FDA Bans Red Dye No. 3 in the US
The US Food and Drug Administration has banned the use of red dye No. 3 in food, beverages and ingested drugs, more than 30 years after scientists discovered links to cancer in animals, the agency announced Wednesday.
The move acts on a November 2022 petition submitted by multiple advocacy organizations and individuals, including the Center for Science in the Public Interest and the Environmental Working Group, which cited links to cancer. The decision by the federal agency also follows in the footsteps of California, whose government banned the additive in October 2023.
Manufacturers using red No. 3 in food and ingested drugs have until January 15, 2027, and January 18, 2028, respectively, to reformulate their products, according to the FDA. Foods imported to the United States also must comply with the requirements.
FD&C Red No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. The FDA estimates that FD&C Red 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. FD&C Red No. 3 has been primarily used in certain food products, such as candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs.
According to the publication Unbiased Science, run by public health scientist Dr. Jessica Steier and neurobiologist Dr. Sarah Scheinman, studies showed that male rats exposed to very high levels of Red #3 developed thyroid tumors. This occurred through a hormone mechanism specific to male rats that doesn’t exist in humans. The FDA’s own analysis shows a 210-fold safety margin between typical human exposure (0.25 mg/kg body weight per day) and levels causing effects in rats (35.8 mg/kg per day). Studies in other animals – including female rats, mice, gerbils, and dogs – showed no cancer effects. Human studies have consistently failed to show evidence of harm at normal exposure levels.
Red #3 is used far less frequently than many people assume. It’s primarily found in:
- Maraschino cherries
- Some candies (especially red cinnamon candies)
- Select gummies and jello cups
- Certain ice creams
- Some baked goods
Most red-colored foods actually use Red 40 (Allura Red), which isn’t affected by this ban.
Different countries have taken varying approaches to Red #3:
- The European Union requires warning labels rather than bans
- Canada continues to permit its use
- Japan and other Asian markets allow it under the name erythrosine
- Australia and New Zealand have specific usage limits