The United States Food and Drug Administration (FDA) has recently issued a directive prohibiting the use of Red No. 3 in food products and ingestible medications, citing potential carcinogenic risks. This decision comes after decades of deliberation, with the dye already banned in cosmetics and topical drugs since 1990. The ban was prompted by a petition from the Center for Science in the Public Interest (CSPI) and other organizations, supported by data showing adverse effects on lab animals. Additionally, CSPI's Principal Scientist Thomas Galligan has highlighted concerns over other additives like aspartame, BHA, and potassium bromate, which have also been linked to cancer.
Red No. 3 has long been under scrutiny for its potential health risks. Despite initial intentions announced in 1992 to extend the ban to food, it took until this week for the FDA to take definitive action. The CSPI and 23 other organizations submitted compelling evidence that male rats exposed to high levels of Red No. 3 developed cancer. This move underscores the growing concern over food additives and their impact on human health. Galligan emphasized that Red No. 3 is not an isolated case; several other common food additives are under similar scrutiny.
Aspartame, a zero-calorie artificial sweetener found in various diet and sugar-free products, has become a focal point of concern. In 2023, the International Agency for Research on Cancer (IARC) classified aspartame as potentially carcinogenic to humans based on extensive human evidence. However, the FDA remains unconvinced, maintaining that aspartame is safe for consumption. Galligan expressed disappointment in the FDA's stance, noting that ignoring IARC's findings is deeply troubling given the organization's global authority on cancer research.
BHA, an antioxidant preservative widely used in the U.S. food supply, has also raised red flags. Numerous healthcare professionals have voiced concerns over its cancer risk, particularly due to animal studies indicating tumor development at high doses. Despite being banned in the European Union, BHA remains prevalent in American foods. Dr. Neha Pathak, MD, from WebMD's Medical Team, stressed that the evidence, while primarily from animal studies, warrants caution and calls for a ban.
Potassium bromate and azodicarbonamide, two additives commonly found in bread, have also faced criticism. Potassium bromate, banned by the World Health Organization (WHO), and azodicarbonamide, which breaks down into chemicals linked to cancer, continue to be allowed in the U.S. despite bans in other countries. Galligan noted that these additives highlight the broader issue of outdated regulations and the need for systemic reform in how food additives are approved and monitored.
The CSPI aims not only to ban individual harmful additives but also to overhaul the approval process for food chemicals. Galligan pointed out that the prolonged delay in banning Red No. 3 exemplifies a larger problem within the federal system, allowing unsafe substances to persist in the food supply. With thousands of chemicals currently permitted in U.S. food or packaging materials, a comprehensive reform is crucial to ensure public safety. While the future of regulatory changes remains uncertain, advocacy groups will continue to push for a more stringent and effective system.