Thursday, October 2, 2025

FDA bans Red No. 3

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FDA Bans Red No. 3, Artificial Coloring Used in Candy and More

The Food and Drug Administration said it’s banning the use of Red No. 3, a synthetic dye that gives food and drinks their bright red cherry color but has been linked to cancer in animals.

What is Red Dye No. 3?

Red Dye No. 3, approved for use in foods in 1907, is made from petroleum. The FDA first became aware that the additive was possibly carcinogenic following a study in the 1980s that found tumors in male rats who were exposed to it in high doses. The agency banned the additive in cosmetics in 1990.

Why is Red No. 3 being banned?

The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in human or animals. Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.

What does the ban mean for food manufacturers?

Food manufacturers will have until January 15, 2027, to reformulate their products. Companies that make ingested drugs, such as dietary supplements, will get an additional year.

What are the concerns about Red No. 3?

Red No. 3 has been linked to cancer in animals, and some consumer advocacy groups and lawmakers have long urged the FDA to revoke its approval, citing evidence that its use in beverages, dietary supplements, cereals, and candies may cause cancer as well as affect children’s behavior.

What are the next steps?

The FDA has said it has been actively reviewing Red No. 3’s approval following a petition filed by a coalition of organizations, including the Center for Science in the Public Interest, asking the FDA to revoke the additive’s approval in foods, noting its potential cancer risks.

Conclusion

The ban on Red No. 3 is a victory for consumer advocacy groups and some U.S. lawmakers who have long urged the FDA to take action. The decision to ban the additive removes an unnecessary hazard from the American food supply, and while some may argue it should have occurred sooner, it is a step in the right direction.

FAQs

  • What is Red No. 3?
    Red No. 3 is a synthetic dye used to give food and drinks their bright red cherry color.
  • Why is Red No. 3 being banned?
    The FDA has found that Red No. 3 is linked to cancer in animals, and its use is no longer authorized.
  • What is the timeline for food manufacturers to reformulate their products?
    Food manufacturers will have until January 15, 2027, to reformulate their products, while companies that make ingested drugs, such as dietary supplements, will get an additional year.
  • Where is Red No. 3 already banned?
    Red No. 3 is already banned or severely restricted in places outside the U.S., including Australia, Japan, and countries in the European Union.
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