The U.S. Food and Drug Administration (FDA) has not formally re-evaluated the safety of a food dye called Red 40 in more than a decade, and the agency's top food official was asked this month about new concerns about its potential behavioral health effects. Expressed when concerned.
The agency has launched a new effort to revisit some previously approved additives. But Jim Jones, the FDA's deputy commissioner for human food, warned that their budgets are too small and it will take years to catch up with other countries.
“We are decades behind our European and Canadian counterparts in that they have the legal authority to re-evaluate chemicals that have been authorized,” Jones told Sen. Tommy Tuberville during a Senate Health Committee hearing.
Tuberville also asked Jones about a different food dye called Red 3advocacy groups have filed petitions against it due to studies showing it causes cancer in animals. Jones said it could take weeks before the agency takes action to ban the practice.
The decades-long controversy over synthetic food dyes is once again drawing attention on Capitol Hill, in part because of Robert Kennedy Jr.the choice of President-elect Donald Trump department head Oversees the FDA and other health agencies.
“Senator Tuberville looks forward to working with the incoming Trump Administration, Make America Healthy Again“, a spokesman for the Alabama Republican said, referring to the slogan promoted by RFK Jr., a spokesman for Tuberville said, “He was shocked to learn that the FDA did not review the safety of Red 40 for so long.” .
What is Red Dye 40?
FD&C Red No. 40, or Red 40 for short, is the name of the FDA and refers to the color additive first registered with the agency in the 1970s. The chemical is known as Allura Red AC in the food industry and as E 129 in Europe.
Now it is mainly synthesized from petroleum.
A further chemical reaction combines the dye with the aluminum, creating what is known as “Red 40 Lake.” Lakes are often used in products such as chewing gum because there is not enough moisture to dissolve the dye into the product, or in products such as frosting to help prevent color bleeding.
The FDA said it has conducted an enhanced review of the production of Red 40 and some other synthetic dyes, screening each batch for the presence of any contaminants.
Of the dyes certified for this purity, Red 40 is consistently the most produced in production each season.
“People think 'I know which foods have dyes and which don't', but no, you don't. White foods can have dyes, foods marketed as healthy and natural can have dyes, egg noodles can have dyes, it's just hard,” says Environmental Health Consultant Lisa Lefferts says: “Be aware of and avoid them unless you read the label. “
Lefferts has been closely involved in the Center for Science in the Public Interest's campaign to the FDA to curb the use of synthetic food dyes, as well as a new California law that would ban the use of Red 40 and some other dyes in school meals starting in 2028.
“If you talk to parents whose children are dye-sensitive, they will tell you how difficult it is to avoid using dyes and what a huge change it makes for their entire family to try to remove these dyes from their child's diet,” she said.
What foods and drinks contain red dye 40?
An FDA study published in 2016 estimated that children are most exposed to Red 40 through beverages, frozen desserts and cereals.
A database published by the U.S. Department of Agriculture and the nonprofit Environmental Working Group counts thousands of foods containing Red 40.
That includes products like Kellogg's Froot Loops, the cereal brand Kennedy criticized. Food manufacturers have face phone call Remove the artificial coloring, as is done with the less fluorescent Froot Loops sold in other countries such as Canada. Other major cereal brands, such as General Mills' Lucky Charms, also carry Red 40.
Froot Loops manufacturer WK Kellogg says its food is safe and its ingredients 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 Ice Cream Cups and Blue Bunny's Strawberry-flavored soft-frozen dairy desserts.
Red 40 is also used in many soft drinks, such as Gatorade juice punch and Fanta soda. Other kinds of drinks may also contain this dye, such as some brands of strawberry milk or generic manufacturers of various pink lemonade mixes.
Why are some calling for a ban on red dye 40?
Most calls to restrict Red 40 stem from research commissioned by UK food authorities in 2007, which linked an increase in ADHD in children to synthetic dye mixtures.
Following the findings, European authorities stopped short of banning the dye across the continent. Canada also continues to allow the use of Red 40 and some other synthetic dyes.
But the UK and Europe did add warnings to food labels containing any of the dyes in the tested mixtures, including Red 40, saying they “may have adverse effects on children's activity and concentration”.
The California Environmental Protection Agency reviewed dozens of studies in 2021 and concluded that “synthetic food dyes may cause or exacerbate neurobehavioral problems in some children,” including Red 40.
Lefferts said removing synthetic dyes from the food supply was “a no-brainer” given concerns about the risk. She praised California's review for integrating data from animal and laboratory studies and helping to fill gaps in human research to prove cause and effect.
“Synthetic food colorings are completely unnecessary. They can be omitted entirely or replaced with safe alternatives. Their purpose is purely decorative, and we have all the evidence for that,” Lefferts said.
In a statement, the International Color Manufacturers Association cited findings from past FDA advisory panels and European and international health authorities that did not conclude a causal link between Red 40 and ADHD.
“The FDA regulates the safety and labeling of all color additives and does so based on scientific evidence. Therefore, the FDA has determined and continues to maintain that FD&C Red No. 40 is safe,” said Sarah Codrea of the trade group.
Why isn't red dye 40 banned in the United States?
After British research led European authorities to issue warnings about dyes such as Red 40, the FDA convened a meeting of food advisors in 2011 to review their safety.
The panel narrowly voted against a similar warning. Most said they believed the studies failed to prove a cause-and-effect relationship, but there was disagreement over whether the studies warranted warnings.
“Cause and effect is a distant aspiration, but certainly these data do not give us any confidence that we can say there is nothing to worry about here,” committee member Dr. Francisco Xavier Castellanos told the meeting. .
An FDA spokesperson said that a meeting of the agency's scientific committee in late 2019 concluded that “despite evidence that some children may be in sensitive subgroups, it is not appropriate for most children to eat foods containing color additives.” will have any impact”.
“As new relevant data becomes available, re-evaluating the safety of chemicals in food is a top priority for the FDA,” the spokesperson said.
Taking previously approved chemicals off the market is an uphill battle, requiring a cumbersome federal “rulemaking” process that requires the agency to sue companies that oppose the measure, often with millions of dollars at stake. to respond to any questions or concerns you may have.
“The agency can't just wave a magic wand and say, we don't like these anymore,” said former FDA director Dennis Keefe. “The entire industry is using this color additive, but they all know it's safe.” Food additives Security Office.
Keefe said adding the warning would require the agency's attorneys to present “compelling public health reasons” given that the First Amendment sets a high bar for forcing speech on labels.
Keefe said the agency faces more pressing public health priorities with its limited food budget before Congress steps in to force changes or fund such expensive studies to fill gaps in previous research.
“The agency needs a scientific defense in court to take action. They have to have good data that Red 40 in particular is causing these hyperactivity. And the data really isn't that rigorous,” Keefe said.
