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:

                Search for FDA Guidance Documents

Search for FDA Guidance Documents

                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents Home
          Regulatory Information
          Search for FDA Guidance Documents
          Guidance for Industry: Dear Manufacturer Letter Regarding Front-of-Package SymbolsSearch for FDA Guidance Documents INDUSTRY LETTER
	Guidance for Industry: Dear Manufacturer Letter Regarding Front-of-Package Symbols
					
		
		December 2008


	 

    Final

	  
	  
	Share
    Post
    Linkedin

    Email
    PrintDocket Number:
		    FDA-2020-D-1924
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


Office of Nutrition, Labeling and Dietary Supplements
Food Labeling and Standards Staff, HFS-820
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
(Tel) 240-402-2375

*This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this document.*

Dear Manufacturer,

The U.S. Food and Drug Administration (FDA) is taking this opportunity to remind food manufacturers and distributors about current regulatory schemes and requirements with regard to nutrition claims in light of the expanding use in the marketplace of front-of-package symbols on food products.

FDA has been following the emergence of front-of-package symbols in the marketplace. These front-of-package symbols are associated with programs from sources including manufacturers, retailers, and third party organizations (e.g., trade and health organizations). The front-of-package symbols are intended to assist consumer choice by providing simplified information on the nutritional attributes of a food. The nutrient levels required for eligibility in the front-of-package symbol programs vary by program. With the increasingly widespread availability sof various front-of-package symbol programs it is possible that eligible food products could bear multiple front-of-package symbols that highlight several nutrients.

In 2007, FDA held a public hearing to solicit information about the criteria used for displaying front-of-package symbols, as well as, information regarding consumer experience with the front-of-package symbol programs currently in use. FDA is evaluating the information presented as part of the hearing docket. A webcast of the hearing is currently available.

While the agency continues to evaluate comments from the public hearing and consider whether any regulatory changes are necessary to ensure these claims are not false or misleading, FDA feels it is imperative to remind its constituents that front-of-package symbols can at times constitute nutrient content claims that are subject to the requirements of Title 21 Code of Federal Regulations (CFR) 101.13 and Subpart D of Part 101. Nutrient content claims are claims that directly or by implication characterize the level of a nutrient in a food (e.g., low fat, 100 calories) (21 CFR 101.13(b)). The requirements that govern the use of nutrient content claims (21 CFR 101.13 and Subpart D of Part 101) help ensure that claims are used consistently for all types of food products and are meaningful to consumers.

The regulations governing nutrient content claims describe other information that may be required to prevent a claim from being misleading. Nutrition labeling is required for any food for which a nutrient content claim is made (21 CFR 101.13(n)). A disclosure statement, a statement that calls the consumer's attention to one or more nutrients in the food that may increase the risk of a disease or health-related condition that is diet related, is required when a nutrient content claim is made on a food that contains more than 13.0 grams (g) of total fat, 4.0 g of saturated fat, 60 milligrams (mg) of cholesterol or 480 mg of sodium per reference amount customarily consumed (RACC), per labeled serving, or, for foods with small serving sizes, per 50 g (21 CFR 101.13(h)(1)). A disclaimer statement is also required for percent and amount claims when the claim implies a defined level and is not consistent with an established definition (21 CFR 101.13(i)(2)). Percent and amount disclaimers state that a food is not low in the nutrient or not a good source of the nutrient.

Front-of-package symbols that are viewed as explicit or implied nutrient content claims are subject to the requirements of 21 CFR 101.13 and Subpart D of Part 101. For example, a front-of-package symbol that states or implies that a food is a good source of calcium would need to meet the minimum nutrient content level for calcium in the RACC of the food in question (21 CFR 101.54 (c), 101.65 (c) and (d)). If the level of fat, saturated fat, cholesterol, or sodium in a food that includes such a nutrient content claim exceeds the disclosure levels specified for any of these nutrients in 21 CFR 101.13(h) the claim needs to be accompanied by a disclosure statement (21 CFR 101.13(h)(2)). If the front-of-package symbol includes a percent or amount claim that is placed in a context that implies that the food is a good source of fiber and the product does not contain at least 10 percent of the Daily Value for fiber, the label would need to carry the required disclaimer that the food is not a good source of fiber (21 CFR 101.13(i)).

Accurate food labeling information can assist consumers in making healthy nutritional choices. FDA recommends that manufacturers and distributors of food products that include front-of-package symbols ensure that these claims are consistent with FDA's current laws and regulations. We will notify manufacturers when we see any front-of-package symbols that are explicit or implied nutrient content claims that are not consistent with current requirements or where such front-of-package symbols are used in a manner that is false or misleading.

Sincerely,

Barbara O. Schneeman, Ph.D.
Director
Office of Nutrition, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
Food and Drug Administration

[1] This guidance has been prepared by the Office of Nutrition, Labeling and Dietary Supplements in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

Related Information

Labeling & Nutrition Guidance Documents & Regulatory InformationSubmit Comments
	   		  			    		Submit Comments Online
					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
						If unable to submit comments online, please mail written comments to:
						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2020-D-1924.

                                                                                  Content current as of:
      09/20/2018
         
                  
Regulated Product(s)
		 Food & BeveragesTopic(s)
			  LabelingSearch for FDA Guidance Documents

        Search for FDA Guidance Documents

          
                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents
 
 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