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Use of the Term ‘Healthy’ in the Labeling of Human Food Products: Guidance for Industry; Availability

Use of the term ‘Healthy’ in Labeling Human Food Products – The FDA is seeking information and comments on this topic – In addition, FDA has received a citizen petition asking that the Agency “… update, among other things, … nutrient content claim regulations to be consistent with current federal dietary guidance. In particular, the petitioners request that FDA amend the regulation defining the nutrient content claim ‘healthy’ with respect to total fat intake and amend the regulation to emphasize whole foods and dietary patterns rather than specific nutrients …” – FDA has also issued a guidance for industry entitled “Use of the Term ‘Healthy’ in the Labeling of Human Food Products” which “… advises manufacturers who wish to use the implied nutrient content claim ‘healthy’ to label their food products as provided by [FDA’s] regulations. More specifically, the guidance advises food manufacturers of [FDA’s] intent to exercise enforcement discretion with respect to the implied nutrient content claim ‘healthy’ on foods that have a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of ‘low fat’, or that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D …”

Document Title: * The title of the September 27, 2016 FDA pre-publication Federal Register Final Rule is “Use of the Term ‘Healthy’ in the Labeling of Human Food Products: Guidance for Industry; Availability”
* The title of the September 27, 2016 FDA pre-publication Federal Register Proposed Rule is “Use of the Term ‘Healthy’ in the Labeling of Human Food Products; Request for Information and Comments”
* The title of the September 27, 2016 FDA CFSAN Constituent Update is “FDA to Redefine ‘Healthy’ Claim for Food Labeling”

Organization: The September 27, 2016 pre-publication Federal Register Final Rule and Proposed Rule were signed on September 23, 2016 by Leslie Kux who is the Associate FDA Commissioner for Policy

Source: * September 27, 2016 FDA pre-publication Federal Register Final Rule
* September 27, 2016 FDA pre-publication Federal Register Proposed Rule
* September 27, 2016 FDA CFSAN Constituent Update

Comments Due By: * Comments on FDA guidances may be submitted at any time
* Within 120 days of September 28, 2016 for the Proposed Rule

Web site: The September 27, 2016 FDA pre-publication Federal Register Final Rule is posted at
http://s3.amazonaws.com/public-inspection.federalregister.gov/2016-23367.pdf

The September 2016 FDA “Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products” is posted at
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm521690.htm

The September 27, 2016 FDA pre-publication Federal Register Proposed Rule is posted at
http://s3.amazonaws.com/public-inspection.federalregister.gov/2016-23365.pdf
* The FDA Final Rule and Proposed Rule are scheduled to be published in the Federal Register on September 28, 2016 and will be available at
http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR

The September 27, 2016 FDA CFSAN Constituent Update is posted at
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm520703.htm

Contact: Questions may be directed to Vincent de Jesus who is with the FDA Center for Food Safety and Applied Nutrition in College Park, Maryland at 240 402 1450; e-mail: Vincent.deJesus@FDA.HHS.gov

Summary: The text of the September 27, 2016 FDA CFSAN Constituent Update follows:

The U.S. Food and Drug Administration (FDA) today announced that it has started a public process to redefine the “healthy” nutrient content claim for food labeling. Redefining “healthy” is part of an overall plan to provide consumers with information and tools to enable them to easily and quickly make food choices consistent with public health recommendations and to encourage the development of healthier foods by the industry.

While FDA is considering how to redefine the term “healthy” as a nutrient content claim, food manufacturers can continue to use the term “healthy” on foods that meet the current regulatory definition. FDA is also issuing a guidance document stating that FDA does not intend to enforce the regulatory requirements for products that use the term if certain criteria described in the guidance document are met.

Public health recommendations for various nutrients have evolved, as reflected by the 2015-2020 Dietary Guidelines for Americans and the updated Nutrition Facts label. For example, healthy dietary patterns now focus on food groups, the type of fat rather than the total amount of fat consumed and now address added sugars in the diet. Also, the nutrients of public health concern that consumers aren’t getting enough of have changed. FDA is publishing a “request for information” to solicit public input as it redefines the term “healthy.” In addition, the Agency is planning other public forums to receive additional public input.

For more information:

* Federal Register Notice for the Guidance for Industry
http://www.federalregister.gov/documents/2016/09/28/2016-23367/guidance-for-industry-use-of-the-term-healthy-in-the-labeling-of-human-food-products
* Federal Register Notice for the Request for Information
http://www.federalregister.gov/documents/2016/09/28/2016-23365/use-of-the-term-healthy-in-the-labeling-of-human-food-products
* Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm521690.htm
* Blog: Making Sure ‘Healthy’ Means What It Says on Food Packages
http://blogs.fda.gov/fdavoice/
* “Healthy” on Food Labeling
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm520695.htm

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