The U.S. Food and Drug Administration (FDA) announces a ban on FD&C Red No. 3, a synthetic dye commonly used in candy, cakes, frostings, and strawberry-flavored desserts, as well as certain pharmaceuticals and dietary supplements. did. The decision requires manufacturers to phase out the dye in foods by January 15, 2027, and in ingested medicines by January 18, 2028.
The ban is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the use of additives shown to cause cancer in humans or animals. Studies have shown that high doses of FD&C Red No. 3 caused cancer in male rats, but the FDA noted that these effects do not occur in humans at typical exposure levels.
Known for its bright cherry red color, FD&C Red No. 3 is used in a variety of food products, including candies, cakes, frostings, frozen desserts, and strawberry-flavored treats. This dye is also found in some oral medications and dietary supplements. A search of the U.S. Department of Agriculture’s branded food database identified 9,201 foods containing Red No. 3, indicating that Red No. 3 is widely used.
The Delaney provision prohibits the FDA from approving additives found to cause cancer in humans or animals, regardless of their relevance to human health. Although the cancer observed in male rats was caused by a rat-specific hormonal mechanism that does not occur in humans, this provision requires a ban on the dye. Other studies, including studies in humans and other animals, have not shown similar effects.
Consumers can check the ingredient label to determine if a product contains FD&C Red No. 3. May be listed under the following names:
- FD&C Red No. 3
- FD&C Red 3
- red 3
This dye is used in foods such as maraschino cherries, fruit cocktails, popsicles, and seasonal candies such as candy corn. It may also be found in medications such as acetaminophen (a pain reliever), fluoxetine (an antidepressant), gabapentin (an anticonvulsant), and omeprazole (a heartburn medication). However, in 1990, its use in cosmetics and topical medicines was banned.
The FDA emphasized that typical human exposure to FD&C Red No. 3 is much lower than levels tested in animal studies. Nevertheless, the agency is obligated by the Delaney Clause to revoke its authorization. Manufacturers of affected products must reformulate their products within specified deadlines to comply with U.S. regulations. Other countries, where the dye is known as erythrosine, continue to allow its use, but food imported into the country must also comply with these standards.
This decision builds on FDA’s extensive commitment to ensuring consumer safety and transparency in food and drugs. The agency encourages consumers to stay informed by checking product labels and making choices based on their preferences.
