Draft Guidance for Industry: The Use of an Alternate Name for Potassium Chloride in Food Labeling
Submit Comments by 09/17/2019
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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-2019-D-0892
- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Nutrition and Food Labeling
The purpose of this draft guidance is to advise food manufacturers of our intent to exercise enforcement discretion for declaration of the name "potassium chloride salt" in the ingredient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This draft guidance is consistent with FDA's Nutrition Innovation Strategy to reduce the burden of chronic disease in the United States through improved nutrition, by empowering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 This draft guidance is also consistent with FDA's previous activities to encourage manufacturers to reduce the sodium levels in food products in the interest of public health.
FDA's guidance documents, including this draft guidance, do not establish legally enforceable responsibilities.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.