FDA Bans Red Dye No. 3: What Food and Drug Manufacturers Need to Know

In a significant move, the Food and Drug Administration (FDA) has officially banned the use of Red Dye No. 3 in food and ingested drugs in the United States. The agency announced this decision on January 15, 2025, revoking its authorization for FD&C Red No. 3 as a matter of law, based on the “Delaney Clause” of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Delaney Clause prohibits FDA authorization of a food or color additive if it has been found to cause cancer in humans or animals.  

"This is a landmark decision by the FDA, reflecting the agency's ongoing focus on the safety of food additives," says David Graham, food law attorney and litigator at Gardner Law. "Manufacturers need to act swiftly to reformulate their products and ensure compliance."

Why the Ban?

The FDA's decision comes in response to a 2022 color additive petition. The petition cited studies showing that high levels of FD&C Red No. 3 caused cancer in male laboratory rats, although the mechanism is specific to rats and doesn't occur in humans. While studies in other animals and humans didn't show these effects, and relevant exposure levels are typically much lower in humans, the Delaney Clause mandates that no additive can be approved if it's found to induce cancer in humans or animals. This clause leaves no room for debate on the level of risk.  

Compliance Timeline

The FDA is providing a transition period for manufacturers to reformulate their products:

• Food: Compliance is required by January 15, 2027.  

• Ingested Drugs: Compliance is required by January 18, 2028.

Background on Red Dye No. 3 and FDA Regulations

All color additives must be approved by the FDA before they can be used in food sold in the U.S. There are 36 FDA-approved color additives, nine of which are synthetic dyes like Red Dye No. 3. Notably, in 1990, the FDA banned Red Dye No. 3 from use in cosmetics and topical drugs under the Delaney Clause, as it was found to cause cancer in laboratory animals.  

Implications for the Industry

While Red Dye No. 3 is reportedly not as widely used as other color additives, it is still present in certain products like candies, cakes, cookies, frozen desserts, frostings, and some ingested drugs. Manufacturers who use this dye must now find suitable alternatives and reformulate their products within the specified timeframe.

How Gardner Law Can Help

Gardner Law is a boutique firm with experienced FDA law attorneys ready to assist food and drug manufacturers with navigating this new regulatory landscape. We can provide the guidance you need to:

• Understand the specific requirements of the ban.

• Identify compliant alternative ingredients.

• Reformulate your products effectively.

• Ensure proper labeling and regulatory compliance.

Do you have questions about the ban on Red Dye No. 3 or need help reformulating your products? Contact us today. Our dedicated food law team will address your questions and provide the expert legal counsel you need during this critical transition.