NYC Gazette

The Food and Drug Administration (FDA) is responsible for overseeing the safety of the U.S. food supply, including setting requirements for nutrition labeling, working with companies on food recalls, and responding to outbreaks of foodborne illness. However, according to a new article in the American Journal of Public Health, the FDA has taken a hands-off approach regarding additives already in our food and the safety of certain ingredients.

The current FDA process allows the food industry to regulate itself concerning thousands of added ingredients by determining which should be considered “generally recognized as safe” (GRAS). Companies decide independently whether or not to disclose these ingredients’ use and underlying safety data to the FDA. Consequently, many new substances have been added to the food supply without government oversight.

“Both the FDA and the public are unaware of how many of these ingredients—which are most commonly found in ultra-processed foods—are in our food supply,” said Jennifer Pomeranz, associate professor at NYU School of Global Public Health and study’s first author.

Since 1958, while compounds considered “food additives” must be reviewed and approved by the FDA before they are used in foods, GRAS ingredients are exempt from these regulations. Initially established for common substances like vinegar and spices, under a rule since 1997, companies can independently determine which new substances fall into this category without notifying or sharing findings with the FDA.

“Notably, the court did not find that the FDA’s practices on GRAS ingredients support the safety of our food supply,” said Pomeranz. “The court only ruled that the FDA’s practice was not unlawful.”

“As a result of the FDA’s policy, the food industry has been free to ‘self-GRAS’ new substances they wish to add to foods without notifying FDA or the public,” said Dariush Mozaffarian from Tufts University. “There are now hundreds, if not thousands, of substances added to our foods for which true safety data are unknown.”

Researchers highlight that after an ingredient is added to foods if research later suggests harms, only then can action be taken by reviewing new data. In March 2024, an exception occurred when 21 chemicals were announced for review by the FDA due to potential harm.

An example is potassium bromate—a chemical banned in several countries but still used in some U.S. baked goods despite evidence suggesting it may cause cancer. States like California have recently passed laws banning its use.

“This is a stark example of the FDA’s regulatory gap,” said Pomeranz.

The agency rarely revokes GRAS designation; only 15 substances have been reclassified out of many present today. For instance, caffeine approved at low levels in sodas now appears at higher levels in energy drinks causing health issues.

“In 1977, caffeine was approved as a GRAS substance for use in sodas at a low level: 0.02 percent,” noted Pomeranz.

Study co-author Emily Broad Leib emphasized that stronger protections could involve mandatory public notification about GRAS ingredient usage before market entry and robust post-market review processes funded either through additional Congressional resources or user fee programs paid by companies.

“Both the FDA and Congress can do more to enable [the agency] to meet its mission of ensuring a safe food supply,” concluded Pomeranz.

This research received support from National Institutes of Health grant (2R01HL115189-06A1).