Department of Health and Human Services May 13, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is proposing to amend the regulation authorizing a health claim on noncariogenic carbohydrate sweeteners and dental caries, i.e., tooth decay, to include sucralose, a nonnutritive sweetener. Similar to the sweeteners currently authorized to make a health claim, sucralose is used as a sugar substitute that is minimally fermented, relative to sugar, by oral microorganisms and thus does not contribute to production of organic acids by plaque bacteria as do the fermentable sugars for which it is a substitute. FDA is taking this action in response to a health claim petition filed by McNeil Nutritionals. The agency 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, FDA now has determined that the nonnutritive sweetener sucralose, like the sugar alcohols, is not fermented by oral bacteria to an extent sufficient to lower dental plaque pH to levels that would contribute to the erosion of dental enamel. Therefore, FDA has concluded that sucralose does not promote dental caries, and it is proposing to amend the regulation authorizing a health claim relating certain noncariogenic sweeteners and nonpromotion of dental caries to include sucralose as a substance eligible for the claim.