FDA Takes Action: Red Dye No. 3 Banned in Food and Medications Over Cancer Concerns

The FDA has taken a crucial step by banning Red Dye No. 3, also called erythrosine, in food and medications. This decision follows research that connected the dye to cancer in lab rats. Food manufacturers have until January 15, 2027, to eliminate the dye from their products. Drug makers have a bit longer, with a deadline of January 18, 2028.

Concerns about Red Dye No. 3’s safety, especially for children, have been raised for years. In 2022, health groups, including the Center for Science in the Public Interest, petitioned the FDA to ban the dye due to these risks. Reports show that high doses of this dye caused tumors in male rats, which led to the FDA’s decision.

This ban is significant, especially since Red Dye No. 3 had already been banned in cosmetics nearly 35 years ago due to similar health concerns. Health advocates argue that no food additive linked to cancer should be approved for use. The FDA’s Deputy Commissioner for Human Foods emphasized that additives can’t be authorized if they pose cancer risks.

Despite warnings, Red Dye No. 3 remained in many food products, raising alarm among health advocates who highlighted its potential dangers, particularly for kids.

Now, companies must reformulate their products to remove this dye. Drug manufacturers will have an extra year to comply with the regulations. The ban aligns the U.S. with global health standards, as Red Dye No. 3 has already been prohibited in the European Union, Australia, and New Zealand.

Industry representatives are committed to adhering to the FDA’s new rules, emphasizing that food safety is their top priority.

While some experts note that the levels of Red Dye No. 3 that people are typically exposed to are much lower than those that caused cancer in rats, concerns remain. Studies suggest that synthetic food colorants, including Red Dye No. 3, could affect children’s behavior.

In response to the ban, many manufacturers are exploring natural alternatives for coloring, such as beet juice, carmine, and pigments from fruits and vegetables like purple sweet potato and red cabbage.

The FDA’s ban is grounded in the Delaney Clause, part of U.S. law that prohibits any food additive shown to cause cancer at any dose. This decision reflects a growing trend towards prioritizing public health and safety in food production.