Food Labeling: Health Claims; D-tagatose and Dental Caries

The Food and Drug Administration (FDA) is amending the regulation authorizing a health claim on sugar alcohols and dental caries, i.e., tooth decay, to include the sugar D-tagatose, a novel food ingredient. Similar to the sugar alcohols currently listed in Sec. 101.80 (21 CFR 101.80), D-tagatose is a carbohydrate sweetener that is slowly fermented by oral microorganisms, thus producing less acid than more fermentable carbohydrates. We (FDA) are taking this action in response to a petition filed by Arla Foods Ingredients amba. We previously concluded that there was significant scientific agreement for the relationship between slowly fermented carbohydrate sugar substitutes, specifically certain sugar alcohols, and the nonpromotion of dental caries. Based on the totality of publicly available scientific evidence, we now have determined that the sugar D-tagatose, like the sugar alcohols, is not fermented by oral bacteria to an extent sufficient to lower dental plaque pH to levels that would cause the erosion of dental enamel. Therefore, we have concluded that D-tagatose does not promote dental caries, and we are amending the regulation authorizing a health claim relating certain sugar alcohols and nonpromotion of dental caries to include D-tagatose as a substance eligible for the claim. Moreover, because D-tagatose is a sugar, we are denying the petitioner's request to exclude D-tagatose from the definition of "sugars," and instead are exempting foods containing D- tagatose from the requirement that foods bearing a health claim about nonpromotion of dental caries be sugar-free. Accordingly, although products containing D-tagatose will not be permitted to be labeled as "sugar-free," they will be authorized to say that D-tagatose sugar does not promote, or may reduce the risk of, tooth decay.