Food and Drug Administration Revokes Red No. 3 Authorization

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FDA Announces Red No. 3 Authorizations to be Revoked as Matter of Law, not Safety

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Wednesday, January 15, 2025

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Today FDA announced that it is revoking the color additive authorizations for Red No. 3 in food (including dietary supplements) and ingested drugs based on evidence showing that Red No. 3 is carcinogenic to male rats (not humans, or even female rats) and the so-called “Delaney Clause” of the Federal Food, Drug, and Cosmetic Act (FD&C Act) which prevents the agency from authorizing an additive that has been found to cause cancer in humans or animals. The Delaney Clause as it pertains to color additives can be found in section 721(b)(5)(B) of the FD&C Act (21 USC 379e(b)(5)(B)) and a similar provision pertaining to food additives can be found in section 409(c)(3)(A) (21 USC 348(c)(3)(A)).
FDA’s announcement makes clear that the currently available scientific information does not support safety concerns regarding the use of Red No. 3 and that its decision was one it feels it was required to make based on the extremely broad scope of the Delaney Clause, which was added to the FD&C Act over 60 years ago and has not been updated since to keep up with new scientific understandings of cancer.
More specifically, consistent with its prior statements on Red No. 3, FDA concluded that Red No. 3 causes cancer in male rats at high doses by increasing the levels of a thyroid hormone (TSH). However, this mechanism of action is not relevant to humans; rats are much more sensitive to changes in TSH levels and studies in humans have not demonstrated that Red No. 3 changes thyroid hormone levels, including TSH. Finally, carcinogenicity of Red No. 3 has not been observed when female rats were tested, or when either sex of mice, gerbils, or dogs were tested.
The decision will be published in the federal register tomorrow (01/16/2025), but a pre-publication version of the federal register notice is available here. Manufacturers using Red No. 3 in food will have until January 15, 2027 to reformulate their products while manufacturers using Red No. 3 in ingested drugs will have until January 18, 2028 to reformulate.
This follows California’s ban of Red No. 3 with the signing of the California Food Safety Act in 2023 by Gov. Gavin Newsom which will go into effect in 2027 as well.