Understanding the FDA’s Ban on FD&C Red No. 3: Implications and Protective Measures for Companies

The U.S. Food and Drug Administration (FDA) has published an order to ban the use of FD&C Red No. 3, also known as erythrosine, in foods (including dietary supplements) and ingested drug products in the Federal Register through a rule published January 16, 2025, 90 Fed. Reg. 4628. The order repeals the color additive regulations that permit the use of this dye. FDA's order will be effective January 15, 2027, for food products and January 18, 2028, for ingested drug products. The procedure is rulemaking on a formal record. FDA will accept objections to the order and requests for a hearing related to this order until February 18, 2025.

This article aims to inform companies about the reasons for the ban, the implications and potential legal risks involved, and the steps they can take to protect themselves from liability, including challenging the ban.

What is FD&C Red No. 3?

FD&C Red No. 3 (Red No. 3) has a long history in the food and drug industries, primarily used for its “cherry-red” color in products such as candies, desserts, and even medications. Although the FDA has convened advisory committees to investigate color additives in the past, banning FD&C Red No. 2 in 1976, Red No. 3 has survived decades of scrutiny. In 1992, the FDA first announced its intention to remove authorization for Red No. 3 based on findings related to its carcinogenic effects in male rats, as published in a study from 1987. This study gained renewed attention in 2023 when it was cited in a petition proposing that the FDA reevaluate the color additive regulations for Red No. 3, ultimately leading to the recent ban.

The FDA’s recent ban is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic (FD&C) Act, which prohibits any food or color additive that has been found to induce cancer in humans or animals. This prohibition must be read broadly to ban color additives that pose even de minimis or trivial risks to humans, as determined by the U.S. Court of Appeals for the D.C. Circuit in 1987.¹

Although further evaluation of Red No. 3 was postponed when the case was decided in 1987, the precedent is particularly relevant to the FDA’s decision today. When re-evaluating the original study linking Red No. 3 to cancer in rats, the FDA admitted that the study’s relevance to humans is limited. The cancer observed in the study was attributed to a “rat-specific” hormonal mechanism, and the FDA noted that even the highest dietary exposure is far below the previously established acceptable daily intake. Because the study was found to induce cancer in animals, the FDA was required to repeal Red No. 3’s authorization “as a matter of law” under the Delaney Clause. Nevertheless, the rulemaking on a formal record process can be lengthy.  Factual and legal issues can exist that must be raised by Feb. 18.  

Potential Impacts of the Ban

While the FDA’s ban on Red No. 3 necessitates significant restructuring and reformulation of food and drug products that use the additive, it also carries potential legal consequences that manufacturers, distributors, and producers must be mindful of:

1. Regulatory Action: Under 21 U.S.C. § 348, food additives are only permissible if there is a regulation allowing their use. Products containing unapproved additives are considered “adulterated” and subject to regulatory action by the FDA. Companies that continue to market products with Red No. 3 after the effective dates of the order risk the potential seizure and condemnation of their products. This could lead to significant financial losses and disruptions in production.
2. Negligence Per Se: Including banned or dangerous food additives exposes manufacturers and distributors to negligence per se claims by private parties. Now that the Red No. 3 color additive regulations have been revoked, public interest groups may be empowered to seek recovery from companies that have used the additive.²
   
3. Failure to Warn Claims: Companies may face legal action for failing to warn consumers about the risks associated with products containing Red No. 3.³
   
4. Consumer Class Actions: The widespread use of Red No. 3 in various products increases the likelihood of consumer class action lawsuits, where affected consumers may band together to seek damages. These suits can be especially damaging as they often attract media attention and can result in substantial settlements or judgments.

Companies must also stay aware of additional state-specific regulations that may complicate compliance efforts, further exposing manufacturers to liability. Different states may have varying standards for food additives, as well as different remedies for consumers. Failure to comply with these regulations can lead to additional legal challenges.

How Can You Protect Yourself?

To minimize the risks associated with the FDA’s ban on Red No. 3, companies should consider the following measures:

1. Begin Phasing Out Use of Red No. 3: Begin the process of reformulating products to eliminate Red No. 3. Companies are required to discontinue use of Red No. 3 in food products by January 15, 2027, and by January 18, 2028, for ingested drug products. Companies should explore alternative colorants that are both safe and compliant with FDA regulations.
2. Understand State-Specific Regulations: Be aware of any state-specific regulations that apply to your company and note that you may be subject to state regulations in all places where your products enter the stream of commerce. Companies should conduct a thorough review of state-specific food additive regulations to ensure they are not inadvertently violating any laws.
3. Determine Whether to Object to the Order: FDA is accepting objections to the order and requests for a hearing related to this order until February 18, 2025. Any objections and requests for hearing filed after February 18 will not be considered, so the time to act is now.  
4. Monitor Legal Trends: Stay informed about legal trends related to FDA regulations and color additives, including any further procedures related to this Order. This vigilance can help you avoid future reformulation costs and potential legal challenges. Engaging with industry associations and legal experts can provide valuable insights into emerging trends and best practices.
5. Reassess Compliance: Conduct a thorough review of your compliance with all FDA regulations. Ensuring that your products meet current standards is essential for protecting your business. This may involve updating labeling, conducting safety assessments, and implementing quality control measures.
6. Consult Legal Experts: Engage with legal counsel specializing in food and drug law to navigate the complexities of compliance and liability. Their expertise can provide valuable insights and strategies for risk management. Regular consultations can help you stay ahead of regulatory changes and prepare for potential legal challenges.

Conclusion

The FDA’s ban on Red No. 3 presents potential challenges for manufacturers in the food and drug industries. By understanding the implications of this decision and taking proactive steps to protect themselves, companies can mitigate the risks of product liability and ensure compliance with regulatory standards. If you have concerns about how this ban may impact your business or if you need assistance navigating these changes, we encourage you to contact one of our skilled attorneys. Our team of multi-disciplinary experts is here to provide the legal support and guidance you need to protect your interests in this evolving landscape.