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Posted June 26, 2006

FDA Warns Candy Maker Making Heart Health Claims

On May 31, 2006, the U.S. Food and Drug Administration (FDA) sent a warning letter to Masterfoods USA, the manufacturer Cocoa Via candy bars, that it was in violation of FDA regulations for adding folic acid to a candy product and claiming that its candy bars promote heart health, despite containing high levels of saturated fat.

The FDA letter stated, "Folic acid is an ingredient for which there is a food additive regulation.... The food additive regulation for folic acid does not provide for the addition of folic acid to candy products. The restrictions in the regulation are important. The foods to which folic acid can be added are designed to keep total folic acid intake under the 1 mg level.... The consumption of higher levels of folic acid can mask anemia in persons with vitamin B 12 deficiency. Under those circumstances, the consequences of the anemia (i.e., severe and irreversible neurological damage) would go undetected."

"In addition, your Cocoa Via™ Original Chocolate Bars and Blueberry & Almond Chocolate Bars are misbranded ... because their labels bear false or misleading claims that the products promote heart health. For example, the labels of these products bear the claims "Promotes a Healthy Heart" and "Now you can have real chocolate pleasure with real heart health benefits." These claims are false or misleading because of the high levels of saturated fat in the products.

The manufacturer was asked to notify the FDA within 15 days of steps being taken to correct these and other violations.

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