Sweet Ruling for Sucralose

FDA has given the green light to food and beverage manufacturers that use the sweetener sucralose in their products to make a limited health claim stating that the sweetener doesn't promote tooth decay. The ruling was in response to a 2004 petition asking for the health claim submitted by McNeil Nutritionals, Ft. Washington PA, a unit of Johnson & Johnson, which sells the high-intensity sweetener under the trade name Splenda®. The petition was based on studies that show that the oral bacteria responsible for tooth decay do not use sucralose as a nutrient source.

Products that contain sucralose can add to their labels the following statement: "Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. Sucralose, the sweetening ingredient used to sweeten this food, unlike sugars, does not promote tooth decay." The FDA does not allow the claim to be made for McNeil's retail Splenda sweetener products sold in individual packets as a tabletop sweetener or in granular form, because they contain fermentable bulking agents and so wouldn't qualify as "sugar-free."

Sucralose is derived from sugar through a process that selectively substitutes three atoms of chlorine for three hydroxyl groups on the sugar molecule. This creates a nondigestible sweetener that is 600 times sweeter than sucrose, but provides no calories. FDA approved sucralose in 1998 for use as a tabletop sweetener and for use in products such as baked goods, nonalcoholic beverages, chewing gum, frozen dairy desserts, fruit juices and gelatins, and later amended the regulation to allow it as a general-purpose sweetener for all foods. Tate & Lyle PLC, headquartered in London, is currently the manufacturer of sucralose and is responsible for worldwide food and beverage ingredient sales.

The ruling became effective on Mar. 29, 2006, when FDA published the decision in the Federal Register as an amendment to Title 21 Code of Federal Regulations, Sec. 101.80, which authorizes a health claim regarding the relationship between noncariogenic carbohydrate sweeteners and dental caries (http://www.fda.gov/OHRMS/DOCKETS/98fr/06-3007.htm). FDA has already authorized the use of the "does not promote tooth decay" health claim for products containing erythritol, hydrogenated starch hydrolysates, isomalt, lactitol, maltitol, mannitol, sorbitol and xylitol, or a combination of these, and D-tagatose, as long as the finished product complies with all other requirements for a tooth-friendly product.