From: Sent: Monday, December 09, 2002 3:49 PM To: fdadockets@oc.fda.gov Subject: docket no. 02P-0462 (CARBOLITE brand name = nutrient content claim) December 9, 2003 Dockets Management Branch (HFA-305) FDA 5630 Fishers La., Rm. 1061 Rockville, MD 20852 Re: Use of CARBOLITE as an implied nutrient content claim Ladies/Gentlemen: The use of the brand name CARBOLITE as an implied nutrient content claim will be misleading to consumers and counterproductive to the current nutrition labeling system. "Sugar-free" is not the same as "carbohydrate-free" or "low-carbohydrate" (two unauthorized, undefined and excessively abused terms), since a food that is sugar-free, as defined in 21 CFR 101.9(c)(6)(ii), does not necessarily contain zero carbohydrate. Before an implied claim for anything relating to carbohydrates can be established, there must be a definition in place for "low-carbohydrate." This has not been done, yet hundreds of products are already using such claims illegally (amazingly, even wholegrain bread products, with a clear majority of calories coming from carbohydrate, are using "low-carb" claims); the situation is out of control. Allowing CARBOLITE to use a claim for sugar content when its name really implies a claim for carbohydrates would only further encourage abuse of nutrient content claims relating to sugars and carbohydrates. In addition, it sends a message to already confused and misled consumers that there is something inherently bad about carbohydrates. CARBOLITE should not be allowed to make implied claims relating to carbohydrate and/or sugar content. Sugar claims should be restricted to those currently permitted under 21 CFR 101.60(c). Thank you for your consideration of these comments. Sincerely, Carol Harvey xxxxxxxxxxxxxxx