Federal Register, Volume 84 Issue 97 (Monday, May 20, 2019)

[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]

=======================================================================
-----------------------------------------------------------------------

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Labeling; Draft Guidance for Industry; Availability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.

-----------------------------------------------------------------------

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availability of a draft guidance for industry entitled ``The Use of an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 The draft
guidance, when finalized, will explain our intent to exercise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DATES: Submit either electronic or written comments on the draft
guidance by July 19, 2019 to ensure that we consider your comment on
the draft guidance before we begin work on the final version of the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