FDA Revokes Red No. 3 Authorization in Food and Ingested Drugs, Setting Reformulation Deadlines in 2027 and 2028
On January 15, 2025, the U.S. Food and Drug Administration (FDA) issued an order amending its color additive regulations to revoke the authorization for the use of FD&C Red No. 3, also known as erythrosine, in foods, including dietary supplements, and in ingested drugs. Manufacturers that use Red No. 3 in foods have until January 15, 2027, to reformulate their products; makers of ingested drugs have until January 18, 2028.
The FDA said the decision rests on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, enacted in 1960 as part of the Color Additives Amendment, which prohibits the agency from authorizing a food additive or color additive that has been found to induce cancer in humans or animals. The order responds to a 2022 color additive petition filed by the Center for Science in the Public Interest and other organizations and individuals.
Two studies cited in the petition showed that male laboratory rats exposed to high levels of Red No. 3 developed thyroid cancer through a hormonal mechanism that occurs in male rats. The FDA noted that this mechanism does not occur in humans and that the available evidence does not show that Red No. 3 causes cancer in people; under the Delaney Clause, however, the additive is deemed unsafe as a matter of law and its authorization must be revoked.
Red No. 3 is a synthetic dye long used to color candies, cakes, baked goods and some ingested drugs. California had already legislated in 2023 to bar Red No. 3 from foods sold in the state, effective January 1, 2027, broadly in line with the federal timetable.
(Source: U.S. Food and Drug Administration)
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
Photo: 图：美国食品药品监督管理局位于马里兰州银泉市白橡树园区的总部入口。（美国食品药品监督管理局，公共领域，经 Wikimedia Commons） / Photo: The entrance to FDA headquarters at the White Oak campus in Silver Spring, Maryland. (U.S. Food and Drug Administration, public domain, via Wikimedia Commons)
