Red Dye 3 Archives

January 15, 2025

FDA announces long-awaited ban on Red Dye 3

By Carey Gillam

US regulators on Wednesday said a food additive long linked to cancer will no longer be allowed in food and drugs that are ingested, a regulatory decision health advocates have demanded for years.

The Food & Drug Administration (FDA) is revoking the authorization for the use of what is known as Red Dye No. 3, a chemical used to give popular candies, cakes, cookies and other foods cherry-red colors.

The action comes in response to a 2022 petition filed by scientists and more than 20 public health organizations that cited studies finding the chemical causes cancer in laboratory animals. The petition cited a federal law that bars the FDA from allowing a color additive to be used in products that are ingested if the additive is found to induce cancer in “in man or animal.”

“This move by the FDA is long overdue, but represents a step in the right direction for consumer safety from harmful, cancer-causing chemicals. This is exactly the action we need to see from the FDA,” said Rebecca Wolf, a policy analyst with Food & Water Watch, which was among the petitioners.

In its announcement Wednesday, FDA officials said they were taking action as “a matter of law,” but stressed that the agency does not believe the dye poses an actual health risk to people. Exposure levels for humans are “typically much lower than those that cause the effects” seen in laboratory rats, the agency said.

“Claims” that the dye puts people at risk “are not supported by the available scientific information,” the agency said.

Manufacturers who use the dye in food have until Jan. 15, 2027 to reformulate products. Drug makers have until Jan. 18, 2028.

December 6, 2024

Spotlight on cancer-causing food additive as advocates demand FDA ban Red Dye 3

By Shannon Kelleher

In the waning days of the Biden administration, a long-fought battle over a cancer-causing food additive is again in the spotlight as consumer advocacy groups and lawmakers demand federal regulators ban Red Dye No. 3, a chemical used to give popular candies, foods and drinks their cherry-red colors.

The issue took center stage Thursday at a US Senate hearing where lawmakers grilled Jim Jones, Food and Drug Administration (FDA) deputy commissioner for human foods, over the issue.

“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,” Sen. Tommy Tuberville said in the hearing. “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?”

Industry studies linked Red Dye 3 to cancer in rodents more than 30 years ago, and public health groups have spent years lobbying food companies and regulators to get the chemical out of foods.

Two years ago, two dozen organizations and scientists submitted a petition to the FDA demanding a ban, citing a 1990 FDA conclusion that the chemical causes cancer when fed to rats.

Last month, 23 members of Congress sent a letter to the FDA also calling for a ban, saying the FDA “should act quickly to protect the nation’s youth from this harmful dye.” The letter noted Red Dye 3 has been banned or mostly banned in Europe, Australia and New Zealand and California has a ban on the dye in food taking effect in 2027.

“Thirty-four years of inaction is far too long,” the letter states.

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, US Rep. Frank Pallone said in a 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.”