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FD&C Red No. 40

Excipient (pharmacologically inactive substance)

What is it?

FD&C Red No. 40 is the water soluble azo dye disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid. FD&C Red No. 40 has an orange-red hue and is approved by the FDA for use in food, drugs, and cosmetics according to the specifications set forth by the FDA.1,2

FD&C Red No. 40, also known as Allura Red AC, is commonly used in liquid medications with cherry, strawberry or "berry" flavoring. It may also be used as a colorant in tablets and capsules. Red No. 40 replaced Red Dye No. 2 in 1976 due to reported links with cancer from Red Dye No. 2.[3]

FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. These colors are then certified by the FDA for safe use according to specifications. The FD&C notation specifies the color is approved for use in foods, drugs and cosmetics.[1] [2]

[1] 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

[2] 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#21:1.0.1.1.27.2.31.35

[3] Anon. Time Magazine US: Regulation: Death of a Dye. February 2, 1976. Accessed 10/21/2011. http://www.time.com/time/magazine/article/0,9171,945520,00.html

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