At long last, the FDA has admitted what European regulators have known for more than 15 years: Synthetic food dyes pose real dangers to consumers.

Yet, unlike in the European Union, where the recognition that food dyes can cause behavioral problems in some children led to new regulations requiring warning labels on foods containing dyes, the FDA has yet to take regulatory action to protect kids from synthetic dyes widely prevalent in US foods.

In a statement on Apr. 22, 2025, FDA Commissioner Makary stated that, “Given the growing concerns of doctors and parents about the potential role of petroleum-based food dyes, we should not be taking risks and do everything possible to safeguard the health of our children.”

But the FDA is not doing everything possible. In fact, it’s hardly doing the bare minimum—at least when it comes to exercising its real authority as a food safety regulator. Makary’s statement accompanied FDA’s launch of an effort to encourage the food industry to voluntarily phase synthetic dyes out of their products.

At a press conference announcing this effort, HHS Secretary Robert F. Kennedy, Jr., stated that the federal government had an “understanding” with food companies that they would comply with this voluntary request.

Many companies seem not to share that understanding, though.

Of the top 24 food companies in the US based on sales in 2020, one third have not made a public commitment to eliminate dyes from any of their products, and less than half have committed to eliminating dyes from all of their products. At least one company, Spangler, has vocally refused to ditch dyes. See CSPI’s Synthetic Dyes Corporate Commitment Tracker to learn more.

FDA’s feeble approach stands in stark contrast to the EU, where decisive regulatory action proved very effective.

Synthetic dye use plummeted in the EU thanks to mandatory warning labels 

In the EU, since 2010, foods containing any one of six synthetic dyes must bear a warning label stating those colors “may have an adverse effect on activity and attention in children.” The list of dyes includes Red 40 (called Allura Red in the EU), Yellow 5 (called Tartrazine), and Yellow 6 (Sunset Yellow) as well as three dyes that are not authorized in the US.

Although synthetic food dyes are listed on the ingredient labels of food and dietary supplements, many consumers simply do not know that consuming synthetic food dyes can adversely affect behavior in some children. Further, expecting consumers to check ingredients for every food purchased in every store and restaurant is impractical. The mandatory EU warning label informs consumers—especially parents, guardians, schools, and others who purchase food and supplement products for children—about the harmful effects of synthetic food dyes and allows them to make informed decisions about whether or not to purchase the product or serve it to children.

The warning label requirement did more than just help inform European consumers about the risks of synthetic dyes. It led to a widespread and rapid phase-out of the synthetic food dyes subject to the warning requirement from the EU packaged food supply.

An analysis of EU food ingredient label information between 2000 and 2024 found that the prevalence of packaged foods and beverages containing the dyes subject to the warning decreased around the time of the adoption (2008) and implementation (2010) of the warning label requirement. 
 

Prior to 2008, the six dyes subject to the warning were found in approximately 3 percent of all EU foods and beverages (Fig. 1). In the 14 years after the warning requirement was implemented, prevalence consistently stayed below 0.5 percent, with prevalence hitting its lowest level in 2015 and 2019, where in each year, only 0.25 percent of products contained one of the dyes subject to the warning.

These results suggest that the warning label policy incentivized food companies in the EU to voluntarily reformulate away from the use of those dyes to avoid applying the warning to their products.

While there was a large relative reduction in the use of synthetic dyes in Europe after the warning, there is a small proportion of products still contain these chemicals. Fortunately, caregivers can easily avoid those products because of the EU’s required warnings.

FDA failure continues under RFK, Jr.

If the FDA had been effectively overseeing the safety of food chemicals, it would have recognized the risks of synthetic dyes years or even decades ago.

If Sec. Kennedy and the Trump Administration were serious about fixing the problems with food chemicals—as their rhetoric might suggest—and if the FDA were doing its job, then the FDA would take decisive regulatory action to protect consumers from these unsafe and unnecessary dyes instead of relying on sometimes empty “understandings.”

But that’s not what’s happening.

The FDA has been failing to protect consumers from unsafe food chemicals for decades, and that failure is continuing under the Trump Administration. Sadly, the synthetic food dye saga proves this point directly.