Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                CFSAN Constituent Updates

CFSAN Constituent Updates Home
          Food
          News & Events from CFSAN
          CFSAN Constituent Updates
          FDA Issues Draft Guidance Regarding the Declaration of Allulose on the Nutrition Facts LabelCFSAN Constituent Updates FDA Issues Draft Guidance Regarding the Declaration of Allulose on the Nutrition Facts Label
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintConstituent Update

April 17, 2019

The U.S. Food and Drug Administration issued a draft guidance today to provide its current view on the declaration of carbohydrates, total sugars and added sugars for products that contain allulose, a sweetener, on the Nutrition Facts label. The draft guidance also provides FDA’s current view on calculating the caloric value of allulose. The guidance is designed to assist manufacturers in complying with the Nutrition Facts label requirements.

FDA is advising manufacturers that it intends to exercise enforcement discretion regarding the requirement that the sweetener allulose be included in the amount of Total Sugars and Added Sugars on the Nutrition Facts label. However, allulose still must be included in the amount of Total Carbohydrates. The draft guidance also advises manufacturers of its intent to exercise enforcement discretion regarding the use of 4 calories per gram of sweetener to calculate the caloric contribution of allulose and instead, allow manufacturers to use a caloric value of 0.4 calories per gram to calculate the caloric contribution of allulose.

Allulose is a low-calorie sweetener that is naturally occurring in small amounts in wheat, fruits such as raisins and dried figs, and in other sweet foods such as brown sugar and molasses. It can also be manufactured. While allulose has a chemical structure similar to other sugars, it is not metabolized by the body in the same way as most sugars and does not contribute the same number of calories.

Under FDA’s 2016 Nutrition Facts label rule, allulose must be included in declarations for Total Carbohydrates, Total Sugars, and Added Sugars. Current requirements also require allulose to be counted as 4 calories per gram of the sweetener. However, FDA stated in the final rule that additional time was needed to fully consider the science as to whether allulose should be excluded from these requirements. FDA has received several petitions related, in part, to whether allulose should be exempt from being included as a carbohydrate, sugar or added sugar and to the caloric value of allulose. This draft guidance conveys FDA’s current thinking regarding allulose.

FDA will soon release other guidance documents regarding FDA’s current views on the Nutrition Facts label requirements. As an example, FDA will finalize its draft guidance on declaring added sugars on honey, maple syrup and certain cranberry products.

Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register of the notice announcing the availability of the guidance to ensure that they are considered before work begins on the final guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2019-D-0725.

**For Additional Information:**

Federal Register Notice
	Draft Guidance for Industry: The Declaration of the Amount of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels

                                                                                  Content current as of:
      04/17/2019
              
              
Regulated Product(s)
		 Food & BeveragesCFSAN Constituent Updates
 Subscribe to CFSAN Constituent Updates
                        Get email updates delivered to your inbox.
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop