[Federal Register Volume 81, Number 106 (Thursday, June 2, 2016)]
[Notices]
[Pages 35363-35367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12950]


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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Prepared Foods; Draft Guidance for Industry; Availability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availability of a draft guidance entitled ``Voluntary Sodium Reduction 
Goals: Target Mean and Upper Bound Concentrations for Sodium in 
Commercially Processed, Packaged, and Prepared Foods.'' The draft 
guidance, when finalized, will describe our views on voluntary short-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. These goals are intended to address the 
excessive intake of sodium in the current population and promote 
improvements in public health.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on the 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on Issues 1 
through 4 listed in section IV of this document by August 31, 2016. 
Submit either electronic or written comments on Issues 5 through 8 
listed in section IV of this document by October 31, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are

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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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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; Draft Guidance for Industry.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Office of Food Additive Safety, Center for Food Safety and Applied 
Nutrition (HFS-255), Food and Drug Administration, 5100 Paint Branch 
Pkwy., 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 (HFS-255), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1376.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    Many expert advisory panels have concluded that scientific evidence 
supports the value of reducing sodium intake in the general population 
(Ref. 1). Recent analysis, including the findings of the 2013 Institute 
of Medicine (IOM) report, ``Sodium Intake in Populations: Assessment of 
Evidence'' (IOM report), continue to support this conclusion (Ref. 2). 
The 2013 IOM report confirmed a positive relationship between higher 
levels of sodium intake and the risk of heart disease, and found 
substantial evidence of population benefit and no evidence of negative 
health effects associated with reductions in sodium intake down to 
2,300 milligrams of sodium per day (mg/day) (Ref. 2). Members of the 
committee which authored the 2013 IOM report also clarified in a 
subsequent publication that different groups using a variety of methods 
and data have obtained results consistent with the committee's analysis 
that current U.S. intake is excessive, that it should be reduced, and 
that reduction is expected to have significant public health benefit 
(Ref. 3). Moreover, the 2015 Dietary Guidelines Advisory Committee 
Sodium Working Group examined the relationship between sodium and blood 
pressure and other cardiovascular outcomes in adults, as well as sodium 
and blood pressure in children. The Committee's recommendations 
concurred with previous reports that sodium intake among the U.S. 
population remains high and that higher levels of sodium intake are 
associated with increased blood pressure and risk of cardiovascular 
disease (Ref. 4).
    Multiple researchers have estimated the public health benefits 
associated with broad reduction in sodium intakes in the United States 
(Ref. 1). Reasonable reductions in average intake (modeled at a variety 
of intake levels below current intake, down to an average level of 
roughly 2,200 mg/day) have been estimated to result in tens of 
thousands fewer cases of heart disease and stroke each year, as well as 
billions of dollars in health care savings over time. A recent study 
(Ref. 5) used three epidemiological datasets to forecast the separate 
public health benefits of reducing the population's average sodium 
intake to 2,200 mg/day over 10 years. (This 2,200 mg/day final mean 
intake level was derived from intake values embedded in the sources of 
evidence used for the study.) Researchers found that this pattern of 
reduction would save between 280,000 and 500,000 premature deaths over 
10 years; sustained sodium reduction would prevent additional premature 
deaths.
    FDA is not conducting rulemaking with regard to sodium, and these 
goals are voluntary. Given the potentially significant benefits to 
public health, as well as FDA's role in safeguarding America's food 
supply and enabling consumers to choose healthy diets, we are committed 
to exploring effective and efficient strategies to promote sodium 
reduction in the food supply. We believe that these voluntary goals can 
be an effective means to achieve significant benefits to public health 
through sodium reduction in commercially processed, packaged, and 
prepared foods.

[[Page 35365]]

II. 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.'' (For purposes of this draft guidance, 
``commercially processed, packaged, and prepared foods'' refers to 
processed, multiple-ingredient foods that have been packaged by a 
member of the food industry for direct sale to consumers or for use in 
restaurants and similar retail food establishments including, but not 
limited to, restaurants, or for resale to other members of the food 
industry, as well as foods that are prepared by food establishments for 
direct consumption.) The draft guidance provides information to the 
food industry on sodium reduction, expressed as measurable voluntary 
goals for sodium content (from sodium chloride, commonly called 
``salt,'' as well as other sodium-containing ingredients) in 
commercially processed, packaged, and prepared foods. Approximately 75 
percent of sodium consumed by Americans is added to foods before they 
are sold (Ref. 6). Thus, the goals are intended to promote reductions 
in the amount of sodium added during processing, manufacturing, and 
preparation, especially for uses not necessary for microbial safety, 
stability, and/or physical integrity. We particularly encourage 
attention by food manufacturers whose products make up a significant 
proportion of national sales in one or more categories and restaurant 
chains that are national or regional in scope.
    Broad adoption of these voluntary recommendations by the industry 
members would create a meaningful reduction in population intake over 
time and support adjustment of consumer taste preferences. We recognize 
that many companies have initiated sodium reduction efforts and have 
made commitments on their own. The voluntary goals are intended to 
support ongoing efforts, including progress that has already been made 
by industry. This approach also builds on other efforts such as an 
initiative by New York City in partnership with local and State health 
departments and health organizations and international approaches from 
foreign governments such as Canada and the United Kingdom. The 
voluntary goals are intended to provide a shared framework for 
describing and analyzing the success of voluntary reduction efforts by 
various industry stakeholders and to promote continued discussion on 
sodium reduction opportunities. The guidance is intended to help 
achieve public health goals and see safe, gradual, and broadly 
distributed change over time across the full range of commercially 
processed, packaged, and prepared foods. To accomplish these goals, 
discussion and collaboration among FDA, Federal partners, the food 
industry, consumers, and other stakeholders will be essential.
    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 the FDA on this 
topic. It does not establish any rights for any person and is not 
binding on FDA or the public. You may use an alternate approach to 
reducing sodium as long as these approaches satisfy the requirements of 
the applicable statutes and regulations.
    The draft guidance provides our tentative views with respect to 
identifying challenging, yet feasible, target mean and upper bound 
concentrations of sodium (referred to in this document as ``sodium 
concentration goals'') across a wide variety of food categories. Our 
targets are based on our analysis of the current minimum and upper 
bound levels of sodium in a variety of identified food categories, 
available literature on the amount of salt needed for different 
functions in food, and discussions with experts on different food 
categories. Our milestone date for the short-term goals is the second 
year after publication of the final guidance. Our milestone date for 
the long-term goals is the 10th year after publication of the final 
guidance. The short-term targets are intended to be more easily 
achievable and as many as half of all products may already have 
achieved these interim targets. We recognize that the longer term 
targets are more difficult to achieve. We are aware that new 
ingredients capable of replacing some salt as well as other innovative 
strategies are being explored and more research and development may be 
needed. We also want to make clear that broader public health goals and 
maintenance of nutritional quality are important considerations in 
developing sodium reduction or reformulation strategies. For example, 
sodium reduction that relies on increases in added sugars would not be 
consistent with the public health goals of this guidance.
    The sodium concentration goals in this voluntary draft guidance are 
intended to:
     Support increased food choice for consumers seeking to 
consume a diverse diet that is consistent with recommendations of the 
2015-2020 Dietary Guidelines for Americans;
     support the 2015-2020 Dietary Guidelines and the Healthy 
People 2020 recommendations of less than 2,300 mg per day for many 
individuals;
     provide shared goals as metrics (mg/100g) for voluntary 
reduction efforts by various industry stakeholders;
     support successful efforts already underway in the private 
sector to reduce sodium content;
     focus on total amount of sodium in a given food as opposed 
to any individual sodium-containing ingredient; and
     support and extend industry's voluntary efforts to reduce 
sodium across the range of commercially processed, packaged, and 
prepared foods.
    This guidance does not:
     Recommend specific methods and technologies for sodium 
reduction;
     prescribe how much of any individual sodium-containing 
ingredient, such as salt or sodium nitrite, should be used in a 
formulation (in other words, we focus on the total amount of sodium in 
a given food);
     focus on foods that contain only naturally occurring 
sodium (e.g., milk); or
     address salt that individuals add to their food.
    As described in the notice ``Approaches to Reducing Sodium 
Consumption; Establishment of Dockets; Request for Comments, Data, and 
Information'' (76 FR 57050, September 15, 2011, referred to in this 
document as the 2011 request for comment), current sodium intake is 
substantially higher than what scientific and public health agencies 
and organizations have recommended in recent years. There have been a 
number of public and industry initiatives to reduce sodium intake, as 
well as initiatives in other countries (76 FR 57050 at 75051). In April 
2010, IOM released a report titled ``Strategies to Reduce Sodium Intake 
in the United States'' which concluded that sodium intake, with the 
greatest contribution from salt, remains well above recommended levels 
(Ref. 1).
    We recognize that a successful effort to reduce sodium intake 
requires information on a wide variety of topics, resulting from a 
genuine dialogue with all interested persons. To begin this dialogue, 
in 2011, FDA and the U.S. Department of Agriculture's (USDA's) Food 
Safety and Inspection Service (FSIS) opened parallel dockets for public 
comment and described the rationale for sodium intake reduction and 
identified 15 specific issues for

[[Page 35366]]

comment by all interested persons (76 FR 57050). These issues concerned 
multiple aspects of sodium reduction, including technical challenges 
and opportunities, implementation of reduction targets, and potential 
unintended consequences of reduction.
    In November 2011, FDA and FSIS, in conjunction with other Federal 
agencies interested in sodium reduction efforts, including the Centers 
for Disease Control and Prevention and USDA's Agricultural Research 
Service and Center for Nutrition Policy and Promotion, sponsored a 
public meeting to provide a forum for discussion of the issues raised 
in the 2011 request for comment. FDA and FSIS together received 
approximately 1,500 comments, which addressed the following key themes:
     The need for slow and gradual change;
     the importance of acknowledging technical and regulatory 
constraints;
     the need for consumer acceptance and market viability of 
new or reformulated products;
     the critical importance of maintaining a safe food supply;
     the potential health consequences of broad sodium 
reduction;
     the costs associated with broad reductions in sodium;
     the potential for positive incentives to promote 
reformulation; and
     reports of successful reduction efforts.
    We reviewed the comments submitted to the 2011 request for comments 
as well as other available information. In particular, we have 
considered the 2013 IOM report, ``Sodium Intake in Populations: 
Assessment of Evidence.'' The IOM report concluded that evidence from 
studies on direct health outcomes associated with sodium intake was 
sufficient to support reducing excessive sodium intake, noting a 
benefit for cardiovascular disease outcomes if population sodium intake 
came down to a level of 2,300 mg/day. Ultimately, this report 
reaffirmed the association between sodium intake and health outcomes, 
which supports the need to engage in population-based efforts to lower 
excessive dietary sodium intakes (Ref. 2).

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). 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 0910-0783.

IV. Issues for Consideration

    We developed the sodium targets using the best available 
representation of sodium in the food supply, based on product nutrition 
data from manufacturers and widely used sales data. We welcome comment 
on any issues related to the methods for developing the sodium targets 
and for implementation of this guidance. In particular, we are 
interested in comments on collecting and organizing these data into 
food categories, our methods for quantifying sodium content, 
refinements to the specific mean and upper bound targets based on 
adjustments of our category structures and data, and any challenges of 
implementing the voluntary goals. Please provide the reasoning behind 
your comments, including, where available, any data you may have.
    1. Are there categories where foods have been grouped together that 
should be separated on the basis of different manufacturing methods or 
technical effects relating to the potential for sodium reduction? 
Conversely, are there categories which could be merged due to similar 
sodium functionality and potential for reduction? Are there foods that 
contribute to sodium intake that we have not effectively captured? Are 
the categories amenable for use by restaurant chains and if not, how 
should they be modified to make them amenable for use by restaurant 
chains?
    2. Are the baseline sodium concentration values reasonably 
representative of the state of the food supply in 2010? For categories 
that do not appear representative, what food products are not 
adequately represented? Are there situations in which our method of 
quantification could lead to unrepresentative baseline values?
    3. Are there categories for which the 2-year target concentration 
goals are infeasible? If so, why are these targets not feasible, e.g., 
for technical reasons? What goals would be feasible in the short-term 
(2-year), and why? For reference, a supplementary memorandum to the 
docket is provided to further describe the type of information needed, 
``Target Development Example: Supplementary Memorandum to the Draft 
Guidance'' (Ref. 7).
    4. Are the short-term (2-year) timeframes for these goals 
achievable? If the timeframes are not achievable, what timeframes would 
be challenging, but still achievable?
    5. Are there categories for which the 10-year target concentration 
goals are infeasible? If so, why are these targets not feasible, e.g., 
for technical reasons? What goals would be feasible in the long-term 
(10-year), and why? For reference, a supplementary memorandum to the 
docket is provided to further describe the type of information needed, 
``Target Development Example: Supplementary Memorandum to the Draft 
Guidance'' (Ref. 7).
    6. Are the long-term (10-year) timeframes for these goals 
achievable? If the timeframes are not achievable, what timeframes would 
be challenging, but still achievable?
    7. What specific research needs or technological advances (if any) 
could enhance the food industry's ability to meet these goals? What are 
possible innovations in the area of sodium reduction and are there any 
unintended consequences associated with their use?
    8. What amendments to FDA's standard of identity regulations in 21 
CFR parts 130-169 are needed to facilitate sodium reduction by 
permitting alternative ingredients to be used in standardized foods? 
For example, amendments could include revisions to specific standards 
(e.g., cheese or cheese products) and to the general requirements for 
foods named by use of a nutrient content claim (e.g., ``reduced 
sodium'') and a standardized term under 21 CFR 130.10.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances, or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

VI. References

    The following references are on display in FDA's Division of 
Dockets Management (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 http://www.regulations.gov. 
FDA has verified the Web site addresses, but FDA is not responsible for 
any subsequent changes to Web sites after this document publishes in 
the Federal Register.

    1. IOM. ``Strategies to Reduce Sodium Intake in the United 
States,'' Washington DC: The National Academies Press (2010).
    2. IOM. ``Sodium Intake in Populations: Assessment of Evidence 
Institutes of

[[Page 35367]]

Medicine (IOM) Report,'' Washington DC: The National Academies Press 
(2013).
    3. Strom, B. L., C. A. M. Anderson, and J. H. Ix. ``Sodium 
Reduction in Populations: Insights From the Institute of Medicine 
Committee.'' Journal of the American Medical Association. July 3, 
2013; 310(1): 31-32.
    4. ``Scientific Report of the 2015 Dietary Guidelines Advisory 
Committee,'' Part B, Chapter 6. http://www.health.gov/dietaryguidelines/2015-scientific-report/. Accessed March 9, 2015.
    5. Coxson, P. G., N. R. Cook, M. Joffres, Y. Hong, et al. 
``Mortality Benefits From U.S. Population-Wide Reduction in Sodium 
Consumption.'' Hypertension. March 2013; 61:564-570.
    6. Mattes, R. D. and D. Donnelly. ``Relative Constitutions of 
Dietary Sodium Sources.'' Journal of the American College of 
Nutrition. August 1991;10(4):383-93.
    7. FDA. ``Memo: Target Development Example: Supplementary 
Memorandum to the Draft Guidance (2016).''

    Dated: May 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12950 Filed 6-1-16; 8:45 am]
 BILLING CODE 4164-01-P