FDA Bans Use of Red Dye No. 3
- Adeel Arman
- January 17, 2025
- 9:59 am
- 35
- Trending
The FDA has decided to ban FD&C Red No. 3 in food and ingested drugs, citing the Delaney Clause in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action comes after a 2022 petition raised safety concerns about the dye.
Why Is Red Dye No. 3 Being Banned?
The petition pointed to studies showing cancer in male rats exposed to high doses of the dye due to a specific hormonal reaction in rats. Scientists note that this reaction does not occur in humans, and typical human exposure to the dye is much lower than the levels tested in the studies. Other research involving humans and animals did not find the same risks, suggesting that claims of harm from Red No. 3 are not supported by current scientific evidence.
What Is the Delaney Clause?
The Delaney Clause, introduced in 1960, bans the FDA from approving any food or color additive that has been proven to cause cancer in humans or animals. This isn’t the first time the FDA has acted under this rule. In 2018, the agency also banned certain synthetic flavors based on the Delaney Clause.
Where Is Red Dye No. 3 Found?
Red Dye No. 3 is a synthetic coloring that gives food and drinks a bright, cherry-red color. It has been used in:
- Candies
- Baked goods like cakes and cookies
- Frozen desserts
- Frostings and icings
- Certain medicines
The FDA reports that Red No. 3 is less commonly used than other food dyes, according to data from food labels, manufacturers, and public records.
Key Dates for Compliance
Manufacturers have deadlines to stop using Red Dye No. 3:
- Food Products: January 15, 2027
- Ingested Drugs: January 18, 2028
Although some countries still allow the dye (where it’s called erythrosine), all foods imported into the U.S. must follow U.S. regulations.
What’s Next?
This decision shows the importance of strict reviews for food additives and highlights the FDA’s role in ensuring public safety. It also reminds consumers to stay informed about what goes into their food and medicines.
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