and beverage will need to re-evaluate portfolio companies for regulatory exposure, particularly if a UPF tax or labeling mandate follows.

Action Plan for Food Manufacturers and Investors

For manufacturers:

• Audit all ingredients currently sold under self-GRAS determinations. Begin assembling safety data and usage information now to take advantage of the proposed streamlined submission pathway before it closes.
• Map your product portfolio against the proposed UPF definition once finalized. Even without immediate regulation, retailers and institutional buyers may begin using the federal definition in their own sourcing criteria.
• Reformulation efforts should prioritize ingredients with existing FDA-reviewed GRAS notifications, reducing future regulatory risk and potential supply chain disruptions.

For investors and retailers:

• Scrutinize food portfolio companies’ reliance on undisclosed GRAS ingredients and the proportion of revenue derived from products likely to be classified as ultra-processed. Early movers with transparent supply chains may gain shelf space as retailers anticipate consumer and regulatory pressure.
• Expect incremental compliance costs across the sector in the near term, with a widening margin gap between large, well-resourced firms and smaller players that may struggle to bear the documentation burden.