Red #3 Banned
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EmailRead about how the Delaney Clause of the Food, Drug, and Cosmetics Act factors into the FDA's January 2025 decision to revoke authorization of Red No. 3 in food, dietary supplements, and ingested drugs
The FDA is revoking the regulations authorizing Red No. 3 (erythrosine) in food, dietary supplements, and ingested drugs (90 Fed. Reg. 4628-4634, Jan. 16, 2025).
The FDA finds no health risk to humans at levels consumed, but the evidence indicates that Red No. 3 causes cancer in male (but not female) rats. The Delaney Clause, section 721(b)(5)(B)(i) of the Food, Drug, and Cosmetics (FD&C) Act (21 USC 379e(b)(5)(B)), deems as unsafe and prohibits the authorization of a color additive that has been found to cause cancer in humans or animals.
The revocation will be effective January 15, 2027, for food coloring. For ingested drugs, the revocation will be effective January 18, 2028. Use of FD&C Red No. 3 after its authorization ceases will result in the food or ingested drugs being adulterated. However, food and ingested drugs manufactured with FD&C Red No. 3 before the revocation date will not be regarded as adulterated by reason of the use of the color additive.
Learn more about U.S. food laws and regulations with MSU's online graduate courses, particularly:
- Food Laws and Regulations in the United States (fall and spring semesters)
MSU's Institute for Food Laws and Regulations offers online graduate courses to food industry professionals. Most IFLR students work full time for food companies or regulators, and take one online course at a time to further their professional development. Students may take as few or as many courses as they desire, and may earn a Certificate in International or United States food law after completing twelve qualifying credits (usually four courses).
