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FDA to Revoke Authorization for Red No. 3 in Food and Drugs

Jan 15, 2025 | Drug & Biologic Product Submissions, Life Sciences, Pharmaceutical and Cosmetics

In a noteworthy development, the FDA is taking a decisive step to revoke the authorization for the use of Food, Drug & Cosmetic Red No. 3 in food and ingested drugs. This decision is anchored in the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a piece of legislation that has been safeguarding public health since 1960. The Delaney Clause is quite clear: it prohibits the approval of any additive that has been found to cause cancer in humans or animals. This move by the FDA comes in response to a 2022 petition that urged the agency to reevaluate the safety of Red No. 3, pointing to studies that linked high exposure levels to cancer in male rats. It is crucial to highlight, though, that these effects have not been observed in humans, and the levels of exposure for humans are typically much lower than those that caused cancer in the rats.

Red No. 3

The Delaney Clause has a history of influencing FDA decisions. For instance, back in 2018, the FDA revoked the authorization for certain synthetic flavors based on this very clause. FD&C Red No. 3, known for its vibrant cherry-red color, is not as widely used as some other certified colors. However, it does make its way into a variety of products, including candies, cakes and even some ingested drugs.

Manufacturers who currently use FD&C Red No. 3 have been given a timeline to adjust. They have until January 15, 2027 for food products and January 18, 2028 for drugs to reformulate their products. This gives ample time to find suitable alternatives and ensure compliance with the new regulations. It is interesting to note that while other countries may still allow the use of Red No. 3, any foods imported into the US must meet American standards.

This decision by the FDA underscores its ongoing commitment to consumer safety and adherence to established legal standards. It is a reminder of the FDA’s role in ensuring that the products we consume are safe and free from harmful additives. As we move forward, it will be interesting to see how manufacturers adapt to these changes and what new innovations might arise in the world of food and drug coloring.