FDA Allows Oral Health Claim for Spherix's Sweetener

Dec. 10, 2002
Tooth-friendly label for product seen as especially beneficial for nonfood uses of new ingredient.

Spherix reports that the U.S. FDA has allowed the claim that tagatose does not cause tooth decay, and that use of the Company's full-bulk, low-calorie sweetener may actually reduce the risk of that disease. After studying test data, the Agency amended its regulation (21 CFR 101.80) to permit the labeling of tagatose to that effect. Spherix officials believe this action, effective with the FDA's announcement in the Federal Register
(Volume 67, Number 231, Dec. 2, 2002), will boost the market appeal of food products made with tagatose. Such tooth-friendly labeling could be especially beneficial for non-food uses of the novel ingredient.

The FDA statement said, "Based on the totality of publicly available scientific evidence, we have now determined that the sugar D-tagatose ... is not fermented by oral bacteria to an extent sufficient to ... cause the erosion of dental enamel." The FDA also examined scientific evidence from two human studies comparing the effects of D-tagatose to those of table sugar. D-
tagatose produced less acid in the mouth, thereby reducing the risk of dental caries. "Therefore," the Agency stated, "we have concluded that D-tagatose does not promote dental caries."

The FDA pointed out that the Department of Health and Human Services' Healthy People 2010 Objectives "recognizes dental caries as the single most common chronic disease of childhood, and states that 30 percent of adults have untreated dental decay." In granting the health claim, the Agency also said, "FDA concludes that the petitioner has satisfied the requirement of Sec. 101.14(b) (3) (ii) to demonstrate that the use of D-tagatose as a sweetener is safe and lawful."