Janice R. Andrews
Robert F. Kennedy Jr., President-elect Donald Trump’s nominee for the nation’s top health role, has pledged to “remove harmful chemicals” from America’s food supply. His commitment comes as growing concerns about the health effects of food additives gain national attention.
These chemical ingredients—added to enhance the flavor, texture, color, or shelf life of ultra-processed foods—are staples in the average American diet. Yet, the process of determining their safety often bypasses the oversight of the Food and Drug Administration (FDA). Instead, it’s largely left to the companies producing and selling these products.
Research reveals a significant regulatory gap allowing unapproved additives to permeate the food supply, sometimes with dire health consequences. In one notable instance two years ago, a toxic additive known as tara flour caused hundreds of illnesses and sent over 130 individuals to hospitals.
Now, an increasing number of politicians and lawmakers are demanding reforms. Kennedy has vowed to revamp federal food safety regulations under his “Make America Healthy Again” initiative. Meanwhile, several states, including New York and Illinois, are introducing legislation to tighten restrictions on food additives.
“The average consumer assumes that the FDA thoroughly vets all preservatives, ingredients, and flavorings in their food before they hit supermarket shelves,” said Pieter Cohen, an associate professor of medicine at Harvard Medical School. “But that belief is a misconception.”
A Loophole Few Know About
Under federal law, the FDA is tasked with ensuring that all food ingredients are safe. In theory, companies must undergo a rigorous premarket approval process before introducing new food additives.
However, a major exemption exists. Additives labeled as “generally recognized as safe” (GRAS) are not subject to the same rigorous approval process. This designation was initially intended for common ingredients with a long history of safe use, such as vinegar, salt, and baking soda.
The problem lies in how GRAS determinations are made. Companies can decide on their own if an additive is safe without consulting the FDA. While they may convene a panel of experts to assess the ingredient’s safety, this step is optional. Often, these panels consist of company-funded experts, raising concerns about potential conflicts of interest.
“The food industry essentially self-regulates, deciding what is safe for us to eat without input from the FDA,” said Thomas Galligan, principal scientist for food additives at the Center for Science in the Public Interest.
A 2022 analysis by the Environmental Working Group found that nearly 99% of the 766 new food chemicals introduced since 2000 bypassed FDA approval.
The FDA acknowledges this gap in oversight. A spokesperson stated that companies are not legally required to notify the agency about GRAS ingredients. They added that food manufacturers are responsible for ensuring their products meet the safety standard of “reasonable certainty of no harm.”
When a ‘Safe’ Additive Turns Toxic
One glaring example of the system’s shortcomings occurred two years ago. A plant-based ground beef substitute, French Leek and Lentil Crumbles, sold by Daily Harvest, led to nearly 400 reported illnesses. Of those affected, more than 130 required hospitalization, with some undergoing gallbladder removal.
The culprit was tara flour, a protein-rich ingredient derived from the seeds of a South American tree. Although no toxicological studies had been conducted on tara flour, it was classified as GRAS by its supplier and introduced into the U.S. food market.
In response, the FDA later declared tara flour an unapproved food additive, stating that insufficient evidence existed to consider it GRAS.
The incident highlights how harmful additives can infiltrate the food supply, especially when adverse effects are not immediately apparent. “If an additive doesn’t cause acute illness but contributes to long-term issues like heart disease or cancer, tracing it back to the food companies is nearly impossible,” said Cohen.
The Push for Stricter Oversight
Lawmakers at both state and federal levels are pushing for change.
California recently became the first state to ban four food additives linked to cancer and hyperactivity in children: red dye No. 3, brominated vegetable oil, potassium bromate, and propyl paraben. Other states, like New York, are following suit with broader bans that include additives such as titanium dioxide and BHA.
Proposed legislation in New York would require companies to disclose the use of additives deemed GRAS without FDA notification. They would also need to provide scientific evidence proving the safety of these ingredients, which would be stored in a publicly accessible database.
“It’s simply about transparency,” said New York Assemblymember Anna Kelles, a nutritional epidemiologist. “If you want to use a chemical in New York State, you should be able to prove it’s safe.”
At the federal level, Rep. Rosa DeLauro has proposed the Toxic Free Food Act, aiming to eliminate the GRAS loophole. The act would mandate FDA review and approval of all new food additives and require companies to submit safety data for public review.
“The FDA has a congressional mandate to protect our food supply, but it can’t fulfill this duty if it remains unaware of what’s in our food,” said Galligan of CSPI.
Additives and Their Health Risks
Here are five controversial additives permitted under the GRAS designation, along with their associated health concerns:
1. Butylated Hydroxyanisole (BHA)
- Uses: Preservative found in cereals, chips, gum, and oils.
- Concerns: Studies show BHA causes cancer in animals. The National Toxicology Program lists it as a “reasonably anticipated human carcinogen.”
2. Carboxymethyl Cellulose (CMC)
- Uses: An emulsifier in ice cream, dressings, candies, and sauces. Prevents ingredient separation and enhances texture.
- Concerns: Linked to gut microbiome disruptions and inflammation.
3. Polysorbates
- Uses: Emulsifiers in frozen desserts, salad dressings, and baking mixes.
- Concerns: Found to cause intestinal inflammation and harm the gut microbiome.
4. Erythritol and Xylitol
- Uses: Low-calorie sweeteners in gums, protein bars, and sugar-free treats.
- Concerns: Associated with increased risks of heart attacks and strokes, promoting blood clot formation.
5. Propyl Paraben
- Uses: Preservative in tortillas, jams, and baked goods; also used in cosmetics.
- Concerns: May mimic estrogen, disrupting hormone signals and reducing fertility.
Looking Ahead
With Kennedy’s proposed reforms and growing state-level initiatives, the push for safer food regulation is gaining momentum. Public awareness and advocacy will play a critical role in reshaping the regulatory landscape to prioritize consumer health over corporate interests.
As Cohen aptly stated, “The assumption that our food is rigorously vetted for safety is not just wrong—it’s dangerous. Transparency and accountability are long overdue.”
