The U.S. Food and Drug Administration is banning a synthetic food dye that gives foods and drinks a pop of bright red color. However, it will be a few years before the ban goes into full effect.
The ban is the result of the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. The clause prohibits the FDA from authorizing food additives, including coloring, that have been found to cause cancer in humans or animals.
Studies have found that FD&C Red No. 3 causes cancer in male rats, although this research also has established that the way the dye triggers cancer in rats does not occur in humans, according to the FDA.
In addition, the amount of exposure that most people have to FD&C Red No. 3 — also known as Red Dye No. 3, Red Dye 3 and erythrosine — is much lower than the amounts that caused cancer in rats, the FDA says.
According to the FDA:
“Claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.”
The dye, which is made from petroleum, is not as widely used as others, according to the FDA. But it has been found in products such as:
- Candy
- Cakes and cupcakes
- Cookies
- Frozen desserts
- Frostings and icings
- Drugs that are ingested (swallowed), such as those in pill or tablet form
Manufacturers that use FD&C Red No. 3 in food will have until Jan. 15, 2027, to reformulate their products. For those who make ingested drugs, the deadline is Jan. 18, 2028.
Foods imported into the U.S. also must comply with the new requirements.
A few years ago, the Center for Science in the Public Interest led a petition drive to urge the FDA to ban FD&C Red No. 3. Proponents of the ban said the dye is a known carcinogen that has been linked to hyperactivity and other neurobehavioral problems in children.
The FDA’s ban of the dye is a response to that petition, which was signed by a total of 24 organizations and scientists.
Consumer Reports also created a separate petition requesting a ban. More than 80,000 consumers signed that petition.
Brian Ronholm, director of food policy at Consumer Reports, said after the FDA announced the ban:
“Red Dye 3 poses an unacceptable risk to our health, especially when safer alternatives are readily available. By banning Red Dye 3, the FDA will protect the public by encouraging manufacturers to switch to safer ingredients already used in products sold in Europe and numerous other countries.”
FD&C Red No. 3 is already banned in cosmetics and topical drugs (those applied to the skin). The FDA banned it in the early 1990s based on the Delaney Clause because it causes cancer in rats.
At that time, the federal agency also intended to ban the use of the dye in foods and ingested drugs but “decided not to take action,” citing a lack of resources.
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