The FDA’s current regulations allow food companies to independently determine the safety of thousands of ingredients considered “generally recognized as safe” (GRAS), often without notifying the FDA or disclosing safety data. This practice has led to the addition of many unreviewed substances to the U.S. food supply, raising concerns about the adequacy of post-market oversight and the potential risks of such ingredients.
The food industry can decide which substances are considered “generally recognized as safe” due to gaps in FDA oversight.
The Food and Drug Administration (FDA) is responsible for ensuring the safety of the U.S. food supply, including setting nutrition labeling standards, collaborating with companies on food recalls, and addressing foodborne illness outbreaks. However, a recent article in the American Journal of Public Health suggests that the FDA has adopted a more hands-off stance regarding the safety of food additives and certain ingredients already in use.
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.
“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 of public health policy and management at NYU School of Global Public Health and study’s first author.
Classifying GRAS
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.”
MORE:
scitechdaily.com/a-legal-loophole-is-allowing-companies-to-include-unsafe-ingredients-in-us-foods/
www.futurity.org/legal-loophole-unsafe-ingredients-food-fda-3244462/
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