On January 16, 2025, the Food and Drug Administration (FDA) revoked the “Use of FD&C Red No. 3 in Food and Ingested Drugs” amending 21 CFR Part 74.

The document summarizes the following points:

• Red No. 3, also known Erythrosine (E127), is a synthetic food dye that gives foods and drinks a bright, cherry-red color;
• The FDA under the Delaney Clause, mandates its removal from food and drug products, citing carcinogenicity despite minimal human health risk;
• Food manufacturers utilizing Red No. 3 must reformulate their products by January 2027 to comply with the updated regulations;
• Use of FD&C Red No. 3 after its certificate ceases to be effective will result in foods being adulterated.

This order is effective January 15, 2027, except for amendatory instruction 4, which is effective January 18, 2028.

To ensure compliance with the FDA’s updated regulations, food manufacturers must proactively manage ingredient changes and reformulation processes. Trace One Regulatory Compliance helps businesses stay ahead of evolving requirements by centralizing regulatory data, tracking ingredient restrictions, and streamlining compliance workflows. With our solution, you can confidently navigate regulatory updates like the FD&C Red No. 3 ban, ensuring your products remain market-ready and compliant. Learn more about Trace One Regulatory Compliance here.