The Delaney Clause is clear; the FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals. Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No.3, said Jim Jones, the FDA's deputy commissioner for human foods. The decision reflects a regulatory requirement that necessitates removing any additive proven to cause cancer, ensuring consumer safety.
While the FDA has previously maintained that the risks associated with Red 3 do not extend to humans, the decision emphasizes compliance with the Delaney Clause and public health priorities, balancing between scientific evidence and regulatory obligations. This illustrates the tension between historical approvals and contemporary health standards that prioritize consumer safety over existing market practices.
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