Today, the Food and Drug Administration (FDA) issued an order that will prohibit the use of Red No. 3 in food products and pharmaceuticals that are consumed.
Since 1990, the dye has been prohibited from use in cosmetics and topical medications due to the fact that there is evidence that it can cause cancer. The dye was initially allowed for usage in 1907. In Australia, Japan, and several nations in the European Union, the use of this substance in food is already prohibited or regulated.
Red No. 3 is a color that is frequently found in confections, gum, and cookies. Some examples of these products include strawberry Ensure, Betty Crocker sprinkles, and Brach’s candy corn.
In the event that it is removed from any and all items, food manufacturers will have until January 15, 2027 to do so, while manufacturers of ingested pharmaceuticals will have until January 18, 2028 to do so.
Specifically, the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which was passed into law in 1960, serves as the foundation for the new prohibition.
Because of the Delaney Clause, the Food and Drug Administration is not allowed to give approval to any food or color additive that has been discovered to cause cancer.
“The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in human or animals,” Jim Jones, the FDA’s deputy director for human foods stated. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.”
The Center for Science in the Public Interest and 23 other organizations petitioned for the action, citing studies that showed male lab rats exposed to high concentrations of Red No. 3 developed cancer.
The FDA stated that “available data does not raise safety concerns for humans,” pointing out that research conducted on humans and other animals did not reveal the same effect.
They added that Red No. 3, often known as erythrosine, is utilized in Canada and Europe.
Red No. 3 has been outlawed in topical medications and cosmetics for almost 35 years, but it is still present in food and swallowed medications, albeit with little caution.
For years, the public has called for restrictions on food dyes.
“The widespread use of red dye No. 3 is particularly concerning since it is found in many products marketed to children who are especially at risk of developing health problems from exposure,” Brian Ronholm, director of food policy for Consumer Reports, stated.
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In reality, the FDA had previously stated in 1992 that it planned to outlaw it in food, but finally decided against it due to the resources required to revoke its authorization.
Red No. 3 and three other food additives were outlawed in California under the California Food Safety Act more than a year prior to the federal ban. Additionally, that law won’t go into effect until 2027.
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New York, New Jersey, Pennsylvania, Maryland, West Virginia, Illinois, and South Dakota are among the other states that have already submitted bills.
The National Confectioners Association, which had previously referred to California’s law as a “slippery slope” and chastised the state for “making decisions based on soundbites rather than science,” stated that they support the FDA’s food regulation efforts in light of the FDA’s follow-up.
“Food safety is the number one priority for US confectionery companies, and we will continue to follow and comply with FDA’s guidance and safety standards,” they stated.
“Our consumers and everyone in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework. We have been saying for years that FDA is the rightful national regulatory decision maker and leader in food safety.”
