The regulatory body on Wednesday amended rules authorizing a health claim on non-cariogenic carbohydrate sweeteners to include sucralose.
Similar to sweeteners that already have the green light to make a health claim, sucralose is used as a sugar replacer and is minimally fermented, relative to sugar, by oral microorganisms.
Consequently, the FDA backs the reasoning that sucralose does not contribute to the production of organic acids by plaque bacteria, as do the fermentable sugars that it replaces.
Sucralose is currently bringing strong gains to UK firm Tate & Lyle, which makes and sells the product under the Splenda brand. This latest FDA authorization is likely to bring further sales success for the product.
The petition was originally filed in 2004 by McNeil Nutritionals, the firm that markets the tabletop Splenda product in the US.
The FDA said its decision, which was based on the availability of sufficient scientific backing, permits producers who use sucralose to place the dental caries health claim on their product labeling.
According to the agency, this new regulation could have a number of possible effects on the market. It could prompt a price increase of sucralose-containing products, which in turn may either cause consumers to opt for cheaper alternatives, or encourage them to pay higher prices for added benefits.
"Producers not using sucralose will be affected differently depending on the type of product that they produce, and it is impossible to tell beforehand how the approval of this health claim will affect different producers," said the FDA.
It added that the new rule would preclude States from issuing any health clam labeling requirements for sucralose and reduced risk of dental caries that are not identical to those required by this final rule.
The announcement comes at a time when Tate & Lyle's ability to retain a monopoly on the lucrative global sucralose market with its patented Splenda product has been called into question. In January, India-based Pharmed Medicare revealed to FoodNavigator.com that it has developed an alternative patent-pending process that would put the firm into direct competition with the UK ingredient giant.