The Food and Drug Administration (FDA) is expected to announce a decision in the next few weeks on whether to revoke approval for the dangerous artificial food color Red Dye No. 3 (Red 3) due to its allegedly carcinogenic properties.
There is a resounding demand from consumer advocacy groups and lawmakers for federal regulators to ban the use of Red 3, a dye that infuses popular candies, foods, and drinks with bright red colors.
Synthetic dyes became available in the 1900s. Early artificial colors were called "coal-tar" colors because the base materials were derived from bituminous coal. Today, most synthetic coloring comes from petroleum or crude oil.
Natural food dyes have been used for centuries to color food. However, synthetic colors can be mass-produced at a fraction of the cost. And synthetic dyes, which often last longer than natural ones, are not limited to the smaller color palette available in nature.
The issue was raised Thursday at a U.S. Senate hearing, where lawmakers grilled FDA Commissioner Robert M. Califf and FDA Deputy Commissioner Jim Jones about food chemical additive safety.
Sen. Tommy Tuberville (R-AL) questioned Jones and Califf on Red 3 and Red 40, which, along with other food dyes, have become a key target of President-elect Donald Trump’s Health and Human Services (HHS) secretary nominee, Robert F. Kennedy Jr. The HHS oversees the FDA.
While the Trump platform is heavily on deregulation, Kennedy has spent years advocating against food additives he says are “literally poisoning our children.”
Kennedy has built a career railing against corporate influence and calling for tighter regulations, particularly for the food, pharmaceutical, and chemical industries.
Many environmental and public health advocates are hopeful he will make the necessary changes for a healthier America.
Tuberville asked whether the FDA still believes that Red 40 and Red 3 are safe for children to consume and why Red 3 is still allowed in the U.S. food supply when it is banned for use in cosmetics due to its possible carcinogenic effects.
“Red 3 has been known to cause cancer in cosmetics, but we still allow it to be put in our food. I don’t understand that,” Tuberville said. “If we know something is deadly for anybody that ingests it, how do we continue to just study that and not say, hey, enough is enough?”
Jones told the Senate Committee on Health, Education, Labor, and Pensions (HELP Committee) last week that his office is currently reviewing a 2022 petition to revoke approval for Red 3.
At the time, more than 20 public health advocates, including Consumer Reports, the Center for Environmental Health, and Breast Cancer Prevention Partners, filed a petition to revoke Red 3's official color additive listing, citing a 1990 FDA conclusion that the chemical causes cancer when fed to rats.
Still, the FDA has not prohibited its use in food and beverages because “the scientific consensus is that the mechanism of carcinogenicity in rats is not applicable in humans.”
What is concerning is that Red 3 was banned for cosmetic use and some drugs in 1990 for its known links to cancer, but it has not been removed from edible products.
“We are hopeful within the next few weeks we will be acting on that petition, that a decision is forthcoming,” said Jones.
“Thirty-four years of inaction is far too long,” the petition stated.
Food dye is also used in several non-food applications, like cosmetics and pharmaceuticals.
The use of food dye is thought to have originated in Egypt as early as 1500 B.C. Ancient candy makers used natural extracts and wine to enhance the appearance and color of their products.
During the Industrial Revolution, the demand for low-cost food, coupled with primitive chemistry and a lack of regulation, meant that food adulteration flourished.
In the U.S., the Pure Food and Drug Act of 1906 was created to outlaw compromised products. The legislation reduced the permitted list of synthetic colors from a whopping 700 to seven. Still, food adulteration continued for many years.
Today, the FDA must approve every batch of certified coloring a manufacturer produces. This approval process involves rigorous testing and evaluation to ensure the safety of the food dyes before they are allowed in the market.
Currently, seven artificial colors are generally permitted in food: Blue No. 1, Blue No. 2, Green No. 3, Red No. 3, Red No. 40, Yellow No. 5, and Yellow No. 6.
In 2021, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment released a report that concluded synthetic food dyes have been linked to health issues in some children. The report also found that children are often exposed to levels of Red 3 that exceed the FDA’s Acceptable Daily Intake Level, posing a serious health risk.
As part of its effort to fight the use of such products, the California Food Safety Act, passed in October 2023, bans Red Dye 3 from foods sold or manufactured in the state, coming into effect in January 2027. Similarly, the California School Food Safety Act, which was passed in August, banned Red Dye 40 from foods offered in California public schools beginning in December 2027.
Following California’s lead, nine other states are currently working on legislation to ban Red 3, and Pennsylvania is proposing a ban on five other food additives as well.
Critics complain that the FDA takes a lax approach to regulating food additives.
In public comments filed with the FDA last year, a letter signed by the American Bakers Association, Consumer Brands Association, and National Confectioners Association states that results found in lab rats are irrelevant to humans.
The groups requested that the FDA conduct a scientific review of research to determine the safety of Red 3 and keep it on the permanent list of color additives.
But in Thursday’s hearing, Jones said the agency was “hopeful” it would “be acting on that petition” in the “next few weeks.”
It is “long past time” for the FDA to ban the dye, U.S. Rep. Frank Pallone said in the Dec. 5 letter to the FDA. “With the holiday season in full swing where sweet treats are abundant, it is frightening that this chemical remains hidden in these foods that we and our children are eating.”
The agency’s inaction, which persists despite a clause in the Federal Food, Drug, and Cosmetic Act that requires the agency to ban cancer-causing food additives, has long frustrated public health advocates.
Let’s hope the FDA finally bans Red 3 for good. It’s time for us and our children to stop being fed dangerous chemicals.
Image: Pixabay
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