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FD&C Blue No. 1

Excipient (pharmacologically inactive substance)

Medically reviewed by Drugs.com. Last updated on May 1, 2018.

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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