The FDA’s Decision on Red Food Dye (FD&C Red No. 3)
The FDA has issued an order to revoke the authorization of FD&C Red No. 3 in food and ingested drugs. This decision, effective January 15, 2027, for food and January 18, 2028, for ingested drugs, stems from concerns related to potential health risks. Manufacturers are granted this timeframe to reformulate their products and remove this red food dye. Consumers might still encounter products containing FD&C Red No. 3 after these dates if the products were manufactured before the effective revocation dates.
The Delaney Clause and Red Food Dye
The FDA’s decision is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This clause prohibits the approval of any food or color additive found to induce cancer in humans or animals, regardless of the dosage. A 2022 color additive petition presented data suggesting that high levels of FD&C Red No. 3 caused cancer in male laboratory rats due to a hormonal mechanism specific to male rats. Importantly, similar studies in other animals and humans did not replicate this finding, and there’s currently no evidence linking red food dye (FD&C Red No. 3) to cancer in humans.
Regulation of Color Additives Like Red Food Dye
The FD&C Act mandates pre-market approval for all color additives, including red food dye, before they can be used in food, drugs, cosmetics, or medical devices with significant human or animal contact. The approval process involves a rigorous evaluation of safety data submitted by manufacturers, considering factors like consumption levels, intended use, manufacturing process, and chemical properties. Only after thorough review and a determination of safety does the FDA issue authorization for a color additive’s use.
Labeling Requirements for Red Food Dye
Approved color additives have specific labeling requirements. FD&C Red No. 3 must be clearly declared in the ingredient list on food labels, either as “FD&C Red No. 3,” “Red 3,” or “FD&C Red 3.” While the U.S. moves towards removing this red food dye, other countries, including Canada and Europe, still permit its use under the name erythrosine.
Past Regulatory Actions and Ongoing Monitoring of Red Food Dye
FD&C Red No. 3 was permanently listed for use in foods and ingested drugs in 1969. In 1990, a petition to extend its use to cosmetics and topical drugs was denied due to the Delaney Clause and the findings in rat studies. A subsequent attempt to revoke its use in food and ingested drugs in 1992 was ultimately not pursued due to resource constraints and the lack of evidence of harm to humans. The FDA remains committed to evaluating scientific data and monitoring the safety of all color additives, including any new information regarding the potential effects of red food dye.
Conclusion: The Future of Red Food Dye
The FDA’s decision to revoke the authorization of FD&C Red No. 3 marks a significant change for food and drug manufacturers. While questions about the long-term effects of red food dye in humans remain, the FDA’s action underscores its commitment to upholding the Delaney Clause and prioritizing consumer safety. The coming years will see a transition in the food industry as manufacturers adapt to this regulatory change and reformulate products without this common red food dye.
