The U.S. Food and Drug Administration (FDA) often determines nutrition standards, oversees food recalls, and handles foodborne illnesses to protect the nation’s food supply.
Despite this, a recent study points to the FDA’s more hands-off approach when it comes to regulating food additives and certain pre-approved ingredients.1
This lack of oversight has allowed unsafe substances to slip through the cracks and enter the food we eat every day. So, just how safe are the foods on our shelves?
GRAS Label Stems from Loopholes in FDA Oversight
Currently, the FDA permits the food industry to self-regulate many of the substances added to our food. Companies can decide for themselves which ingredients are classified as “generally recognized as safe” (GRAS) without needing to report their use or share the underlying safety data with the FDA.(ref) This legal gap has allowed countless new substances to enter the food supply with little to no government oversight.
According to Jennifer Pomeranz, associate professor of public health policy and management at NYU School of Global Public Health and the lead author of the study, neither the FDA nor the public knows the full extent of these ingredients in the food supply, which are most commonly found in ultra-processed foods.(ref)
How Food Safety Has Fallen Into Industry Hands
Since 1958, the FDA has been checking the safety of new chemicals and ingredients before they are added to foods and sold to the public.
However, U.S. food safety laws draw a distinction between “food additives” and “generally recognized as safe” (GRAS) ingredients. While food additives must undergo FDA review and approval before being used in foods, GRAS ingredients are exempt from these requirements.(ref)
The GRAS label was first for common ingredients like canola oil, vinegar, and spices.(ref) But a 1997 rule change let companies decide which new substances are GRAS.(ref) Now, they can assess the safety of these ingredients themselves without needing to inform the FDA or share their safety data.
The FDA recommends that companies share their safety findings, but it’s not required. This has led to many new substances entering the food supply without proper oversight. In the study, the researchers point out that both the FDA and the food industry have failed to regulate these ingredients effectively. A 2021 federal court case confirmed the FDA’s lenient approach to this issue.(ref)
What’s Really in Our Food?
Researchers mention that the FDA has no formal process or enough resources to review food additives and GRAS substances already on the market. If new research shows health risks, the FDA can act to limit or remove harmful ingredients.
However, this rarely happens. In a rare move, the FDA announced in March it would review 21 chemicals in foods—just a small fraction of the thousands of additives and GRAS substances in use today. (ref)
In FDA’s review, one of the additives on the food ingredient list is potassium bromate,(ref) a chemical used in baked goods and beverages that has been linked to cancer.(ref) While potassium bromate is banned in Europe, Canada, China, India, and Japan,(ref) it remains legal in the U.S. California recently passed a law to ban its use, along with three other chemicals, and similar legislative efforts are underway in Illinois, Missouri, New York, and Pennsylvania.(ref)
The FDA’s oversight of GRAS ingredients already on the market is similarly limited. The agency rarely revokes GRAS status. One example of a GRAS substance currently shelved off the market is brominated vegetable oil (BVO),(ref) which can damage the heart, kidney, and liver due to its derivatives.(ref)
The study also finds that the FDA does not consistently monitor foods containing GRAS ingredients that can be safe in small amounts but harmful in larger quantities, such as caffeine, salt, and sugar.
In 1977, the FDA approved caffeine as a GRAS substance for sodas at a low level of 0.02 percent.(ref) Yet today, caffeine is added to energy drinks at much higher levels, leading to caffeine-related health risks.(ref) Despite its regulatory authority, the FDA has yet to set limits on caffeine in these beverages.
Improving Food Safety
The authors of the study propose several steps the FDA and Congress can take to better regulate GRAS substances and food additives.
These recommendations include requiring companies to publicly notify the FDA about the use of GRAS ingredients and submit their safety data before these substances are added to foods.
In addition, the authors suggest creating a rigorous review process to reevaluate the safety of GRAS ingredients and food additives that are already on the market. Clarifying the distinction between GRAS ingredients and food additives is also best to improve oversight.
To support enhanced regulation of the food supply, the researchers recommend that Congress could either allocate more resources to the FDA or implement a user fee program, where food companies would pay the FDA to review the safety of their ingredients before they are introduced into foods.(ref)
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Martha A. Lavallie
Martha is a journalist with close to a decade of experience in uncovering and reporting on the most compelling stories of our time. Passionate about staying ahead of the curve, she specializes in shedding light on trending topics and captivating global narratives. Her insightful articles have garnered acclaim, making her a trusted voice in today's dynamic media landscape.