The chance “is close to zero” that synthetic dyes will be fully removed from the US food supply by the end of next year, as suggested by FDA and HHS last week, because there is “no hammer” to force reformulation, said former FDA Deputy Commissioner for Human Foods Jim Jones.
Likewise, the current administration’s fixation on chemical safety and dyes could threaten FDA’s ability to execute other core functions – including detecting and preventing food-borne illness outbreaks – and initiatives, such as implementation of the new definition of ‘healthy,’ added Jones in a wide-ranging fireside chat at the DC chapter of IFT’s Food Policy Impact earlier this week.
Jones’ scathing assessment of the current administration’s approach to food safety and nutrition comes weeks after he abruptly resigned as one the agency’s top leaders because he said he felt he “would be spending most of my time not on food policy, but on dismantling an organization that we just put in place.”
During Jones’ short tenure at FDA, he helped reorganize the agency to create the Human Foods Program and kicked off an effort by FDA to better ensure the safety of the US food system and to mitigate the impact of a patchwork of state legislation by enhancing FDA’s post-market assessment of chemicals in food.
Many of these initiatives are now under review by the new administration and could be unraveled – potentially “degrading” the agency’s core infrastructure and ability to function, warned Jones.
Push to remove dyes may fall flat without a ‘hammer’ for compliance
Even the agency’s apparent pet projects, including removing synthetic dyes from the US food supply, could fall flat because the agency is deviating from conventional channels for change in an attempt to move more quickly.
For example, Jones said he doubts the removal of synthetic food dyes from the US food supply will follow the ambitious timeline projected by the current leadership because FDA is not pursuing a formal rulemaking to remove the dyes – rather it is relying on an “understanding” outlined April 22 by HHS Secretary Robert F Kennedy Jr and FDA Commissioner Marty Makary.
As part of that “understanding,” FDA suggested Red 40, Yellow 5 and 6, Blue 1 and 2 and Green 3 would be phased out by the end of 2026, Red Dye 3 would be removed ahead of the previously set 2027-2028 deadline and “within weeks” little-used Citrus Red #2 and Orange B would be revoked.
In response, several trade groups reiterated the safety of these colors and the National Confectioners Association emphasized the importance of “science-based evaluation of food additives” to “rebuild trust in our national food safety system.”
The FDA’s proclamation last week does not rely on the same level of scientific- and data-based evidence as the agency’s recent formal decision to deauthorize Red Dye 3.
Gut-checking Kennedy’s and Makary’s optimism for voluntary compliance, Jones acknowledged that some companies will be able to reformulate by the end of next year, but, he added, many won’t and “some will not even plan to do it.”
He added: “There is no consequence to not doing it.”
Do budget cuts hinder FDA’s ability to expand chemical safety assessments?
Jones also questioned Kennedy’s declaration HHS would “expand safety assessments” and reassess previously approved chemicals in food and food contact materials given widespread staff and funding cuts at the agency.
Those cuts – including what Jones previously described as the “indiscriminate” layoffs of 89 employees from FDA’s Human Foods Program, including those with highly technical expertise in nutrition, infant formula and food safety response – prompted Jones to abruptly retire from his leadership position at the agency in February.
“Even though you are having words come out of FDA saying, ‘We’re going to really put a lot of energy into this,’ there are only 30 people in the post market staff at FDA, and that is not enough people to do more than a couple of chemicals a year,” said Jones.
Late last September, FDA proposed a new process for reassessing chemicals in food, which many stakeholders considered a step in the right direction but also criticized it as “thin on details,” including sufficient transparency about how it would select ingredients for review.
The agency is currently reviewing the more than 70,000 comments submitted in response to its proposed post-market chemical safety review process, but it expects to reveal additional details for how it will “continue to march forward in the post-market space in the coming weeks,” Mark Hartman, director of the office of food chemical safety, dietary supplements and innovation at FDA, said at the same IFT event.
Could FDA ‘miss the opportunity’ to save lives by following states’ lead?
Without limited resources and staff to conduct post-market reviews of food chemicals and additives, FDA appears to be leaning on, and following, state legislators to decide the fate of chemicals in food – a practice that Jones lobbied against while he was at FDA.
A contributing factor to FDA’s recently announced “understanding” with industry to phase out select food dyes was industry’s request for national leadership amid an exponential explosion of state laws banning food dyes and other ingredients.
Currently, nearly 30 states have proposed or passed legislation to ban select ingredients from food and beverages sold within their borders. California was the first state in 2023 to pass legislation banning select ingredients and dyes beginning in January 2027.
Since then, Virginia, West Virginia and Utah passed legislation limiting common dyes and additives either from sale within their borders or within their schools. The most ambitious deadline of these is West Virginia’s ban within schools set for August 2025.
Recognizing the difficulty of navigating different state laws, industry trade groups including the Consumer Brands Association have long asked HHS and FDA to “reestablish themselves as the country’s leading regulatory authority.”
While Jones said he agrees that having Secretary Kennedy’s leadership on food chemicals is a “good thing,” he said Makary and Kennedy’s recent actions send the signal that FDA will follow the states rather than take the lead.
“The signal that they sent is, ‘States, do whatever you would like and we will just embrace it. We are not resourced to actually follow up in any meaningful way. But, since the states are going to create an environment where manufacturers cannot operate without getting rid of these chemicals, then the federal government will just basically follow instead of lead,” said Jones.
This is a shift from a system where FDA and EPA have used science and data to make informed choices “to a system where state legislators are going to decide by voting,” explained Jones.
While he acknowledged the latter is “arguably more democratic,” it could lead to mistakes in resource allocation “because legislators are going to focus on some things that don’t have much risk, that are going to impose costs on manufacturers to get rid of things” that won’t actually protect anybody, “when they could be focusing on more risky things.”
Likewise, Jones said, FDA’s focus on chemical safety could cause it to “miss the opportunity” to have a more meaningful impact on “hundreds of thousands of lives” by reducing its focus on characteristics of food that “we know with a high degree of certainty” make people sick – including sodium, saturated fat and added sugars.
Could food safety cuts threaten the Trump administration?
If FDA wants “to get serious about nutrition and chemical food safety,” and if Congress does not allocate more money to the food program, the agency may need to reallocate resources from other food safety areas, which could threaten the Trump administration if a food poisoning outbreak occurs or goes on unchecked, Jones argued.
“That actually is their biggest risk,” he said, reflecting on the impact of high-profile food-borne disease outbreaks on other countries’ governments, such as the outbreak of bovine spongiform encephalopathy – or mad cow disease – on the UK government and so-called Dioxin Affair in Belgium in which polychlorinated biphenyls were detected in animal food products.
Jones explained that while the Trump administration has been careful to exclude inspectors from mass layoffs, the broader “infrastructure is being degraded,” which increases the risk of a high-impact food-borne illness outbreak.
“It is very nearly impossible to predict when it will happen, but if you degrade the ability to detect and respond, you will find yourself in a situation where an outbreak goes on longer than it otherwise would have,” he said.
To support his argument, he pointed to laboratory analysts “spending their time on administrative activities, because they have no administrative people to buy the equipment or to buy the reagents that will, overtime, degrade their ability to quickly run samples” and “ultimately affect the ability to respond.”
Could FDA’s focus on chemical safety delay updates to ‘healthy’ claim
The lack of consideration for chemicals in FDA’s recently released final rule on what qualifies for “healthy” claims could prompt the new leadership to “recompose” the rule to be “more robust,” Jones said.
While FDA published the final rule to update the “healthy” nutrient content claim in the 11th hour of the Biden administration on Dec. 19 with an effective date of Feb. 25, the agency postponed its effective date to April 28 to comply with a Jan. 20 memo from President Donald Trump that required the review of any rules published in the Federal Register that had not yet taken effect.
FDA has not published an update on the rule’s status.
Jones noted that Makary is unlikely to embrace the new healthy standard given his “substantive issues” with how the rule handles food processing and the levels identified as high, medium and low for saturated fat and sodium.
“So, he may be interested in recomposing that” to “make it more robust in his view,” Jones said.
