Notice2021-22453
Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Guidance for Industry; Availability
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Published
October 14, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods." The guidance describes our views on voluntary short-term (2.5-year) goals for sodium reduction in a variety of identified categories of foods that are commercially processed, packaged, or prepared. These goals are intended to address the excessive intake of sodium in the current population and promote improvements in public health.
Full Text
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<title>Federal Register, Volume 86 Issue 196 (Thursday, October 14, 2021)</title>
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[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Pages 57156-57159]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-22453]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0055]
Voluntary Sodium Reduction Goals: Target Mean and Upper Bound
Concentrations for Sodium in Commercially Processed, Packaged, and
Prepared Foods; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice 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 ``Voluntary
Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for
Sodium in
[[Page 57157]]
Commercially Processed, Packaged, and Prepared Foods.'' The guidance
describes our views on voluntary short-term (2.5-year) goals for sodium
reduction in a variety of identified categories of foods that are
commercially processed, packaged, or prepared. These goals are intended
to address the excessive intake of sodium in the current population and
promote improvements in public health.
DATES: The announcement of the guidance is published in the Federal
Register on October 14, 2021.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2014-D-0055 for ``Voluntary Sodium Reduction Goals: Target Mean and
Upper Bound Concentrations for Sodium in Commercially Processed,
Packaged, and Prepared Foods.'' Received comments will be placed in the
docket and, except for those submitted as ''Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 guidance to the
Office of Food Additive Safety, Center for Food Safety and Applied
Nutrition (HFS-255), 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 guidance.
FOR FURTHER INFORMATION CONTACT: Kasey Heintz, Center for Food Safety
and Applied Nutrition, Office of Food Additive Safety, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1376;
or Deirdre Jurand, Center for Food Safety and Applied Nutrition, Office
of Regulations and Policy, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``Voluntary Sodium Reduction Goals: Target Mean and Upper
Bound Concentrations for Sodium in Commercially Processed, Packaged,
and Prepared Foods.'' 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 June 2, 2016 (81 FR 35363), we made
available a draft guidance for industry entitled ``Voluntary Sodium
Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium
in Commercially Processed, Packaged, and Prepared Foods.'' The draft
guidance described our tentative views on voluntary short-term and
long-term goals for sodium reduction in a variety of identified
categories of foods that are commercially processed, packaged, or
prepared. Section IV of the Federal Register notice, ``Issues for
Consideration,'' listed eight specific questions (or ``issues'') (81 FR
35363 at 35366). The comment period for issues related primarily to
short-term goals (Issues 1 through 4) was scheduled to close on August
31, 2016, and the comment period for issues related primarily to long-
term goals (Issues 5 through 8) was scheduled to close on October 31,
2016. In the Federal Register of August 30, 2017 (81 FR 59640), we
published a notice extending the comment period for Issues 1 through 4
until October 17, 2016, and for Issues 5 through 8 until December 2,
2016.
We received approximately 200 comments on the draft guidance. The
comments generally recognized and
[[Page 57158]]
supported the benefit of sodium reduction efforts for public health.
Many comments discussed the categories proposed in the draft guidance,
including requests for greater clarity on our approach to establishing
categories and suggestions for how certain categories should be
changed. The comments also discussed sodium reduction efforts
generally, including examples of successful sodium reduction across
product categories or portfolios, examples of sodium reduction
technologies, and examples of successful sodium reduction initiatives
in other countries and jurisdictions. Some comments emphasized the
barriers to sodium reduction, such as the time and cost associated with
product reformulation, the standards of identity limitations for
certain foods, and consumer preferences for certain kinds of
ingredients. Several comments also requested more time to achieve the
targets. Other general comments discussed the role of sodium in foods,
recommended that we establish a monitoring plan, and recommended that
we establish a comprehensive, national consumer education campaign for
sodium reduction.
After careful review of the comments, we have modified the guidance
to clarify the voluntary sodium targets, timeframe, product categories,
and descriptions. The guidance is intended to support an average sodium
intake reduction to 3,000 milligrams/day. In addition, we have extended
the milestone date for the short-term goals from 2 years to 2.5 years
from the publication of the final guidance. The 2.5-year goals are
intended to balance the need for broad and gradual reductions in sodium
and what is publicly known about technical and market constraints on
sodium reduction and reformulation. We are not finalizing the long-term
(10-year) sodium reduction targets discussed in the draft guidance at
this time. We revised the layout as well as category names and
descriptions of the sodium guidance target table to improve
understanding and provide additional clarity as to how foods should be
categorized, and made changes to categories where they were supported
by scientific data (e.g., we merged the ``Ready-to-Eat Cereal, Flakes''
category with the ``Ready-to-Eat Cereal, Puffed'' category and moved
Provolone cheese from the ``Monterey Jack and Other Semi-Soft Cheese''
category to the ``Pasta Filata Cheese (soft)'' category). We also made
technical corrections and editorial changes throughout the guidance to
improve clarity, and included more recent data in our references.
The guidance announced in this notice finalizes the draft guidance
with respect to the short-term sodium reduction goals.
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. The collections of information in 21 CFR 101.11 have
been approved under OMB control number 0910-0782.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 also are available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> because they have copyright
restriction or are not publications. Some may be available at the
website address, if listed. References without asterisks are available
for viewing only at the Dockets Management Staff or, in the case of
non-publication references, at any website listed. 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. Mattes RD and Donnelly D., ``Relative contributions of
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3. U.S. Department of Agriculture and U.S. Department of Health
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(2016).*
6. Food and Drug Administration, ``Memo: Survey of
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7. Food and Drug Administration, ``Memo: Survey of
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Development Example'' (2016).*
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15. Newberry SJ, Chung M, Anderson C, Fu W, Chen C, Tang A, Zhao
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Outcomes and Risks.'' Comparative Effectiveness Review, No. 206
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processed foods 2020-2025. Available at: <a href="https://www.canada.ca/en/health-canada/services/food-nutrition/healthy-eating/sodium/sodium-reduced-targets-2020-2025.html">https://www.canada.ca/en/health-canada/services/food-nutrition/healthy-eating/sodium/sodium-reduced-targets-2020-2025.html</a> (accessed 1/28/2021).
37. Food and Drug Administration, ``Memo: Documentation of
access to and use of updated data sources from what was used for the
draft Voluntary Sodium Reduction Goals Guidance'' (2019).*
Dated: October 8, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22453 Filed 10-13-21; 8:45 am]
BILLING CODE 4164-01-P
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