FDA Finally Bans Cancer-Causing Red Dye After Decades of Use
Published Date: 1/16/2025
Rule
Summary
The FDA is banning the use of FD&C Red No. 3 in foods, dietary supplements, and ingested drugs because studies showed it can cause cancer in male rats. This change affects food makers, drug companies, and anyone who uses this color additive. The ban starts January 15, 2027, with some parts kicking in by January 18, 2028, and there’s a chance to object by February 18, 2025.
Analyzed Economic Effects
4 provisions identified: 1 benefits, 3 costs, 0 mixed.
Ban on FD&C Red No. 3 in Foods
The FDA is revoking authorization to use FD&C Red No. 3 in foods, including dietary supplements, effective January 15, 2027. Food and dietary supplement makers that currently use this color additive will no longer be able to sell products with it after that date.
Ban on FD&C Red No. 3 in Ingested Drugs
The FDA will remove authorization for FD&C Red No. 3 in ingested drugs effective January 18, 2028. Drug makers using FD&C Red No. 3 in pills or other ingested drug products must stop using it by that date.
Certificates End; Use Becomes Adulteration
When the listings are removed, the FDA will stop issuing certificates for FD&C Red No. 3 and existing certificates will cease to be effective on the applicable effective dates. Using FD&C Red No. 3 after its certificate ceases to be effective will make the food or ingested drug an adulterated product.
Right To Object and Request Hearing
Anyone who will be adversely affected may file objections and request a hearing on this order by February 18, 2025. Objections must be separately numbered and specify the provisions objected to; requests for hearings must include detailed factual information you intend to present.
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