The Food and Drug Administration (FDA) has announced a ban on Red No. 3, a synthetic Red Food Coloring linked to cancer in animal studies. This decision impacts thousands of food products, from candies and cereals to fruit cocktails and milkshakes, where Red No. 3 provides a vibrant cherry-red hue. The Center for Science in the Public Interest (CSPI), a food safety advocacy organization, has long campaigned for this ban, citing data indicating over 9,200 food items contain the dye. While Red No. 3 is being removed, other artificial food colorings, like Red No. 40, which has been associated with behavioral problems in children, remain permitted.
The FDA’s action responds to years of urging from consumer groups and lawmakers concerned about the potential cancer risk and behavioral impacts of Red No. 3 in various food and beverage products. This ban signifies a victory for these advocates who have presented evidence highlighting the potential dangers of the dye.
The FDA’s decision rectifies a long-standing contradiction: Red No. 3 was banned in cosmetics in 1990 due to the Delaney Clause, a law prohibiting food and cosmetic additives shown to cause cancer in humans or animals. Yet, it remained legal in food. Dr. Peter Lurie, president of the CSPI, celebrated the ban, highlighting the absurdity of permitting a cancer-causing substance in food for children while prohibiting it in lipstick.
Food manufacturers have until January 15, 2027, to reformulate products and remove Red No. 3. Manufacturers of ingested drugs, including dietary supplements, have an additional year to comply. The FDA emphasizes that any food or color additive proven to cause cancer in humans or animals cannot be authorized. This decision underscores the FDA’s commitment to ensuring the safety of ingested products.
Red No. 3, a petroleum-derived dye, was first approved for food use in 1907. The FDA’s efforts to ban it stem from a 1980s study linking high doses of the dye to tumors in male rats. Despite the decades-long delay, the ban is lauded as a significant step towards a safer food supply.
Advocacy groups like the Environmental Working Group welcome the ban as a crucial victory for consumers. They express hope that this action will prompt further scrutiny of other artificial food dyes raising concerns. This move is seen as a positive response to growing consumer anxieties about food ingredients.
The Consumer Brands Association, representing food and beverage companies, affirms its commitment to food safety and compliance with the FDA’s ban. They emphasize the industry’s dedication to following scientific evidence and adhering to food safety regulations. This ensures consumers have safe and accessible food choices.
Even before the federal ban, California and ten other states had already taken steps to restrict or prohibit the use of Red No. 3 in food products. Internationally, countries like Australia, Japan, and those in the European Union have also banned or heavily restricted the dye. This global trend reflects growing awareness of the potential health risks associated with Red No. 3. Many US food manufacturers had proactively removed artificial dyes, including Red No. 3, anticipating regulatory changes.
The National Confectioners Association, representing the confectionery industry, reiterates its commitment to complying with FDA guidance and emphasizes the importance of a science-based national regulatory framework for food safety.
All color additives require FDA approval before use in food sold in the US. Of the 36 approved color additives, nine are synthetic dyes. The FDA’s ongoing review of food additives, prompted by petitions from organizations like the CSPI, demonstrates a responsiveness to concerns about potential health risks.
While the FDA’s 2011 review found no definitive link between artificial dyes and hyperactivity in children, concerns persist. The FDA’s current ban on Red No. 3 addresses the cancer risk, while the debate on behavioral effects continues. California’s proactive ban on Red No. 3 and other potentially harmful food additives, along with its ban on six synthetic dyes in public school food, demonstrates a strong commitment to food safety at the state level.
This federal ban on Red No. 3 signals a potential shift in food regulation, with growing bipartisan support for removing potentially harmful substances from the food supply. This action might pave the way for further regulatory changes in the food industry.
