FDA Bans Red Dye No. 3 from Food, 35 Years After Cosmetic Ban, Over Cancer Concerns

The U.S. Food and Drug Administration (FDA) has formally prohibited the use of Red Dye No. 3, a synthetic colorant commonly found in food, dietary supplements, and oral medications, citing concerns about its potential health hazards. This decision comes after decades of scrutiny and follows evidence from animal studies linking the dye to cancer. Commonly known as erythrosine, the dye has been used for decades in a variety of products, including candies, baked goods, and certain medications, because of its vibrant red hue.

Background of Red Dye No. 3 and Health Concerns:

Red Dye No. 3 is a petroleum-based synthetic dye classified as FD&C Red No. 3. It gained popularity in the food and pharmaceutical industries for its ability to produce a bright cherry-red color. However, its safety has been questioned since the 1990s. At that time, the FDA banned its use in cosmetics and topical drugs due to studies showing it caused thyroid tumors in laboratory rats. Despite this, the dye continued to be permitted in foods and ingested medications, a regulatory inconsistency criticized by consumer advocacy groups.

The FDA’s decision to revoke the authorization for Red Dye No. 3 was spurred by a 2022 petition from health and food safety organizations, including the Center for Science in the Public Interest (CSPI). The petition highlighted studies demonstrating the dye’s carcinogenic effects in male rats and called for its removal from the food supply. Jim Jones, the FDA’s Deputy Commissioner for Human Foods, explained that while the mechanism causing cancer in rats does not appear to affect humans, the Delaney Clause mandates a ban on any additive shown to cause cancer in humans or animals.

Implementation of the Ban:

The ban will be implemented gradually, giving manufacturers until January 2027 to reformulate food products and until January 2028 to remove the dye from oral medications. Enforcement begins immediately for new product approvals. Imported products must also comply with the updated regulations, ensuring that food and drugs entering the U.S. market no longer contain Red Dye No. 3.

Foods and Products Affected:

According to the CSPI, Red Dye No. 3 is present in over 9,200 food products in the U.S., including:

• Candies and sweets

• Beverages

• Baked goods

• Protein shakes and energy drinks

• Processed meats

• Puddings and desserts

Additionally, some over-the-counter and prescription medications, such as acetaminophen (pain relievers), fluoxetine (antidepressants), gabapentin (anticonvulsants), and omeprazole (heartburn treatments), contain the dye.

Industry and Advocacy Responses:

Consumer advocacy groups have praised the FDA’s decision, with Dr. Peter Lurie of CSPI applauding the move as a long-overdue correction to regulatory inconsistency. He noted the irony of banning Red Dye No. 3 in cosmetics while allowing its use in children’s candies and other foods. However, some industry groups, such as the International Association of Color Manufacturers, argue that the dye is safe at levels typically consumed by humans. These groups cite studies by global organizations, including the World Health Organization, which have deemed the dye safe under certain conditions.

Legal and Global Context:

The FDA’s decision could face legal challenges from food manufacturers, as evidence linking Red Dye No. 3 to cancer in humans remains inconclusive. FDA Commissioner Dr. Robert Califf has acknowledged the likelihood of court battles over the ban.

Globally, the regulation of Red Dye No. 3 varies. It is already banned for food use in Europe, Australia, and New Zealand, except in specific applications like certain cherries. California plans to implement its own ban starting in January 2027, and other states, such as Tennessee, Arkansas, and Indiana, have proposed restricting artificial dyes in foods served in public schools.

Looking Ahead:

The FDA’s decision marks a significant step in addressing concerns over artificial food additives and may signal further scrutiny of other synthetic dyes, such as Yellow No. 5 and Blue No. 1. While some manufacturers have already begun reformulating products using natural alternatives like beet juice, carmine, and extracts from red cabbage or radishes, the broader industry must adapt to meet the new requirements.

This ban reflects growing awareness of the potential health risks associated with artificial additives and a commitment to prioritizing consumer safety in the U.S. food supply.

Reference:

U.S. Food and Drug Administration. "FDA to Revoke Authorization for Use of Red No. 3 in Food and Ingested Drugs." Accessed January 4, 2025. https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs.

(Input from various sources)

(Rehash/Sai Sindhuja K/MSM)