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FDA: red dye No. 3 (erythrosine) to be removed from IID entries; manufacturers given compliance date
Summary
The presenter said FDA revised 21 CFR color additives to remove red dye No. 3 (erythrosine) and that drug manufacturers have until Jan. 18, 2028 to remove the additive from products; IID entries and alternate names for the dye were removed.
The agency official addressed a specific regulatory change affecting color additives: red dye No. 3, also known as erythrosine. She said FDA published a Federal Register notice revising 21 CFR color additive regulations to remove the dye and that the agency removed IID entries and alternate names tied to the additive.
"Drug manufacturers now have until 01/18/2028 to remove this color additive," the agency official said, and she directed attendees to posted Federal Register resources and the IID for updated information.
