Written and Reviewed by Team Pharmacally
The U.S. Food and Drug Administration (FDA) said on January 15, 2025, that the use of FD&C Red No. 3 in foods and swallowed medications would no longer be authorized. The Federal Food, Drug, and Cosmetic Act’s (FD&C Act) Delaney Clause, which forbids the approval of any food ingredient that has been shown to cause cancer in either humans or animals, serves as the foundation for this ruling.
Background on FD&C Red No. 3
Erythrosine, another name for FD&C Red No. 3, is a synthetic dye that gives a variety of goods a vivid cherry-red hue. It is mostly found in several foods, such frostings, cakes, cookies, candies, and frozen desserts, as well as in some swallowed medications.
Scientific Findings and Regulatory Actions
The FDA’s ruling comes after research showed that male rats developed thyroid cancers when given high doses of FD&C Red No. 3. Importantly, the dye does not cause cancer in people by the same method that it does in these animals, and the normal exposure levels in humans are far lower than those that have negative effects in rats. The Delaney Clause requires a ban if an additive is discovered to cause cancer in any animal species, even though there is no concrete proof connecting FD&C Red No. 3 to cancer in humans.
FD&C Red No. 3 has previously been the subject of regulatory attention. Because of comparable carcinogenic concerns, the FDA prohibited its use in topical medications and cosmetics in 1990. But up until the latest revocation, it was being used in meals and swallowed medications.
Implementation Timeline
The following deadlines must be met by manufacturers who use FD&C Red No. 3 in their products:
Foods: January 15, 2027 (including dietary supplements)
Drugs consumed: January 18, 2028
The industry is given enough time by these timetables to find and switch to substitute colour additives.
Global Perspective and Alternatives
Internationally, there are differences in the regulatory position on FD&C Red No. 3. Some nations have restricted or even banned its usage, while others still allow it under certain circumstances. For example, the European Union has strict rules about the dye’s use, while Australia has outright banned it.
Manufacturers are looking into natural substitutes for FD&C Red No. 3 in response to the FDA’s ban. Beet extract, carmine, and colors from plants like red cabbage and purple sweet potatoes are possible alternatives. In addition to reducing health risks, these natural colorants satisfy customer demands for more transparent and clean food manufacturing methods.
Conclusion
The FDA’s decision to revoke FD&C Red No. 3 demonstrates its dedication to protecting the Delaney Clause and guaranteeing the security of food and medication additives. The legal framework requires precautionary precautions even though the scientific community recognizes that the carcinogenic consequences seen in animal research may not directly translate to people. It is expected that this action will promote the use of safer, natural colorants, leading to a change in food and medication manufacturing procedures that are more transparent and health-conscious.
References:
1. FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs, US Food and Drug Administration, Published on 15 Jan 2025
2. Part III: Drugs and Foods under the 1938 Act and Its Amendments, US Food and Drug Administration, Published on 01 February 2018
3. FDA’s Red Dye No. 3 Ban, Explained—What It Means For Food and Trust, Forbes, 16 January 2025
4. FD&C Red No. 3, US Food and Drug Administration, Published on 15 Jan 2025
5. Natural alternatives for synthetic, FD&C colors, Natural colors can replace synthetic coloring and can be utilized in a wide variety of food and beverage applications, Supply side supplemental journal, published on 24 September 2013
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