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U.S. Department of Health and Human Services

Food

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Guidance for Industry: Dear Manufacturer Letter Regarding Front-of-Package Symbols

 

December 2008

 

Additional copies are available from:
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
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) 301-436-2375 (Updated phone: 240-402-2375)
http://www.cfsan.fda.gov/guidance.html

You may submit written or electronic comments regarding this guidance at any time. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Nutrition, Labeling and Dietary Supplements
December 2008


Guidance for Industry[1]
Dear Manufacturer Letter Regarding Front-of-Package Symbols

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.