How potentially harmful additives have infiltrated America’s food

Robert F. Kennedy Jr., President-elect Donald Trump’s pick for the nation’s top health post, has vowed to “get the chemicals out” of America’s food amid mounting concerns over the health effects of additives.

These chemical ingredients — designed to enhance the flavors, textures, colors, and shelf life of ultra-processed foods — are in many of the foods that Americans eat. But who determines whether they are safe?

In many cases, it’s not the Food and Drug Administration that decides if chemical additives are safe to use in food. Instead, it’s the companies that make and sell the products that contain them.

Research shows that a regulatory loophole has allowed for America's food to be saturated in largely unapproved additives. The health consequences can be dire. In one case two years ago, a toxic food additive known as tara flour that was allowed into the food supply through this loophole was blamed for sickening hundreds of people and sending at least 130 to the hospital.

Now, a growing number of politicians and lawmakers are demanding changes. Kennedy has pledged to overhaul federal food regulations as part of his "Make America Healthy Again" plan. (A spokesperson for Kennedy did not respond to a request for comment.) And several states, including New York and Illinois, are considering new rules that would more strictly regulate the additives used by food companies.

“The average consumer would absolutely assume that new preservatives, ingredients and flavors in food are all checked out by the FDA before they arrive on our supermarket shelves,” said Pieter Cohen, an associate professor of medicine at Harvard Medical School, who co-authored a recent report on the loophole in the New England Journal of Medicine. “That’s what’s commonly believed. But it’s a false narrative.”

Under federal law, the FDA has a mandate to ensure that all ingredients used in food are safe. Companies are not supposed to use new food additives in their products until they have gone through a thorough safety review process and received premarket approval from the FDA.

The problem, experts say, is that food additives are exempted from the premarket approval process if they’re considered “generally recognized as safe,” or “GRAS” for short. This designation was created so that common household ingredients with a long history of safe use in food — like oil and vinegar, baking soda, and everyday spices and seasonings — would not have to go through rigorous safety reviews.

Under current rules, however, companies can skirt the premarket approval process and determine on their own that a new food additive or substance is “generally recognized as safe.”

Exactly how companies go about determining that a new ingredient is safe is up to them. The FDA says that companies can convene a “panel of qualified experts” to evaluate the scientific data. But it’s not a requirement. And studies show that even when food companies do convene a panel of experts, the experts are usually handpicked and paid for by the companies, creating financial conflicts of interest.

“The food industry is deciding by itself without any input from the FDA what is safe for us to eat,” said Thomas Galligan, the principal scientist for food additives and supplements at the Center for Science in the Public Interest, a consumer advocacy group. “Most consumers would be shocked to know that the FDA has essentially handed the reins over to the food industry.”

An analysis published in 2022 by the Environmental Working Group, an advocacy organization, found that 98.7% of the roughly 766 new food chemicals introduced to the food supply since 2000 were not approved by the FDA.

In a statement, a spokesperson for the FDA acknowledged that under federal law, food companies do not have to get premarket approval from the agency to use ingredients in their products “that meet the criteria for GRAS.” The spokesperson said that the federal law governing food additives doesn’t give the FDA the authority to mandate that companies provide the agency with any information about the ingredients they use in their foods that are considered GRAS.

“The food industry is responsible for ensuring the safety of the ingredients they use in foods before they go to market,” the spokesperson added. “All uses of ingredients considered GRAS, food additives, color additives, and food contact substances must meet the same safety standard — reasonable certainty of no harm.”

Anna Rosales, the senior director of government affairs and nutrition for the Institute of Food Technologists, a food industry group, said in a statement that the process for approving new food additives should be more transparent.

“IFT believes it is essential to recognize that both pre- and post-market assessments should ensure end-to-end transparency in the approval of ingredients and foods,” she added. “Transparency is critical to building public trust and ensuring consumer confidence in the U.S. food supply.”

A tragic example of how this system can go wrong occurred two years ago, when nearly 400 people got sick after eating a ground beef substitute — called French Leek and Lentil Crumbles — sold by Daily Harvest, the popular food subscription service. More than 130 of the people who got sick were hospitalized with gastrointestinal distress, liver injuries, and other symptoms, and at least 39 people had to have their gallbladders removed.

Investigators determined that the most likely cause of the sickness was a new ingredient in the crumbles called tara flour — a high-protein flour made from the seeds of a tree grown in South America. Even though there were no published toxicological studies of tara flour and the FDA had not evaluated its safety, a company that imported tara flour from Peru had claimed that it was GRAS and supplied the ingredient to distributors in the United States.

Daily Harvest declined to comment. In previous statements, the company said that it was no longer buying ingredients from the producer that supplied it with tara flour. “This was the first and only time we’ve used tara flour,” the company said.

Earlier this year, the FDA announced that it had evaluated tara flour and determined that it was an “unapproved” food additive that didn’t meet the standards for being “generally recognized as safe.” The agency said it found that there was “not enough data on the use of tara flour in food, or a history of its safe use, to consider it GRAS.”

The incident showed that companies can get away with using harmful new additives so long as they don’t cause immediate symptoms, said Cohen at Harvard.

“If a new food ingredient doesn’t make people immediately sick, and people are just getting heart disease and cancer, then no one is going to trace it back to the companies,” he said. “I went into this thinking that the vetting process for new food ingredients was weak. And instead what I’ve learned is that the vetting is nonexistent.”

Some state and federal lawmakers are pushing back.

Last year, California became the first state to ban four food additives — red dye No. 3, brominated vegetable oil, potassium bromate, and propyl paraben — that have been linked to an increased risk of cancer and hyperactivity in children. Earlier this year, Democratic state lawmakers in New York introduced legislation to ban those same four food additives as well as three others that have been linked to health problems: titanium dioxide, azodicarbonamide, and butylated hydroxyanisole, also known as BHA.

These additives are collectively used in thousands of processed foods, such as bread, breakfast cereals, candy, pastries, fruit jams, frostings, frozen dairy desserts and frozen fruit bars.

The New York bill would require companies to tell the state if the products they sell in New York contain food additives that they privately determined were GRAS without notifying the FDA. The companies would also have to provide a report explaining how they assessed the safety of the ingredients and what evidence they have that shows that they’re safe. The reports would go into a publicly available database.

Companies shouldn’t find it difficult to disclose this information, said Anna Kelles, a nutritional epidemiologist and New York assembly member who sponsored the bill. She said that under federal law, companies are already supposed to scientifically evaluate chemicals and “do their due diligence” to demonstrate that they are safe before declaring them GRAS.

“It’s a transparency issue,” Kelles said. “All this bill is saying is, ‘Hey, if you want to use this chemical in New York State then we’d like to see your proof that this is GRAS, and once you’ve done that then you can go on your way.’”

Another bill first introduced in Congress in 2021 by Rep. Rosa DeLauro (D-Connecticut) would go further. The bill, called the Toxic Free Food Act, would close the GRAS loophole and require companies to notify and get approval from the FDA before introducing new chemical additives into the food supply.

Companies would also be required to submit adequate safety data to the FDA, which would be made available to the public.

“The FDA has a mandate from Congress to ensure the safety of our food supply and it simply can’t do that if it doesn’t know what’s in our food and whether or not chemicals came to market through a rigorous safety assessment,” said Galligan at CSPI.

Five examples under the “generally recognized as safe” loophole

Uses: A preservative found in breakfast cereals, potato chips, chewing gum, beer, butter, and vegetable oils.

Concerns: Studies have found that it causes cancer in animals. The federal government’s National Toxicology Program says that BHA is “reasonably anticipated to be a human carcinogen.”

Uses: An emulsifier found in ice cream, salad dressings, candy, cookies, sauces, and some peanut butters. It prevents oil and water from separating and improves the texture of some foods.

Concerns: Studies have found that it disrupts the gut microbiome and promotes gut inflammation and other digestive issues.

Uses: A group of emulsifiers found in ice cream, salad dressings, icings, baking mixes, frozen desserts, and other processed foods. They prevent ingredients from separating.

Concerns: Studies have found that polysorbates promote intestinal inflammation and have a “detrimental impact” on both the function and composition of the gut microbiome.

Uses: Erythritol and xylitol belong to a group of low-calorie sweeteners called sugar alcohols. They are found in many foods, including chewing gums, breath mints, protein bars, low-carb ice cream, and sugar-free desserts and candies.

Concerns: Scientists at the Cleveland Clinic have found that consuming xylitol and erythritol increases the risk of cardiovascular events such as heart attacks and strokes. Their studies indicate that these low-calorie sweeteners promote the formation of blood clots.

Uses: A preservative found in tortillas, pastries, jams, and baked desserts. Also used in many cosmetics.

Concerns: Some researchers have found that it can mimic estrogen and disrupt hormone signaling, leading to diminished fertility and other problems.