The United States Food and Drug Administration (FDA) has made a significant regulatory decision on January 15, 2025, by announcing the revocation of authorization for the color additive FD&C Red No. 3 in food products and ingestible medications. This move follows a petition filed in 2022 and processed by the FDA in 2023. The primary reason behind this action is rooted in the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which mandates the prohibition of any color additives shown to cause cancer in humans or animals. Specifically, studies have indicated that FD&C Red No. 3 can induce cancer in male rats through a specific hormonal mechanism. However, no such effects have been observed in other species or sexes tested. Despite this, the clause necessitates the removal of FD&C Red No. 3 from use. Manufacturers have until January 15, 2027, for food products and January 18, 2028, for drugs to comply with this regulation.

The decision to revoke the authorization for FD&C Red No. 3 is grounded in stringent safety protocols outlined by the Delaney Clause. This clause stipulates that any substance found to be carcinogenic in either humans or animals must be banned from use in food and drugs. In this case, research conducted on various animal models revealed that only male rats exhibited signs of cancer when exposed to FD&C Red No. 3. The carcinogenic effect was linked to a unique hormonal response observed exclusively in these animals. Importantly, no similar outcomes were noted in female rats or any other species tested, including mice, gerbils, and dogs. Nevertheless, the Delaney Clause leaves no room for exceptions, requiring the FDA to take decisive action based on the available evidence.

The timeline for compliance varies depending on the product type. Food manufacturers have a grace period until January 15, 2027, to reformulate their products and remove FD&C Red No. 3. Meanwhile, pharmaceutical companies have an extended deadline of January 18, 2028, to adjust their formulations. Interestingly, California has enacted its own legislation, AB 418, which will prohibit the use of FD&C Red No. 3 in food products starting from January 1, 2027, slightly ahead of the FDA's nationwide ban.

This regulatory change underscores the FDA's commitment to public health and safety. By adhering to the Delaney Clause, the agency aims to eliminate potential risks associated with food and drug additives. While the scientific evidence is limited to male rats, the precautionary principle guides this decision. Moving forward, both food and drug manufacturers will need to adapt to these new regulations, ensuring that their products remain safe and compliant with federal standards.