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New GRAS rules offer consumers confidence but companies are concerned

Public health campaigners are celebrating the US government’s move to close the Generally Recognised as Safe (GRAS) loophole, but companies worry it will stifle innovation.

The US Department of Health and Human Services (HHS) proposed a rule requiring manufacturers to notify the US Food and Drug Administration (FDA) when concluding that the use of a substance added to human or animal food is Generally Recognised as Safe (GRAS).

At a glance:

• GRAS change is designed to close a loophole in approvals that is loved and hated in equal measure.
• A new definition for ultra-processed foods (UPFs) is submitted but the government stays silent on details.
• Also proposed are changes to the threshold of regulation (TOR) procedure, which would expand exemptions to substances used directly in food as well as food contact substances.

The federal government’s first proposed definition of ultra-processed foods (UPFs) was also ssubmitted by HHS and the US Department of Agriculture (USDA), for review.

The two landmark actions will “modernise federal oversight of food ingredients and establish a stronger scientific foundation for future nutrition policy”, it said.

The moves – the first food regulation proposed by the Make America Healthy Again (MAHA) administration – represented “the biggest news in food reform in modern history”, said HHS secretary Robert F. Kennedy, in a press conference in August.

“Americans deserve confidence that the ingredients in their food are subject to transparent, science-based oversight, and today’s actions strengthen both sides of that equation,” said acting FDA commissioner Kyle Diamantas. “By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply,” he added.

Since 1958, the FDA has been responsible for evaluating the safety of new chemicals and substances added to foods before they go to market. However, food safety laws distinguish between food additives and GRAS ingredients. While compounds considered food additives must be reviewed and approved by the FDA before they are used in foods, ingredients considered GRAS are exempt from these regulations.

The GRAS designation was initially established for ingredients already found in foods – for instance, vinegar and spices. But under a rule used since 1997, the FDA has allowed the food industry to independently determine which substances fall into this category, including many new substances added to foods.

An accompanying HHS factsheet explained that the new proposal:

• requires manufacturers to notify the FDA when concluding that the use of a substance added to human or animal food is GRAS;
• expands the existing public inventory of submitted GRAS notifications;
• improves the FDA’s visibility into ingredients entering the food supply, allowing for greater post-market oversight; and
• increases transparency for consumers and industry.

For substances already on the market based on prior self-GRAS conclusions, the proposal “establishes a time-limited, streamlined submission pathway that would allow manufacturers to notify the FDA of existing GRAS uses while enabling the agency to prioritise post-market safety evaluations, where appropriate”, the sheet explained.

Jennifer Pomeranz, an associate professor of public health policy and management at New York University, told the New York Times, that she “couldn’t be more thrilled” that the FDA had moved to close the GRAS loophole, adding that the proposed rule would mean that companies could no longer add ingredients without the FDA’s knowledge and oversight.

Research on the federal law loophole led by Pomeranz and published in the American Journal of Public Health in 2024 warned there were hundreds, if not thousands, of substances added to foods for which the true safety data are unknown to independent scientists, the government, and the public.

Industry reaction to the new GRAS has been mixed, with some believing the move could stymie innovation in food and ingredients, including that in the alternative protein space. Megan Mullinix, senior account executive at McCormick Flavor Solutions, said redefining GRAS has been an active area of discussion and the direction of the regulatory change is “worth watching closely” for manufacturers and food ingredients suppliers.

“[...] these broad sweeping changes can influence more than regulations – they shape renovation and innovation priorities, technology focus, sourcing strategies and ultimately competitive advantage and relevance to the end consumer,” she said.

Comments on the proposed rule can be submitted until 9 December 2026.

Marion Nestle, Paulette Goddard professor of nutrition, food studies and public health at New York University, Emerita, said: “Food advocates for years have called for making GRAS notifications mandatory [and close the so-called ‘GRAS-loophole’]. So this move is obvious, and long-awaited.”

FDA to propose definition of ultra-processed foods (UPFs)

The FDA also proposed changes to its threshold of regulation (TOR) procedure. Under the new proposal, FDA would expand TOR exemptions to substances used directly in food as well as food contact substances and make qualifying uses exempt from the proposed mandatory GRAS notification requirement, explained the Food Packaging Forum in a regulatory update.

The FDA’s proposal also includes replacing the 0.5 ppb threshold with a body-weight-adjusted exposure limit of 0.025 µg/kg body weight/day, updating the criterion for carcinogenic impurities to a lifetime cancer risk of no more than one in one million, and removing the requirement that a substance have no technical effect in food.

HHS and USDA also submitted for final review the federal government's first proposed definition of UPFs.

Although research has linked high consumption of UPFs to preventable chronic diseases, including type 2 diabetes and heart disease, the absence of a standardised federal definition has posed problems. The proposed definition incorporates feedback from thousands of stakeholders, including industry, consumer organisations, researchers, and members of the public. Further details are not yet available, despite a promise to have this definition in place by April this year.