May 22, 2022

Volume XII, Number 142

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May 20, 2022

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FDA Clarifies Labeling Rules for Quantitative Claims About Sugar

  • 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.

  • While FDA’s clarification resolves an important point of contention in recent consumer class actions, we caution that the general requirements for nutrient content claims do apply to the claims “0 g Sugars” and “0g Total Sugars.”  As such, if certain nutrients exceed a specified level (i.e., >13g total fat, >4g saturated fat, >60mg cholesterol and >480mg sodium) then the product bearing a quantitative sugar claim must include a disclosure statement as required under 21 CFR § 101.13(h)(1).  For example, if a product claims, “0 g Sugars” and the total fat in a serving exceeds 13g, then the product must include the disclosure, “See nutrition information for fat content.”

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 24
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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