[Federal Register Volume 85, Number 244 (Friday, December 18, 2020)]
[Rules and Regulations]
[Pages 82332-82333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27750]


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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; 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 final guidance for industry entitled ``The Use of an 
Alternate Name for Potassium Chloride in Food Labeling.'' This guidance 
explains our intent to exercise enforcement discretion for the 
declaration of the name ``potassium salt,'' as an alternative to 
``potassium chloride,'' in the ingredient statement on the labels of 
foods that contain potassium chloride as an ingredient.

DATES: The announcement of the guidance is published in the Federal 
Register on December 18, 2020.

ADDRESSES: You may submit either electronic or written comments on FDA 
guidances 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, 240-
402-7500.
     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.govinfo.gov/content/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 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, 240-402-7500.
    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.

[[Page 82333]]


SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``The Use of an Alternate Name for Potassium Chloride in Food 
Labeling.'' We are issuing this guidance consistent with our good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
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 alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.
    In the Federal Register of May 20, 2019 (84 FR 22749), we made 
available a draft guidance for industry entitled ``The Use of an 
Alternate Name for Potassium Chloride in Food Labeling'' (``draft 
guidance''), which was 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.'' The draft guidance considered, in part, a NuTek Food 
Science citizen petition requesting that we issue guidance recognizing 
``potassium salt'' as an additional common or usual name for potassium 
chloride (see Citizen Petition from NuTek Food Science, LLC, dated June 
27, 2016, FDA-2016-P-1826-0001 at page 1). Additionally, we 
specifically invited comment on how the use of the name ``potassium 
chloride salt'' in the ingredient statement as an alternative to 
``potassium chloride'' would improve consumer understanding of the 
ingredient and what alternate names to ``potassium chloride salt'' 
would better promote consumer understanding of potassium chloride (84 
FR 22749 at 22750 through 22751). We gave interested parties until July 
19, 2019, to submit comments for us to consider before beginning work 
on the final version of the guidance.
    In response to requests for more time to comment on the draft 
guidance, we issued a notice in the Federal Register of July 10, 2019 
(84 FR 32848) extending the comment period to September 17, 2019. We 
received more than 70 comments on the draft guidance. Many comments 
expressed concerns that declaration of the alternate name ``potassium 
chloride salt'' would be confusing or would not achieve the public 
health goal of reduced sodium consumption, as food manufacturers would 
likely not use the alternate name. Food manufacturers, public health 
and consumer advocacy groups provided comments and data supporting 
``potassium salt'' as an alternate name to ``potassium chloride.''
    After careful review and consideration of the comments to the draft 
guidance, some of which led us to further review of relevant published 
literature, we have modified the final guidance. Changes to the 
guidance include:
     Exercising enforcement discretion for declaration of 
``potassium salt,'' rather than ``potassium chloride salt,'' in the 
ingredient statement on food labels as an alternative to declaration of 
the common or usual name ``potassium chloride;'' and
     Further explaining potassium chloride's technical role as 
a partial substitute for sodium chloride in food manufacturing through 
the inclusion of additional examples and references.
    As discussed in the final guidance, we have made these changes with 
the following considerations in mind: Potential public health benefits 
to the U.S. population 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.
    The guidance announced in this notice finalizes the draft guidance 
dated May 2019.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections 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 for this guidance. The previously approved 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.

III. Electronic Access

    Persons with access to the internet may obtain the 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.

    Dated: December 11, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27750 Filed 12-17-20; 8:45 am]
BILLING CODE 4164-01-P