[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)]
[Proposed Rules]
[Pages 22749-22751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10401]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101 and 102

[Docket No. FDA-2019-D-0892]


The Use of an Alternate Name for Potassium Chloride in Food 
Labeling; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``The Use of an 
Alternate Name for Potassium Chloride in Food Labeling.'' The draft 
guidance, when finalized, will explain our intent to exercise 
enforcement discretion for the declaration of the name ``potassium 
chloride salt,'' as an alternative to ``potassium chloride,'' in the 
ingredient statement on the labels of foods that contain potassium 
chloride as an ingredient.

DATES: Submit either electronic or written comments on the draft 
guidance by July 19, 2019 to ensure that we consider your comment on 
the draft guidance before we begin work on the final version of the 
guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-0892 for ``The Use of an Alternate Name for Potassium 
Chloride in Food Labeling.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments

[[Page 22750]]

received, go to https://www.regulations.gov and insert the docket 
number, found in brackets in the heading of this document, into the 
``Search'' box and follow the prompts and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Office of Nutrition and Food Labeling, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740. Send two self-addressed adhesive labels to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Andrea Krause, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``The Use of an Alternate Name for Potassium Chloride in Food 
Labeling.'' We are issuing the draft guidance consistent with our good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA 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 alternate approach if it satisfies the 
requirements of the applicable statutes and regulations. This draft 
guidance is not subject to Executive Order 12866.
    This draft guidance, if finalized, is intended to explain to food 
manufacturers our intent to exercise enforcement discretion for the 
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.'' This flexibility in declaring potassium 
chloride in the ingredient statement on food labels may help inform 
consumers of the use of potassium chloride as at least a partial 
substitute for sodium chloride, thereby leading to the selection of 
foods with lower sodium content and decreasing the amount of sodium 
consumed. This draft guidance is consistent with FDA's Nutrition 
Innovation Strategy (accessed at https://www.fda.gov/food/labelingnutrition/ucm602651.htm) 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.
    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 
the ``2015-2020 Dietary Guidelines for Americans'' (Ref. 1). Over 70 
percent of sodium consumed comes from processed and prepared foods, 
which makes it difficult for consumers to control their sodium intake 
(Ref. 2). High levels of sodium intake are associated with increased 
blood pressure, which increases risk of cardiovascular disease (Refs. 3 
to 6); researchers have estimated that reductions in sodium intake have 
the potential to prevent tens of thousands of premature deaths and 
illnesses each year (Ref. 7). Thus, associations between sodium intake 
and health outcomes support the need to engage in population-based 
efforts to lower excessive dietary sodium intakes. This draft guidance, 
when finalized, may facilitate development of lower sodium food options 
and is consistent with our previous actions to encourage stakeholders 
to reduce sodium levels in food products.
    Sodium reduction techniques include the use of replacement 
ingredients to replicate the taste and preservative function of sodium 
chloride in foods. One such ingredient is potassium chloride. Potassium 
chloride is an ingredient that is generally recognized as safe when 
used under conditions specified in our regulations at 21 CFR 184.1622. 
The food industry has used potassium chloride to reduce sodium chloride 
in prepared and processed foods. In most instances, potassium chloride 
is used as a partial substitute for sodium chloride. Adequate potassium 
intake is beneficial in lowering blood pressure, and potassium intake 
is generally low in comparison to Federal recommendations (Refs. 8 and 
9).
    Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the 
label of a food fabricated from two or more ingredients must bear the 
common or usual name of each such ingredient (section 403(i)(2) of the 
FD&C Act (21 U.S.C. 343(i)(2))). 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. See 21 CFR 102.5(d). The common or 
usual name of potassium chloride has been established by common usage 
as ``potassium chloride.''
    The draft guidance takes into consideration a citizen petition from 
NuTek Food Science, dated June 27, 2016 (Docket No. FDA-2016-P-1826), 
requesting that we issue guidance recognizing ``potassium salt'' as an 
additional common or usual name for potassium chloride (Ref. 10). 
However, ``potassium salt'' is not a name in common usage for potassium 
chloride, and we are unaware of evidence that would support a 
regulation establishing ``potassium salt'' as the common or usual name.
    In contrast, the name ``potassium chloride salt'' may signal to 
consumers that potassium chloride is a substitute for salt. Informing 
consumers that potassium chloride is a substitute for sodium chloride 
(salt) could result in consumers selecting food options with less 
sodium. This, in turn, could encourage industry to continue to reduce 
sodium levels in processed foods by substituting potassium chloride for 
some sodium chloride, thereby decreasing overall sodium intake, 
increasing potassium intake, and benefitting public health. Because 
``potassium chloride salt'' includes the entire common or usual name of 
the ingredient, we consider it unlikely that consumers will confuse it 
with sodium chloride or other potassium-containing salts. Therefore, we 
tentatively intend to exercise enforcement discretion for the 
declaration of ``potassium chloride salt'' in the place of ``potassium 
chloride'' in the ingredient statement on labels of foods containing 
potassium chloride as an ingredient.

II. Other Issues for Consideration and Request for Information

    We will review any consumer data and other information that is 
submitted to us to determine whether ``potassium chloride salt'' has 
become an alternate common or usual name for potassium chloride in the 
future.
    We invite comment on the following questions. Please provide the 
reasoning behind your comments, including, where available, any data or 
other supporting information.
    1. How would use of the name ``potassium chloride salt'' in the 
ingredient statement as an alternative to ``potassium chloride'' 
improve consumer understanding of this ingredient? What other methods 
or approaches could improve consumer understanding? Please provide any 
relevant data or information to support your answer.

[[Page 22751]]

    2. What alternate names to ``potassium chloride salt'' would better 
promote consumer understanding of potassium chloride? Please provide 
any relevant data or information to support your answer.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

IV. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) 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 
Ed., December 2015. http://health.gov/dietaryguidelines/2015/guidelines/, accessed December 10, 2018.*
2. Harnack, L.J., M.E. Cogswell, J.M. Shikany, et al., ``Sources of 
Sodium in US Adults From 3 Geographic Regions.'' Circulation, 
135:1775-1783, 2017.
3. Institute of Medicine, ``Dietary Reference Intakes for Water, 
Potassium, Sodium Chloride and Sulfate.'' Washington DC: The 
National Academies Press. 2005.
4. Sacks, F.M., L.P. Svetkey, W.M. Vollmer, et al., ``Effects on 
Blood Pressure of Reduced Dietary Sodium and the Dietary Approaches 
to Stop Hypertension (DASH) diet.'' DASH--Sodium Collaborative 
Research Group. New England Journal of Medicine, 344(1): 3-10, 2001.
5. Graudal, N.A., T. Hubeck-Graudal, and G. J[uuml]rgens, ``Effects 
of Low-Sodium Diet vs. High-Sodium Diet on Blood Pressure, Renin, 
Aldosterone, Catecholamines, Cholesterol, and Triglyceride (Cochrane 
Review).'' American Journal of Hypertension, 25(1):1-15, 2012. PMID: 
22068710. http://www.ncbi.nlm.nih.gov/pubmed/22068710, accessed 
December 10, 2018.
6. Eckel, R.H., J.M. Jakicic, J.D. Ard, 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.'' Journal of the 
American College of Cardiology, 63(25 Pt B):2960-2984, 2014. PMID: 
24239922. http://www.ncbi.nlm.nih.gov/pubmed/24239922, accessed 
December 10, 2018.
7. Coxson, P.G., N.R. Cook, M. Joffres, et al., ``Mortality Benefits 
From US Population-wide Reduction in Sodium Consumption: Projections 
from 3 Modeling Approaches.'' Hypertension, 61:564-570, 2013.
8. U.S. Department of Agriculture and U.S. Department of Health and 
Human Services. ``Scientific Report of the 2015 Dietary Guidelines 
Advisory Committee,'' Part B, Chapter 6. http://www.health.gov/dietaryguidelines/2015-scientific-report/, accessed December 10, 
2018.*
9. Jackson, S.L., M.E. Cogswell, L. Zhao, et al., ``Association 
Between Urinary Sodium and Potassium Excretion and Blood Pressure 
Among Adults in the United States: National Health and Nutrition 
Examination Survey, 2014.'' Circulation, 137:237-246, 2018.
10. Petition from Brian L. Boor, President and Chief Operating 
Officer, NuTek Food Science, LLC, to Division of Dockets Management, 
Food and Drug Administration, Docket No. FDA-2016-P-1826, dated June 
27, 2016.*

    Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10401 Filed 5-17-19; 8:45 am]
 BILLING CODE 4164-01-P


