Allulose Is an Emerging Sweetener That Has It All

It is important, however, that consumers are not misled to believe the sweetener will have the same physiological effects of what has traditionally been defined as sugar. The examples that fall under the FDA’s current definition for “sugar” include monosaccharides like fructose, galactose, and glucose, as well as disaccharides. Further, the FDA’s definition of “added sugar” describes those that are added during the processing of foods or packaged alone as such. Under the Nutrition Facts and Supplement Facts Label final rule issued in 2016, a monosaccharide like allulose would, by default, be required to be listed as an Added Sugar under the Total Sugar listed on packages. In that final rule, however, the FDA stated that it needed more time to consider information provided in citizen petitions and in public comments regarding allulose.

One of the citizen petitions submitted by Calorie Control Council member company Tate & Lyle recommended exempting allulose from the 2016 proposed labeling requirements based on the following premises:

• Allulose is not metabolized like sugar;
• Allulose does not raise blood glucose levels;
• Allulose has negligible calories; and
• Labeling allulose as sugar will lead to confusion, especially for those with diabetes and consumers who may be otherwise monitoring their blood glucose levels.

In addition, the petition reminded that, “the FDA has previously provided labeling exemptions for two other foods where the Agency determined that the product did not provide metabolizable energy for humans (wax esters in orange roughy; 21 CFR part 101) and for not being considered a source of fat or calories and because it is not absorbed and thus not unavailable to the body (olestra; 61 FR 3118 at 3126).”

FDA Exemption from Total and Added Sugars

The FDA announced in the draft guidance its decision to exercise enforcement discretion for excluding allulose from the Total Sugars and Added Sugars declared on labels. The agency explained that Total Sugars have traditionally been determined based on chemical structure. However, “due to advances in food technology, novel sugars are now available that are not metabolized and that do not contribute 4 kcal/g to the diet like other traditional sugars. Consequently, we need to consider how information about sugars like allulose should be captured on the label.”

The FDA goes on to explain its current thinking, stating “… we should consider not only the chemical structure of sugars, but also other evidence including their association with dental caries, their effect on blood glucose and insulin levels, as well as their caloric contribution when determining whether a sugar should be included in the declaration of ‘total sugars’ on the label.”

Since allulose does not significantly impact glycemic and insulinemic responses, contributes far less than 4 kcal/g, and does not promote dental caries, the FDA intends to exercise enforcement discretion with respect to the exclusion of Total Sugars, and its subset of Added Sugars, including the % Daily Value declaration. However, the FDA determined that a physiological effect-based definition would not be appropriate for allulose under Total Carbohydrates because of the wide variety of physiological effects elicited by different types of carbohydrates (e.g., starch, dietary fiber, sugar alcohols, etc.), as opposed to the common effects shared by traditional sugars.

Larger Manufacturing Scope of Use

Now that FDA has clarified how the unique sugar substitute may be labeled in order to comply with the new Nutrition Facts label requirements, manufacturers are free to take advantage of the diverse technical functionalities of allulose. Whereas alternative sweeteners have been used for decades in beverages like diet soda, their application in foods that face freezing or baking temperatures has proven to be a more difficult challenge.