FDA Moves to Ban FD&C Red No. 3 in Food and Injectable Drugs by 2028

On January 15, 2025, the U.S. Food and Drug Administration (FDA) began revising its regulations concerning color additives, specifically targeting FD&C Red No. 3 (also known as Erythrosine). This action is rooted in the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits food additives that are found to induce cancer in humans or animals.

What is FD&C Red No. 3?

FD&C Red No. 3 is a synthetic dye that imparts a vibrant cherry-red color to various food items and beverages. It is commonly used in products such as:

• Candies
• Cakes and cupcakes
• Cookies
• Frozen desserts
• Frostings and cream decorations

Additionally, this dye is found in certain swallowable medications.

FDA's Findings

According to the FDA, the use of FD&C Red No. 3 is not as prevalent in food and drugs compared to other certified color additives. This  is based on an analysis of third-party food labeling databases, manufacturers' websites, and FDA certification data. Notably, studies conducted by the FDA have indicated that the dye may cause cancer in male rats, leading to the decision to ban any food additives that could potentially cause cancer in humans or animals.

Transition Period for Producers

Food manufacturers and pharmaceutical companies using FD&C Red No. 3 will have a transition period to reformulate their products. The deadlines for compliance are:

• January 15, 2027 for food manufacturers
• January 18, 2028 for drug manufacturers

Implications for Imports

While other countries may still permit FD&C Red No. 3 under certain circumstances, any food imported into the U.S. must adhere to this new FDA regulation. Consequently, foreign food producers wishing to export to the U.S. must ensure their products comply with the latest requirements regarding the use of FD&C Red No. 3.

The FDA's decision to ban FD&C Red No. 3 highlights a growing emphasis on consumer safety and the regulatory body's commitment to eliminating additives that pose potential health risks. As manufacturers prepare for these changes, the move is expected to reshape the landscape of food and drug production in the United States.