FDA Issues Draft Guidance Regarding Labeling of Allulose (the Monosaccharide That is Not a Sugar); More Guidance on Added Sugars to Follow

FDA’s nutrition labeling rules have defined most nutrients based on chemical structure.  However, in light of evidence on allulose, FDA may need to reconsider that focus.

Allulose is a monosaccharide, and the nutrition labeling regulation defines sugars as mono- and disaccharides.  Thus, under the regulations, allulose counts as a sugar.  However, as explained in three citizen petitions and in comments to FDA’s nutrition labeling regulation, allulose is a special type of monosaccharide.  Apparently, although allulose is a monosaccharide, it does not behave like one. Allulose does not have the metabolic properties of other mono-(and di-)saccharides, such as glucose and sucrose,  it contributes less than 0.4 kcal/gram (vs. 4 kcal/gram for sucrose), and does not raise blood sugar levels like other sugars.  Moreover, allulose is not cariogenic (i.e., it does not contribute to tooth decay).

On April 10, 2015, Tate & Lyle Ingredients America LLC (Tate & Lyle) submitted a Citizen Petition requesting that FDA amend the nutrition labeling regulation to exempt allulose from being included as a carbohydrate, sugar and added sugar in the nutrition facts box.  Tate & Lyle claimed that inclusion of allulose as carbohydrates and (added) sugar in the Nutrition Facts box would lead to confusion for consumers, especially consumers that monitor blood glucose levels such as consumers with diabetes.  Although the Petition had been submitted before FDA issued the revised nutrition labeling regulation, FDA did not decide on a possible exemption of allulose.  Instead, it concluded that allulose, as a monosaccharide, would need to be included in the amount of the declaration of “Total Carbohydrate,” “Total Sugars,” and “Added Sugars.”  The final rule also did not address the caloric value for allulose.

Subsequently, FDA received two additional Citizen Petitions, one by Tate & Lyle and one by Food Lawyers, requesting that FDA adjust the caloric value for allulose.

Based on of the Citizen Petitions and the scientific evidence, FDA recognizes that it may need to reconsider its focus on chemical structure in determining whether allulose is a sugar.  While it is pondering its best course of action, FDA has issued draft guidance announcing that FDA intends to exercise enforcement discretion to allow manufacturers to exclude allulose from total and added sugars declarations and to use 0.4 calories per gram of allulose when calculating the calories from allulose in a serving of a product.

Comments to the draft guidance must be submitted by June 17, 2019.

In the press release announcing the draft guidance, FDA mentioned that we can expect additional guidance regarding the new nutrition labeling requirements, including a guidance for added sugars labeling on packages and containers of honey, maple syrup and certain cranberry products.  With the mandatory compliance date of Jan. 1, 2020 looming, this is welcome news.