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


How to Comment

Submit electronic comments on to docket number FDA-2016-D-2335.

Submit written comments to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852. 
All comments should be identified with the docket number FDA-2016-D-2335.

For additional information on commenting, including details on making submissions with confidential information, see the Federal Register Notice.

Contains Nonbinding Recommendations

September 2016

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 for Industry (PDF 40KB)

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