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FDA bans Red No. 3 in food and ingested drugs
On Jan. 15, 2025, the FDA revoked authorization for Red No. 3 in food and ingested drugs under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, requiring manufacturers to comply by Jan. 18, 2028.
On Jan. 15, 2025, the FDA announced the revocation of authorization for Red No. 3 in food and ingested drugs, citing the Delaney Clause of the Federal Food, Drug and Cosmetic Act (FD&C Act).
This decision, rooted in a 2022 color additive petition, stems from studies showing a cancer risk in male laboratory rats exposed to high levels of the dye. While these studies highlight a rat-specific mechanism unlikely to affect humans, the FDA's decision adheres strictly to the Delaney Clause, which prohibits the authorization of additives that induce cancer in humans or animals.
Broader industry implications
The revocation marks another notable application of the Delaney Clause in modern regulatory decisions. For the pharmaceutical sector, this change has significant implications for manufacturers that have relied on FD&C Red No. 3 in ingested drugs.
With a compliance deadline of Jan. 18, 2028, these manufacturers must reformulate their products to meet regulatory requirements. This transition period underscores the complexity of aligning manufacturing practices with evolving safety standards, particularly when regulatory decisions are influenced by legislative mandates rather than contemporary scientific risk assessments.
Impact on reformulation strategies
Reformulating pharmaceuticals to exclude FD&C Red No. 3 might pose challenges for manufacturers, particularly in maintaining product stability, consumer appeal and cost-effectiveness. While this synthetic dye is less commonly used than other certified colors, it has been integral to the aesthetic and brand identity of certain products.
This shift might drive investments in alternative coloring agents, potentially favoring natural or plant-based solutions. Such changes align with broader industry trends emphasizing clean-label products, which are increasingly sought by health-conscious consumers and healthcare providers.
Implications for global trade and regulatory harmonization
The FDA's decision could create discrepancies in global regulatory standards, as erythrosine (the international term for FD&C Red No. 3) is still permitted in certain applications outside the U.S.
Manufacturers exporting to the U.S. must comply with this revocation, potentially increasing production costs and complicating supply chain logistics. For multinational corporations, this divergence emphasizes the need for harmonized regulatory frameworks to minimize disruption.
Opportunities for innovation in color additives
The revocation also represents an opportunity for innovation within the color additive sector. As companies move to replace FD&C Red No. 3, the demand for safe, effective and compliant alternatives is likely to grow.
This transition could spur partnerships between food and pharmaceutical companies and ingredient manufacturers to develop next-generation colorants that meet safety, regulatory, and consumer expectations.
Industry lessons
The FDA's decision serves as a reminder of the enduring impact of the Delaney Clause on regulatory decisions, even when scientific evidence suggests minimal risk to humans. For the pharmaceutical industry, this highlights the importance of proactively monitoring regulatory trends and engaging in scientific dialogue to shape future policy decisions.
The revocation of FD&C Red No. 3's authorization, while specific to a single color additive, underscores the ongoing evolution of the regulatory environment. For pharma and life sciences companies, the path forward involves compliance while leveraging the transition as an opportunity to innovate, adapt and align with the growing demand for safer, more sustainable product formulations.
Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.
