Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs
fda-food · Food and Drug Administration · Rule · Published 2025-01-16 · Effective 2027-01-15 · 90 FR 4628
Document
Document number
2025-00830
Federal Register citation
90 FR 4628
CFR reference
21 CFR 74
Type
Rule
Action
Final amendment; order.
Category
fda-food
Sub-agency
Food and Drug Administration
Publication date
2025-01-16
Effective date
2027-01-15
HHS docket
Docket No. FDA-2023-N-0437
Abstract
The Food and Drug Administration (FDA or we) is granting a color additive petition submitted by Center for Science in the Public Interest, et al., by repealing the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. The petitioners provided data demonstrating that this additive induces cancer in male rats. Therefore, FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No. 3 in the color additive regulations.