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Draft Guidance for Industry: The Use of an Alternate Name for Potassium Chloride in Food Labeling May 2019


Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

May 2019

The purpose of this draft guidance is to advise food manufacturers of our intent to exercise enforcement discretion for declaration of the name "potassium chloride salt" in the ingredient statement on food labels as an alternative to the common or usual name "potassium chloride."

FDA intends to exercise this enforcement discretion to provide industry with greater flexibility when labeling their food products, including those that are formulated to reduce sodium content. This enforcement discretion may result in manufacturers using potassium chloride as a substitute ingredient for sodium chloride and lead to increased consumer understanding of the use of potassium chloride as a replacement for sodium chloride (i.e., salt).

This draft guidance is consistent with FDA's Nutrition Innovation Strategy to reduce the burden of chronic disease in the United States through improved nutrition, by empowering consumers with information, and supporting and fostering industry innovation in developing and promoting healthfulness of food options. This draft guidance is also consistent with FDA's previous activities to encourage manufacturers to reduce the sodium levels in food products in the interest of public health.

FDA's guidance documents, including this draft guidance, do not establish legally enforceable responsibilities.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Download the Draft Guidance

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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:

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-2019-D-0892.

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