NYC Gazette

The Food and Drug Administration (FDA) may gain new resources to enhance food safety oversight through user fees from food companies, according to a recent analysis in Health Affairs. Currently, the FDA collects fees from drug and medical device companies but relies on Congressional appropriations for food-related activities. "The FDA is persistently understaffed and underfunded, hampering its ability to ensure the safety of our country’s food supply," said Jennifer Pomeranz of NYU School of Global Public Health.

The study notes FDA's responsibility for regulating about 78 percent of the U.S. food supply, including packaged foods and additives. Concerns arise due to the GRAS (generally recognized as safe) loophole, where food companies can self-certify new ingredients without FDA oversight. "The sum effect is a food supply that is increasingly unsafe and unhealthy," stated Emily Broad Leib of Harvard Law School.

In 2022, user fees made up a larger portion of the FDA's budget for drugs and tobacco compared to food, where they contributed only 1 percent. User fees have been shown to expedite drug approval processes, and a similar program for food could offer benefits. "For too long, the work and budget of the FDA has neglected foods," said Dariush Mozaffarian of Tufts University.

The FDA's food ingredient oversight is constrained by resources, affecting both pre-market and post-market reviews. Companies can introduce GRAS ingredients with minimal FDA intervention, raising safety issues. Sean Cash of Tufts University highlighted the positive impact user fees could have: "User fees can help provide the FDA with much-needed resources that can both make us safer and increase consumer trust in the U.S. food supply."

The study calls for closing the GRAS loophole and increasing FDA authority, potentially through Congressional action. The research received support from the National Institutes of Health.