FDA撤销红色3号在食品与口服药物中的授权：企业须在2027至2028年期限前改配方
2025年1月15日，美国食品药品监督管理局（FDA）发布命令，修改色素添加剂法规，撤销 FD&C 红色3号（又称赤藓红）在食品（包括膳食补充剂）与口服药物中的使用授权。使用红色3号的食品生产商须在2027年1月15日前完成配方调整，口服药物生产商的期限为2028年1月18日。
FDA 表示，这一决定依据的是《联邦食品、药品和化妆品法》中的「德莱尼条款」——该条款于1960年作为《色素添加剂修正案》的一部分制定，规定凡被发现会在人类或动物身上诱发癌症的食品添加剂或色素添加剂，FDA 不得授权其使用。此次命令是对2022年由公共利益科学中心等多家机构与个人提交的色素添加剂请愿的回应。
请愿援引的两项研究显示，接触高剂量红色3号的雄性实验大鼠患上了甲状腺癌，其路径是雄性大鼠特有的一种激素机制。FDA 同时说明，这种机制不会在人体内发生，现有证据并不表明红色3号会在人类身上致癌；但按德莱尼条款的法律要求，该添加剂在法律上即被认定为不安全，授权必须撤销。
红色3号是一种合成色素，长期用于糖果、糕点、烘焙装饰与部分口服药物等产品着色。加利福尼亚州已于2023年立法禁止在州内销售的食品中使用红色3号，禁令自2027年1月1日起生效，与联邦时间表大体衔接。
（来源：美国食品药品监督管理局）
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)
来源：美国食品药品监督管理局
发布：GSM·美国（发布链接）
图片来源：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)
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