Red Dye No. 3 is a synthetic food coloring derived from petroleum and has long been used to add a bright, cherry-red color to a wide variety of consumer products, including candies, snacks, drinks, oral medications and dietary supplements.
On January 15, 2025, the U.S. Food and Drug Administration (FDA) issued an order revoking authorizations for the use of Red Dye No. 3—aka FD&C Red No. 3, erythrosine or E127—in food, beverages and ingestible drugs. See generally 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, 90 Fed. Reg. 4628 (Jan. 16, 2025) (to be codified at 21 C.F.R. pt. 74).
This decision follows a complex regulatory journey. In 1990, FDA banned Red Dye No. 3 in cosmetics due to concerns about its safety. In October 2023, California became the first U.S. state to prohibit the dye in foods, and many countries worldwide—including Japan, Australia, New Zealand and those in the European Union—have already restricted or banned its use in food products.
FDA's decision is grounded in the Delaney Clause of the Federal Food, Drug and Cosmetic Act, which mandates the ban of any food or color additive shown to cause cancer in humans or animals. See 21 U.S.C. §§ 379(e), §348(c)(3)). This action follows a 2022 petition submitted by the Center for Science in the Public Interest and other advocacy groups, which presented evidence linking high levels of Red Dye No. 3 to thyroid cancer in male laboratory rats. Although FDA acknowledged that these findings do not suggest a direct cancer risk to humans, the Delaney Clause compels the agency to revoke approval for any additive found to be carcinogenic in animals, even if the risk to humans is not established. See Public Citizen v. Young, 831 F.2d 1108, 1122 (D.C. Cir. 1987) (rejecting FDA's attempt at creating a de minimis exception in the Delaney Clause as to additives that pose a trivial cancer risk to humans).
Delaney Clause Review and FDA's Response
Commentors noted advances in scientific understanding of the dye's carcinogenic potential, the lack of evidence in showing a significant cancer risk to humans, and the nongenotoxic nature of the dye in reconsideration of the ban. However, FDA relied upon the Delaney Clause, which prohibits FDA's discretionary decision-making power when food additives are shown to induce cancer in humans or animals, regardless of scientific advances in rejecting the merits of these comments.
Industry Implications and Compliance
Industry participants must now anticipate navigating a complex regulatory landscape to ensure compliance with both federal and state requirements. For example, manufacturers currently using Red Dye No. 3 in their food, beverage or ingestible drug products must reformulate their recipes to eliminate the dye by the applicable compliance deadlines. This includes removing Red Dye No. 3 from ingredient lists and updating product labels accordingly. Likewise, importers of goods containing Red Dye No. 3 must ensure their products are compliant with the ban, removing the dye and updating labels to reflect the changes.
To avoid potential penalties or market disruptions, businesses should act swiftly to ensure that all affected products are in full compliance before the regulatory deadlines. This will likely involve thorough auditing of supply chains to identify and eliminate Red Dye No. 3 in all forms. Failing to meet these deadlines could lead to product recalls and legal penalties.
Deadlines
The final compliance deadline for food and beverage manufacturers is January 15, 2027, while companies producing ingestible drugs have until January 18, 2028. See (21 C.F.R. §§ 74.303, 1303) (2025). After these dates, FDA will no longer issue certificates for the use of Red Dye No. 3. Consequently, any new lots of products containing the dye will be considered uncertified, and use of uncertified dye in products will be considered adulterated. However, products manufactured while the certification for Red Dye No. 3 was still valid will not be considered adulterated, as long as they comply with prior regulations.
Action Steps for Industry Participants
As FDA revokes approval for Red Dye No. 3, industry participants may wish to consider taking proactive steps to comply with the new regulations and ensure compliance, which may include consulting with counsel and considering the following:
- Assessing Product Impact: Identify which products are affected by the ban, including food, beverages, ingestible drugs and dietary supplements.
- Preparing for Reformulation: Begin the process of reformulating products to eliminate Red Dye No. 3 and explore FDA-approved alternative colorants.
- Complying with Deadlines: Ensure that all reformulations are in place before the compliance deadlines (January 15, 2027, for food and January 18, 2028, for drugs).
- Updating Labels and Marketing: Revise product labels to reflect the removal of Red Dye No. 3 and ensure marketing materials align with these changes.
For example, regulatory counsel may be consulted to assist with ensuring that compliance with requirements such as removal of the dye from the supply chain of products and updating the necessary labels will be met by the imposed deadlines. On the other hand, intellectual property counsel may be consulted regarding the reformulation of products, such as determining whether there is freedom to operate with the use of alternative components to obtain the distinct color of Red Dye No. 3 in a particular product or to enforce trademark rights against bad actors continuing to use the banned dye in products using confusingly similar marks, thereby tarnishing the trademark. Litigation counsel may provide insight and advice as to implications and risks of the ban such as the impact of mass product recalls or the likelihood of injury from use of such products containing the banned dye (e.g., increased risk of cancer) and helping to mitigate such risks.
Industry participants are encouraged to take action sooner than later to evaluate use of Red Dye No. 3 in their products, whether manufactured, purchased, distributed or sold, and to begin to take the necessary steps to ensure compliance by the appropriate deadline.
For More Information
If you have any questions about this Alert, please contact Christiane Schuman Campbell, Thomas J. Kowalski, Frederick R. Ball, Morgan L. Swing, Brandon A. Chan, Ph.D., Jessica Santacroce, Kelly A. Bonner, any of the attorneys in our Intellectual Property Practice Group, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact.
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