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FDA Issues Final Guidance on Allulose and Solicits Information for Rulemaking on Nutrition Labeling for Sugars That are Metabolized Differently Than Traditional Sugars

The U.S. Food and Drug Administration (FDA) released a draft guidance on April 18, 2019 (as discussed here) for the exclusion of allulose, a monosaccharide used as a sugar substitute, from the amount of “Total Sugars” and “Added Sugars” declared on the label and the use of a general factor of 0.4 calories per gram for allulose when determining “Calories” on the Nutrition and Supplemental Facts labels of conventional foods and dietary supplements made with allulose.  On October 19, 2020, FDA announced it has finalized The Declaration of Allulose and Calories From Allulose on Nutrition and Supplement Facts Labels guidance document with no substantive changes and will continue to exercise enforcement discretion pending review of the issues in a rulemaking.

In an October 19, 2020 Federal Register notice, FDA solicited comments and information to inform potential amendments to the nutrition labeling rules for allulose and other sugars that are metabolized differently than traditional sugars.  Scientific data and other evidence are invited on topics pertinent to such sugars as follows:

The chemical properties or physiological effects of other such sugars, besides allulose, D-tagatose, and isomaltulose, which are already well known to FDA;

Consumer awareness or understanding of the differences between such sugars traditional sugars;

Potential regulatory approaches for the declaration of such sugars in ‘‘Total Sugars,’’ e.g., declaring the full amount, excluding the full amount, or declaring an adjusted gram amount;

Any factors aside from pH of dental plaque after consumption, caloric value, and glycemic and insulinemic response that may impact whether such a sugar should be excluded from the declaration of ‘‘Total Sugars;’’

Potential regulatory approaches for such sugars in the declaration of ‘‘Added Sugars,’’ e.g., declaring the full amount, excluding the full amount, or adjusting the gram amount of the ‘‘Added Sugars’’ or the percent daily value (%DV) declaration based on their caloric contribution to the diet;

Adjusting the %DV for ‘‘Added Sugars’’ for the U.S. population 4 years of age and older based on the caloric contribution of the sugar; and

Potential regulatory approaches to the label declaration of such sugars in the ingredient statement;

FDA has provided additional questions in subparts for certain of the above topics and has requested an explanation of the reasoning for each comment that is submitted, along with studies, data, and other supporting evidence as applicable to the topic that is being addressed.  The solicitation period for comments is scheduled to close on December 18, 2020.  

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 293
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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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