In recent decades, the safety of food additives has come under scrutiny, revealing significant gaps in oversight that have implications for public health. Nearly 70 years ago, Congress made a pivotal change to the Federal Food, Drug, and Cosmetic Act, mandating that food additives be thoroughly evaluated for safety prior to their use. Unfortunately, this legislative intent has not been fully realized.
The Food Additives Amendment, enacted in 1958, established two distinct pathways for food additives. One path involves a comprehensive safety review by the Food and Drug Administration (FDA), while the other allows common ingredients that are deemed “generally recognized as safe” (GRAS) to bypass this scrutiny. Examples of these GRAS ingredients include vinegar and baking soda.
Today, however, a significant majority of new ingredients—most of which are industrially produced—find their way to market through the GRAS pathway. Jennifer Pomeranz, an associate professor of public health policy and management at the NYU School of Global Public Health, highlights concerns raised by researchers, physicians, nonprofits, and the Government Accountability Office. They argue that many of these ingredients are not truly recognized as safe. Instead, food companies have capitalized on what is often referred to as the “GRAS loophole.”
This loophole is problematic for several reasons. First, the 1958 amendment does not clearly define what constitutes GRAS status. Moreover, companies are permitted to conduct their own safety assessments, often relying on unpublished studies. This enables them to market ingredients without notifying the FDA or disclosing their safety data, effectively bypassing both FDA review and public awareness.
The food industry has portrayed the regulatory landscape differently. The Consumer Brands Association, a trade group representing manufacturers of packaged goods, maintains a website asserting that food and beverage companies adhere to “strict regulations and rigorous safety protocols.” The stated goal is to promote transparency and empower consumers to make informed decisions.
Recently, the Trump administration has taken steps toward addressing this issue. In March, Health Secretary Robert F. Kennedy Jr. instructed the FDA commissioner to investigate potential new rules that would require companies to notify the FDA and share safety data before introducing new ingredients into the food supply.
Undark spoke with Pomeranz to delve deeper into these concerns. The following interview has been edited for length and clarity.
Undark: Are there many new ingredients in the food supply that the FDA is unaware of?
Jennifer Pomeranz: Unfortunately, yes, likely thousands. Companies are not required to inform the FDA when they add these ingredients to food products.
Additionally, there are concerns regarding labeling. Although we assume all ingredients are listed, labels often use general terms like “corn oil” or “flavorings,” which obscure the specific chemicals or compounds present. This makes it difficult for consumers to know what new ingredients are being added.
UD: Are the majority of substances using the GRAS pathway these days chemicals that contribute to ultra-processed foods?
JP: Yes, the hallmark of ultra-processed foods is their reliance on industrial ingredients. These compounds, which should be classified as food additives, differ drastically from traditional ingredients like salt, sugar, vegetable oil, and paprika that were commonly used 100 years ago. What we see now are intricate chemicals that are typical in ultra-processed foods.
UD: The term GRAS seems somewhat misleading; it almost sounds like it suggests something natural, like “grass.”
JP: Indeed, even the phrase “generally recognized as safe” is misleading. Furthermore, studies indicate that when the food industry conducts safety assessments, they rely on a GRAS panel intended to comprise independent experts. However, this panel is often made up entirely of individuals compensated by the industry, creating potential conflicts of interest.
This leads to a scenario reminiscent of the fox guarding the henhouse.
UD: Once a substance is on the market, it can take decades to remove it if it’s found to be harmful. Can you discuss the case of trans fats?
JP: Partially hydrogenated vegetable oil is a form of industrially produced trans fat, although trans fats can occur naturally as well.
It took over 30 years for the FDA to take action regarding partially hydrogenated vegetable oil, even after evidence emerged linking it to health risks. Research dating back to the 1950s noted its dangers, and significant findings in the 1990s demonstrated its negative health impacts. By 2005, the Institute of Medicine, now the National Academy of Medicine, reported on these harms. Despite citizens’ petitions in 2004 and 2009, the FDA only proposed to revoke its status in 2013, finalizing the decision years later—in 2023.
UD: That is astonishing.
JP: Indeed, the FDA has historically been slow to act, often lagging behind actions taken by other countries like Canada and those in Europe. Such international decisions do not typically spur the FDA into expedited review.
UD: With the recent directive from Robert F. Kennedy, Jr. asking the FDA to explore ways to eliminate the GRAS loophole, do you think this would be a beneficial move? Is it likely to happen?
JP: Yes, this would be a significant step forward by removing companies’ ability to introduce unapproved ingredients into the food supply without notifying the FDA. I fully support this potential development, which has long been overdue. A regulation is currently under review by the [Office of Management and Budget], but details remain unclear. There’s also concern about how existing ingredients that were permitted through the GRAS loophole will be handled.
Regarding the likelihood of change, I believe there is administration support for the MAHA movement, but it conflicts with MAGA and initiatives aimed at reducing regulatory authority. Funding the FDA will be critical to ensure thorough safety data reviews, either through user fees or sustained appropriations, which will need to be long-term. My colleagues and I have proposed a user fee to help support this new pathway.
UD: There is a precedent for this; pharmaceutical companies currently pay user fees to the FDA, correct?
JP: Yes, and some entities have even requested user fees based on the benefits they see. User fees expedite processes and offer a guaranteed timeline for reviews. Unfortunately, the FDA currently does not meet its review deadlines for food products.
It’s crucial to clarify that user fees are not a bribe for favorable outcomes. They merely aim to fund the review process itself.
UD: Is there anything else you would like to convey?
JP: I’d encourage people to maintain an open mind. Regardless of their feelings toward the current administration, if they can successfully close the GRAS loophole, it would be a significant step forward in the food sector. However, we also need to ensure that ingredients already in the food supply are reviewed as well.
