If the FDA charged food companies user fees it could strengthen its oversight of food safety, according to a recent study.
The study, “Advancing the FDA’s Human Foods Program Through Additional Authorities and User Fees,” was published in the journal Health Affairs in May and includes analysis of the lack of user fees on the food side of the Food and Drug Administration.
The FDA already collects user fees from drug and medical device companies and accreditation and certification bodies to supplement the annual funding Congress provides. The fees cover well more than half of the agency’s costs for its drugs programs.
The fees were implemented to help the agency provide the timely availability of innovative FDA-regulated drugs and medical device products.
According to the new study, in 2022, user fees made up 66 percent of the $2.1 billion budget for regulating drugs and all of the FDA’s $680 million tobacco budget.
In contrast, the FDA’s existing food fees cover only 1 percent of the $1.1 billion foods program budget. Congress determines the FDA’s funding, including the amount of FDA user fees, and the agency can only spend user fees on activities that Congress specifically allows.
Under the Food Safety Moderniization Act, the FDA currently has the authority to collect limited food-specific user fees.
The study’s authors point to budget shortfalls on the food side of the FDA as a good reason to consider adding more user fees.
“The FDA is persistently understaffed and underfunded, hampering its ability to ensure the safety of our country’s food supply,” said Jennifer L. Pomeranz, associate professor of public health policy and management at 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 the FDA’s review of products and ingredients — both before and after they go to market — to improve public health.”
The agency’s lack of resources was documented in an assessment of the FDA’s food budget by the independent Reagan Udall Foundation. It showed shortfalls in the agency’s ability to ensure a safe food supply because of funding constraints. The assessment was done in 2022 and budget shortfalls continue, according to the recent research report.
In particular, the researchers’ analysis raises concerns about the FDA’s ability to fulfill critical food safety responsibilities related to its review of food and color additives and ingredients deemed “generally recognized as safe” (GRAS) by industry, especially unreviewed ingredients added to ultra-processed foods. It also highlights the recent rash of state bans on food ingredients, which the study says have exposed “the limits of the FDA’s oversight and created regulatory inconsistency.”
The research findings support the position of Secretary of Health and Human Services Robert F. Kennedy and FDA Administrator Martin Makary regarding artificial dyes. They have asked the food industry to voluntarily remove such dyes from their products.
The recent analysis shares data that suggests the FDA does not meet the statutory and regulatory timelines set for its review of premarket submissions, including food and color additive petitions, proposed labeling claims and new infant formula notifications.
The study authors say user fees could help ensure the health of the public.
“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.”
Sean B. Cash and Emily Broad Leib were part of the research team and are also listed as authors on the report.
Read the full study here.
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