FDA must close GRAS loophole and charge food industry user fees, urges new legal analysis

A new legal analysis urges US Congress to authorize user fees for food companies to boost FDA funding and close safety loopholes, including the controversial GRAS rule (generally recognized as safe) that allows companies to self-approve ingredients. The Center for Science in the Public Interest (CSPI) warns that underfunding and restructuring threaten FDA oversight, while major food and health groups are urging Congress to allocate US$30 million for chemical safety reviews.

The study from New York University (NYU), US, anticipates that the FDA’s understaffing and underfunding will negatively impact its ability to ensure food supply safety. The FDA regulates around 78% of the US food supply, which includes packaged products, food additives, and infant formula. 

Researchers believe that the disruptions to the FDA may lead to a lack of oversight of ingredients and chemicals found in ultra-processed foods.

“The FDA is persistently understaffed and underfunded, hampering its ability to ensure the safety of our country’s food supply,” says Jennifer Pomeranz, associate professor of public health policy and management at NYU School of Global Public Health and study’s first author. 

“A comprehensive user fee program for food could benefit the food industry and facilitate the FDA’s review of products and ingredients — both before and after they go to market — to improve public health.”

FDA compromised

CPSI president Dr. Peter Lurie is concerned that the FDA’s food and medical product programs are facing chaos due to mass layoffs and reorganization plans, which will only add to the disarray.

CSPI warns that FDA underfunding and restructuring could compromise food safety oversight.Recently, the Trump administration revealed plans to lay off 20,000 staff at US health agencies. It faces backlash from public health and disease prevention experts while scientists are suing the National Institutes of Health for research funding cuts. 

Senator Patty Murray commented: “Let’s be crystal clear — there’s nothing strategic about firing thousands of people who inspect our food and ensure our prescriptions and babies’ formula are safe.”

Lurie says: “Unfortunately, the chaos at the agency is poised to get much worse. A plan to reorganize the FDA, leaked to Inside Health Policy, would recklessly rip apart the specialized centers within the agency and create new offices based on function, presumably reporting to the commissioner.”

“According to the report, one of these will contain all the agency’s review functions, undermining the current system designed to protect reviewers from the kinds of political interference that can damage public health.”

He adds that the leaked proposal will hamper the year-long efforts of FDA staff organizations to solve emerging problems such as the “groundbreaking” reorganization of the FDA Human Foods Program. The food reorganization implemented lessons from the 2022 infant formula outbreak, when the expertise and knowledge needed to respond were scattered across the agency, leading to delays and chaos.

The reorganization will “reverse and destroy” alignments while rushing through it “without adequate stakeholder input.”

Addressing safety loophole

The FDA regulates various ingredients, however, loopholes remain. For example, food companies decide whether their new ingredient is GRAS, which Robert F. Kennedy Jr., Secretary of Health and Human Services, seeks to remove.

NYU analysis calls for user fees from food companies to strengthen FDA funding and close safety gaps.Companies can voluntarily submit pre-market notifications for GRAS ingredients to the FDA. However, if the FDA has an issue with the GRAS claim, they can withdraw the notifications, allowing the product to be brought to market, explains the study published in Health Affairs.

“The sum effect is a food supply that is increasingly unsafe and unhealthy,” says study author Emily Broad Leib, director of Harvard Law School Center for Health Law and Policy Innovation and founding director of the Harvard Law School Food Law and Policy Clinic. 

“The FDA needs additional resources to maintain the staff necessary for oversight of the large and growing number of additives and GRAS substances and to close the GRAS loophole by requiring premarket notification of GRAS substances.”

The researchers also note how a lack of staffing often leads to them missing its 180-day deadline, which causes a backlog of pre-market petitions. 

Additionally, the FDA’s post-market review of ingredient safety is limited by insufficient resources, often completed decades after an ingredient’s safety is questioned:

“For instance, partially hydrogenated vegetable oils were known to be harmful as early as 1993, but their GRAS status wasn’t revoked until 2015, with implementation stalled until December 2023,” says Broad Leib. “Earlier this year, the FDA banned the color additive Red No. 3 from foods, 35 years after the agency stopped allowing it in cosmetics and 31 years after Europe prohibited its use in nearly all foods.”

Leading food and health organizations are urging Congress to allocate US$30 million for food chemical safety reviews.Study author Sean Cash, the Bergstrom Foundation Professor in Global Nutrition at the Friedman School of Nutrition Science and Policy at Tufts, comments: “User fees can help provide the FDA with much-needed resources that can make us safer and increase consumer trust in the US food supply.” 

Raising funds

A large part of FDA funding comes from Congress. However, the agency also collects user fees from industries it regulates. The study reveals that in 2022, user fees accounted for 66% of the US$2.1 billion drug and US$680 million tobacco budgets, while only 1% of the US$1.1 billion foods program budget was allocated to these programs.

“For too long, the work and budget of the FDA has neglected foods — which have far greater cumulative health benefits and harms for Americans’ health than drugs,” says study senior author Dariush Mozaffarian, director of the Food is Medicine Institute and distinguished professor at the Friedman School of Nutrition Science and Policy at Tufts University. 

“It’s time to put the ‘F’ back in FDA, with real resources designated by Congress, which could include a carefully crafted user fee program.”

Researchers note that though Congress must authorize new user feeds, industries can support them with user fees to enable the FDA to review things faster.

Meanwhile, a group of sustainable policy, food, and health organizations has sent an open letter to Congress, urging it to provide an increase of US$30 million for food chemical reassessment.

Signatories include the Calorie Control Council, Cargill, CPSI, Danone North America, and Nestlé.

“We believe that strong federal oversight of food ingredients will provide consumers with confidence in the safety of our food system, as well as offer industry predictability for producing safe and affordable foods for US consumers,” reads the letter. 

“Congress cannot allow the FDA foods program to remain under-resourced. We therefore renew the request many of our organizations made last year and urge you to provide an additional US$30 million in funding to the FDA in FY 2026 to address food chemical safety.”