The 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 the FDA's oversight of foods, according to a new legal and policy analysis published in the journal Health Affairs .
"The FDA is persistently understaffed and underfunded, hampering its ability to ensure the safety of our country's food supply," said 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."
An increasingly complex food landscape
The FDA is tasked with regulating roughly 78 percent of the US food supply, including packaged products, food additives, and infant formula. There are growing concerns about the FDA's lack of oversight of ingredients and chemicals added to food, including those often found in ultra-processed foods.
Food and color additives are regulated by the FDA; however, food companies can decide for themselves that their new ingredients are "generally recognized as safe," or GRAS. This is a loophole that allows new substances to be added to the food supply without government oversight —and one which Department of Health and Human Services Secretary Kennedy recently instructed the FDA to review . An analysis by the Environmental Working Group found that 99 percent of new ingredients are added to the food supply through this GRAS loophole.
"The sum effect is a food supply that is increasingly unsafe and unhealthy," said 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."
Fees for food?
The 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, they have eventually supported their use given the benefits and stability fees bring to the regulated industries. For example, user fees enable the 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 the FDA more than doubled after user fees were implemented.
"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," said 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."
Before and after
The FDA's oversight of food ingredients—and timing for reviewing them, if at all—depends on the type of ingredient. For food and color additives, manufacturers are required to submit petitions to the FDA for approval before introducing them into the food supply. Yet the 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.
With GRAS ingredients, companies can voluntarily submit a pre-market notification to the FDA, but even if the FDA takes issue with a GRAS claim, a company can withdraw its notification and still bring the product to market. Alternatively, with the GRAS loophole , a company can just determine for itself that the ingredient is GRAS and add it to the food supply without any FDA oversight or public notification.
The 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. Earlier this year, the FDA banned the color additive Red No. 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 took the matter into its own hands and enacted its own ban.
"These decades-long timelines starkly demonstrate the inefficiencies and lack of timeliness of the FDA's post-market review process," said Pomeranz. "An increase in resources could support the FDA in both meeting deadlines for pre-market reviews and creating a more efficient and effective regulatory process for post-market reviews of substances in the food supply. But in the absence of Congress creating user fees or providing the FDA with a substantially increased budget, the food industry will continue to police itself."
While user fees could better fund the FDA's oversight of foods, the researchers note that the agency could benefit from additional authority to prevent unsafe ingredients from entering the food supply in the first place. A starting place, according to their article, is to close the GRAS loophole by requiring companies to notify the 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.
"These troubling gaps in FDA oversight are jeopardizing our health and well-being," said study author Sean Cash, the Bergstrom Foundation Professor in Global Nutrition at the Friedman School of Nutrition Science and Policy at Tufts. "User fees can help provide the FDA with much-need resources that can both make us safer and increase consumer trust in the U.S. food supply."
The research was supported by the National Institutes of Health (2R01HL115189-06A1).
