The U.S. Food and Drug Administration (FDA) is launching a “stronger, more systematic review process for food chemicals” — a move the agency described Thursday as a “major step to increase transparency and ensure the safety of chemicals in our food.”
“No parent should ever worry about what’s in their child’s food,” U.S. Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. said in a statement. “We’re taking decisive action and using every authority we have to clean up the food supply and protect American families.”
The new process will include a “modernized, evidence-based prioritization scheme” for existing chemicals, a “systematic post-market review process” for food chemicals that will be “shaped by stakeholder input,” and the development of an “updated list of chemicals under review.”
Some of the chemicals subject to review include BHT and BHA (butylated hydroxytoluene and butylated hydroxyanisole), used as preservatives; ADA (azodicarbonamide), a foaming agent added to sandwiches; phthalates; propylparaben, a preservative; and titanium dioxide. These and other chemicals have been linked to health risks, including reproductive harms, hormone disruption and cancer.
The process is expected to roll out over the coming months. The FDA said it will share information about the status of its review process on its website, “as part of the agency’s push for greater transparency.”
‘More transparency and accountability’ around food safety
Kendall Mackintosh, a board-certified nutrition specialist and member of the “MAHA Moms” movement, applauded the new initiative, calling it “a long-overdue and necessary step in the right direction.”
“The announcement signals progress toward more transparency and accountability, and I’m hopeful this opens the door for deeper systemic reform,” Mackintosh said.
Food safety advocates have long argued that the FDA’s procedures for regulating food safety, including chemicals in the food supply, have been lacking. That’s partly because food manufacturers were allowed to self-certify the safety of many ingredients under the “Generally Recognized as Safe” (GRAS) certification process.
“Industry influence over GRAS determinations has been a major concern for decades, and any progress must directly address that,” Mackintosh said. “The GRAS loophole allowed food manufacturers to self-certify safety without FDA review or public disclosure. There has been little to no post-market surveillance of chemicals once approved.”
For instance, the FDA granted GRAS certification to BHA and BHT in 1958 and 1959, respectively, despite their documented risks to human health.
“Until now, the FDA has conducted post-market reviews on a case-by-case basis, often in response to citizen petitions or new scientific evidence. This new framework will be proactive, science-based, and built for long-term impact,” the FDA stated.
FDA Commissioner Marty Makary said the agency is “prioritizing” its resources and “leveraging gold standard science to create, for the first time, a systematic post-market review program that consumers can trust and rely on.”
“Only by improving the safety and transparency of the food supply and ensuring consumers can make healthful food choices will we overcome the long-standing trajectory of chronic diseases,” Makary said.
The announcement also noted that earlier this year, the FDA initiated a rulemaking procedure to eliminate the GRAS loophole allowing companies to self-certify their products.
A focus on the chronic disease epidemic in the U.S. is part of Kennedy’s “Make America Healthy Again” (MAHA) agenda. The epidemic, which includes rising rates of cancer, diabetes, obesity and other conditions, has been attributed, in part, to toxic chemicals and other harmful ingredients in the domestic food supply.
Food safety advocates welcomed the news. Zen Honeycutt, founding executive director of Moms Across America and the Neighborhood Food Network, said, “We finally have an administration that is listening to mothers and acting to ‘Make America Healthy Again.’ While we wish to see pre-market policy changes, so that the chemicals do not get into the food in the first place, we understand that smaller steps need to be taken first to create huge change.”
New process ‘part of a larger initiative to improve food chemical oversight’
According to the FDA, the agency’s new post-market review process “is part of a larger initiative to improve food chemical oversight.” This has included a series of actions in recent weeks to address concerns about the safety of ingredients commonly found in food.
Last month, HHS announced it would phase out all petroleum-based synthetic dyes from U.S. foods and medications.
As part of the announcement, HHS said it was revoking authorization for two synthetic food colorings — Citrus Red No. 2 and Orange B — and working with industry to eliminate the six remaining synthetic dyes currently in use.
Jaydee Hanson, policy director at the Center for Food Safety, said the FDA is “moving in the right direction,” but called for more decisive action on the part of public health agencies, noting that the current proposals rely “on vague promises from industry.”
“It is a good step that they are promising to end GRAS review of food additives, but no indication of whether they will revoke GRAS certifications and on what basis,” Hanson said.
HHS said it would also partner with the National Institutes of Health (NIH) to perform research on how food additives affect children’s health and development. Previous studies have linked synthetic dyes to neurobehavioral issues in children.
Earlier this month, the FDA followed up this action with the approval of three new natural food dyes — galdieria extract blue, butterfly pea flower extract and calcium phosphate. Several high-profile brands, including PepsiCo and Tyson Foods, also announced synthetic dye removal plans.
In March, HHS and the FDA launched “Operation Stork Speed,” a program that will require increased testing for heavy metals and other contaminants in infant formula and which will introduce a nutrient review process.
Several studies have highlighted the risks of exposure to toxic chemicals. A study published in January in the New England Journal of Medicine found that “An estimated 350,000 manufactured chemicals, chemical mixtures, and plastics” listed in global inventories are “subject to few legal or policy constraints” — and contribute to the chronic disease epidemic.
According to the study, chronic diseases are the main cause of illness and death for children in the U.S. and Europe.
Mackintosh agreed. “This broken system has fueled the chronic disease epidemic. We’ve seen skyrocketing rates of food allergies, ADHD [attention-deficit/hyperactivity disorder], autoimmune conditions, obesity, metabolic disorders, reduction in fertility and even early puberty, all of which have documented connections to chemical exposures in food.”
A 2021 risk assessment by the state of California found that synthetic dyes used as colorants in many common foods and drinks can negatively affect attention and activity in children.
Studies have also shown that chemical-laden ultraprocessed foods pose significant risks, especially to children.
A study published in the journal Frontiers in Nutrition in February found that teenagers consuming more ultraprocessed foods have significantly lower muscle mass and lean body mass due to the lack of essential nutrients like protein and face a higher risk of obesity, Type 2 diabetes and cardiovascular diseases.
A 2019 study published in The BMJ also linked ultraprocessed foods to a higher risk of cardiovascular disease.
Mackintosh said the FDA’s new proposals are welcome, but more is needed.
“We also need preventive oversight, not just reactive measures. … We need a complete overhaul of the GRAS loophole, a ban on chemicals already linked to endocrine disruption, neurodevelopmental harm and cancer, and stronger protections for vulnerable populations — especially children, who are disproportionately affected,” Mackintosh said.
Hanson agreed. “We will be watching how they implement these promises. If they do move as they are promising, they will finally be taking steps we have been asking the FDA to take for over 10 years.”
Related articles in The Defender- FDA Approves 3 Natural Food Dyes in Move to Phase Out Toxic Synthetics
- ‘Always Listen to the Mom’: U.S. to Phase Out Artificial Dyes Used in Food Products
- ‘Operation Stork Speed’: HHS, FDA Launch Plan for More Testing, Scrutiny of Infant Formula Ingredients
- ‘Grave Concern’: Chronic Diseases Are Killing Kids — and Exposure to Chemicals Is Driving the Epidemic
- ‘We Are Literally Poisoning Our Children,’ Kennedy Tells Senate Roundtable
- ‘True Corruption’: Agency Capture Responsible for Chronic Disease Epidemic in U.S.
