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.

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 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:

• 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.” 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 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 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 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 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 https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov 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 dietary sodium sources.” Journal of the American College of Nutrition, 10(4) (Aug. 1991): pp. 383-393.

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3. 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 1/26/2021).*

4. 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 01/28/2021).

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6. Food and Drug Administration, “Memo: Survey of Microbiological Issues in FDA-Regulated Products” (2016).*

7. Food and Drug Administration, “Memo: Survey of Microbiological Issues in Meat and Poultry Products” (2016).*

8. Food and Drug Administration, “Memo: Salt Taste Preference and Sodium Alternatives” (2016).*

9. Food and Drug Administration, “Memo: Supplementary Target Development Example” (2016).*

10. Institute of Medicine. Strategies to Reduce Sodium Intake in the United States. Report Brief (April 2010). Washington DC: The National Academies Press.

11. National Salt Reduction Initiative Corporate Achievements. Available at: http://www1.nyc.gov/assets/doh/downloads/pdf/cardio/nsri-corporate-commitments.pdf (accessed 01/28/2021).

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15. Newberry SJ, Chung M, Anderson C, Fu W, Chen C, Tang A, Zhao N, Booth M, Marks J, Hollands S, Motala A, Larkin K, Shanman R, Hempel S., “Sodium and Potassium Intake: Effects on Chronic Disease Outcomes and Risks.” Comparative Effectiveness Review, No. 206 (June 2018). Southern California Evidence-based Practice Center for the Agency for Healthcare Research and Quality. Available at https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/cer-206-report-sodium-potassium-update.pdf (accessed 01/28/2021).*

16. Kochanek KD, Xu J, Arias E., “Mortality in the United States, 2019,” NCHS Data Brief, No. 395 (December 2020): National Center for Health Statistics, Centers for Disease Control and Prevention, U.S. Dept. of Health and Human Services.*

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18. Cogswell ME, Loria CM, Terry AL, Zhao L, Wang CY, Chen TC, Wright JD, Pfeiffer CM, Merritt R, Moy CS, Appel LJ., “Estimated 24-hour urinary sodium and potassium excretion in US adults.” Journal of the American Medical Association, 319(12) (March 27, 2018): pp. 1209-1220.

19. Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, et al., “Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet.” New England Journal of Medicine, 344(1) (Jan. 4, 2001): pp. 3-10.

20. He F, Li J, MacGregor G., “Effect of longer term modest salt reduction on blood pressure: Cochrane systematic review and meta-analysis of randomised trials.” BMJ, 346 (April 4, 2013).

21. Institute of Medicine. Dietary Reference Intakes for Water, Potassium, Sodium Chloride and Sulfate. 2005. Washington, DC: The National Academies Press.

22. Eckel RH, Jakicic JM, Ard JD, de Jesus JM, Houston Miller N, Hubbard VS, et al., “2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.” Journal of the American College of Cardiology, 2014;63(25 Pt B) (2014): pp. 2960-2084.

23. Dietary Guidelines Advisory Committee. Scientific Report of the 2020 Dietary Guidelines Advisory Committee: Advisory Report to the Secretary of Agriculture and the Secretary of Health and Human Services. 2020. Washington, DC: U.S. Department of Agriculture, Agricultural Research Service. Available at https://www.dietaryguidelines.gov/sites/default/files/2020-07/ScientificReport_of_the_2020DietaryGuidelinesAdvisoryCommittee_first-print.pdf (accessed 2/5/2021).*

24. World Health Organization (WHO). Guideline: Sodium intake for adults and children. 2012. Geneva: WHO Press. Available at https://www.who.int/publications/i/item/9789241504836 (accessed 01/28/2021).

25. Santos JA, Tekle D, Rosewarne E, Flexner N, Cobb L, Al-Jawaldeh A, Kim WJ, Breda J, Whiting S, Campbell N, Neal B, Webster J, Trieu K., “A Systematic Review of Salt Reduction Initiatives Around the World: A Midterm Evaluation of Progress Towards the 2025 Global Non-Communicable Diseases Salt Reduction Target.” Advances in Nutrition, nmab008 (March 7, 2021): p. 3.

26. McLaren L, Sumar N, Barberio AM, Trieu K, Lorenzetti DL, Tarasuk V, Webster J, Campbell NRC., “Population-level interventions in government jurisdictions for dietary sodium reduction.” Cochrane Database of Systematic Reviews, Issue 9 (Sept. 16, 2016).

27. Coxson PG, Cook NR, Joffres M, Hong Y, Orenstein D, Schmidt SM, Bibbins-Domingo K., “Mortality benefits from US population-wide reduction in sodium consumption: projections from 3 modeling approaches.” Hypertension, 61(3) (Feb. 11, 2013): pp. 564-570.

28. Pearson-Stuttard J, Kypridemos C, Collins B, Mozaffarian D, Huang Y, Bandosz P, Capewell S, Whitsel L, Wilde P, O'Flaherty M, Micha R., “Estimating the health and economic effects of the proposed US Food and Drug Administration voluntary sodium reformulation: Microsimulation cost-effectiveness analysis.” PLoS Medicine, 15(4) (April 10, 2018).

29. Smith-Spangler CM, Juusola JL, Enns EA, Owens DK, Garber AM., “Population strategies to decrease sodium intake and the burden of cardiovascular disease: a cost-effectiveness analysis.” Annals of Internal Medicine, 152(8) (April 20, 2010): pp. 481-487.

30. Dehmer SP, Cogswell ME, Ritchey MD, Hong Y, Maciosek MV, LaFrance AB, Roy K., “Health and Budgetary Impact of Achieving 10-Year U.S. Sodium Reduction Targets.” American Journal of Preventative Medicine, 2020 Aug; 59(2): 211-218.

31. National Salt and Sugar Reduction Initiative. Available at: https://www1.nyc.gov/site/doh/health/health-topics/national-salt-sugar-reduction-initiative.page (accessed 01/28/2021).

32. Webster JL, Dunford EK, Hawkes C, Neal BC., “Salt reduction initiatives around the world.” Journal of Hypertension, 29(6) (June 2011): pp. 1045-1050.

33. He FJ, Pombo-Rodrigues S, Macgregor GA., “Salt reduction in England from 2003 to 2011: its relationship to blood pressure, stroke and ischaemic heart disease mortality.” BMJ Open, 4(4) (April 14, 2014).

34. Public Health England, Salt Reduction Targets for 2024 (September 2020). Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/915406/2024_salt_reduction_targets_070920-FINAL-1.pdf (accessed 01/28/2021).

35. Health Canada, Sodium Reduction in Processed Foods in Canada: An Evaluation of Progress toward Voluntary Targets from 2012 to 2016. Available at: https://www.canada.ca/content/dam/hc-sc/documents/services/food-nutrition/legislation-guidelines/guidance-documents/guidance-food-industry-reducing-sodium-processed-foods-progress-report-2017/pub1-eng.pdf (accessed 01/28/2021).

36. Health Canada, Voluntary sodium reduction targets for processed foods 2020-2025. Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/healthy-eating/sodium/sodium-reduced-targets-2020-2025.html (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).*