The U.S. Food and Drug Administration (FDA) collects user fees from drug and medical device companies to fund its work ensuring the safety of these products. Creating a similar program that collects fees from food companies could generate much-needed resources to strengthen FDA’s oversight of foods, according to a new legal and policy analysis published in the journal Health Affairs. The research for the analysis was supported by the U.S. National Institutes of Health (NIH).

“FDA is persistently understaffed and underfunded, hampering its ability to ensure the safety of our country’s food supply,” said Jennifer Pomeranz, J.D., M.P.H., Associate Professor of Public Health Policy and Management at the New York University (NYU) School of Global Public Health and the study’s first author. “A comprehensive user fee program for food could benefit the food industry and facilitate FDA’s review of products and ingredients—both before and after they go to market—to improve public health.”

The Complexities of FDA Food Ingredients Oversight, or Lack Thereof

FDA is tasked with regulating roughly 78 percent of the U.S. food supply, including packaged products, food additives, and infant formula. There are growing concerns among the public about FDA’s lack of oversight of ingredients and chemicals added to food.

Food and color additives are regulated by FDA; however, food companies can decide for themselves if their new ingredients are “generally recognized as safe,” or GRAS. Critics consider GRAS to be a "loophole" that allows new substances to be added to the food supply without government oversight—and one which U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. recently instructed FDA to review.

Study author Emily Broad Leib, J.D., 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, argues that FDA needs additional resources to maintain the staff required to oversee food additives and GRAS substances, and to close the GRAS "loophole" by requiring premarket notification of GRAS substances.

One way to acquire the funds necessary to adequately resource food chemical reviews at FDA is by collecting food industry user fees, say the authors. 

User Fees for Food Industry Could Help Put the "F" Back in FDA

At present, FDA primarily relies on appropriations from Congress to fund its food-related activities. In contrast, the agency collects user fees from other industries that it regulates. In 2022, user fees made up 66 percent of the $2.1 billion budget for regulating drugs and all of the $680 million tobacco budget, compared to only 1 percent of the $1.1 billion foods program budget.

Any new FDA user fee for food will have to be authorized by Congress. While industries have sometimes initially opposed user fees, historically, stakeholders eventually support their use given the benefits and stability that fees bring to regulated industries. For example, user fees enable FDA to more efficiently review applications for new drugs, allowing companies to go to market more quickly. In the case of generic drugs, the annual number approved by FDA more than doubled after user fees were implemented. 

The authors argued that, despite the enormous importance of food to humans' daily lives and its public health impacts, food regulation is neglected at FDA, in both its work priorities and budget, compared to its other regulated products. “It is time to put the ‘F’ back in FDA, with real resources designated by Congress, which could include a carefully crafted user fee program," said study senior author Dariush Mozaffarian, Dr.Ph., M.D., M.P.H, Director of the Food is Medicine Institute and Distinguished Professor at the Friedman School of Nutrition Science and Policy at Tufts University. 

How FDA's Food Ingredients Oversight is Hampered by a Lack of Resources, Authorities

FDA’s oversight of food ingredients—and timing for reviewing them, if at all—depends on the type of ingredient, according to the policy study. For food and color additives, manufacturers are required to submit petitions to FDA for approval before introducing them into the food supply. Yet FDA does not have the staffing needed to quickly review them, often missing its own 180-day deadlines and resulting in a backlog of pre-market petitions, say the study's authors.

With GRAS ingredients, companies can voluntarily submit a pre-market notification to the FDA, but even if FDA takes issue with a GRAS claim, a company can withdraw its notification and still bring the product to market. Alternatively, under GRAS, a company can determine for itself that the ingredient is GRAS and add it to the food supply without any FDA oversight or public notification.

FDA also has the authority to review the safety of ingredients after they are in the food supply, but these post-market reviews are also limited by insufficient resources—often completed decades after an ingredient’s safety is called into question. 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. Additionally, earlier in 2025, FDA banned the controversial color additive red dye 3 from foods—35 years after the agency stopped allowing it in cosmetics, 31 years after Europe prohibited its use in nearly all foods, and two years after California enacted its own ban with the California Food Safety Act.

The authors point to the the inefficiencies and lack of timeliness of FDA’s post-market chemical review process, warning that, in the absence of Congress creating user fees or providing FDA with a substantially increased budget, the food industry will continue to police itself.

Even before the authors published their policy analysis in Health Affairs, top FDA officials have been calling attention to the need for greater funding and resources in order to meet the growing demand for stricter food ingredients oversight. For example, recently resigned FDA Deputy Commissioner for Human Foods Jim Jones, who was known for his efforts to develop a systematic post-market review process for food chemicals, said in an October 2024 webinar that the agency's food chemical activities are “very under-resourced compared to what people hope [FDA] is able to do.” 

Mr. Jones was leading FDA's Human Foods Program when it revoked its authorization for red dye 3 in foods. In a Congressional hearing that took place shortly before FDA effected its ban on the colorant, Mr. Jones and former FDA Commissioner Robert F. Califf, M.D. again expressed the need for additional resources to undertake the vast amount of food ingredients oversight being demanded by the public and Congress. “[Food dyes] are a priority," Dr. Califf said to Congress, “…but I want to point out that we have a very small staff and we have repeatedly asked for better funding for chemical safety. Please look at our request for funding for the people who do this work.”

Mr. Jones resigned from FDA in February 2025 after mass layoffs handed down from the Trump Administration affected 89 of his staffers within the Human Foods Program, further constraining the resources Mr. Jones had at his disposal to execute food chemical safety work. With thousands more layoffs implemented at HHS agencies, including FDA, in the months since Mr. Jones' resignation, industry stakeholders and experts have shared their concerns about how food safety oversight will be upheld with dwindling resources and staff.

While user fees could better fund FDA’s oversight of foods, the policy analysis researchers note that the agency could also benefit from additional authority to prevent unsafe ingredients from entering the food supply in the first place. A starting point, according to their article, is to close the GRAS "loophole" by requiring companies to notify FDA and submit data on all new ingredients before going to market, rather than permitting voluntary notifications. This could be done by FDA action or with a clearer mandate from Congress.