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GUIDANCE DOCUMENT

Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products September 2016

Final

Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products

Docket Number:
FDA-2016-D-2335
Issued by:
Guidance Issuing Office
Office of Nutrition and Food Labeling

The purpose of this guidance is to advise manufacturers who wish to use the implied nutrient content claim “healthy” to label their food products as provided by our regulations.

More specifically, this guidance is intended to advise food manufacturers of our intent to exercise enforcement discretion relative to foods that use the implied nutrient content claim “healthy” on their labels which:

(1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or

(2) contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

This guidance is immediately effective because the agency has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)).

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

Download the Guidance

“Healthy” on Food Labeling


Submit Comments

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:

Division of Dockets Management (HFA- 305)
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-2016-D-2335.