Food regulation update August 14: The latest on MAHA and related developments

CHICAGO, August 14, 2026 – The following is a roundup of regulatory developments affecting the food-away-from-home business, including policy changes that are part of the Administration’s Make America Healthy Again (MAHA) initiative. The report is compiled and written by Dr. Joy Dubost, a renowned food scientist and registered dietitian with strong knowledge of what’s happening on the regulatory front.

HHS

Food Policy Announcements & Celebration

The Trump administration brought together senior federal officials, nutrition researchers and food advocates for a food policy celebration highlighting the administration’s nutrition agenda and announcing two significant actions that could reshape federal food policy: proposed changes to the Generally Recognized as Safe (GRAS) framework and advancement of the federal government’s first proposed definition of ultra-processed foods (UPFs). HHS announced that FDA is releasing a proposed rule that would require manufacturers to notify the agency when concluding that the use of a substance added to human, food contact substances or animal food is GRAS. At the same time, HHS and USDA submitted to OMB a white paper with the first proposed federal definition of UPFs. “Nearly 60% of the American diet is made up of UPFs, and childhood obesity now affects more than one in five American children,” HHS Secretary Kennedy said in announcing the actions. “We cannot reverse America’s chronic disease epidemic without transforming our food system. These historic actions bring greater transparency to what’s in our food and stronger science to federal nutrition policy. President Trump and I promised to Make America Healthy Again, and today we are turning that promise into policy.”

GRAS Reform Takes Center Stage

GRAS reform was one of the clearest regulatory messages of the event. Kennedy argued that the GRAS exemption created by Congress in 1958 for well-understood substances has evolved into a system in which companies can independently determine that substances are GRAS without notifying FDA. He said this has left the agency without a complete picture of substances entering the food supply. The proposed rule would change that framework by making GRAS notification mandatory. Acting FDA Commissioner Kyle Diamantas explained that a person introducing a new GRAS substance or use into the food supply would generally be required to notify FDA and provide the basis for the GRAS conclusion, unless an exemption applies. For substances already on the market based on industry self-GRAS conclusions, FDA is proposing a time-limited, streamlined submission pathway. The approach is intended to allow manufacturers to provide information on existing uses while expanding FDA’s publicly facing inventory of submitted GRAS notices and supporting post-market safety review. Diamantas also stressed during the event that the proposal is a regulatory blueprint open to public comment and acknowledged the limitations of FDA’s existing statutory authority. He noted bipartisan interest in GRAS reform and said the administration would continue working with Congress on legislative options.

Secretary Kennedy made clear that the administration views the proposed GRAS rule and other executive actions as only part of a broader food policy overhaul. “We are changing federal nutrition policy. Americans are changing the way that they eat, and companies are changing what they put on our store shelves,” Kennedy said. “But HHS cannot complete this work through administrative action alone. We are doing everything that we can do within our legal power.” He added that Congress needs to provide FDA with additional tools “to keep pace with a changing food supply and protect the American people.” Kennedy connected the actions to the administration’s broader pledge to “overhaul outdated food regulations” and increase transparency about what is in the food supply. HHS similarly encouraged Congress in its announcement to build on the administration’s efforts through legislation that further strengthens ingredient safety.

The remarks are significant because they suggest that the proposed GRAS regulation may not represent the endpoint of reform. Additional statutory changes could follow as the administration works with Congress on GRAS and other food safety and nutrition policies.

First Federal Definition of Ultra-Processed Foods Moves Forward

The second major announcement was the advancement of the federal government’s first proposed definition of UPFs via a white paper for review by OMB. Secretary Kennedy said establishing a common federal definition would provide a consistent framework for studying UPFs, understanding their potential health effects and developing future nutrition policy. The proposed definition could have implications well beyond research.

Nutrition researcher Dr. Dariush Mozaffarian, who was also on-stage delivering remarks, called defining UPFs and changing the GRAS framework among FDA’s most consequential food and nutrition actions in decades. He argued that a standardized definition could ultimately inform consumer purchasing as well as food procurement by schools, hospitals, workplaces, the military and other institutions. He also suggested that it could encourage manufacturers to reformulate products and eventually inform front-of-pack labeling. Importantly, Mozaffarian cautioned against treating processing as the only measure of nutritional quality. He acknowledged variation in the healthfulness of foods categorized as ultra-processed and argued that a definition should include exemptions for foods meeting clearly established criteria for being healthy. He characterized ultra-processing as a distinct dimension of food quality that should complement, not replace existing nutrition science.

The event also demonstrated how closely the administration is linking regulatory policy with voluntary industry reformulation. Kennedy highlighted food companies that have committed to removing artificial colors and other additives. He specifically pointed to Kellogg’s announcement that it would eliminate artificial colors from all of its cereals by the end of 2026, which he said puts the company a year ahead of schedule. He also cited Kraft Heinz, General Mills, Nestlé, Conagra, J.M. Smucker and Utz among companies that have made commitments to remove artificial colors and other additives. Food activist Vani Hari similarly highlighted voluntary industry action, saying approximately half of the food industry is either removing artificial food dyes or has already done so. She specifically called on PepsiCo and Mars to make similar commitments.

HHS adviser Calley Means placed the announcements within the administration’s broader MAHA agenda, pointing to changes involving SNAP, the Dietary Guidelines for Americans, artificial food dyes and GRAS reform. Means argued that consumer behavior is also beginning to change, citing increased purchases of what he characterized as “real food” and slower growth for UPFs. He said the shift is becoming significant enough that “every boardroom in America” is grappling with changing consumer preferences. He also emphasized what he described as growing bipartisan alignment around food transparency and nutrition policy, pointing to cooperation among lawmakers, medical organizations and advocacy groups that may disagree with the administration on other issues.

Closing the event, HHS Chief Counselor and Deputy Secretary nominee Chris Klomp placed the announcements within a longer-term effort to shift the health system toward prevention. He identified transparency and healthier food as one pillar of that strategy, specifically connecting GRAS and UPF policies with other administration initiatives involving regenerative agriculture, hospital food and medical nutrition.

What This Means for the Food Industry

The food policy celebration made clear that GRAS reform and UPFs are moving rapidly from policy discussions toward federal frameworks that could have significant implications across the food and ingredient industries. For GRAS, the immediate focus will be FDA’s proposed transition from voluntary to mandatory notification and, importantly, the details surrounding the streamlined pathway for substances already on the market. Companies will need to closely evaluate the proposed requirements, timelines, information expectations and potential implications for existing self-GRAS determinations. For UPFs, the proposed federal definition could ultimately have an even broader impact. While the initial purpose is to establish consistency for research and federal nutrition policy, speakers repeatedly connected the definition to institutional procurement, product reformulation, consumer purchasing and potentially front-of-pack labeling.

At the same time, voluntary industry commitments are becoming an increasingly visible part of the administration’s food policy strategy. Companies that have announced reformulation efforts are being publicly recognized, while others are facing growing pressure from advocates to follow. Perhaps most importantly, Kennedy’s call for congressional action indicates that the current regulatory initiatives may be the beginning rather than the culmination of federal food policy changes. As he told attendees, HHS intends to use its existing authority, but Congress will need to provide FDA with additional tools to keep pace with an evolving food supply.

FDA

GRAS

FDA has proposed an overhaul of the Generally Recognized as Safe (GRAS) framework that would convert the current voluntary notification system into a mandatory GRAS notification program for substances used in human and animal food. The proposal does not eliminate GRAS or prohibit companies from making self-affirmed GRAS conclusions. Rather, it would generally require companies relying on a GRAS conclusion to notify FDA of the basis for that conclusion, subject to specified exceptions. Acting FDA Commissioner Kyle Diamantas emphasized that the proposal is not intended to create a new premarket approval system. As he explained, “This process, this new notification system, does not establish a pre-market review program.” Companies would still be able to reach their own GRAS conclusions and would not be required to wait for FDA to complete its substantive review before marketing the substance. This distinction is important. A substance that is GRAS under its intended conditions of use would remain exempt from the food additive premarket approval requirements under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act. The proposed rule changes FDA’s visibility into GRAS determinations, but it does not change the underlying statutory GRAS exemption.

Mandatory Notification, Not FDA Approval

Under the proposal, any person introducing a substance into interstate commerce based on the GRAS provision would generally be required to notify FDA and provide the basis for concluding that the substance is GRAS under its intended conditions of use. The rule covers both directly added ingredients and indirectly added substances, including food-contact substances. FDA would have 45 days to conduct an initial review and determine whether to file the submission as a GRAS notice. Once FDA decides whether to file the notice, the agency proposes notifying the submitter within two business days. Filing the notice would generally satisfy the notification requirement, but it would not mean FDA has completed its scientific review or agreed with the GRAS conclusion. FDA anticipates receiving a significant influx of notices once the system becomes mandatory and proposes a staggered approach to handling submissions. This is particularly relevant for companies with multiple existing self-GRAS substances that may need to be brought into the new notification framework.

Several Important Exceptions

The proposed rule includes a number of exceptions intended to avoid duplicative submissions where FDA already has sufficient visibility into a substance or its use.

These exceptions would include certain substances or uses that are:

• covered by an FDA “no questions” letter;
• listed as GRAS in FDA regulations;
• prior-sanctioned substances;
• covered by certain FDA premarket consultation programs;
• covered by a Threshold of Regulation exemption; covered by an effective Food Contact Notification; and
• eligible existing self-GRAS uses submitted through the proposed time-limited streamlined pathway.

The exceptions are important because the rule is not designed to require companies to re-notify FDA about every substance already subject to an existing FDA regulatory or review mechanism.

Streamlined Pathway for Existing Self-GRAS Substances

One of the most significant provisions for industry is FDA’s proposed transition mechanism for substances already on the market. For substances introduced into interstate commerce before the effective date of the final rule based on an independent GRAS conclusion, FDA proposes a time-limited option allowing companies to make a streamlined submission rather than immediately preparing a complete GRAS notice. The streamlined submission would generally identify the substance, its intended uses and use levels, and provide evidence that it was introduced into interstate commerce before the effective date of the final rule. Unlike a full GRAS notice, the streamlined submission would not initially require the complete scientific safety narrative supporting the GRAS conclusion. FDA would use the information to develop greater visibility into existing self-GRAS substances and prioritize substances for post-market review. The streamlined option would be available for only one year following the effective date of the final rule. Not every existing self-GRAS substance would qualify. The streamlined pathway would not be available where FDA previously issued an “insufficient basis” letter for the relevant conditions of use or where FDA has already determined that the use is not GRAS. In those circumstances, a new full GRAS notice or potentially another regulatory pathway, such as a food additive petition, would be necessary.

FDA Review and Post-Market Oversight

A key feature of the proposal is that companies would not need to wait for FDA to complete its substantive review before marketing a substance. This distinguishes the GRAS notification process from a food additive petition, which requires FDA authorization before use. However, the increased visibility would give FDA substantially more information with which to conduct post-market oversight. FDA states that mandatory notification would help the agency determine whether a purported GRAS use actually meets the statutory GRAS standard or instead constitutes a food additive use requiring premarket authorization.

Failure to comply with the notification requirement would not automatically mean that a substance becomes an unlawful food additive. Instead, FDA proposes treating noncompliance as a factor when prioritizing substances for post-market review. This is another important distinction: the rule creates a mandatory reporting obligation, but FDA is not proposing that the act of notification itself establishes GRAS status.

Food-Contact Substances and Threshold of Regulation

The proposal also makes changes to the Threshold of Regulation (TOR) provisions for human food. FDA proposes expanding the TOR provisions beyond their current focus on substances used in food-contact articles to encompass qualifying substances used directly in food as well as food-contact substances. If FDA grants a TOR exemption for an intended use, that use would be exempt from the proposed mandatory GRAS notification requirement.

Similarly, an intended use already covered by an effective Food Contact Notification would generally not require a separate GRAS notice. This is especially relevant for companies evaluating whether GRAS, Food Contact Notification or TOR is the most appropriate regulatory pathway for food-contact substances.

What Does Not Change

Several aspects of GRAS remain intact under the proposal. The rule would not eliminate self-GRAS conclusions. It would not convert GRAS into an FDA approval program. It would not require companies to wait for FDA’s substantive review before marketing an ingredient. And it would not change the statutory principle that GRAS status applies to the conditions of intended use of a substance, rather than simply to the substance itself. For substances whose GRAS status is based on scientific procedures, the underlying scientific standard also remains unchanged: the safety conclusion must be based on evidence of the quantity and quality generally required to support the safety of a food additive, with general recognition among qualified experts.

Congress May Still Be Needed

FDA and HHS have also been explicit that the proposed rule reflects what the administration believes it can accomplish under existing statutory authority. At the event announcing the proposal, HHS Secretary Kennedy said HHS is doing everything it can within its existing legal authority but “cannot complete this work through administrative action alone.” He called on Congress to provide FDA with additional tools to strengthen oversight of the food supply. This is significant because the proposed rule may not represent the final stage of GRAS reform. Additional legislative changes could eventually expand FDA’s authority beyond the notification framework proposed here.

Timing

The proposed rule is open for public comment for 120 days, with comments due December 9, 2026. If finalized as proposed, the rule would become effective 60 days after publication of the final rule. The mandatory GRAS notification requirements would have a compliance date 18 months after the effective date, while the streamlined submission option for eligible substances already in commerce would remain open for one year after the effective date.

Key Takeaways

The proposal is best characterized as a shift from voluntary disclosure to mandatory disclosure of GRAS conclusions — not a shift from GRAS to FDA premarket approval.

Companies could still independently determine that a substance is GRAS, and they would generally be able to market the substance without waiting for FDA to complete its review. What would largely disappear is the ability to rely on a self-GRAS conclusion without FDA knowing that the substance and use exist. For industry, the most immediate step will be to inventory existing GRAS positions and determine which substances and uses fall into the following categories: those already covered by FDA “no questions” letters or another exception; existing self-GRAS uses that may qualify for the one-year streamlined pathway; and new or otherwise non-exempt GRAS uses that would require a complete mandatory GRAS notice. The proposed rule therefore creates both a significant new compliance obligation and a strategic regulatory exercise for companies with large ingredient portfolios. The details of the exceptions, transitional pathway, FDA review process, and treatment of existing self-GRAS substances will likely be among the most important issues raised during the comment period.

Fresh Cut Produce

FDA has released final guidance to help manufacturers and processors of ready-to-eat fresh-cut produce comply with the FSMA Preventive Controls for Human Food rule. The guidance provides recommendations for controlling biological hazards in products such as chopped lettuce, cut melon, diced onions and shredded carrots, which are typically consumed without a kill step. It addresses contamination risks that can occur during growing, transport, processing, commingling and retail. The final guidance reflects comments on the 2018 draft and replaces FDA’s 2008 fresh-cut produce guidance. FDA also encourages industry to continue developing commodity- and process-specific food safety best practices.

MAHA

Eat Real Food – Secretary Kennedy’s Show

New Episode: “How to make the PERFECT Omelet.”

STATES

New York

The New York City Economic Development Corporation (NYCEDC) has issued a Request for Proposals (RFP) seeking up to five grocery store operators to manage the city’s planned “NYC Groceries” initiative, a key component of Mayor Zohran Mamdani’s effort to improve access to affordable food across the city. NYCEDC is seeking experienced grocery operators with expertise in sourcing products, merchandising, staffing, customer service, and day-to-day retail operations. Proposals are due October 16, 2026, and the city has launched a dedicated website outlining the initiative and procurement process. The municipal grocery store concept is intended to expand access to affordable groceries, particularly in underserved communities, while complementing not replacing existing private retailers. According to city officials, the stores are expected to focus on essential grocery items and fresh foods rather than serving as full-service supermarkets with expanded retail offerings. The proposal continues to generate significant discussion among retailers, policymakers, and community stakeholders. The Food Industry Alliance of New York (FIANY) is actively monitoring the initiative and engaging with city officials and industry representatives as implementation plans continue to evolve.