FD&C Blue No. 2 is also called indigo blue or indigotine. It is a synthetic version of indigo, a dye naturally produced from plants. Indigotine, on the other hand, is a petroleum product, with the chemical formula C16H10N2O2. It is used in baked goods, cereals, ice cream, snacks, candies and cherries.
In September 2007, a study reported by D. McCann and colleagues in the journal “The Lancet” linked artificial colorings, including Blue No. 2, to hyperactivity. Nearly 300 children in the study were given a beverage with artificial colors and a preservative. Drinking the beverage resulted in increased hyperactivity in the children, which the researchers attributed to the artificial coloring or the preservative or both. As a result, one candy company, Nestlé-Rowntree, stopped selling one of its candies with a blue shell until it replaced the artificial color with a new blue color made from spirulina, a blue-green algae.
In a group of studies reviewed by the Center for Science in the Public Interest, Blue No. 2 did not affect reproduction or cause birth defects in rabbits or rats. However, male rats in one group that received a high dosage of Blue No. 2 had statistically significant increases in brain cancers and other abnormal cell development. No human studies have been reported, and experts disagree about the safety of Blue No. 2, according to the CSPI. However, the U.S. Food and Drug Administration says that FD&C blue no. 2 is safe for use in food and supplements, according to the Code of Federal Regulations. The CSPI asserts that Blue No. 2 is not safe for human consumption. Since it adds nothing to the nutritive value of food and evidence for its safety is questionable, CSPI recommends it not be used in foods.
- CBS News: Food Dyes Linked to Allergies, ADHD and Cancer: Group Calls on US to Outlaw Their Use; David Freeman; June 2010
- U.S. Food and Drug Administration; Food Ingredients and Colors; 2010
- “The Lancet”; Food Additives and Hyperactive Behavior in 3-Year-Old and 8/9-Year-Old Children in the Community; D. McCann et al.; November 2007
- “Scientific American”; Where Does Blue Food Dye Come From?; Brendan Borrell; January 2009
- Center For Science In The Public Interest; Food Dyes–A Rainbow of Risks; S. Kobylewski, M. F. Jacobson; 2010
- USHHS Food and Drug Administration; What is the difference between the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA guidance?; 2010
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