FDA Bans FD&C Red No. 3: What You Need too Know About the Synthetic Dye’s Phase-Out
The U.S. Food and Drug Administration (FDA) has announced a ban on FD&C Red No. 3,a synthetic dye widely used in candies,cakes,frostings,and strawberry-flavored desserts,and also in certain medications and dietary supplements. Manufacturers must phase out the dye by January 15,2027,for food products and January 18,2028,for ingested drugs.
This decision stems from the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the use of additives shown to cause cancer in humans or animals. While studies revealed that high doses of FD&C Red No. 3 caused cancer in male rats, the FDA clarified that these effects do not occur in humans at typical exposure levels.
the Widespread Use of FD&C Red No. 3
Known for its shining cherry-red color, FD&C Red No. 3 is a staple in a variety of foods, including maraschino cherries, fruit cocktails, ice pops, and seasonal treats like candy corn. It’s also present in oral medications such as acetaminophen (pain reliever),fluoxetine (antidepressant),gabapentin (anticonvulsant),and omeprazole (heartburn treatment).A search of the U.S. Department of Agriculture’s Branded Foods Database identified 9,201 food products containing the dye, highlighting its prevalence.
Why the Ban?
The Delaney Clause mandates that the FDA cannot authorize additives found to induce cancer in humans or animals, regardless of the relevance of the findings to human health. In the case of FD&C Red No. 3,the cancer observed in male rats was caused by a rat-specific hormonal mechanism that does not occur in humans. Other studies involving humans and different animals showed no similar effects.Despite the FDA’s assurance that typical human exposure to the dye is far lower than the levels tested in animal studies, the agency is legally bound to revoke its authorization.
What Consumers Shoudl Look For
Consumers can check ingredient labels to determine whether FD&C Red No. 3 is present. It may be listed under the following names:
- FD&C Red No. 3
- FD&C Red 3
- Red 3
Global Implications
While the U.S. is phasing out FD&C red No. 3, other countries, where the dye is known as erythrosine, continue to allow its use. Imported foods entering the U.S. must comply with the new regulations, ensuring consistency in consumer safety standards.
A Commitment to Safety
This ban reflects the FDA’s broader commitment to ensuring consumer safety and clarity in food and drug products. The agency encourages consumers to remain informed by reviewing product labels and making choices aligned with their preferences.| Key Points | Details |
|—————-|————-|
| Ban Effective Dates | Food products: January 15, 2027; Ingested drugs: January 18, 2028 |
| Reason for Ban | Delaney Clause prohibits cancer-causing additives |
| Common Products | Candies, cakes, frostings, medications |
| Alternative Names | FD&C Red No. 3, FD&C red 3, Red 3 |
| Global Status | Banned in the U.S.; allowed in other countries as erythrosine |
As manufacturers work to reformulate their products, consumers are urged to stay vigilant and informed. For more details on the FDA’s decision, visit the FDA’s official website.
What are your thoughts on this ban? Share your opinions and stay updated on food safety regulations by following trusted sources like the U.S. Department of Agriculture.
