The Food and Drug Administration hasn’t formally reevaluated the safety of a food coloring called Red 40 in more than a decade, the agency’s top food official said this month about its potential behavioral health effects. when asked about new concerns.
The agency has launched a new effort to review several previously approved additives. But Jim Jones, the FDA’s deputy commissioner for human foods, warned that the agency’s budget is so small that it will take years to catch up with other countries.
“We’re decades behind European countries and Canadian countries because European countries have a legal obligation to re-evaluate the chemicals they approve,” Jones said at a Senate Health Committee hearing. ” Jones told Sen. Tommy Tuberville during a Senate Health Committee hearing.
Mr. Tuberville also asked Mr. Jones about another food coloring called . red 3which advocacy groups are petitioning against because studies have shown it causes cancer in animals. Jones suggested it could be weeks before the agency moves toward a ban.
The decades-old debate over synthetic food dyes is receiving new attention on Capitol Hill, thanks in part to outspoken criticism from some in the government. Robert F. Kennedy Jr.President-elect Donald Trump will choose: serve as department head Oversees the FDA and other health agencies.
“Senator Tuberville will work with the incoming Trump administration to make america healthy again“A spokesperson for the Alabama Republican Party said, referring to the slogan RFK Jr. has promoted, that Tuberville was “shocked to learn that the FDA had not reviewed the safety of Red 40 for a long time. ” he said.
What is Red Dye 40?
FD&C Red No. 40, or Red 40 for short, is the FDA name for a color additive that was first registered with the FDA in the 1970s. This chemical is known in the food industry as Allura Red AC and in Europe as E 129.
Currently, it is mainly synthesized from petroleum.
Further chemical reactions combine the dye and aluminum to create what is known as “Red 40 Lake.” Lakes are often used in products such as chewing gum where there is not enough moisture to dissolve the dye into the product, or in products such as frosting to prevent color bleeding.
The FDA says it is subjecting the production of Red 40 and several other synthetic dyes to enhanced testing, testing each batch for contaminants from the manufacturing process.
Among the dyes that receive this purity certification, Red 40 consistently ranks as the dye with the highest volume produced each quarter.
“People think, ‘I know which foods have dyes in them and which foods don’t,’ but that’s not true. White foods can have dyes in them. , foods that are marketed as healthy and natural may contain dyes, and even egg noodles may contain dyes. Unless you see them, you need to know about them and avoid them,” said environmental health consultant Lisa Lefferts.
Lefferts was closely involved in the FDA’s Center for Science in the Public Interest’s push to curb the use of synthetic food dyes, as well as California’s new law banning Red 40 and other dyes from school lunches starting in 2028. . .
“If you talk to any parent who has a child who is sensitive to dyes, they will tell you how difficult it is to avoid dyes and how trying to eliminate dyes from their child’s diet has been a big change for the whole family,” she says. Said.
What is red dye 3?
A dye called Red No. 3 is also made from petroleum and gives many foods and candies their bright cherry red color.
“At least in rats, there appears to be an increased risk of thyroid cancer, and we also see an association with hyperactivity in children,” says CBS News Medical Contributor and KFF Health Public Health Editor said Dr. Celine Gounder, Director. This was reported on Tuesday’s “CBS Mornings.”
Scientists, consumer protection groups and food safety groups have petitioned the FDA to withdraw its approval of Red No. 3, and the agency is expected to take action in the coming weeks, Gounder said. said.
This dye has already been banned for use in cosmetics and topical medicines since 1990.
What foods and drinks contain red dye 40?
An FDA study published in 2016 estimated that children are most exposed to Red 40 from drinks, frozen desserts, and cereal.
A database published by the U.S. Department of Agriculture and the nonprofit Environmental Task Force tallies thousands of foods as falling under the Red 40 category. Pharmaceuticals and cosmetics also contain Red 40.
That includes products like Kellogg’s Fruit Loops, the cereal brand criticized by President Kennedy. Food manufacturers are faced phone This is to remove artificial colors, similar to the less fluorescent versions of Froot Loops sold in other countries such as Canada. Other major cereal brands such as General Mills’ Lucky Charms also have Red 40.
WK Kellogg, the maker of Fruit Loops, said its food is safe and all of its ingredients comply with federal regulations.
Several frozen desserts include Turkey Hill’s Black Raspberry Premium Ice Cream, Briers’ M&M’s Mini Caramel Fudge Light Ice Cream, Bluebell’s Birthday Cake Vanilla Flavored Ice Cream Cup, and Blue Bunnies’ Strawberry Flavored Soft Frozen Dairy Dessert The product also relies on Red 40.
Red 40 is also used in many soft drinks, including Gatorade Fruit Punch and Fanta Soda. Other types of beverages may also contain this dye, such as some strawberry milk brands and pink lemonade mixes from various generic manufacturers.
Gounder said it’s important to check the label because it’s the only way to know if a product contains synthetic dyes.
“You can’t see the color. Even white foods may have synthetic dyes used to lighten the color,” she said.
Why are there calls to ban red dye 40?
Most of the calls to limit Red 40 stem from a study commissioned by British food authorities in 2007, which linked increased hyperactivity in children to a mixture of synthetic dyes.
After this discovery, European authorities did not ban the dye across the continent. Canada also continues to allow the use of Red 40 and several other synthetic dyes.
However, the UK and Europe have added a warning to the labels of foods containing the dyes in the mixtures tested, including Red 40, that they “may have an adverse effect on children’s activity and alertness”.
A review of dozens of studies conducted in 2021 by the California Environmental Protection Agency found that “synthetic food colorings, including Red 40, cause or worsen neurobehavioral problems in some children. Agreed that it is a possibility.
Lefferts said that given concerns about this risk, eliminating synthetic dyes from the food supply “makes sense.” He praised California’s review for integrating data from animal studies and laboratory studies, helping to bridge the gap with human studies to prove causation.
“Synthetic food colors are completely unnecessary. They can be omitted completely or replaced with safe alternatives. Their purpose is purely cosmetic and we have all the evidence for this.” said Lefferts.
In a statement, the International Association of Color Industries cited previous FDA advisory committees and studies by European and international health authorities that stopped short of concluding that there was a causal link between Red 40 and hyperactivity. did.
“The FDA regulates the safety and labeling of all color additives, and they do so on a scientific basis,” said Sara Codrea of the industry group. We have determined that this is the case and continue to maintain it.” Managing director.
Why isn’t red dye 40 banned in the US?
The FDA convened a Food Advisory Council in 2011 to review its safety after a British study alerted European authorities to dyes like Red 40.
The committee narrowly voted against a similar warning. Most people think the study falls short of proving causation, but said they disagree on whether the study merits warning.
“Causality is a long shot, but certainly these data do not give us confidence to say there is nothing to worry about,” commission member Dr. Francisco Xavier Castellanos said at the meeting. .
An FDA spokesperson said at a meeting of the agency’s scientific committee in late 2019 that “most children will not be affected by consuming foods containing color additives, but some evidence suggests that “These results suggest that children may be part of a sensitive subpopulation.”
“It is FDA’s priority to reevaluate the safety of chemicals in food as new relevant data becomes available,” the spokesperson said.
Removing previously approved chemicals from the market is an uphill battle that goes through the federal government’s cumbersome “rulemaking” process, in which opponents of the action (often hundreds of thousands of You need to defend your answers to any questions or concerns raised by companies with millions of dollars at stake.
“The agency can’t just wave a wand and say, ‘We don’t like this anymore,'” said former FDA Commissioner Dennis Keefe. “It is being developed.” Food Additive Safety Administration.
Keefe said the agency’s lawyers needed “compelling public health reasons” to add the warning, given that the First Amendment sets a high bar for mandatory speech on labels. He said he needed to make a statement.
Keefe said that as Congress refrains from mandating changes or funding expensive research to close gaps in previous research, agencies will be able to improve public health outcomes with limited food budgets. He said he was faced with more pressing priorities.
“For a government agency to sue, it would need to be scientifically defended in court. And it would need to have enough data that Red 40 in particular is causing this overactivity. And the data would actually is not that rigorous,” Keefe said. .
