On 15 January 2025, the US Food and Drug Administration (FDA) announced that it will revoke the color additive authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingestible drugs. This ban responds to a 2022 color additive petition submitted by several interested parties and filed by FDA in 2023.
In support of the revocation, FDA is relying on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 379e(b)(5)(B)), which requires FDA to ban color additives that are found to cause or induce cancer in humans or animals. Specifically, FDA is invoking the Delaney clause as a result of data that shows FD&C Red No. 3 causes cancer in male rats via a sex- and species-specific hormonal mechanism. In fact, according to the preamble of the final rule, "the carcinogenicity of FD&C Red No. 3 was not observed when tested in other animals including female rats and either sex of mice, gerbils, or dogs." In other words, there is no demonstrable link between consumption of the food additive and cancer in any animal other than male rats, and most importantly, between consumption of the food additive and cancer in humans. The Delaney clause nevertheless requires the revocation of the clearance for FD&C Red No. 3 based on the male rat carcinogenicity data.
Food manufacturers will have until 15 January 2027 to reformulate products containing FD&C Red No. 3, whereas drug producers will have until 18 January 2028. California's ban on FD&C Red No. 3 in food (along with three other additives) under AB 418 goes into effect a few weeks before FDA's ban, on 1 January 2027. Our Health Care and FDA team continues to monitor FDA's post-market review of cleared substances and is well-equipped to advise clients on questions.
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