Joseph Shea, an athletic wear retailer in Myrtle Beach, South Carolina, is both curious and concerned about the food he consumes.
The chemical ingredients with perplexing names, the vague mentions on labels of unspecified natural or artificial flavors, and the inexpensive junk food that seems addictive yet leaves him feeling unwell weigh on his mind.
Shea, who was one of 1,310 participants in a KFF poll regarding health care concerns, trusts that the FDA is ensuring the safety of food ingredients.
Unfortunately, this is often not the case.
A recent analysis by KFF Health News reveals that the FDA’s regulations on food ingredients are limited and notably weaker compared to European standards. According to expert estimates, there are at least 950 substances approved for use in the U.S. that are banned in Europe, and numerous chemicals associated with health risks are present in countless products in American grocery stores.
Robert F. Kennedy Jr., the new head of the Department of Health and Human Services, has long criticized food additives, insisting on halting “the mass poisoning of American children.” During a confirmation hearing on March 6, Martin Makary, then-President Donald Trump’s nominee for FDA head, expressed anxiety regarding foods containing numerous synthetic molecules unrecognized in nature.
“These are chemicals the industry claims are safe, but some of them are concerning,” he stated.
However, initial steps taken by the Trump administration to reduce FDA staffing prompted Jim Jones, director of its food safety unit, to resign last month and raised alarms among food safety advocates about potential reductions in oversight.
In reality, the FDA largely relies on food manufacturers to determine the safety of their ingredients and additives, and companies are not obligated to inform the FDA about these decisions or disclose all ingredients on product labels.
While pharmaceutical companies must share human research data with the FDA, the agency lacks insight into the data that food manufacturers possess about their products.
“Food companies conduct extensive research that we are not privy to,” Robert Califf mentioned to a Senate committee in December as he concluded his tenure as FDA commissioner.
The result? The FDA’s regulation of food additives is considerably weaker than that of prescription drugs.
“There are ample reasons to be vigilant regarding the chemicals regularly found in much of our food,” Califf testified.
Food is a significant industry, with American consumers spending nearly $1.7 trillion annually on food and beverages, as reported by Circana, a research and advisory firm.
Despite this, major American food companies maintain secrecy regarding the ingredients in their products.
KFF Health News approached nine of the largest food manufacturers — including The Coca-Cola Co., Conagra Brands, General Mills, Kellanova (formerly Kellogg), The Kraft Heinz Co., Mondelēz International, Nestlé, PepsiCo, and Unilever — asking for information on unnamed ingredients in their products, ingredients considered safe without FDA input, and substances permitted in the U.S. but banned in Europe.
None of the companies responded to these inquiries.
“We prioritize the quality of our ingredients, all of which meet regulatory standards,” stated Nestlé spokesperson Dana Stambaugh.
Compounds like titanium dioxide and potassium bromate, which raise safety concerns, are permitted in foods in the U.S. but prohibited in Europe.
A July 2024 FDA-funded report cautioned that companies might overlook potential risks.
Potentially harmful ingredients “are not necessarily required to be disclosed on product labels,” the report by the Reagan-Udall Foundation for the FDA indicated, based primarily on interviews with industry representatives.
“Some companies might opt not to monitor these ingredients due to fears of future litigation,” the report noted.
Some additives remain undisclosed to the public under broad terms like “spices” and “artificial flavors,” as reported by the Center for Science in the Public Interest, or other exemptions from disclosure mandates.
Additionally, potential allergens such as milk, wheat, eggs, and dyes have sometimes gone unlisted on product labels, as evidenced by numerous food recalls. The lapses in oversight have raised alarms among political leaders from both parties, the U.S. Government Accountability Office, watchdog organizations like the CSPI, and academic researchers.
The rise of ultra-processed foods only adds to the anxiety. These products utilize a diverse range of chemicals to enhance flavor and color, extend shelf life, lower costs, manage texture or consistency, and generally encourage increased consumption. Research estimates suggest that ultra-processed foods now account for 73% of the food supply in the U.S. Senator Bernie Sanders from Vermont expressed concerns that evidence indicates these foods are “strategically designed to be addictive,” contributing to an obesity crisis — a rare point of agreement between him and Kennedy.
At his confirmation hearing, Makary mentioned that certain ingredients might trigger chronic, low-grade inflammation in the gastrointestinal tract. “And what are we doing? We are drugging our nation’s children on a massive scale,” he asserted.
The KFF poll indicated that 58% of respondents desired the Trump administration to focus on imposing stricter limits on chemicals in the U.S. food supply.
The Consumer Brands Association, which represents many leading food manufacturers, defends the regulatory framework as “rigorous,” “evidence-based,” and “proven.” Sarah Gallo, the association’s senior vice president of product policy, indicated in a statement to KFF Health News that the system allows companies to “innovate to meet consumer desires.”
“Food manufacturers attest to the safety of an ingredient through comprehensive scientific evidence and third-party expert review,” Gallo added.
More than ten years ago, Pew Charitable Trusts estimated that around 10,000 additives were allowed in U.S. foods, with the FDA having not reviewed the safety of about 3,000 of them.
“The system is fundamentally flawed,” said Thomas Neltner, one of the authors of the Pew study. “It’s so broken that nobody — not even the FDA — knows what is in our food.”
Banned abroad
The FDA permits titanium dioxide to enhance the appearance of foods and other functions. According to an Environmental Working Group (EWG) database, it’s an ingredient in over 1,900 products, including various candies.
The European Union adopts a more cautious stance. In 2021, an E.U. regulatory panel determined that titanium dioxide “can no longer be deemed safe as a food additive,” stating it could potentially harm chromosomes.
Potassium bromate is permitted by the FDA for use in baking, appearing in more than 200 products such as bread, buns, and bagels, per the EWG database.
This chemical has been banned in many countries, including European Union member states, Canada, India, and Peru. California announced its ban on it from food starting in 2027, and the U.K. has prohibited it since 1990. Over 25 years ago, the International Agency for Research on Cancer classified it as possibly carcinogenic. In 1992, a committee jointed by the U.N. and the World Health Organization identified it as a “genotoxic carcinogen.”
On its website, the FDA states that it collaborates with the industry to minimize potassium bromate levels and is reviewing the safety of this and other chemicals.
The EWG points out that it created its database to aid consumers in making healthier decisions and that the raw ingredient data on product labels is provided by Label Insight, a subsidiary of NielsenIQ, a key industry data provider. The EWG advocates for stricter food regulation.
A review of FDA and E.U. databases indicates that the U.S. employs at least 950 additives not permitted in the European Union, according to Erik Millstone, an emeritus professor at the University of Sussex in England, who has studied food safety policy since the late 1970s.
Direct comparisons are challenging due to the significant differences in regulatory systems and record-keeping practices. A precise tally is hard to obtain since the FDA does not require companies to report all food ingredients used in the U.S.
“This lax approach would be intolerable in Europe,” Millstone remarked.
“Several decades behind Europeans”
Once the FDA approves substances for food use, it can allow decades to pass without re-evaluating them, even if new research brings their safety into question.
In January, when the FDA prohibited Red Dye No. 3 from foods, it referenced studies dating back to 1987. (The FDA maintained it had no evidence that the dye posed a threat to human health; citing a strict consumer protection law from 1960, it noted that any additive found to induce cancer in animals cannot be used.)
In the European Union, all substances allowed in food must acquire regulatory approval prior to their introduction, and E.U. regulators must reassess all additives on the market as of January 20, 2009, a process currently in progress.
“Although the FDA has the authorization for post-market assessments, there is no legal requirement to perform them,” Jim Jones, former deputy commissioner of the FDA’s Human Foods Program, informed a Senate committee in December. “We lag several decades behind the Europeans and our Canadian peers because they have statutory obligations to re-evaluate previously authorized chemicals.”
Since 2010, the FDA’s website has recorded 19 post-market assessments declaring certain substances not “generally recognized as safe.” Four of these relate to chemical constituents of a singular mushroom and the mushroom itself, while others involve an anabolic steroid, caffeinated alcoholic drinks, cannabidiol (CBD), Ginkgo biloba, melatonin, and partially hydrogenated oils.
Conversely, trichloroethylene, which the Environmental Protection Agency labeled in December as “an extremely toxic chemical linked to liver cancer, kidney cancer, and non-Hodgkin’s lymphoma,” remains permissible for use under FDA regulations as a solvent in food production.
FDA spokesperson Enrico Dinges stated that the agency intends to collaborate with the new leadership at HHS “to ensure the safety of the food supply through both pre-market and post-market safety assessments of food supply chemicals.”
“The loophole swallowed the law”
The most significant lapse in FDA scrutiny of foods dates back several generations.
In 1958, Congress mandated that, prior to the use of additives in food, manufacturers must demonstrate their safety and receive FDA endorsement. However, Congress created an exception for substances deemed “generally recognized as safe” or GRAS.
Originally, GRAS was intended to ease regulation for common ingredients like salt, sugar, vinegar, and baking powder, alongside various chemicals.
Over time, “the loophole consumed the law,” stated a 2014 report by Neltner and Maricel Maffini for the Natural Resources Defense Council.
Companies now have the latitude to declare any ingredient as already recognized as safe without requiring FDA approval or even notification to the agency.
A more accurate interpretation of GRAS could be “Generally Recognized as SECRET,” noted the Natural Resources Defense Council report.
The Government Accountability Office reached a similar conclusion, warning in 2010 that “GRAS substances can be marketed without FDA’s consent or even its awareness.”
This circumvented the FDA’s need to review countless substances.
For advice on whether certain ingredients qualify as GRAS, companies may assemble panels of experts. The FDA has acknowledged that members of these panels might be compensated by the companies commissioning the evaluations, but stated in guidance that “such compensation does not inherently constitute a conflict of interest.”
According to George Southworth, executive director of the Flavor and Extract Manufacturers Association of the United States (FEMA), around 3,000 flavoring ingredients have been classified as GRAS by a panel of scientists associated with the organization.
Southworth described the panel as being scrupulous about conflict-of-interest guidelines, with their GRAS decisions compiled in an online database managed by the FDA.
When questioned about how often FEMA’s panel deemed a flavoring unsafe, Southworth declined to provide specifics but indicated that some evaluations are aborted before any conclusions are reached.
“Publishing these figures without complete context could yield misunderstandings about the safety of these substances,” he cautioned.
Another way
Food manufacturers have another choice: to voluntarily inform the FDA that they believe their product meets the GRAS standard for its intended application, presenting their justification — effectively seeking the agency’s endorsement.
If they opt for this method, they may proceed with marketing the item without awaiting a response from the FDA.
Moreover, the risk is minimal. If the FDA identifies deficiencies in a company’s reasoning or has concerns regarding a chemical’s safety, it typically retracts its review rather than declaring the substance unsafe.
FDA records on its website reveal that the agency often advises companies to withdraw their applications for evaluation, leaving the firm free to continue product sales, according to food safety advocates.
For companies that voluntarily submit their products for FDA review, success is merely a letter stating that the agency has no issues concerning the product.
However, if companies market substances as “generally recognized as safe” without a solid basis, they risk potential FDA enforcement actions, such as issuing warnings or halting sales — but this is contingent on the FDA even noticing the product.
Psyched out
On March 8, 2022, a Canadian company, Psyched Wellness, announced in a news release that it had received approval to market products in the United States.
An “independent scientific review panel” declared that the extract the company created, AME-1, was “Generally Recognized As Safe,” allowing its sale in bulk and as an ingredient, according to the announcement.
The company celebrated the panel’s conclusion as a successful “certification” and a significant milestone. This extract was derived from a hallucinogenic mushroom, Amanita muscaria, which the company claimed “holds remarkable healing and medicinal properties.” Later, the company reiterated in a news release that it had acquired “self-GRAS status.”
In June 2024, Psyched Wellness announced it would soon introduce Amanita muscaria watermelon gummies.
However, the FDA later raised concerns about the company and its product.
In a memo dated September 9, 2024, an FDA toxicologist asserted that Psyched Wellness’ GRAS certification claim was unsubstantiated. The company failed to demonstrate that its extract was generally recognized as safe, according to the memo.
Concerning the mushroom and its known “pharmacologically active components,” the FDA memo cautioned that they posed “a risk for serious harm and adverse effects on the central nervous system.”
The FDA scrutinized the mushroom in light of a wave of medical emergencies linked to another company’s “Diamond Shruumz” brand chocolate bars, gummies, and infused cones. When that company initiated a recall in June 2024, it reported that a chemical present in Amanita mushrooms could be responsible for symptoms including seizures and loss of consciousness.
The memo referenced that recall, noting one fatality and 30 hospitalizations may have been connected.
While the memo did not associate Psyched Wellness with the outbreak or the Diamond Shruumz products, it did highlight the FDA’s concerns.
The CEO of Psyched Wellness, Jeffrey Stevens, did not respond to requests for an interview or written questions.
As recently as February 1, Psyched Wellness declared in a securities filing that it would “continue to market its products in the U.S. using the Self-GRAS designation.”
“Probably poisoning us”
Acute reactions to food ingredients — those that send individuals to the emergency room, for instance — might make potential hazards easier to detect, prompting regulatory action. However, many critics express more concern about health effects that could take years or decades to manifest.
When the damage is evident, discerning the link to a specific ingredient may be challenging.
This predicament leaves individuals like Joseph Shea of Myrtle Beach feeling trapped.
For a time, Shea attempted to shop at a market with an extensive range of organic options, he mentioned in an interview, but found it to be too costly.
Shea expressed that the whole situation is “incredibly frustrating.”
“They’re probably poisoning us, and we don’t realize it,” he lamented. “We’ll only discover the truth 30 years down the line when we fall ill.”
KFF Health News serves as a national newsroom dedicated to in-depth reporting on health issues and constitutes one of the primary operating programs at KFF, the independent authority on health policy research, public opinion polling, and journalism.
