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FDA Bans Use of Red No. 3 in Food and Ingested Drugs

The U.S. Food and Drug Administration (FDA) announced on Wednesday that it is banning the use of Red Dye No. 3 in food, beverages, and ingested drugs. This decision comes more than three decades after the agency prohibited its use in cosmetics due to potential cancer risks.

Background and Rationale

FD&C Red No. 3, also known as erythrosine, is a synthetic coloring agent derived from petroleum that has been used to impart a bright cherry-red hue to various products. The FDA’s decision to revoke its authorization is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the use of any additive found to cause cancer in humans or animals.The ban stems from studies showing that high levels of Red No. 3 were linked to cancer in male laboratory rats. However, the FDA has emphasized that the mechanism by which the dye causes cancer in rats does not occur in humans, and there is no evidence of risk to human health at typical exposure levels.

“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. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No.3. Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.”

Implementation Timeline

Food manufacturers will have until January 15, 2027, to reformulate their products, while makers of ingested drugs will have until January 18, 2028, to comply with the new regulations. Additionally, imported foods containing Red No. 3 must adhere to these new requirements to be sold in the United States.

Industry and Consumer Response

Consumer advocacy groups have praised the FDA’s decision, with many arguing that it was long overdue. Dr. Peter Lurie, president of the Center for Science in the Public Interest, stated, “At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy.” The food industry, represented by the Consumer Brands Association, has indicated that manufacturers will comply with the agency’s ruling. Some companies have already begun transitioning to alternative food colorants, a trend that intensified after California became the first state to ban Red No. 3 along with three other food additives in 2023.

Global Context

Red No. 3 is already banned or heavily restricted in several countries, including Australia, Japan, and various European Union nations. The FDA’s decision aligns the United States with these international standards and responds to growing concerns about synthetic food additives.

Conclusion

While the FDA maintains that claims of Red No. 3 posing a risk to human health are not supported by available scientific information, this ban represents a significant shift in food safety regulation. As the food industry adapts to this change, consumers can expect to see reformulated products in the coming years, potentially leading to a broader reevaluation of synthetic food additives in the American food supply.

Russ Jones
Russ Jones
Russ Jones is an accomplished journalist and media professional with decades of experience delivering compelling stories to audiences across the nation. As a contributor to DRTV Channel, Russ combines his sharp investigative skills and storytelling expertise to explore topics that matter most to viewers. Known for his integrity and dedication, Russ has a talent for uncovering the heart of every story, from local community issues to global trends. His work reflects a commitment to truth, excellence, and engaging content that informs and inspires. Russ is an Adjunct Professor and Ph.D. candidate at Libety University. He is married to Jackie Jones. Together they have four children, and one grandchild.
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