2 replies to this topic

[Sheena Bliss]

Looking for regulatory (FDA) guidelines on making a claim of XX% Fewer Carbs than competitors. I see the general guidance about making relative claims, but are there regulations that address carbohydrate claims like this specifically? 

 

I want to know if we can make a "Fewer Net Carbs" claim and if the statement "Net Carbs = Total Carbs - Dietary Fiber" needs to be immediately adjacent to all mentions of this claim on pack. 

 

Thank you!

[hello.fizz]

I can't speak for the FDA, but in our country some health claims like this require you to state the other products carbohydrate amount and yours. I have previously approved a label that said "25% less carbohydrates than original xxx product" (original product was also from our brand). This statement was under the nutritional panel and the front of the pack said 'lower carbohydrates'. 

 

If you are really stuck, you could see what similar products in the market say, which might help you narrow down which part of the FDA rules you need to meet.

[Scampi]

Nutrient Content Claims

The Nutrition Labeling and Education Act of 1990 (NLEA) permits the use of label claims that characterize the level of a nutrient in a food (i.e., nutrient content claims) if they have been authorized by FDA and are made in accordance with FDA's authorizing regulations. Nutrient content claims describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite. An accurate quantitative statement (e.g., 200 mg of sodium) that does not otherwise "characterize" the nutrient level may be used to describe the amount of a nutrient present. However, a statement such as "only 200 mg of sodium" characterizes the level of sodium by implying that it is low. Therefore, the food would have to meet the nutritional criteria for a “low” nutrient content claim or carry a disclosure statement that it does not qualify for the claim (e.g., “not a low sodium food”). Most nutrient content claim regulations apply only to those nutrients that have an established Daily Value: A Food Labeling Guide - VII. Nutrition Labeling. The requirements that govern the use of nutrient content claims help ensure that descriptive terms, such as high or low, are used consistently for all types of food products and are thus meaningful to consumers. Healthy is an implied nutrient content claim that characterizes a food as having "healthy" levels of total fat, saturated fat, cholesterol and sodium, as defined in the regulation authorizing use of the claim. Percentage claims for dietary supplements are another category of nutrient content claims. These claims are used to describe the percentage level of a dietary ingredient in a dietary supplement and may refer to dietary ingredients for which there is no established Daily Value, provided that the claim is accompanied by a statement of the amount of the dietary ingredient per serving. Examples include simple percentage statements such as "40% omega-3 fatty acids, 10 mg per capsule," and comparative percentage claims, e.g., "twice the omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)." (See 21 CFR 101.13(q)(3)(ii)). A summary of the rules for use of nutrient content claims can be found in Chapter VI of The Food Labeling Guide. Examples of nutrient content claims can be found in Appendices A and B of The Food Labeling Guide: Appendix A: Definitions of Nutrient Content Claims and Appendix B: Additional Requirements for Nutrient Content Claims.

 

8. CLAIMS Nutrient Content Claims N1. Whatis a nutrient content claim (NCC)? Answer: It is a claim on a food product that directly or by implication characterizes the level of a nutrient in the food (e.g., "low fat," "high in oat bran," or "contains 100 calories"). 21 CFR 101.13(b), 21 CFR 101.13(a) N2. What nutrient levels must be present in a food to use NCCs on food labels? Answer: The nutrient levels needed to use NCCs are shown in Appendices A and B of this guidance. N3. If a NCC is notincluded in FDA's regulations can it be used on a label? Answer: No. Only those claims, or their synonyms, that are specifically defined in the regulations may be used. All other claims are prohibited. 21 CFR 101.13(b) N4. Where are NCCs specifically defined by the agency? Answer: In 21 CFR 101.13, Subpart D of part 101, and parts 105 and 107. 21 CFR 101.13(b) N5. Are there any requirements for NCCs regarding the size or style oftype? Answer: Yes. A NCC may be no more than twice as prominent as the statement of identity (the name of the food). Specifically, the type size of the claim may be no more than two times the type size of the statement of identity. If the style of the type makes the claim unduly prominent compared to the statement of identity, it will be in violation of the regulations (even if the size of the type is appropriate). 21 CFR 101.13(f) N6. Is there any additional information that is required when a claim is made? Answer: Yes. A variety of information is required depending on the claim and what information is needed to prevent the claim from being misleading. Nutrition labeling is required for virtually all claims. 21 CFR 101.13(n)