The Food and Drug Administration (FDA) already collects fees from drug and medical device companies, but it may want to consider collecting fees from food companies as a way to fund the agency's oversight of food safety efforts, according to an analysis yesterday in Health Affairs.
GRAS loopholes
Every year, the FDA is tasked with assessing thousands of food additives, color additives, and ingredients deemed "generally recognized as safe" (GRAS) by the food industry. But in the era of ultra-processed food, the authors say GRAS ingredients might not necessarily be safe, and that 99% of new ingredients are added to the food supply through the GRAS loophole.
If a manufacturer deems an ingredient as GRAS, it can bypass certain FDA reviews, the study authors explained. Moreover, if an ingredient was considered GRAS and then later found to be harmful to human health, the FDA is hamstrung by post-market review processes to remove or limit exposure to the ingredient.
The authors used brominated vegetable oil to illustrate their point. Brominated vegetable oil, which is linked to nervous system damage, was no longer considered GRAS in 1953, but the FDA did not revoke its status as an approved food additive until July 2024.
"Instead of removing it from the food supply at that time, the agency designated it as an approved food additive, allowing it to remain in certain products. Many additional examples exist, such as nonnutritive sweeteners implicated in metabolic risk," the authors explained.
The FDA needs additional resources to maintain the staff necessary for oversight of the large and growing number of additives and GRAS substances.
"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," said Emily Broad Leib, study co-author and director of Harvard Law School Center for Health Law and Policy Innovation, in a press release from NYU.
User fees allowed, but not used for food programs
The FDA primarily relies on congressional appropriations to fund its food-related activities. But user fees are allowed under the Food Safety Modernization Act of 2011—they are just rarely implemented, the authors said.
In 2022, user fees made up 66% of the $2.1 billion human drugs budget and 100% of the $680 million tobacco budget, compared with only about 1% of the $1.1 billion foods program budget.
"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," said first author Jenifer Pomeranz, PhD, from the NYU School of Global Public Health and study’s first author.
