Gaps in FDA oversight enable the food industry to determine which substances are “generally recognized as safe”
The Food and Drug Administration (FDA) is tasked with overseeing the safety of the U.S. food supply, setting requirements for nutrition labeling, working with companies on food recalls, and responding to outbreaks of foodborne illness. But when it comes to additives already in our food and the safety of certain ingredients, FDA has taken a hands-off approach, according to a new article in the American Journal of Public Health.
The current FDA process allows the food industry to regulate itself when it comes to thousands of added ingredients—by determining for itself which ingredients should be considered “generally recognized as safe,” or GRAS—and deciding on their own whether or not to disclose the ingredients’ use and the underlying safety data to the FDA. As a result, many new substances have been added to our food supply without any government oversight.
Since 1958, the FDA has been responsible for evaluating the safety of new chemicals and substances added to foods before they go to market. However, food safety laws distinguish between “food additives” and “GRAS” ingredients. While compounds considered “food additives” must be reviewed and approved by the FDA before they are used in foods, ingredients considered GRAS are exempt from these regulations.
The GRAS designation was initially established for ingredients already found in foods—for instance, vinegar and spices. But under a rule used since 1997, the FDA has allowed the food industry to independently determine which substances fall into this category, including many new substances added to foods. Rather than disclose the new use of these ingredients and the accompanying safety data for FDA review, companies can do their own research to evaluate an ingredient’s safety before going to market, without any notification or sharing of the findings. The FDA suggests—but does not require—that companies voluntarily notify the agency about the use of such substances and their findings, but in practice, many such substances have been added without notification.
In their analysis, the researchers review the history of the FDA’s and industry’s approach around adding these new compounds to foods and identify the lack of any real oversight. This includes a federal court case in 2021 upholding the FDA’s hands-off approach.
“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 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. “There are now hundreds, if not thousands, of substances added to our foods for which the true safety data are unknown to independent scientists, the government, and the public.”
An example of the 21 food additives to be reviewed is potassium bromate, a chemical added to baked goods and drinks with evidence that it may cause cancer. Potassium bromate is banned in Europe, Canada, China, and Japan; California recently passed a law to ban its use, along with three other chemicals, and similar bills have been introduced in Illinois, New York, and Pennsylvania.
“This is a stark example of the FDA’s regulatory gap,” said Pomeranz. “We’re seeing states starting to act to fill the regulatory void left by the FDA’s inaction over substances increasingly associated with harm.”
https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2024.307755
