The US FDA bans colour additive Red No. 3 from use in oral solid dosage forms

Published: 16-Jan-2025

Ingestible drug manufacturers will have until January 18, 2028 to reformulate their products, as Red No. 3 has been linked to cancer in male rats

The US Food and Drug Administration (FDA) has altered its regulatory framework surrounding FD&C Red No. 3, which means it is no longer permitted for use as an additive in ingestible drugs. 

This also applies to food products, including confectionery, fizzy drinks and cake frosting. 

Drug manufacturers who use FD&C Red No. 3 have until early January 2028 to reformulate their products.

The US regulatory board has decided to revoke the approval of Red No. 3 due to the Delaney Clause of the Federal Food, Drug and Cosmetic Act. 

This decision was based on data from the 2022 colour additive petition show, which indicated that this ingredient causes cancer in male laboratory rats.

Scientists believe that Red No. 3 is carcinogenic as it is able to stimulate the uncontrolled activation of a hormonal mechanism in male rats — though this effect has not been observed in humans to date.

The FDA plans to draft guidance protocol for drug manufacturers to view, which will cover replacement and reformulation recommendations.

 

 

 

You may also like