FDA Bans Use of Red Dye No. 3 in Food Due to Cancer Concerns

Federal law prohibits regulators from approving the use of dyes linked to cancer risks in food or drugs, a restriction advocates say should apply to Red No. 3.

More than 30 years after banning Red Dye No. 3 in cosmetics due to health concerns, federal regulators are taking further action to prohibit its use in food and medications, addressing long-standing safety risks associated with the artificial coloring.

FD&C Red Dye No. 3, also known as erythrosine, is a synthetic dye made from petroleum, which can give medications, candies and other foods a bright red color. However, side effects of Red Dye No 3 have been linked to numerous forms of cancer, child behavioral issues and reproductive issues.

Despite the potential health risks, Red Dye No 3 is still used in hundreds of food products in the United States, including candy, cupcakes, yellow rice, mashed potatoes, frostings, bacon bits and children’s nutritional shakes like Pediasure.

Red Dye No. 3 is commonly found in a variety of supplements and prescription medications, including gummy vitamins, Tylenol, Prilosec, the ADHD medication Vyvanse, Neurontin, doxycycline antibiotics and Prozac. In 2021 alone, over 200,000 pounds of Red No. 3 were used in food and pharmaceutical products.

However, on January 15, the U.S. Food and Drug Administration (FDA) announced it is revoking Red No. 3’s authorization to be used in food and ingested drugs, specifically citing the increased risks of cancer.

The FDA issued the ban in response to a 2022 color additive petition, which cited two studies suggesting the dye caused thyroid cancer in male lab rats. The agency is bound by the Delaney Clause, part of the Food, Drug and Cosmetic Act since 1958, which prohibits it from authorizing any food dye or additive that is found to cause cancer in humans or animals.

According to the agency, exposure levels for humans are much too low to cause cancer and the current data does not show Red No. 3 puts humans at risk of cancer. However, the agency opted to ban the dye in both foods and medications.

Manufacturers have until January 15, 2027, to reformulate food products to comply with the ban, and January 18, 2028, to reformulate drug products.

This new decision comes more than 30 years after the FDA banned Red No. 3 from being used in cosmetics, like lipstick and topical drugs in 1990. The dye was also banned by the European Union in 1994, and later banned by Australia and New Zealand.

While health advocates applaud the FDA for the move to ban the dye, critics have questioned why the move took 30 years.

Following California’s 2023 decision to become the first state to ban Red Dye No. 3, some brands began reformulating their products to use alternatives like Red Dye No. 40. For example, Mars replaced Red No. 3 with Red No. 40 in red M&M’s. Meanwhile, Illinois and New York have proposed similar legislation to ban the dye in foods, drinks, and other products, with bans potentially taking effect in 2028 and 2026, respectively.

In response, some manufacturers have opted for natural food colorings, such as those derived from beets and red cabbage. However, the dye remains widely permitted in most states and continues to be used in items like maraschino cherries, cereals, and medications, requiring manufacturers to adapt recipes to comply with emerging regulations.