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• The FDA has banned the use of red dye No. 3 in food and ingested drugs due to cancer concerns in laboratory animals.
• The ban follows a 2022 petition by consumer groups and health advocates, citing studies that linked the dye to cancer in male rats.
• Food manufacturers have until January 15, 2027, to reformulate their products.

Quick Brief

2-Minute Digest

Essential Context

The FDA’s decision to ban red dye No. 3, also known as erythrosine or FD&C Red No. 3, comes after decades of debate over its safety. Despite the FDA’s assertion that the dye’s carcinogenic effects in animals do not apply to humans, the agency was compelled to act under the Delaney Clause, a law requiring the ban of any additive found to cause cancer in humans or animals.

Core Players

• FDA – U.S. Food and Drug Administration
• Center for Science in the Public Interest (CSPI) – Led the 2022 petition against red dye No. 3
• Consumer Reports – Supported the petition and advocates for consumer health
• Congress Members – Nearly two dozen members urged the FDA to ban the dye

Key Numbers

• January 15, 2027 – Deadline for food manufacturers to reformulate products
• 1990 – Year the FDA banned red dye No. 3 in cosmetics
• 2022 – Year the petition to ban red dye No. 3 in food was filed
• 80,000 – Number of signatures on a Consumer Reports petition against red dye No. 3

Full Depth

Complete Coverage

The Catalyst

The FDA’s ban on red dye No. 3 was triggered by a 2022 petition filed by the Center for Science in the Public Interest and other health advocates. This petition cited studies showing that high levels of the dye caused cancer in laboratory male rats.

“The FDA is taking action that will remove the authorization for the use of FD&C Red No. 3 in food and ingested drugs,” said Jim Jones, the FDA’s deputy commissioner for human foods.

Inside Forces

The FDA’s decision reflects the agency’s compliance with the Delaney Clause, despite its own stance that the scientific evidence does not support a human health risk. This clause mandates the ban of any food additive found to cause cancer in animals.

Internal dynamics within the FDA involved balancing public pressure and scientific consensus. The agency had to weigh the concerns of consumer groups and lawmakers against the available scientific data.

Power Dynamics

The ban highlights the influence of consumer advocacy groups and lawmakers. The Center for Science in the Public Interest and Consumer Reports played significant roles in pushing for the ban. Additionally, nearly two dozen members of Congress supported the ban, citing the need to protect public health.

The International Association of Color Manufacturers has defended the dye, pointing to research by the United Nations and the World Health Organization that reaffirmed its safety in food.

Outside Impact

The ban has broader implications for food safety regulations. It aligns with international standards, as red dye No. 3 is already banned in foods in the EU, Australia, and New Zealand. California has also passed laws banning the dye, with the California Food Safety Act set to take effect in January 2027.

Other states may follow California’s lead, and there is growing pressure to review the safety of other synthetic food dyes linked to neurobehavioral problems in children.

Future Forces

The FDA’s decision marks a shift in how the agency approaches food additive safety. The ban on red dye No. 3 is part of a larger effort to reassess the safety of food chemicals already on the market.

Consumer Reports is continuing to push for the ban of other synthetic food dyes, such as red 40, yellow 5, yellow 6, blue 1, blue 2, and green 3, which are targeted by the California School Food Safety Act effective December 31, 2027.

Data Points

• 1969: Red dye No. 3 was unconditionally approved for food and ingestible medication.
• 1990: FDA banned red dye No. 3 in cosmetics and externally applied drugs.
• 2022: Petition filed to ban red dye No. 3 in food.
• January 15, 2025: FDA announces the ban on red dye No. 3 in food and ingested drugs.
• January 15, 2027: Deadline for food manufacturers to comply with the ban.