Yesterday, the FDA gave notice that it was banning Red Dye number 3 from foods and pharmaceuticals. Technically, it revoked the authorization for the use of the dye.[1]
Formally, FDA granted a petition by an “white hat” and “empty head” consortium of individuals and NGOs that included the Center for Science in the Public Interest, Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Chef Ann Foundation, Children’s Advocacy Institute, Consumer Federation of America, Consumer Reports, Defend Our Health, Environmental Defense Fund, Environmental Working group, Feingold Association of the United States, Food & Water Watch, Health Babies Bright Futures, Life Time Foundation, Momsrising Prevention Institute, Public Citizen, Public Health Institute, Public Interest Research Research Group, Real Food for Kids, Lisa Y. Lefferts, Linda S. Birnbaum, and Philip J. Landrigan.[2]
As the FDA notice explained, a federal statute known as the “the Delaney Clause,” which was added by Congress in 1960 to the Color Additives Amendment to the Food, Drug and Cosmetics Act, prohibits FDA authorization of a food color additive that has been found to induce cancer in humans or animals. The FDA agreed with petitioners that there were two studies that found higher rates of cancer in laboratory male rats exposed to high levels of red dye #3. The agency pointed out that:
“The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats. Studies in other animals and in humans did not show these effects; 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 FDA rule making extrapolates across species, across dose levels, across sex, without evidence and indeed against evidence. Nonetheless, the 65 year old Delaney Clause, based upon out-dated and invalidated scientific methods, required the FDA action. Even the IARC does not consider red dye #3 a human carcinogen. While we can all agree that inbred laboratory male rats should not be fed food colored with red dye number 3, we have to ask ourselves are we more like this subset of the rat world, or more like mice and hamsters?
The formal FDA decision is dated today, January 16, 2025, and can be found in the Federal Register.[3] Richard Williams, a former FDA officer, called the rule making “another failed attempt” at educating and protecting consumers.[4]
[1] FDA, “FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs,” (Jan. 15, 2025).
[2] Color additive petition pursuant to 21 U.S.C. §§ 379e, 721(b)(1) to remove FD&C Red No. 3 from the permanent list of color additives approved for use in food and dietary supplements, 21 C.F.R. § 74.303, and for use in ingested drugs, 21 C.F.R. § 74.1303, because the FDA has found that the additive induces cancer and is unsafe (Oct. 24, 2022).
[3] “Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs – A Rule by the Food and Drug Administration,” Fed. Reg. (Jan. 16, 2025).
[4] Richard Williams, “Red Dye 3, New Nutrition Labels, and More,” (Jan. 16, 2025).
