The Food and Drug Administration (FDA) has announced its decision to revoke the listing of FD&C Red No. 3, a widely used food and drug colour additive, due to its carcinogenic effects in laboratory animals. This decision, published on 16 January 2025, follows a petition by the Center for Science in the Public Interest and other advocacy groups, citing health risks associated with the additive.
What is FD&C Red No. 3?
FD&C Red No. 3, a synthetic dye used in various food products and ingested drugs, has been under scrutiny for its potential health risks. The FDA's decision to revoke its listing is based on evidence that the additive induces cancer in male rats. This aligns with the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the approval of any food additive found to cause cancer in humans or animals.
The Delaney Clause and Its Implications
The Delaney Clause, a critical component of the FD&C Act, mandates that any additive shown to induce cancer cannot be deemed safe for consumption. Despite arguments from some stakeholders that the clause is outdated, the FDA maintains that it must adhere to this regulation. The agency's review of FD&C Red No. 3 concluded that the evidence of carcinogenicity in animal studies is sufficient to warrant revocation.
Public and Scientific Response
The decision has sparked a mixed response from the public and scientific community. While some applaud the FDA's precautionary approach, others argue that the relevance of animal studies to human health is limited. The FDA acknowledges these concerns but emphasises that the Delaney Clause leaves no room for discretion in such cases.
Impact on Industry and Consumers
The revocation of FD&C Red No. 3 will impact manufacturers who rely on the additive for its vibrant colour properties. Companies will need to seek alternative colourants that meet safety standards. Consumers are advised to check product labels and stay informed about the ingredients in their food and drugs. The FDA's decision underscores the importance of ongoing research and regulation to ensure public safety.
