Article: Regulations: Scientific Health Claims Review -- October 2007
The FDA has reaffirmed its regulatory position with regard to “sugar-free” claims in two letters: the first, a Warning Letter to a maker of “sugar-free” assortments; and, the second, a guidance document in the form of a “Dear Manufacturer” letter.
In the letters, FDA reminds manufacturers that the claim of “sugar-free” (or similar claims) may not be used on or in connection with food products, unless the food meets the requirements of a “low-calorie” or “reduced-calorie” food or is labeled as a food for special dietary usefulness. If the food does not meet these weight-control criteria, the label must include the disclaimer that the food is “not a low-calorie food” or is “not a reduced-calorie food” or is “not for weight control.” The disclaimer must be in proximity to the “sugar-free” claim and be of appropriate type size.
FDA is concerned that consumers associate a “sugar-free” claim with weight control or caloric reduction, and if the food is not reduced or low, this fact must be conspicuously disclosed. The FDA indicates that its prime focus will be on foods which fail to bear the correct disclaimer.