Search results for: allulose

  • Plaintiffs’ lawyers are continuing to file class action lawsuits alleging that “zero sugar” claims on products containing allulose are misleading consumers, with products ranging from dietary supplement gummies to candies to baking mixes being hit in the past week.
  • As we have previously blogged, FDA has stated its intent to exercise enforcement discretion for the exclusion of allulose from the amount of total and added sugars on the label. However, a recent federal court decision in Illinois found that because allulose is considered a sugar, its inclusion in a product precludes the product from being labeled with claims such as “zero sugar” or “no added sugar.”
  • Allulose is a monosaccharide that is used as a sugar substitute in various foods and beverages and that meets the definition of “sugar” in FDA’s nutrition labeling regulations at 21 CFR 101.9(c)(6)(ii). However, in FDA’s enforcement discretion guidance, the Agency explained that because allulose does not behave like other sugars in the body, it does not need to be declared as a sugar or added sugar. In FDA’s regulations governing the use of nutrient content claims for the calorie content of foods at 21 CFR 101.60, “sugar free” and “no added sugar” type claims may be made if, among other requirements, the food contains less than 0.5 g of sugar or no amount of sugars, respectively.
  • The recent lawsuits allege that reasonable consumers take the claims at face value and “wouldn’t know that allulose is an added sugar.” According to the plaintiffs, because allulose meets FDA’s definition of “sugar,” products containing the sweetener do not qualify for these claims.
  • One complaint references FDA’s enforcement discretion guidance but notes that the discretion “creates no rights and binds neither the agency nor the public” and is “pending a rulemaking that never occurred.” The plaintiff further alleges that FDA confirmed in an amicus brief in the decision cited above that the definition of sugar includes allulose and that “[a]n agency’s decision not to enforce its own regulation is not a federal ‘requirement’ . . . and it does not authorize a nutrient content claim that the regulation forbids.” Therefore, according to the plaintiff, FDA’s enforcement discretion does not permit companies to make such claims on products containing allulose.
  • Keller and Heckman will continue to report on lawsuits targeting sugar claims on products containing 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.
  • Starbucks is being sued over its “sugar-free” protein beverages (Law360 subscription required), which plaintiffs claim are deceptively labeled due to containing 13 to 21 g of sugar per venti-size beverage from naturally occurring lactose in milk.
  • According to the plaintiffs, Starbucks is misleading consumers seeking to reduce or avoid sugar by labeling its beverages as “sugar-free” despite containing up to 25 times the amount of sugar permitted in a product making that claim. In accordance with 21 CFR 101.60(c)(1), a “sugar-free” claim may only be made on a food that contains less than 0.5 g of sugar per reference amount customarily consumed.
  • The plaintiffs cited the recent Franco v. Chobani decision, in which the court determined that allulose is a sugar in accordance with FDA regulations, as we have previously blogged. There has been a large uptick in lawsuits targeting products that contain allulose and make “sugar-free” or “zero sugar” claims, highlighting the interest in these claims. Here, the products do not contain any allulose. According to the complaint, lactose’s status as a sugar is even more clear than allulose because FDA expressly lists lactose as a sugar in 21 CFR 101.9(c)(6)(ii).  Starbucks says the sugar in the protein drinks comes from the protein-boosted milk and Starbucks does not add sugar but uses a sugar-free syrup for flavor.
  • The complaint also alleges that Starbucks violates the mandatory calorie disclaimer for a food labeled as “sugar-free,” but clarifies that the “case is about false and misleading product names.”
  • Keller and Heckman will continue to report on lawsuits targeting sugar claims.
  • Another cereal company has been hit with a lawsuit (Law360 subscription required) for labeling its product using the claims “0g total sugars,” “0g added sugar” and “no added sugar” despite containing allulose. According to the lawsuit, Magic Spoon is “healthwashing” its cereal product, or making the product appear healthier than it is, by making these claims.
  • The lawsuit was filed in Illinois, where the Seventh United States Circuit Court of Appeals in June found that allulose is considered a sugar under federal regulations, as we previously blogged. According to the Court in that decision, because the inclusion of allulose in the calculation of sugars would cause the sugar content to exceed the “less than half a gram of sugar” requirement for a “sugar free” label, the product at issue—yogurt—did not qualify to use the claim.
  • Here, the plaintiff alleges that Magic Spoon’s labeling indicates that the cereals contain between five and ten grams of allulose per serving, depending on flavor. Thus, according to the plaintiff, the products do not qualify for a “sugar free” or “0g Total sugar” claim.
  • Notably, FDA has stated that it intends to exercise enforcement discretion for the exclusion of allulose from the amount of “total sugars” and “added sugars” on the label.
  • Keller and Heckman will continue to monitor this lawsuit and others that target sugar claims on products containing allulose.
  • On August 24, 2026, two more companies were sued over claims of “0g sugar” where the products contain “allulose.”
  • Earlier last month, the Seventh United States Circuit Court of Appeals in Illinois revived a proposed class action finding that allulose, a naturally occurring sweetener in yogurt, constitutes a sugar under federal regulations.  The inclusion of allulose in the calculation of sugars would disqualify the product from being labeled as “sugar free” because the sugar content would exceed the “less than a half gram of sugar” requirement for such a label.
  • FDA advises in its guidance The Declaration of Allulose and Calories from Allulose on nutrition and Supplement Facts Labels, it intend to exercise enforcement discretion for the exclusion of allulose from the amount of “Total Sugars” and “Added Sugars” declared on the label. For more information on FDA’s Final Guidance on Allulose, please see FDA Issues Final Guidance on Allulose and Solicits Information for Rulemaking on Nutrition Labeling for Sugars That are Metabolized Differently Than Traditional Sugars | The Daily Intake.
  • These similar arguments are now being brought in the Northern District of California and Central District of California over “0g Sugar’ claims on energy drinks and “Zero Added Sugar” claims on cereals.
  • All three cases are still in court.  Keller & Heckman will continue to monitor lawsuits that target sugar claims on products that contain allulose.
    • On Thursday, May 29, 2025, Judge John J. Tharp, Jr. at the U.S. District Court for the Northern District of Illinois filed an order granting Chobani’s motion to dismiss a class action lawsuit that alleged “Chobani Zero Sugar” yogurt was misbranded. Chobani’s yogurt contained allulose, a naturally occurring monosaccharide found in figs and raisins, which the plaintiffs argued made any “zero sugar” or “no sugar” claims misleading and deceptive.
    • In its defense, Chobani cited to the Temporary Marketing Permit (TMP) granted by FDA authorizing to the sale of its “Zero Sugar” yogurt that contained “nonnutritive sweeteners.” The Company also referenced FDA Guidance in which FDA stated the agency is exercising enforcement discretion by excluding allulose from the amount of “Total Sugars” on product labels.
    • FDA based its decision on data that showed allulose does not promote cavities, produces a negligible increase in glycemic and insulinemic responses, and substantially reduces the number of total calories in products in which it replaces added sugars.
    • The Court agreed with Chobani that though the guidance is nonbinding, it still represents FDA’s interpretation of how allulose is regulated under 21 C.F.R. § 101.9(c)(6)(ii). This view of the regulation is controlling if it is not “plainly erroneous” or inconsistent with the regulation itself. Because of this, the Court concluded the plaintiff’s claims are expressly preempted by federal law since allulose is not a sugar under the allulose guidance.
    • Keller and Heckman will continue to monitor litigation trends related to product labeling and marketing claims.
    • 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.