89 FR 159 pgs. 66727-66729 - 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Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry (Edition 2); Availability
Type: NOTICEVolume: 89Number: 159Pages: 66727 - 66729
Pages: 66727, 66728, 66729Docket number: [Docket No. FDA-2014-D-0055]
FR document: [FR Doc. 2024-18261 Filed 8-15-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
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Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry (Edition 2); Availability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.
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The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and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 The draft guidance, when finalized, will describe our views on the next voluntary goals (Phase II (3-year)) for sodium reduction in a variety of identified categories of foods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:
[top] Submit either electronic or written comments on the draft guidance by November 14, 2024 to ensure that we consider your comment on the draft
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.
[top] 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
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]
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