Notice2024-18261
Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry (Edition 2); Availability
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Published
August 16, 2024
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The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2)." The draft guidance, when finalized, will describe our views on the next voluntary goals (Phase II (3-year)) for sodium reduction in a variety of identified categories of foods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 to help reduce the burden of diet-related chronic disease, promote improvements in public health, and advance health equity by supporting a healthier food supply.
Full Text
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<title>Federal Register, Volume 89 Issue 159 (Friday, August 16, 2024)</title>
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[Federal Register Volume 89, Number 159 (Friday, August 16, 2024)]
[Notices]
[Pages 66727-66729]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-18261]
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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Prepared Foods; Draft Guidance for Industry (Edition 2); Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice 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availability of a draft guidance for industry entitled ``Voluntary
Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for
Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition
2).'' The draft guidance, when finalized, will describe our views on
the next voluntary goals (Phase II (3-year)) 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 to help reduce
the burden of diet-related chronic disease, promote improvements in
public health, and advance health equity by supporting a healthier food
supply.
DATES: Submit either electronic or written comments on the draft
guidance by November 14, 2024 to ensure that we consider your comment
on the draft
[[Page 66728]]
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:
<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 (Edition 2).'' 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 draft guidance to
the Office of Food Additive Safety, 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: 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 Holli Kubicki, 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 draft guidance for industry
entitled ``Voluntary Sodium Reduction Goals: Target Mean and Upper
Bound Concentrations for Sodium in Commercially Processed, Packaged,
and Prepared Foods (Edition 2).'' 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.
Sodium is widely present in the American diet (most commonly, but
not exclusively, as a result of eating or drinking foods to which
sodium chloride, commonly referred to as ``salt,'' has been added).
More than 70 percent of total sodium intake is from sodium added during
food manufacturing and commercial food preparation (Ref. 1). The
average sodium intake for those 1 year and older in the United States
is approximately 3,400 milligrams/day (mg/day) (Ref 2). The ``Dietary
Guidelines for Americans, 2020-2025'' (Ref. 2) advises individuals 14
years and older to limit their consumption to 2,300 mg/day; this aligns
with recommendations from the National Academies of Sciences,
Engineering, and Medicine, which set the chronic disease risk reduction
intake for sodium at 2,300 mg/day for those 14 years and older (Ref.
3). The guidance aims to help Americans reduce average sodium intake to
2,750 mg/day (Phase II) by encouraging food manufacturers, restaurants,
and food service operations to gradually reduce sodium in a wide
variety of food categories over time. Although we recognize that a
reduction even to 2,750 mg/day still would be higher than the
recommended sodium limit of 2,300 mg/day, the Phase II 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.
In the Federal Register of October 14, 2021, we announced the
availability of the final guidance for industry, ``Voluntary Sodium
Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium
in Commercially Processed, Packaged, and Prepared Foods'' (86 FR
57156). The
[[Page 66729]]
draft guidance builds on the voluntary Phase I (2.5-year) sodium
reduction goals issued in October 2021. When finalized, the draft
guidance will describe our views on the next voluntary goals (Phase II
(3-year)) for sodium reduction in a variety of identified categories of
foods that are commercially processed, packaged, or prepared. The 3-
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. The
distribution of sodium concentrations in currently available products
in each category was a significant factor in developing these
quantitative sodium concentration goals. We developed the goals with a
particular emphasis on maintaining concentrations needed for food
safety, given the function of salt as a food preservative. The Phase II
goals are within the range of concentrations found in currently
marketed foods and are feasible using existing technical strategies.
We note that we do not intend to finalize the draft long-term (10-
year) sodium reduction goals that were included in the 2016 draft of
the first edition of the guidance that we announced in the Federal
Register of June 2, 2016 (81 FR 35363). We plan to announce any future
sodium reduction goals via draft guidance.
II. Paperwork Reduction Act of 1995
While the guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). 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 draft 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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Although FDA
verified the website addresses in this document, please note that
websites are subject to change over time.
1. Harnack L.J., M.E. Cogswell, J.M. Shikany, et al. ``Sources of
Sodium in U.S. Adults From 3 Geographic Regions.'' Circulation, 135
(May 9, 2017): pp. 1775-1783. Available at: <a href="https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.116.024446">https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.116.024446</a> (accessed
December 26, 2023).
2. U.S. Department of Agriculture and U.S. Department of Health and
Human Services. ``Dietary Guidelines for Americans, 2020-2025.'' 9th
Edition. December 2020. Available at: <a href="https://www.dietaryguidelines.gov/">https://www.dietaryguidelines.gov/</a> (accessed December 26, 2023).
3. National Academies of Sciences, Engineering, and Medicine.
``Dietary Reference Intakes for Sodium and Potassium'' (March 2019).
Washington, DC: The National Academies Press. Available at: <a href="http://www.nationalacademies.org/hmd/Reports/2019/dietary-reference-intakes-sodium-potassium.aspx">http://www.nationalacademies.org/hmd/Reports/2019/dietary-reference-intakes-sodium-potassium.aspx</a> (accessed December 26, 2023).
Dated: August 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18261 Filed 8-15-24; 8:45 am]
BILLING CODE 4164-01-P
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