Deputy commissioner for human foods confirms FDA intends to finalize decision on Red Dye 3 soon

FDA Deputy Commissioner for Human Foods Jim Jones confirmed in a Senate hearing this week that the Food and Drug Administration intends to finalize its decision on the carcinogenic food dye FD&C Red No. 3, known as Red 3, in the use of foods fairly soon.

Jones acknowledged that it’s been a while since the FDA and Red Dye No. 3 have been in touch. Jones told the hearing that ” at FDA, we have not evaluated the safety of Red 40 in over a decade.”

Republican Sen. Tommy Tuberville said: “Let me say this: 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.”

 “So, (In) Red 3, we have a petition in front of us to revoke the authorization for it, and we are hopeful that within the next few weeks, we will be acting on that petition, and a decision should be forthcoming, Jones said.

A letter asking the FDA to ban Red Dye No. 3 was signed by 22 members of Congress, led by Connecticut Democratic Rep. Rosa DeLauro.

The DeLauro letter, signed on Nov 25, urged the agency to finalize a ban on the carcinogenic food dye in foods.

“A ban on Red 3 is not only statutorily required, but it is also feasible – alternatives are widely available,” the lawmakers wrote. “Thirty-four years of inaction is far too long. We are calling on the FDA to use its regulatory authority to ban Red 3 from our nation’s food supply before the end of this Congress.” 

In 1990, the FDA banned the use of Red 3 in cosmetics and externally applied drugs based on a study that found it caused cancer in rats. According to the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, the FDA is required to ban any food additive that is found to cause cancer in humans or animals.

The letter said the carcinogenicity of Red 3 is clear. The National Toxicology Program, the European Commission’s Scientific Committee for Food, and the World Health Organization have all concluded that Red 3 causes cancer in animals. The state of California also determined that Red 3 causes neurobehavioral issues in children. There is no aesthetic reason good enough to justify a carcinogen in the food supply.

The FDA is actively reviewing a petition filed by 24 food safety and consumer protection organizations and scientists calling for the review of Red 3’s approval. Red 3 is still authorized for use as a color additive in food and ingested drugs. 

Despite being obligated to rule on the petition within 180 days, the FDA has yet to do so.

“American consumers need to trust that the food in their grocery stores is safe, especially when it is marketed to children,” the lawmakers continued. “It is time for the FDA to make good on its regulatory promise and remove this carcinogen from our food.”

The State of California in 2023 passed a law banning Red Dye 3,

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