What is Red 40 and why hasn’t the FDA banned the dye?

The Food and Drug Administration has not formally reevaluated the safety of a food dye called Red 40 in over a decade, the agency’s top food official said this month when asked about renewed worries over its potential behavioral health effects.

The agency has launched a new effort to take a second look at some previously approved additives. But Jim Jones, the FDA’s deputy commissioner for human foods, warned their budget was too small and that it would take years to catch up to other countries.

“We are several decades behind Europeans and our Canadian counterparts, because they have legal mandates to reevaluate chemicals that have been authorized,” Jones told Sen. Tommy Tuberville at a hearing of the Senate’s health committee.

Tuberville also asked Jones about a different food dye called Red 3, which advocacy groups have petitioned against due to studies showing it causes cancer in animals. Jones suggested the agency could be weeks away from moving to ban it. 

The decades-old controversy over synthetic food dyes has gained renewed attention on Capitol Hill, thanks in part to outspoken criticism from Robert F. Kennedy Jr., President-elect Donald Trump’s pick to head the department overseeing the FDA and other health agencies.

“Senator Tuberville looks forward to working with the incoming Trump administration to Make America Healthy Again,” a spokesperson for the Alabama Republican said, referring to the slogan RFK Jr. has promoted Tuberville was “shocked to learn” the FDA had not reviewed Red 40’s safety for so long, his spokesperson said.

What is red dye 40?

FD&C Red No. 40, or Red 40 for short, is the FDA’s name to refer to a color additive first registered with the agency in the 1970s. The chemical is known as Allura Red AC in the food industry and E 129 in Europe.

It is now mostly synthesized from petroleum. 

Further chemical reactions to combine the dye with aluminum create what’s known as “Red 40 Lake.” Lakes are often used for products like chewing gum where there is not enough moisture to dissolve the dye into the product, or in products like frostings to help prevent the colors from bleeding.

The FDA says it subjects production of Red 40 and some other synthetic dyes to stepped-up scrutiny, screening each batch for any contaminants from its production process.

Among the dyes that undergo this purity certification, Red 40 consistently ranks as the one with the highest quantity produced each quarter.

“People think that ‘I know which foods have dyes and which don’t,’ but no you do not. White foods can contain dyes, foods marketed as healthy and natural can contain dyes, egg noodles can contain dyes, it’s just very hard to know and avoid them, unless you look at the label,” said environmental health consultant Lisa Lefferts.

Lefferts was closely involved with a push by the Center for Science in the Public Interest for the FDA to curb use of synthetic food dyes, as well as a new law in California that will ban Red 40 and some other dyes from school meals starting in 2028. 

“If you talk to parents whose kids are sensitive to dyes, they’ll tell you how difficult it is to avoid dyes and what a huge change it was for their entire household to try to get these dyes out of their kids’ diets,” she said.

What foods and drinks have red dye 40?

An FDA study published in 2016 estimated that children are exposed to Red 40 the most from drinks, frozen desserts and cereal.

Databases published by the U.S. Department of Agriculture and nonprofit Environmental Working Group tally thousands of foods with Red 40. Medications and cosmetics also have it.

They include products like Kellogg’s Froot Loops, a cereal brand that Kennedy has criticized. The foodmaker has faced calls to remove artificial colors, like it did for less fluorescent versions of Froot Loops sold in other countries like Canada. Other major cereal brands like Lucky Charms from General Mills also have Red 40.

Froot Loops maker WK Kellogg has said that its foods are safe and its ingredients all comply with federal regulations.

Several frozen dessert products also rely on Red 40, including Turkey Hill’s Black Raspberry Premium Ice Cream, Breyers’ M&M’s Minis Caramel Fudge Light Ice Cream, Blue Bell’s Birthday Cake Vanilla Flavored Ice Cream Cups and Blue Bunny’s Strawberry Flavored Soft Frozen Dairy Dessert.

A number of soft drinks also use Red 40, like Gatorade Fruit Punch and Fanta Soda. Other kinds of beverages also can contain the dye, like several strawberry milk brands or various generic manufacturers of pink lemonade mixes.

Why are there calls to ban red dye 40?

Most calls to restrict Red 40 stem from research commissioned by British food authorities in 2007, which linked increases of hyperactivity in children to mixtures of synthetic dyes. 

After the findings, authorities in Europe did not ban the dyes across the continent. Canada also continues to permit use of Red 40 and some other synthetic dyes. 

But the United Kingdom and Europe did add warnings to labels for foods containing any of the dyes from the tested mixtures, including Red 40, saying that they “may have an adverse effect on activity and attention in children.” 

A review by California’s Environmental Protection Agency in 2021 looking at dozens of studies agreed “that synthetic food dyes can cause or exacerbate neuro-behavioral problems in some children,” including Red 40.

Lefferts said it was “a no-brainer” that synthetic dyes should be pulled from the food supply, given concerns over this risk. She praised California’s review for integrating data from animal and lab studies, helping to fill in gaps from human research to prove a causal link.

“Synthetic food dyes are completely unnecessary. They can be omitted entirely or replaced with safe alternatives. Their purpose is purely cosmetic and we have all this evidence,” said Lefferts.

In a statement, the International Association of Color Manufacturers cited past FDA advisory panels, as well as findings by European and international health authorities, which have stopped short of concluding there was a causal link between Red 40 and hyperactivity.

“The FDA regulates the safety and labeling of all color additives, and it does so based on scientific evidence. As such, the FDA has determined and continues to maintain that FD&C Red No. 40 is safe,” said Sarah Codrea, the trade group’s executive director.

Why isn’t red dye 40 banned in the U.S.?

After the British study led authorities in Europe to warn about dyes like Red 40, the FDA convened a meeting of its food advisers in 2011 to review their safety. 

The panel voted narrowly against a similar kind of warning. Most said they thought studies had fallen short of proving a causal link, but were split on whether the studies warranted a warning.

“Causality is a distant aspiration, but certainly these data don’t give us any confidence that we can say there’s nothing to worry about here,” committee member Dr. Francisco Xavier Castellanos said during the meeting.

A meeting of the agency’s science board later in 2019 concluded that “most children have no effects from consuming foods containing color additives, though some evidence suggested that certain children may be part of a sensitive subpopulation,” an FDA spokesperson said. 

“Reassessing the safety of chemicals in food as new, relevant data become available is a priority for the FDA,” the spokesperson said.

Pulling previously approved chemicals off the market is an uphill battle through the cumbersome federal “rulemaking” process, which requires the agency to defend its answers to any question or concern raised by opponents of the measure — often companies with millions of dollars at stake.

“The agency can’t just wave a wand and say, we don’t like these anymore. There’s whole industries that have been developed using this color additive with the understanding that it’s safe,” said Dennis Keefe, the former director of the FDA’s office of food additive safety.

Keefe said adding a warning requires the agency’s lawyers to argue a “compelling public health reason,” given the high bar set by the First Amendment to compel speech on labels. 

Short of Congress stepping in to mandate changes or fund the kind of pricey studies to fill the gaps from previous research, Keefe said the agency faced more pressing public health priorities for its limited food budget.

“The agency needs to defend, scientifically, in the courts, to take the action. And they would have to have good data that Red 40 in particular is causing these hyperactivities. And the data just really aren’t that tight,” said Keefe.