•  Consumer class action lawsuits against Goldfish-brand snacks (discussed here) and others have alleged that such products do not comply with 21 CFR § 101.60 (“Nutrient content claims for the calorie content of foods”) because the products claim “0g Sugars” or “0g Total Sugars” (i.e., sugar free claims) without disclosing that they are “not a low calorie food,” “not a reduced calorie food,” or “not for weight control.”  While Section 101.60 does not reference quantitative claims, plaintiffs assert that “0g Sugars” and “0g Total Sugars” are substantively identical to the claims “sugar free,” “free of sugar,” and other claims delineated in the regulation that require such a disclaimer.
  • In a recently updated Q&A segment under “Label Claims” on its website: Industry Resources on the Changes to the Nutrition Facts Label, FDA clarified that the additional statements required when making the sugar content claims defined in Section 101.60(c) are not required for quantitative claims about sugar.  Specifically, FDA stated:

Title 21 CFR 101.60(c) discusses certain sugar content claims and the specific conditions for their use, including the conditions for requiring the accompanying statements “not a reduced calorie food,” “not a low calorie food,” or “not for weight control.” Statements about the amount of the nutrient in a food, which would include “0 g total sugars,” are provided for in 21 CFR 101.13(i), which discusses the specific conditions for their use. Although amount statements are nutrient content claims and would, therefore, have to follow the general requirements for nutrient content claims, amount statements need not follow the requirements provided for specific, individual nutrient content claims as described in Subpart D of 21 CFR 101 (21 CFR 101.54 – 101.67). As such, 21 CFR 101.60(c) does not require “0 g total sugars” amount statements to be accompanied by the additional statements.

  • FDA’s clarification resolves an important point of contention in recent consumer class actions and in our view would be equally applicable to any quantitative claim made.