🚫FDA Revokes FD&C Red No. 3 for Food and Ingested Drugs
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
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The revocation of regulations allowing the use of FD&C Red No. 3 in food and ingested drugs due to health concerns has significant compliance and regulatory implications for food and pharmaceutical businesses. Companies using this additive must consider reformulating products and complying with new safety standards.