The Use of an Alternate Name for 
Potassium Chloride in Food Labeling: 
Guidance for Industry  
 
 
Additional copies are available from: 
Office of Nutrition and Food Labeling 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740 
240-402-1450 
https://www.fda.gov/FoodGuidances 
 
 
You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to https://www.regulations.gov.  Submit written comments to the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.  All comments should be identified with the docket number 
FDA-2019-D-0892.  
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
December 2020    Contains Nonbinding Recommendations 
Table of Contents  
 
I. Introduction
   
II. Background
   
III. Guidance
 
IV.Paperwork Reduction Act of 1995
   
V. References
   
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  Contains Nonbinding Recommendations 
The Use of an Alternate Name for 
Potassium Chloride in Food Labeling: 
Guidance for Industry1 
 
 
  
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) 
on this topic.  It does not establish any rights for any person and is not binding on FDA or the 
public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff or Office 
responsible for this guidance as listed on the title page.  
 
 
I.  Introduction  
 
The purpose of this guidance is to advise food manufacturers of our intent to exercise 
enforcement discretion for declaration of the name potassium 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 some sodium chloride and may lead to reduced sodium intake.  
 
This guidance is consistent with FDAs 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.2,3  This guidance is also consistent with FDAs 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 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. 
                                                           
1 This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and 
Applied Nutrition at the U.S. Food and Drug Administration.   
2 FDA Nutrition Innovation Strategy.  March 2018.  https://www.fda.gov/Food/LabelingNutrition/ucm602651.htm.  
3 Healthy Innovation, Safer Families: FDAs 2018 Strategic Policy Roadmap: 
https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM592001.pdf (pg. 15). 
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II.  Background  
 
Under section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the label of 
food fabricated from two or more ingredients must bear the common or usual name of each 
ingredient.4  A common or usual name is the name by which an article is known to the American 
public.  Common or usual names are generally established by common usage, though in some 
cases they may be established by regulation pursuant to sections 403(a)(1), 403(i), and 701(a) of 
the FD&C Act.  See 21 CFR 102.5(d).5  
 
Salt is the common or usual name of sodium chloride.  See 21 CFR 101.22(h)(4).  Salt is 
defined as a usually whitish crystalline solid, chiefly sodium chloride, used extensively in 
ground or granulated form as a food seasoning and preservative.6  Thus, in the context of food, 
the name salt specifically refers to sodium chloride.  A salt is also defined as an ionic 
chemical compound formed by replacing all or part of the hydrogen ions of an acid with metal 
ions or other cations.7  Both sodium chloride and potassium chloride, in addition to other 
potassium- and sodium-containing food ingredients (e.g. potassium citrate, sodium lactate), are 
salts within this definition.  Although potassium chloride is a type of salt, the common or usual 
name for this ingredient is potassium chloride, as established by longstanding common usage. 
 
Americans consume on average 3,400 milligrams (mg) of sodium per day, nearly 50 percent 
more than the 2,300 mg/day limit recommended by Federal guidelines (Ref. 1).  Excess sodium 
intake increases risk for hypertension (Refs. 2, 3, 4, 5), a leading cause of heart disease and 
stroke, which in 2018 were the first and fifth leading causes of mortality in the United States, 
respectively (Ref. 6).  
 
Over 70 percent of sodium consumed comes from processed and prepared foods (Ref. 7).  Food 
manufacturers wishing to reduce sodium chloride in their products sometimes use substitute 
ingredients that provide similar taste and other technical functions of sodium chloride in foods.  
One such substitute ingredient that can be used across a number of food categories is potassium 
chloride (Ref. 8, 9, 10, 11).  Potassium chloride is also recognized as a substitute for sodium 
chloride by certain Codex standards (Ref. 12).  Potassium chloride is generally recognized as 
safe (GRAS) as a food ingredient when used under the conditions specified in 21 CFR 184.1622.  
These conditions include use as a flavor enhancer, flavoring agent, nutrient supplement, pH 
control agent, stabilizer, and thickener.  From a food technology perspective, sodium chloride 
and potassium chloride to a certain extent have similar taste and functions (e.g. preservation, 
moisture retention) (Ref. 13, 14, 15).  In most instances, potassium chloride is used as a partial 
substitute for sodium chloride.    
 
                                                           
4 See also 21 CFR 101.4(a)(1). 
5 When establishing a common or usual name by regulation, FDA considers the principles under 21 CFR 102.5(a)-
(c). 
6 The American Heritage Dictionary definition for salt.  Available online: 
https://www.ahdictionary.com/word/search.html?q=salt 
7 Id. 
 
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From a nutrition and public health perspective, the substitution of potassium chloride for sodium 
chloride is advantageous due to the over-consumption of sodium and under-consumption of 
potassium at the population level compared to federal recommendations.8  Increased potassium 
intake is associated with improved blood pressure control (Ref. 16).  The 2015-2020 Dietary 
Guidelines for Americans states that potassium is a nutrient of public health concern (Ref. 1).  
The average daily potassium intake in the U.S. is approximately 3,000 mg/day for men and 2,300 
mg/day for women (Ref. 17), but the Adequate Intake of potassium is 3,400 mg/day for men and 
2,600 mg/day for women (Ref. 2).  Potassium is therefore under-consumed in the U.S.   
 
III.  Guidance 
 
Potassium chloride, in some instances, can be used as a partial substitute for sodium chloride in 
food processing and manufacturing, and this use may help to reduce sodium in food.  FDA has 
considered whether declaration of alternate names for potassium chloride may signal to 
consumers that a potassium-based salt has been used as a substitute for sodium chloride in food.  
Such information may help facilitate consumers choices to decrease their sodium consumption.  
 
The alternate name potassium salt may help consumers understand the identity of potassium 
chloride and its use as a salt substitute.  The term salt conveys that the ingredient is a salt, 
similar to sodium chloride (declared as salt).  The term potassium identifies the ingredient as 
containing potassium.  Because potassium chloride does not appear to be generally known to 
consumers as a food ingredient (Ref. 18), FDA considers it unlikely that consumers would be 
confused by declaration of potassium salt when potassium chloride is used as an ingredient, or 
would believe that a different ingredient is present.  Further, because of the addition of the word 
potassium before salt, FDA believes that consumers are unlikely to confuse the ingredient 
with sodium chloride.  Inclusion of potassium in potassium salt should indicate to consumers 
that the ingredient is distinct from the ingredient commonly known and declared as salt.  
Therefore, it is unlikely that the alternate name will mislead consumers. 
 
In summary, FDA considers this approach appropriate in this specific circumstance due to: the 
important public health benefits for the U.S. population that could result from reduced sodium 
and increased potassium intake; the recognition that potassium chloride can substitute for sodium 
chloride in a variety of food manufacturing applications across a number of food categories; and 
the unlikelihood that the alternate name will mislead consumers. 
 
Thus, we consider it appropriate to exercise enforcement discretion for the declaration 
potassium salt in the place of potassium chloride in the ingredient statement of food labels 
when potassium chloride is used as an ingredient in the food. 
 
 
                                                           
8 Information regarding the potassium content of a product is available to consumers via the ingredient listing on 
food packages.  In addition, the updated Nutrition Facts label final rule issued by FDA in 2016 (81 FR 33742) and 
required on most food packages by January 2020, requires a declaration of potassium on the Nutrition Facts label  
both the absolute amount per serving as well as the percent Daily Value.  
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IV.  Paperwork Reduction Act of 1995 
This guidance contains no collection of information.  Therefore, clearance by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3521) is not required. 
 
However, this guidance refers to previously approved FDA collections of information.  These 
collections of information are subject to review by OMB under the PRA.  The collections of 
information in 21 CFR part 101 have been approved under OMB control number 0910-0381. 
 
V.  References 
The following references marked with an asterisk (*) are on display at the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday 
through Friday; they are also available electronically at https://www.regulations.gov.  References 
without asterisks are not on public display at https://www.regulations.gov because they have 
copyright restriction.  Some may be available at the website address, if listed.  References 
without asterisks are available for viewing only at the Dockets Management Staff.  FDA has 
verified the website addresses, as of the date this document publishes in the Federal Register, but 
websites are subject to change over time.  
1.  U.S. Department of Health and Human Services and U.S. Department of Agriculture.  2015  
2020 Dietary Guidelines for Americans.  8th Edition.  December 2015.  Available 
at https://health.gov/dietaryguidelines/2015/guidelines/, accessed December 9, 2020.* 
2.  National Academies of Sciences, Engineering, Medicine.  Dietary Reference Intakes for 
Sodium and Potassium.  Washington DC.  National Academies Press.  2019. 
3.  Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, et al.  Effects on 
blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension 
(DASH) diet.  DASHSodium Collaborative Research Group.  New England Journal of 
Medicine.  Jan. 4, 2001; 344(1): 310. 
4.  Graudal NA, Hubeck-Graudal T, Jurgens G.  Effects of low-sodium diet vs. high-sodium 
diet on blood pressure, renin, aldosterone, catecholamines, cholesterol, and triglyceride 
(Cochrane Review).  Am J Hypertens.  2012; 25(1):1-15.  PMID: 22068710. 
http://www.ncbi.nlm.nih.gov/pubmed/22068710, accessed December 9, 2020. 
5.  Eckel RH, Jakicic JM, Ard JD, de Jesus JM, Houston Miller N, Hubbard VS, et al.  2013 
AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the 
American College of Cardiology/American Heart Association Task Force on Practice 
Guidelines.  J Am Coll Cardiol.  2014; 63(25 Pt B):2960-84.  PMID: 24239922. 
http://www.ncbi.nlm.nih.gov/pubmed/24239922, accessed December 9, 2020. 
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6.  Xu JQ, Murphy SL, Kochanek KD, Arias E.  Mortality in the United States, 2018.  NCHS 
Data Brief, No. 355.  Hyattsville, MD: National Center for Health Statistics, Centers for 
Disease Control and Prevention, US Department of Health and Human Services; 2020.* 
7.  Harnack LJ, Cogswell ME, Shikany JM, Gardner CD, Gillespie C, Loria CM, Zhou X, Yuan 
K, Steffen LM.  Sources of Sodium in US Adults From 3 Geographic Regions.  
Circulation.  2017; 135:1775-1783. 
8.  Henney, JE, Taylor, CL, Boon, CS Ed.  Strategies to Reduce Sodium in the United States 
Institute of Medicine of the National Academies.  The National Academies Press, 
Washington D.C.  2010.  https://www.nap.edu/catalog/12818/strategies-to-reduce-sodium-
intake-in-the-united-states, accessed December 9, 2020. 
9.  Taylor C, Doyle M, Webb D.  The safety of sodium reduction in the food supply: A cross-
discipline balancing actWorkshop proceedings.  Critical Reviews in Food Science.  2018; 
58(10):1650-1659.  https://doi.org/10.1080/10408398.2016.1276431, accessed December 9, 
2020. 
10. Van Buren L, Dotsch-Klerk M, Seewi, G, Newson, RS  Dietary impact of adding potassium 
chloride to foods as a sodium reduction technique.  Nutrients 2016; 8:235. 
https://doi.org/10.3390/nu8040235, accessed December 9, 2020. 
11. Dotsch M, Busch, J, Batenburg, M, Liem, G, Tareilus, E, Mueller, R, Meijer, G.  Strategies 
to reduce sodium consumption: a food industry perspective.  Critical Reviews in Food 
Science and Nutrition. 2009; 49(10):841-851.  https://doi.org/10.1080/10408390903044297, 
accessed December 9, 2020. 
12. Related Standards, Codex Committee on Milk and Milk Products.  http://www.fao.org/fao-
who-codexalimentarius/committees/committee/related-standards/en/?committee=CCMMP, 
accessed December 9, 2020. 
13. Man, CMD.  Technical functions of salt in food products in Reducing Salt in Foods  
Practical Strategies.  Woodhead Publishing.  2007.  Pg. 157-173. 
https://app.knovel.com/hotlink/toc/id:kpRSFPS001/reducing-salt-in-foods/reducing-salt-in-
foods, accessed December 9, 2020. 
14. Kloss L, Meyer JD, Graeve L, Vetter W.  Sodium intake and its reduction by food 
reformulation in the European UnionA review.  NFS Journal.  2015; 1:9-19. 
http://dx.doi.org/10.1016/j.nfs.2015.03.001, accessed December 9, 2020. 
15. Buttriss, JL.  Food reformulation: the challenges to the food industry.  Proceedings of the 
Nutrition Society.  2012; 72(1):61-69.  https://doi.org/10.1017/S0029665112002868, 
accessed December 9, 2020. 
16. Jackson SL, Cogswell ME, Zhao L, Terry AL, Wang CY, Wright J, Coleman King SM, 
Bowman B, Chen TC, Merritt R, Loria CM.  Association Between Urinary Sodium and 
Potassium Excretion and Blood Pressure Among Adults in the United States.  Circulation.  
2018: 137:237246.  https://www.ncbi.nlm.nih.gov/pubmed/29021321, accessed 
December 9, 2020. 
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17. U.S. Department of Agriculture, Agricultural Research Service.  What We Eat in America, 
2013-2014.  2017.  https://ods.od.nih.gov/factsheets/Potassium-HealthProfessional/#en26, 
accessed December 9, 2020.*  
18. International Food Information Council Foundation.  Docket number FDA-2019-D-0892-
0056, The Use of an Alternate Name for Potassium Chloride in Food Labeling: Draft 
Guidance for Industry.  September 11, 2019.  https://foodinsight.org/kcl-research/, accessed 
December 9, 2020. 
 
 
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