The U.S. Food and Drug Administration (FDA) announced Wednesday it is revoking the authorization for the use of FD&C Red No. 3, also known as erythrosine, as a color additive in food and ingested drugs. This decision, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), comes more than three decades after studies linked the synthetic dye to cancer in laboratory animals.
The move follows a 2022 color additive petition filed by advocacy groups including the Center for Science in the Public Interest and the Environmental Working Group. The petition highlighted two studies showing cancer in male rats exposed to high levels of Red No. 3 due to a hormone-specific mechanism not present in humans. Despite these findings, the FDA emphasized that typical human exposure to the dye is much lower than the levels used in the studies and that no evidence suggests it poses a cancer risk to humans.
Regulatory and Industry Response
The Delaney Clause, part of the 1960 Color Additives Amendment to the FD&C Act, mandates the prohibition of additives found to cause cancer in humans or animals, regardless of the exposure level. This clause has prompted similar FDA actions in the past, such as the 2018 revocation of certain synthetic flavors.
Red No. 3, a petroleum-derived dye, has primarily been used to provide a bright cherry-red color to foods such as candy, cakes, cookies, frozen desserts, and frostings, as well as in certain ingested drugs like cough syrups. According to the FDA, its use has declined in recent years compared to other certified dyes, partly due to ongoing scrutiny and restrictions.
Manufacturers using Red No. 3 in food must reformulate their products by January 15, 2027, while those producing ingested drugs have until January 18, 2028, to comply. Imported foods must also meet these updated requirements.
The decision aligns with similar bans in the European Union, Australia, and New Zealand, where the dye has long been restricted. California’s ban on Red No. 3 is set to take effect in January 2027.
Controversy and Alternatives
The FDA’s decision has reignited debate over the safety of Red No. 3. The International Association of Color Manufacturers continues to defend the dye, citing studies from organizations such as the World Health Organization (WHO) and the United Nations, which found it safe at typical consumption levels.
Food manufacturers are increasingly turning to natural alternatives, including beet juice, carmine (a dye derived from insects), and pigments from plants like purple sweet potato, radish, and red cabbage.
Some companies have already eliminated Red No. 3 from their products in anticipation of stricter regulations. “Consumers are driving demand for cleaner labels and natural ingredients, making this transition a win-win,” said a representative from Sensient Food Colors, a U.S.-based supplier of natural food colorings.
Historical Context and Future Implications
This decision marks a significant regulatory shift for the U.S., where Red No. 3 has been used for decades. Although banned in cosmetics and topical drugs since 1990 due to similar cancer concerns, it remained approved for food and ingested drugs until now.
The FDA’s move reflects increasing pressure from advocacy groups and lawmakers to address legacy chemicals and additives in the food supply. In 2022, nearly two dozen members of Congress called for the removal of Red No. 3, citing outdated safety standards.
While some food industry representatives may challenge the ban, its implementation underscores a broader trend toward stricter regulation of synthetic additives and a preference for natural alternatives.
As public awareness grows, consumers are expected to push for transparency and safer ingredients in their food and medications, signaling a long-term shift in industry practices.
