US regulators ban red dye No. 3 following three decades of debate and cancer concerns

The US Food and Drug Administration (FDA) has banned the use of red dye No. 3. The synthetic color additive will no longer be allowed in US food or ingested drugs from January 15, 2027, which gives manufacturers time to reformulate recipes to ditch the controversial ingredients that give food and drink products a bright, cherry-red color.

The ban is expected to disrupt some big players who still use it.

The FDA estimates that red dye No. 3 is not as widely used in food and drugs when compared to other certified colors based on information available in third-party food product labeling databases, food manufacturers’ websites and other public information and the FDA’s certification data.

However, it has been used for decades in a wide range of food products, such as candy, cakes and cupcakes, cookies, frozen desserts and frostings and icings.

Although it has fallen out of favor for some time for many manufacturers in the industry who have switched to using natural coloring solutions, the agency’s official ban will now come into force 30 years after scientists discovered links to cancer in animals. Studies have found it to lead to cancer in male laboratory rats.

Long-time coming

Yesterday’s FDA announcement comes after red dye No. 3 was banned in California in October 2023.

Yesterday’s FDA decision allows food innovators until January 15, 2027, and January 18, 2028, respectively, to reformulate their products. All US food imports must also comply with the new legislation.

The agency was considering the ban following a 2022 petition from food safety and health advocates — including the Center for Science in the Public Interest (CSPI) — calling for red dye No. 3’s authorization to be revoked.

The petition highlighted how the FDA had previously rejected arguments by the food industry that red 3 was only dangerous after it exceeded a certain threshold, an assertion that, according to CSPI, has never been backed up with evidence.

The FDA prohibited the dye from use in cosmetics and topical drugs in 1990, leading to years of mounting concern over its use in food.

“At long last, the FDA is ending the regulatory paradox of red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy,” says CSPI president Dr. Peter G. Lurie.

“The primary purpose of food dyes is to make candy, drinks and other processed foods more attractive. When the function is purely aesthetic, why accept any cancer risk?”

The Delaney Clause

The National Confectionery Association (NCA) points to the legal details of this case, stating that the FDA evaluation and risk assessment concluded that red dye No. 3 “meets the safety standard of a reasonable certainty of no harm required for a color additive.”

However, the FDA revoked the use of red dye 3 in food and drugs because of a legal requirement known as The Delaney Clause. Enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, the Delaney Clause prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals.

This is not the first time the agency revoked an authorization based on the Delaney Clause. In 2018, the FDA revoked the authorization for several synthetic flavors (including synthetically derived benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone and pyridine) based on the Delaney Clause in response to a food additive petition, also raising cancer concerns.

“Food safety is the number one priority for US confectionery companies, and we will continue to comply with the FDA’s guidance and safety standards. Our consumers and everyone in the food industry want and expect a strong FDA and a consistent, science-based national regulatory framework. We have been saying for years that the FDA is the rightful national regulatory decision maker and leader in food safety,” reads an NCA sent to Food Ingredients First.