Search results for: allulose

 

  • The U.S. Food and Drug Administration (FDA) released a draft guidance on April 18, 2019 (as discussed here) for the exclusion of allulose, a monosaccharide used as a sugar substitute, from the amount of “Total Sugars” and “Added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.  Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • On April 18, 2019, FDA released a draft guidance for industry entitled, “The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.” The guidance announces FDA’s intent to exercise enforcement discretion for the exclusion of allulose 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.
  • Allulose is a monosaccharide used as a sugar substitute in certain conventional foods and beverages. In a press statement, Dr. Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition stated, “[t]he latest data suggests that allulose is different from other sugars in that it is not metabolized by the human body in the same way as table sugar. It has fewer calories, produces only negligible increases in blood glucose or insulin levels, and does not promote dental decay.”
  • As a result of FDA’s announcement, the Agency’s decision is likely to generate more interest in allulose as a sugar substitute given the increasing pressure on industry to reduce sugar and calories.
  • In a letter dated May 18, 2022, FDA denied a citizen petition from Bonumose LLC which requested that the Agency (1) exempt D-tagatose from classification as an “Added Sugar” and (2) allow for the voluntary labeling of D-tagatose as a separate declaration under “Total Carbohydrates,” similar to the approach taken for sugar alcohols.
  • By way of background, FDA exercises enforcement discretion which allows allulose to be excluded from the “Total Sugars” and “Added Sugars” label declarations and allows the use of 0.4 kcal/g for allulose when determining “Calories.” See Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.  FDA had also previously requested information on the kinds of sugars that are metabolized differently than traditional sugars, any distinct physiological effects caused by those sugars, and suggestions on how those sugars should be declared and accounted for on food labels. See 85 Fed. Reg. 66335 (Oct. 19, 2020).
  • FDA declined to exempt D-tagatose from classification as an added sugar primarily because its caloric contribution of 1.5 kcal/g was not negligible. FDA explained that the declaration of added sugars is intended to allow consumers to avoid calories that do not make a significant nutritional contribution (i.e., “empty calories”). Although 1.5 kcal/g is significantly less than the 4 kcal/g that most familiar sugars (e.g., sucrose) contribute, it is also significantly more than the 0.4 kcal/g that allulose contributes. FDA also noted that at the use levels indicated in Bonumose’s GRAS Notice for D-tagatose, D-tagatose could significantly contribute to a consumer’s intake of empty calories. However, the Agency did indicate that it would not object to the use of 1.5 kcal/g for D-tagatose when determining “Total Calories.”  Because FDA determined that it was appropriate to consider D-tagatose as an added sugar, it also declined to allow for voluntary labeling of D-tagatose in a manner similar to sugar alcohols.
  • FDA’s response is interesting because it focuses solely on the caloric issue to the exclusion of differences in the way that D-tagatose is metabolized and its physiological effects. FDA’s only comment on the latter points is to note that a health claim that D-tagatose may reduce the risk of dental caries is allowed under 21 CFR 101.80.
  • Industry groups and the sugar industry have submitted comments to the U.S. Food and Drug Administration (FDA) regarding potential labeling exemptions for certain types of sugars that are not fully metabolized in the human body.  Industry members—including General Mills, Hershey, and Unilever—support FDA’s effort to reassess labeling mandates for sugars.  However, the sugar industry opposes the initiative and is urging FDA to continue requiring that all traditional and non-traditional sugars be declared on the Nutrition Facts Panel (NFP).  Currently, FDA looks at sugar by chemical content rather than by physiological effect; thus, there is currently no difference in the way “non-traditional” sugars like allulose, D-tagatose, and isomaltulose are declared on the NFP.
  • By way of background, in October 2020, FDA issued final guidance on the declaration of allulose on the NFP and Supplement Facts and its caloric content.  The Agency intends to exclude allulose from the Total Sugars and Added Sugars declarations on the NFP and Supplement Facts and use a general factor of 0.4 calories per gram (kcal/g) for allulose when calculating declarations.  Further, the Agency requested comments on the nutrition labeling of non-traditional sugars, which are metabolized differently (i.e., contribute fewer calories), are not associated with dental cavities, and lead to lower blood glucose and insulin levels after a meal than traditional sugars.
  • In its comments, the sugar industry argued that FDA’s proposed change would confuse and mislead consumers by indicating non-traditional sugars are healthier and that it fails to clarify that many non-traditional sugars are synthetically produced.  The sugar industry noted that, if non-traditional sugars like allulose are not listed on labels as sugars, then “allulose manufacturers should be precluded from referring to allulose as a ‘rare sugar’ or a ‘natural sugar.’”  We will continue to monitor any developments.