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Senators press FDA on safety reviews of Red 3 and Red 40, Delaney clause complicates action
Summary
Sen. Tommy Tuberville and others questioned FDA about re‑reviews of food colorants; Deputy Commissioner M. Jones said Red 40 has not been reevaluated in over a decade and a petition to revoke Red 3 authorization is under agency consideration under the Delaney clause.
At the Senate HELP hearing, several senators asked FDA officials about the agency's review of food colorants, focusing on Red 3 and Red 40.
Senator Tommy Tuberville asked whether FDA stands by its safety determinations for food dyes. Deputy Commissioner M. Jones replied that FDA "has not evaluated Red 40 in over a decade," and that a petition to revoke authorization for Red 3 is pending and likely to be acted upon in the near term.
Jones explained the legal constraint known as the Delaney clause of the Federal Food, Drug, and Cosmetic Act: substances shown to cause cancer in animals or humans cannot be authorized. He said Red 3 causes cancer in laboratory animals, and that managing the statute’s requirements alongside scientific interpretation of human risk has been a long‑running challenge for the agency.
Commissioner Califf and Jones emphasized that FDA is establishing a post‑market chemical review office and that resource and legal constraints shape the timing and process for chemical reassessments. Jones said the agency hopes to act on the Red 3 petition "within the next few weeks" and noted the agency will continue to face judicial and scientific scrutiny on such decisions.
The exchange underscored the interplay of law (the Delaney clause), evolving science, and agency capacity in determining when and how to remove or restrict long‑authorized food additives. The committee did not take a formal vote on removal of any additive; FDA indicated a pending administrative action on Red 3.
