Red Dye 3 Ban: Why the FDA Is Cracking Down on This Controversial Additive

The U.S. Food and Drug Administration (FDA) is revoking its authorization for the use of Red No. 3 (also known as erythrosine) in food and ingested drugs.

This decision, announced January 15, 2025, is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the use of any food or color additive found to cause cancer in humans or animals. While studies have not conclusively linked Red Dye No. 3 to cancer in humans, the FDA's action follows evidence of tumors in lab rats.

The ban will be phased in, with compliance deadlines of January 2027 for food manufacturers and January 2028 for drug manufacturers. 

Key Themes and Information --

 

FDA Action and the Delaney Clause:

• The FDA's decision to ban Red No. 3 is a direct result of the Delaney Clause. The clause mandates that any substance inducing cancer in animals or humans must be prohibited.
• The official FDA statement says, “The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition.”
• This is not the first time the Delaney Clause has been used for a ban, the FDA previously revoked authorizations for certain synthetic flavors based on the same clause in 2018.
• The FDA acknowledges that the mechanism of cancer development observed in male rats is not applicable to humans and that relevant exposure levels are "typically much lower than those that cause the effects shown in male rats." despite the lack of evidence of cancer in humans, "FDA must prohibit any food additive shown to cause cancer in humans or animals."
• The decision was characterized as a "matter of law" (according to a quote by FDA Deputy Commissioner Jim Jones).

Background on Red Dye No. 3:

• Red Dye No. 3 is a synthetic food dye made from petroleum, giving foods and drinks a bright cherry-red color. It has been used in the US since 1907, with FDA approval in 1969.
• It was previously banned in cosmetics and topical drugs in 1990 due to studies showing it caused cancer in lab rats. However, that ban did not extend to food.
• The dye is used in a range of products, including candies (e.g., Pez, Jelly Belly), baked goods (e.g., Entenmann’s Little Bites), dairy and frozen desserts, maraschino cherries, some strawberry-flavored beverages, and certain medications (e.g., cough syrups).
• Although not as widely used as other dyes, the U.S. food and drug industry used over 200,000 pounds of Red No. 3 in 2021.

Timeline and Compliance:

• Food manufacturers have until January 2027 to remove Red No. 3 from their products.
• Manufacturers of ingested drugs have until January 2028 to comply.
• This phased approach aims to give companies time to reformulate their products using alternative ingredients.

Consumer and Advocacy Group Response:

• Consumer advocates and health organizations like the Center for Science in the Public Interest (CSPI) and the Environmental Working Group (EWG) have been pushing for this ban.
• Groups have submitted multiple petitions over the years, highlighting the lack of logic for the dye to be banned from cosmetics but still present in food.
• They have expressed that the dye's "purely cosmetic" use is not worth the risk (according to CSP President Peter Lurie) and see this as a "monumental victory for consumer health and safety” (according to Ken Cook, president of the Environmental Working Group).
• Advocacy groups have noted that th