[Federal Register Volume 89, Number 159 (Friday, August 16, 2024)]
[Notices]
[Pages 66727-66729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Prepared Foods; Draft Guidance for Industry (Edition 2); Availability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availability of a draft guidance for industry entitled ``Voluntary 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 The draft guidance, when finalized, will describe our views on 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DATES: Submit either electronic or written comments on the draft 
guidance by November 14, 2024 to ensure that we consider your comment 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:
     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-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 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 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 https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, 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 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. 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: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.116.024446 (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: https://www.dietaryguidelines.gov/ (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: http://www.nationalacademies.org/hmd/Reports/2019/dietary-reference-intakes-sodium-potassium.aspx (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