The Food and Drug Administration (FDA) announced on Wednesday that it is banning the use of Red No. 3, a synthetic food dye that has been linked to cancer in animals. This dye, commonly used in products such as candies, cereals, fruit cocktail cherries, and strawberry milkshakes, has been the subject of concern for consumer advocacy groups for years. The Center for Science in the Public Interest (CSPI), which petitioned the FDA in 2022 to ban the dye, reported that over 9,200 food items contain Red No. 3. These products include a wide range of foods produced by major manufacturers.
Despite this ban, the FDA is not targeting other artificial dyes, such as Red No. 40, which has raised concerns about behavioral issues in children. The move to revoke Red No. 3’s approval is a significant victory for consumer groups and lawmakers who have long called for the elimination of this ingredient from food products.
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Dr. Peter Lurie, president of CSPI, called the decision a long-overdue regulatory shift. He pointed out the irony that Red No. 3 was banned in cosmetics in 1990 under the Delaney Clause—a law that prohibits food additives found to cause cancer in humans or animals—but continued to be allowed in edible products.
Under the new rules, food manufacturers have until January 15, 2027, to remove the dye from their products, while companies that produce dietary supplements will have an extra year to comply. The FDA’s deputy director for human foods, Jim Jones, emphasized that the agency cannot authorize any food additive if it is shown to cause cancer, citing studies that found tumors in male rats exposed to high levels of Red No. 3.
What Is Red No. 3?
Red No. 3, a petroleum-based dye approved for use in foods in 1907, has been the subject of scrutiny for decades. The FDA first raised concerns about its carcinogenic potential in the 1980s when studies revealed that rats exposed to high doses developed tumors. Despite this, it continued to be used in food products until now.
Consumer advocates like Melanie Benesh of the Environmental Working Group have welcomed the decision, calling it a long-awaited victory. Benesh also expressed hope that the FDA will take further action on other artificial dyes, as there has been growing concern over the impact of such additives on children’s health.
Industry Response
The Consumer Brands Association, representing food manufacturers, acknowledged the FDA’s decision and emphasized that food safety is their top priority. Sarah Gallo, senior vice president of product policy and federal affairs, expressed the industry’s commitment to complying with the FDA’s science-based regulations.
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California has already taken steps to address the concerns surrounding Red No. 3, becoming the first state to ban the dye in 2023. Other states, along with countries like Australia, Japan, and several European Union members, have either banned or severely restricted its use. California Assembly member Jesse Gabriel, who spearheaded the state’s efforts, celebrated the FDA’s decision, seeing it as a sign that pressure from consumers and lawmakers is prompting action on food safety.
Conclusion
The FDA’s decision marks a significant milestone in food safety, eliminating a cancer-causing chemical from the food supply. Although the ban will not take effect immediately, it signals a growing movement to scrutinize food additives and ensure that they meet modern safety standards. Advocates remain hopeful that this action will inspire further regulatory reviews of other potentially harmful ingredients.
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