FD&C Red No. 3
Medically reviewed by Drugs.com. Last updated on Jan 15, 2025.
Excipient (pharmacologically inactive substance)
What is it?
On January 15, 2025 the FDA revoked authorization for the use of FD&C Red No. 3 in food and ingested drugs in the U.S. Manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until January 15, 2027 or January 18, 2028, respectively, to reformulate their products. FDA has regulatory oversight for color additives used in foods, drugs, cosmetics, and medical devices.
The revoked authorization of FD&C Red No. 3 was done in response to a 2022 petition. Studies suggested cancer development in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat specific hormonal mechanism.
The Agency stated the way FD&C Red No. 3 causes cancer in male rats does not occur in humans. In addition, human exposures to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats, and studies in other animals and in humans did not show these effects. According to the FDA, claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.
Other countries still currently allow for certain uses of FD&C Red No. 3.
FD&C Red No. 3, also known as erythrosine, is a synthetic dye with a cherry-pink stain. In foods it has been used as a dye in cake decorating gel, candies and popsicles, among other food items. Red No. 40 (Allura Red), an azo dye, is often used in place of Red Dye No. 3 and can still be found in use in the food industry. It is not listed as approved for use in cosmetics.[1][2][3]
Some examples of medications containing FD&C Red No. 3
- Acetaminophen and Diphenhydramine Hydrochloride 500 mg / 25 mg
- Acetaminophen and Hydrocodone Bitartrate 500 mg / 2.5 mg
- Dexmethylphenidate Hydrochloride Extended-Release 5 mg
- Doxycycline Monohydrate 100 mg
- Esomeprazole Magnesium Delayed-Release 20 mg
- Fluoxetine Hydrochloride 10 mg
- Fluoxetine Hydrochloride 40 mg
- Fluoxetine Hydrochloride 20 mg
- Gabapentin 300 mg
- Gabapentin 400 mg
- Omeprazole Delayed-Release 40 mg
- Phentermine Hydrochloride 15 mg
- Phentermine Hydrochloride 30 mg
- Phentermine Hydrochloride 30 mg
- Phentermine Hydrochloride 15 mg
- Phentermine Hydrochloride 37.5 mg
- Phenytoin Sodium Extended 100 mg
- Ramipril 5 mg
- Sucralfate 1 gram
- Vyvanse 10 mg
References
- Electronic Code of Federal Registers. Title 21: Food and Drugs. Part 74. Listing of color additives subject to certification. Subpart B. Drugs. Accessed online October 19, 2011. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=c387334e82029536a53dde1171ba5481;rgn=div5;view=text;node=21%3A1.0.1.1.27;idno=21;cc=ecfr#21:1.0.1.1.27.1.31.6
- U.S. Food and Drug Administration. Color Additives: FDA's Regulatory Process and Historical Perspectives. Accessed 10/20/2011. http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/default.htm
- FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs. 1/15/2025. US Food and Drug Administration (FDA). Accessed Jan 15, 2025
Further information
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