FDA Bans Red Dye 3: A Long-Awaited Move to Enhance Consumer Safety
The U.S. Food and Drug Administration (FDA) has officially banned FD&C Red No. 3 (also known as Red Dye 3, Red Dye No. 3, and erythrosine) from the nation’s food supply, following decades of advocacy efforts. This artificial color additive, commonly found in candies, beverages, and other edible products, has been linked to cancer in male rats based on extensive research. The ban, announced last week, requires food manufacturers to reformulate products by January 15, 2027, and drug manufacturers to comply by January 18, 2028.
The decision comes 35 years after the FDA prohibited the use of Red Dye 3 in cosmetics and topical drugs in 1990. Due to its health risks, the synthetic dye has already been banned in the European Union and California.
Why Was Red Dye 3 Allowed in Food but Banned in Cosmetics?
The inconsistency in Red Dye 3’s regulation highlights a notable disparity in the FDA’s approval processes. While the dye was approved for food use before its safety could be fully evaluated for cosmetics, studies in the late 1980s revealed its carcinogenic properties. This led to its prohibition of externally applied products. However, its “permanent” approval for food products remained intact, despite mounting evidence and public pressure for its removal.
The FDA has attributed the delay in banning Red Dye 3 from food to the complex regulatory framework under the Federal Food, Drug, and Cosmetic Act. Critics argue that this inaction has unnecessarily exposed millions, particularly children, to a potentially harmful substance for over thirty years. The situation underscores the need for comprehensive and timely safety assessments across all consumer product categories.
IeB Perspective
This regulatory shift offers companies an opportunity to proactively reassess their ingredient portfolios and explore clean-label alternatives to synthetic dyes. For manufacturers, aligning with emerging global safety standards and consumer expectations could be a competitive advantage. Strategic reformulation, leveraging natural colorants, and navigating regulatory frameworks efficiently will be critical in ensuring compliance while maintaining product appeal.
Check out how we supported a leading plant-based meat manufacturer in maintaining product color and texture by identifying sustainable binders and natural colorants in our latest case study.
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