Last week, the FDA released a draft guidance regarding the low calorie sweetener, allulose, and stated the agency will not treat this ingredient as contributing to total or added sugars content in the nutrition information.

In particular, FDA announced that it will exercise enforcement discretion to allow (1) the exclusion of allulose from the “total sugars” and “added sugars” declarations in the Nutrition Facts Panel, and (2) the use of a general factor of 0.4 calories per gram allulose when determining the caloric contribution of allulose.  FDA will continue to view allulose as a carbohydrate that must be included in the declaration of Total Carbohydrates.  FDA’s determination is based on the agency’s review of information and data submitted in several citizen petitions regarding allulose, as well as FDA’s independent review of the scientific evidence related to allulose and metabolism, caloric value, and dental caries.  FDA states it will exercise enforcement discretion as described above pending the agency’s further review of these issues through rulemaking.  This enforcement discretion applies to both conventional foods and dietary supplements containing allulose.

While the agency has traditionally determined “total sugars” based on chemical structure, FDA explains that due to advances in food technology, some novel sugars may not contribute 4 kcal/g like other traditional sugars.  In light of this, FDA’s current thinking is that the agency should not only consider the chemical structure of sugars, but other factors such as the sugar’s association with dental caries, effect on blood glucose and insulin levels, and caloric contribution, when determining whether a sugar should be included in the declaration of “total sugars,” and by extension, “added sugars” declarations on the label.  The draft guidance signals that the agency may be willing to consider additional factors beyond the chemical structure of a sugar in assessing whether such sugar should be captured in “total sugars” and “added sugars” declarations.

FDA states it considers allulose to be a carbohydrate and it therefore must be included in the “total carbohydrate” declaration.  FDA determined that the “total carbohydrate” declaration captures many ingredients that may not have a significant caloric contribution, and that the calculation method for “total carbohydrate” declarations continues to be appropriate when applied to allulose.  More information can be found at the draft guidance.  See FDA Draft Guidance, The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels, April 2019, available here.

Please let us know if you have any questions regarding FDA’s draft guidance.

 

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Photo of Martin Hahn Martin Hahn

Partner, Washington, DC

Martin Hahn uses his background in food technology and his comprehensive understanding of the laws governing the food industry to navigate clients through the myriad regulatory and business issues impacting the industry from farm to table. He recognizes the demands…

Partner, Washington, DC

Martin Hahn uses his background in food technology and his comprehensive understanding of the laws governing the food industry to navigate clients through the myriad regulatory and business issues impacting the industry from farm to table. He recognizes the demands placed on his clients and finds innovative and creative solutions, particularly when responding to observations raised by regulators  during inspections. Whether the issue involves obtaining the authorization of a new food or dietary ingredient, complying with manufacturing requirements, labeling or advertising, product recalls, or enforcement, Martin serves as an effective advisor and advocate.

Martin’s career has touched on almost every issue impacting the food industry. He has a comprehensive understanding of the laws affecting the labeling and advertising of foods, dietary supplements, infant formulas, medical foods, and foods for special dietary use. He helps clients anticipate new trends and develop the data that is needed to distinguish their products from others on the market. With his understanding of science and technology in the food industry, Martin provides assistance in obtaining regulatory authorizations to market new food ingredients, food packaging materials, and dietary ingredients. He also assists clients in responding to proposed regulations and draft guidance, as well as, tracks and keeps his clients apprised of the latest trends in class action law suits and helps clients anticipate new regulatory initiatives.

Martin grew up on a farm and worked in food processing plants before going to law school. His hands-on experience in the field and degree in food technology allow him to better understand the challenges his clients face in complying with the laws impacting food manufacturing. He understands Hazard Analysis Critical Control Point (HACCP) and the regulations under the Food Safety Modernization Act (FSMA).