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FD&C Blue No. 1

Excipient (pharmacologically inactive substance)

What is it?

FDA has regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. FD&C Blue No. 1, also known as Brillant Blue FCF ("for coloring food"), is a water-soluble artificial blue dye allowed by the FDA for use in foods, drugs and cosmetics. FD&C Blue No. 1 is widely used in food products (candies, confections, beverages, etc.) and there have been no reports of toxicity associated with this general food use.

In September of 2003, the FDA issued a Public Health Advisory to alert healthcare providers of toxicity associated with the use of FD&C Blue No. 1 in enteral feeding solutions. Toxicity, including death, has been reported only in association with FD&C Blue No. 1 tinting of enteral feedings, intended as a means of visually detecting pulmonary aspiration, although causality has not been established.[1] [2]

[1] US Food and Drug Administration. Safety. FD&C Blue No. 1 (Blue 1) in enteral feeding solutions. Accessed 10/19/2011. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm169530.htm

[2] 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

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