The Food and Drug Administration (FDA) has banned the widely used food additive Red No. 3 from food and drugs sold in the United States, citing cancer risks found in animal studies. While the agency acknowledges that human exposure levels are typically lower, it emphasizes the need to prioritize public health.
The Food and Drug Administration ( FDA ) has issued a ban on the widely used food additive Red No. 3 in food and drugs sold in the United States. This decision follows a 2022 petition to revoke the additive's authorization based on the Delaney Clause , which mandates the FDA to prohibit additives identified as causing or inducing cancer in humans or animals through testing. The FDA stated that studies conducted on male rats revealed an elevated cancer risk associated with Red No. 3 .
However, the agency emphasized that the mechanism by which Red No. 3 induces cancer in male rats does not transpire in humans. \The FDA asserted that typical human exposure levels to FD&C Red No. 3 are considerably lower than those triggering the observed effects in male rats. Moreover, studies involving other animal species and humans did not demonstrate these effects. The FDA concluded that claims alleging a heightened cancer risk to individuals from consuming food and ingested drugs containing FD&C Red No. 3 are not substantiated by the available scientific evidence. \Food manufacturers will have a two-year period to reformulate their products, while pharmaceutical companies will have until 2028 to make necessary adjustments. Red No. 3 is commonly employed to impart a vibrant, cherry-red hue to various foods and beverages. It finds extensive use in candies, cakes, cupcakes, cookies, frozen desserts, frostings, and icings. The World Health Organization (WHO) has analyzed a multitude of studies on erythrosine, the chemical name for Red No. 3, and determined that dietary exposures to erythrosine for all age groups do not pose a health concern. The WHO noted that high doses, rather than normal consumption, present a risk. Despite this, advocates maintain that Red No. 3 and similar chemicals should be completely removed from food products. California has already enacted legislation prohibiting the additive in food starting in 2027. Some food manufacturers had already begun making modifications to comply with this California law. According to the Environmental Working Group, Red No. 3 is found in 3,023 food products, encompassing a diverse range from mixed fruits to ice cream, yogurt, protein drinks, and candy. In comparison, Red No. 40 is detected in over 11,600 products. \The National Confectioners Association, an organization representing prominent brands such as Mars Wrigley North America, HARIBO of America, Inc., and The Hershey Company, indicated that it would 'continue to follow and comply with FDA’s guidance and safety standards.' The organization stated, 'Our consumers and everyone in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework. We have been saying for years that FDA is the rightful national regulatory decision maker and leader in food safety,' expressing their support for the FDA's role in ensuring food safety
FDA Red No. 3 Food Additive Cancer Risk Ban Delaney Clause Food Safety
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