The U.S. Food and Drug Administration (FDA) has taken a significant step by revoking the authorization for red dye 3 in food and drugs. This decision follows pressure from consumer advocacy groups and lawmakers. Food companies now have until January 15, 2027, to reformulate their products without this dye.
Even though the FDA claims that red dye 3 isn’t harmful at regular dietary levels, they have decided to ban it due to the Delaney Clause. This clause states that if any substance is found to cause cancer in humans or animals, it cannot be used as a food additive.
The FDA’s decision came after a 2022 petition filed by the Center for Science in the Public Interest and Consumer Reports, along with 22 other organizations. They referenced studies that pointed to cancer in male rats exposed to high levels of red dye 3. However, the FDA argued that these findings in rats might not be relevant to humans, as the levels causing harm in rats are much lower than what humans typically consume. Studies involving humans and other animals haven’t shown similar cancer risks.
Despite the FDA’s stance, many people continue to believe that red dye 3 can pose health risks. In October 2024, Consumer Reports submitted another petition with 80,000 signatures asking the FDA to ban the dye due to concerns not only about cancer but also its links to hyperactivity and other behavioral issues in children. A letter from 23 Congress members added to these concerns, highlighting that red dye 3 is banned in foods across the EU, Australia, and New Zealand.
These health worries contributed to the recent California Food Safety Act. Passed in October 2023, this law will prohibit the manufacture and sale of foods containing red dye 3 as of January 2027.
It’s worth noting that while some countries still allow the use of red dye 3 (known as erythrosine), any foods imported to the U.S. must meet American safety standards.
As the FDA restricts red dye 3, organizations like Consumer Reports are pushing for similar bans on other synthetic dyes linked to health issues in children. The California School Food Safety Act, passed in August 2024, targets six synthetic food dyes—red 40, yellow 5, yellow 6, blue 1, blue 2, and green 3—due to their potential effects on child development and behavior. This act will be effective from December 31, 2027.
As interest in food safety grows, the FDA is working on improving its processes for evaluating the safety of food chemicals already available. With pressure from various groups, including lawmakers and consumers, food dye regulations are being closely watched and reconsidered.
Check out this related article: Unlock Your Future: Apply Now for CCE’s Spring and Fall Food Systems Curriculum Cohorts!
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