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Sunday, September 25, 2016 11:19:10 AM
-FD&C Blue No. 1 is a water-soluble dye allowed by the FDA for use in foods, drugs and cosmetics, based on numerous studies in animals.
-Data from life-exposure animal studies supports an ADI (acceptable daily intake) of Blue 1 of 12.0 milligrams/kilogram body weight/day.
-The dye is batch certified by the FDA and is widely used in food products (candies, confections, beverages, etc.) in amounts consistent with good manufacturing practices (generally at parts per million).
-There have been no reports of toxicity associated with this general use.
Toxicity has been reported only in association with Blue 1 tinting of enteral feedings, intended as a means of visually detecting pulmonary aspiration.
-This use, although a common practice for nearly 30 years, has never been evaluated by the FDA for safety or utility (i.e., there has been no evaluation by the FDA of the sensitivity and specificity of its use in this manner).
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