Overview of the Ban

On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As noted in a prior Husch Blackwell Legal Update, the FDA based its decision on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the approval of additives found to induce cancer in humans or animals. The FDA recognizes that although the hormonal mechanism causing cancer in rats is not applicable to humans, Red Dye No. 3’s presence in the food and drug supply is sufficient to require a ban under the Delaney Clause. The FDA’s decision marks a pivotal shift in food and drug safety regulations.

Implications for Manufacturers

The ban on Red Dye No. 3 presents several immediate and long-term implications for manufacturers in the food and beverage industry:

1. Reformulation Requirements: Manufacturers incorporating Red Dye No. 3 in their products are required to reformulate in accordance with new regulations. The deadline for compliance is January 2027 for food products and January 2028 for ingested drugs. This timeline provides businesses with an opportunity to transition to less controversial alternatives, such as beet powder or vegetable juices. When reformulating, manufacturers must consider whether the alternative is explicitly permitted for the intended use in a regulation. By law, all color additives must have FDA approval for their intended use and be listed in the color additive regulations before they are permitted for use in food or drugs. There are fewer alternatives available for over-the-counter drugs than for food.
2. Supply Chain Adjustments: This revocation necessitates a reevaluation of supply chains to source compliant ingredients. Manufacturers may face challenges in securing reliable suppliers for alternative dyes, potentially impacting production timelines and costs.
3. Labeling and Marketing Changes: Products previously containing Red Dye No. 3 will require updated labeling to reflect the reformulated ingredients. Additionally, marketing strategies may need to be adjusted to communicate these changes effectively to consumers. This may involve updating Universal Product Code (UPC) or National Drug Code (NDC) numbers.
4. Compliance and Enforcement: Manufacturers must ensure compliance with the FDA’s ban to avoid penalties. This includes conducting thorough audits of product lines and implementing robust quality control measures to prevent inadvertent use of the banned dye.

Potential Avenues of Litigation

The FDA’s ban on Red Dye No. 3 opens several potential avenues of litigation that manufacturers should be aware of:

1. Consumer Class Actions: There is a possibility of consumer class action lawsuits alleging harm from past consumption of products containing Red Dye No. 3. Manufacturers may face claims for damages based on alleged health risks associated with the dye. Although the dye has been prohibited in cosmetics since 1990, it was permitted in food and pharmaceuticals until this ban. This regulatory inconsistency has been a subject of debate for many years.
2. Contractual Disputes: The ban may lead to contractual disputes between manufacturers and suppliers, particularly if existing agreements do not account for regulatory changes. Companies exporting to the United States will need to ensure compliance with the Red Dye No. 3 ban, even if the dye is permitted in their home countries. Manufacturers should review and potentially renegotiate contracts to address compliance obligations.
3. Regulatory Challenges: Manufacturers could explore legal challenges to the ban if they believe the regulatory process was flawed or if new evidence emerges that contradicts the FDA’s findings.
4. False Advertising Claims: Brands may face increased scrutiny from consumers demanding transparency about ingredient changes. Companies that fail to update their marketing materials or labels may be subject to false advertising claims. Reviewing and updating product ingredients is essential to ensure accurate representation, thereby mitigating these potential risks.

Looking ahead, the FDA’s decision could open the door to potential litigation against manufacturers who have used Red Dye No. 3 in their products, particularly if they marketed these items to children or failed to disclose potential health risks. Legal claims could center on negligence, failure to warn, or exposure to a carcinogen. Advocacy groups and legal experts may also push for a broader reevaluation of synthetic dyes and other food additives still in use, particularly those linked to health concerns like hyperactivity in children. This decision could serve as a precedent for stricter regulatory oversight of other artificial additives.

Conclusion

The FDA’s ban on Red Dye No. 3 represents a critical development in food and drug regulations with far-reaching implications for manufacturers. By proactively addressing reformulation, compliance, and potential litigation risks, companies can navigate this regulatory landscape effectively. As the industry adapts to these changes, staying informed and prepared will be essential for maintaining consumer trust and a competitive advantage.

Companies seeking strategic or legal assistance with these changes should reach out to Paul Smith, Seth Mailhot, Nikki Multer, or your Husch Blackwell attorney.