FDA adds isomaltulose to list of tooth-safe sweeteners

ROCKVILLE, Md. Isomaltulose, an artificial sweetener, is getting a boost from the Food and Drug Administration after being added to a list of non-cariogenic carbohydrate sweeteners. The ruling is effective immediately and proponents and marketers of the sweetener now may promote its non-association with dental caries.

“FDA is taking this action to complete the rulemaking initiated with the interim final rule,” the FDA said in an article released in the Federal Register May 27.

Manufacturers using isomaltulose in products like gum will now be permitted to make claims like “does not promote tooth decay” and “may reduce the risk of tooth decay.” Items with the sweetener must be completely sugar-free and must not bring the user’s plaque pH to a level lower than below 5.7 for up to 30 minutes after use.

In 2006, Cargill petitioned to have isomaltulose added to the FDA’s list alongside other sweeteners like D-tagatose and sucralose. Isomaltulose is marketed as a sweetener by such companies as Beneo-Palatinat (Palatinose) and Cargill (Xtend).

The FDA approved the entry of isomaltulose to the non-cariogenic list because it proved not to be “fermented by oral bacteria to an extent sufficient to lower dental plaque pH to levels that would contribute to the erosion of dental enamel.”

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