[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57050-57054]
From the Federal Register Online via the Government Printing Office
[FR Doc No: 2011-23753]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0400]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2011-0014]
Approaches to Reducing Sodium Consumption; Establishment of
Dockets; Request for Comments, Data, and Information
AGENCY: Food and Drug Administration, HHS; Food Safety and Inspection
Service, USDA.
ACTION: Notice; establishment of dockets; request for comments, data,
and information.
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SUMMARY: The Food and Drug Administration (FDA) and the Food Safety and
Inspection Service (FSIS) are announcing the establishment of dockets
to obtain comments, data, and evidence relevant to the dietary intake
of sodium as well as current and emerging approaches designed to
promote sodium reduction. FDA and FSIS are particularly interested in
research that will help both organizations understand current and
emerging practices by industry in sodium reduction in foods; current
consumer understanding of the role of sodium in hypertension and other
chronic illnesses, sodium consumption practices; motivation and
barriers in reducing sodium in their food intakes; and issues
associated with the development of targets for sodium reduction in
foods to promote reduction of excess sodium intake. Excess sodium
intake is linked to increased risk of heart disease and stroke. FDA and
FSIS recognize ongoing efforts by a number of members of the restaurant
and packaged food industries to reduce sodium and appreciate the
complexities of reducing sodium in foods. Continued input and support
from industry and other stakeholders are important to support further
progress on this significant public health issue.
DATES: Submit either electronic or written comments and data and
information by November 29, 2011.
ADDRESSES: FDA: Submit electronic comments and data and information to
http://www.regulations.gov. Submit written comments and data and
information to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
All submissions must include the Agency name and docket number FDA-
2011-N-0400.
FSIS: Submit electronic comments and data and information to http://www.regulations.gov. Submit written comments and data and information
to the Docket Clerk, U.S. Department of Agriculture, Food Safety and
Inspection Service, FSIS Docket Room, 1400 Independence Avenue, SW.,
Patriots Plaza 3, Mailstop 3782, Room 163A, Washington, DC 20250-3700.
All submissions must include the Agency name and docket number FSIS-
2011-0014.
FOR FURTHER INFORMATION CONTACT: FDA: Richard E. Bonnette, Center for
Food Safety and Applied Nutrition (HFS-255), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835,
240-402-1235.
FSIS: Rosalyn Murphy-Jenkins, Director, Labeling and Program
Delivery Division, Office of Policy and Program Development, Food
Safety and Inspection Service, U.S. Department of Agriculture, USDA,
FSIS, OPPD, LPDD Stop Code 3784, Patriots Plaza III, 8-161A, 1400
Independence Avenue, SW., Washington, DC 20250-3700.
SUPPLEMENTARY INFORMATION:
I. Background
Research shows that excess sodium consumption is a contributory
factor in the development of hypertension, which is a leading cause of
heart disease and stroke (Ref. 1), the first and fourth leading causes
of death in the United States, respectively (Ref. 2). Research also
shows that the increase in blood pressure seen with aging, common to
most Western countries, is not observed in populations that consume low
sodium diets (Refs. 3 and 4) and that the U.S. population consumes far
more sodium than recommended (Ref. 5 and 7). Moreover, dietary
reduction of sodium can lower blood pressure as has been demonstrated
in the Dietary Approaches to Stop Hypertension (DASH)-Sodium trial
(Ref. 6). Because over three-quarters of sodium in the diet of the U.S.
population is added during manufacturing of foods and preparation of
restaurant foods, reduction in sodium consumption in the United States
involves reduction in the sodium content of food in the U.S.
marketplace (Refs. 5 and 7).
In this document, we refer primarily to ``sodium,'' a component of
sodium chloride, commonly known as ``salt.'' Most but not all sodium is
added to food in the form of salt and we are interested in all sources
of sodium added to foods. The comments, data, and evidence regarding
sodium reduction obtained by the establishment of these dockets will
provide important information about current and emerging practices and
approaches designed to reduce excess sodium intake, primarily coming
from salt.
A. Sodium: Current and Recommended Intake
According to national food survey data from the ``What We Eat in
America, National Health and Nutrition Examination Survey (NHANES)
2007-2008,'' estimated average sodium intake from foods among persons
in the United States aged 2 years or older is approximately 3,300
milligrams per day (mg/d) (excluding salt added at the table) (Ref. 8).
Most of this sodium comes from salt used in the manufacture or
preparation of foods (Ref. 9). In 2005, the IOM set a Tolerable Upper
Intake Level (UL) for sodium at 2,300 mg/d and an Adequate Intake (AI)
at 1,500 mg/d for those 9 to 50 years of age, including pregnant and
lactating women (AIs are lower for those 0-8 years of age and for those
over 50 years of age) (Ref. 1). The 2010 Dietary Guidelines for
Americans recommendations are to ``reduce daily sodium intake to less
than 2,300 milligrams (mg) and further reduce intake to 1,500 mg among
persons who are 51 and older and those of any age who are African
American or have hypertension, diabetes, or chronic kidney disease.''
The 1,500 mg recommendation applies to about half of the U.S.
population (Ref. 7). Current sodium intake is substantially higher
[[Page 57051]]
than what has been recommended by scientific and public health agencies
and organizations in recent years. The Centers for Disease Control and
Prevention (CDC) reported in 2010 that over 80 percent of adults (>=20
years) recommended to consume less than 2,300 mg/d of sodium in fact
consumed more than 2,300 mg/d (Ref. 10).
The 2010 Dietary Guidelines for Americans also stated that ``Given
the current U.S. marketplace and the resulting excessive high sodium
intake, it is challenging to meet even the less than 2,300 mg
recommendation'' and that a concerted effort is needed to reduce sodium
in foods to help consumers meet the levels recommended (Ref. 7).
An analysis of the potential savings from reduced sodium
consumption in the U.S. adult population found that reducing average
dietary sodium intake to 2,300 mg/d among adults 18 years or older
could have substantial health and financial benefits. Estimates showed
potential reduction of 11 million hypertension cases and an annual
savings of $18 billion health care costs (Ref. 11). Another assessment
on the cost-effectiveness of reducing sodium intake found that an
intervention achieving a reduction of 1,200 mg/d would save $10 to $24
billion in health care costs annually, comparable to benefits of
population-wide reductions in tobacco use, obesity, and cholesterol
levels (Ref. 12). Furthermore, this analysis found that a modest
reduction over 10 years of about 400 mg sodium/d would be more cost-
effective than using medications to lower blood pressure in all persons
with hypertension (Ref. 12).
B. Public and Industry Initiatives to Reduce Sodium Intake
Since 1980, the U.S. Department of Agriculture (USDA) and the U.S.
Department of Health and Human Services (HHS) have made recommendations
in the Dietary Guidelines for Americans, including ``avoid too much
sodium,'' ``use salt and sodium only in moderation,'' and ``choose and
prepare foods with less salt'' (Refs. 7 and 13 through 17).
FDA has supported these recommendations with a variety of
initiatives designed to promote informed choices on the part of
consumers. In 1984, FDA required that information on sodium be included
on the label whenever nutrition information appeared on food labels (49
FR 15510, April 18, 1984). In 1990, Congress enacted the Nutrition
Labeling and Education Act (NLEA), which mandated nutrition labeling of
food. In response to the NLEA, in 1993 FDA issued regulations requiring
the declaration of sodium in absolute amounts and as a percentage of
the Daily Value (58 FR 2206, January 6, 1993). FDA has also established
standards for sodium-related nutrient content and health claims (e.g.,
21 CFR 101.13; 21 CFR 101.14; 21 CFR 101.61; 21 CFR 101.74).
Furthermore, under section 403(q)(5)(H)(ii)(III) of the Federal Food,
Drug, and Cosmetic Act, as amended by the Patient Protection and
Affordable Care Act of 2010, certain restaurants and similar retail
food establishments must provide, upon request, written nutrition
information, which includes sodium content, for standard menu items.
Additional efforts by FDA have included consumer education initiatives
such as a joint sodium education initiative in 1981 with the National
Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of
Health (NIH) as part of the National High Blood Pressure Education
Program (Ref. 18), and a November 29, 2007, public hearing concerning
policies regarding salt and sodium in food (72 FR 59973, October 23,
2007). At the hearing, there was general agreement that the levels of
sodium in food are too high, but there was no consensus regarding
approaches for reducing the levels of sodium in food (Ref. 19).
FSIS, the agency responsible for nutrition labeling requirements
for meat and poultry products, also coordinates and collaborates with
FDA on nutrition labeling issues. In 1993, FSIS issued regulations
establishing nutrition labeling requirements for meat and poultry
products (9 CFR 317, part 381, subpart Y). These regulations, similar
to FDA's nutrition labeling regulations, required the declaration of
sodium in absolute amounts and as a percentage of the Daily Value on
the labeling of nonexempted meat and poultry products. In December
2010, FSIS issued regulations to ensure nutrition labeling of the major
cuts of single-ingredient, raw meat and poultry products on labels or
at point-of-purchase, unless an exemption applies (75 FR 82148,
December 29, 2010). These regulations also require nutrition labels on
all ground or chopped meat and poultry products, with or without added
seasonings, unless an exemption applies. Thus, these regulations
increase the type of meat and poultry products that must declare sodium
in absolute amounts and as a percentage of the Daily Value in their
labeling.
Other U.S. public health agencies and organizations have also
sought to inform consumers and encourage reduced sodium intake. In
addition to conveying the benefits of reducing sodium related to
hypertension through professional and consumer education activities,
the NHLBI published guidelines recommending a sodium intake of no more
than 2,400 mg/d dating back to 1993 (Refs. 20 through 26). More
recently, the CDC has provided funding to various states and
communities across the country in support of sodium reduction efforts
to help create healthier food environments and reduce sodium intake by
the population (Ref. 27). In addition, USDA, through the nutrition
programs of the Center for Nutrition Policy and Promotion, promotes
consumer messages related to sodium reductions via the interactive,
web-based dietary assessment and weight management resources at
ChooseMyPlate.gov, as well as through its MyPlate 2010 Dietary
Guidelines for Americans consumer communications initiative and
Consumer Brochure.
In 2008, the New York City Department of Health and Mental Hygiene
initiated the National Sodium Reduction Initiative (NSRI), a
partnership of 70 local and state health departments and health
organizations, which has set targets to reduce sodium in restaurant and
processed foods (Ref. 28). The goal of NSRI is to decrease average
sodium intake by 20 percent over 5 years (2009 through 2014) by
developing stepwise reductions from 2009 base levels to those desired
by 2014. To-date, 28 companies have responded to NSRI, committing to
reductions in the sodium content of some of their products.
These initiatives have been accompanied by efforts by industry,
where a number of companies have played, and continue to play, a
leadership role. Many food companies recognize that reduction of sodium
in the American diet is an important public health issue. Some major
food manufacturers have publicly committed to reducing the sodium
content of their products over time. Certain companies have voluntarily
identified specific product goals for sodium reduction. Many have
demonstrated that substantial reductions in sodium can be achieved in
certain food products and have established research programs to address
key issues such as taste preference, technological advances, safety,
and consumer acceptance in working through challenges and gaps in
knowledge.
Other countries are also engaged in sodium reduction activities
(Refs. 29 and 30).
[[Page 57052]]
C. Institute of Medicine of the National Academies--Report on
Strategies To Reduce Sodium
In April 2010, the IOM released a report entitled ``Strategies to
Reduce Sodium Intake in the United States.'' The report concluded that
sodium intake, with the greatest contribution from salt, remains well
above recommended levels despite several decades of education,
labeling, and outreach efforts to reduce sodium consumption in the
United States (Ref. 5). In the report, the committee considered past
and current sodium reduction initiatives, consumer preference, the
functional roles of sodium in food, research needs, regulatory options,
and nutrition labeling in developing its recommendations. The IOM
report acknowledged a number of complicating factors in reducing sodium
in food. Although sodium primarily plays a role in altering taste, the
IOM report noted that sodium chloride and other sodium-containing
ingredients play a critical role in food safety by reducing the growth
of pathogens thereby improving safety and shelf-life. In addition,
these compounds provide functional and physical properties such as
improving texture, controlling stickiness, and improving meltability.
Among other things, the IOM report noted that more research is needed
to develop and implement new technologies for sodium reduction and
discussed the role of voluntary action by industry.
D. Sources and Function of Sodium in the Typical Diet
According to data presented to the IOM committee during the March
2009 public information gathering workshop (see Appendix L of the IOM
Sodium Report), approximately 75 percent of the total sodium intake for
most individuals is attributed to salt added as an ingredient or
processing aid to processed and restaurant foods (Ref. 5). Sodium in
the form of salt is added to food for many reasons. For example, salt
functions as a seasoning agent and flavor-enhancer, a preservative and
curing agent, a formulating and processing aid, and a dough conditioner
(Ref. 5). Salt added at the table and in cooking provides only a small
proportion of the total sodium that Americans consume (Ref. 9). A
number of other sodium-containing ingredients contribute to sodium
intake in lesser amounts (<1 percent) (Ref. 31). Some examples include
sodium alginate, which alters viscosity; sodium phosphates, which bind
liquid to reduce purge, in particular for solution-enhanced meat and
poultry products; sodium sulfite, sodium nitrite, and sodium benzoate,
which preserve food and inhibit microbial growth; and sodium lactate,
diacetate, and acetate, which are dual purpose for flavoring and
antimicrobial (pathogen reduction) purposes (Ref. 32). Non-sodium forms
of these ingredients, which replace sodium with compounds such as
potassium, calcium, and magnesium, are also available for some of these
applications (Ref. 31).
According to the National Cancer Institute (NCI), individual and
mixed foods contributing the highest proportion of sodium to the U.S.
diet include yeast breads (250 mg/d), chicken and chicken mixed dishes
(233 mg/d), pizza (217 mg/d), pasta and pasta dishes (174 mg/d), and
cold cuts (155 mg/d) (Ref. 33). The CDC reported that close to 40
percent of daily sodium intake comes from grain-based products, such as
breads, cakes, cookies, and crackers, and that almost 30 percent comes
from processed meat products, such as bacon, sausage, lunch meat,
poultry, and fish mixtures (Ref. 10). Sodium occurs naturally in nearly
all foods; however this intrinsic sodium is not a significant dietary
contributor for most Americans. Essentially, any single-ingredient food
is low in sodium.
E. Sodium Reduction Opportunities
FDA and FSIS are considering potential ways to promote gradual,
achievable and sustainable reduction of sodium intake over time.
Research on a variety of issues, including the development of possible
targets for the reduction of the sodium content of foods, is needed to
assist FDA and FSIS in this effort. Sodium-containing food ingredients
are used for multiple purposes at variable levels in diverse foods. The
sodium intake of the U.S. population reflects both the sodium levels of
individual foods and the amounts of foods consumed. As such, there are
a variety of factors that may inform judgments about appropriate
opportunities for sodium reduction. These factors include:
1. The important role that sodium has in food safety with respect
to limiting microbial growth and maintaining the shelf-life of some
foods;
2. The effect of sodium reduction on the physical attributes (e.g.,
consistency, texture, shape, form) of some foods in ways that may
impact consumer acceptance or food processing and manufacturing
practices;
3. The feasibility, practicality, and cost of reducing sodium in
various food categories;
4. The magnitude (time and percent sodium reduction) of any gradual
or stepwise reduction effort;
5. The need to act gradually in a manner that is acceptable to
consumers, while also achieving significant sodium reduction, because
taste preference for sodium is acquired and can be modified (Refs. 34
and 35).
II. Establishment of a Docket and Request for Specific Input on Certain
Topics
FDA and FSIS are establishing dockets to provide an opportunity for
interested persons to submit comments, research, data, and other
information that will better inform them about current and emerging
practices by the private sector in sodium reduction; current consumer
understanding of the role of sodium in hypertension and other chronic
illnesses; sodium consumption practices; motivation and barriers in
reducing sodium in their food intakes; and issues associated with the
development of targets for sodium reduction in foods to promote
reduction in excess sodium intake. In particular, both agencies welcome
input on the following matters:
1. Comments and research related to recent sodium reduction
initiatives by industry and the effects of those initiatives;
2. Comments and research related to consumer understanding of the
role of sodium in hypertension and other chronic illnesses, sodium
consumption practices, and motivation and barriers in reducing sodium
in their food intakes;
3. Comments and research related to effective strategies for
sustainable and meaningful reduction of sodium in foods sold in
packaged or prepared form across the food supply, including and in
particular foods with a high sales volume;
4. Comments and research related to existing or potential positive
incentives for innovation in reformulating packaged and restaurant
foods to reduce added sodium;
5. Comments and research related to the recommendations from the
April 2010 IOM Sodium report on ``Strategies to Reduce Sodium Intake in
the United States,'' including research related to information gaps
identified in the IOM report (taste preferences for sodium,
technological role of sodium/salt, role of food matrix, food safety,
etc.);
6. Comments and research related to the following: (a) Methods for
establishing sodium reduction targets, including information on general
target design (e.g., setting sodium reduction targets based on food
categories, serving size, or formulations), (b) step-wise
[[Page 57053]]
approaches to achieve sustainable sodium reductions and timeframes for
achieving such reductions, and (c) methods for evaluating the impact of
a sodium reduction strategy;
7. Comments and research related to avoiding potential unintended
consequences for food safety, nutrition (including effects on added
sugars or solid fats), or food manufacturing technologies that could
result from interventions to reduce sodium;
8. Comments and research related to existing voluntary sodium
reduction efforts, including the voluntary sodium reduction targets set
by the New York City-initiated NSRI partnership, and their
applicability to a potentential federal sodium reduction initiative;
9. Comments and research related to food formulation, processing,
production, and other technology that could lead to meaningful and
sustainable reductions in the amount of sodium in food, including
specific food categories, targets, and methods to monitor;
10. Comments and research on the role that food standards of
identity play in promoting or limiting the feasibility of sodium
reduction of foods (among other things, standards of identity for
certain foods define the nature of those foods, generally in terms of
how those foods are prepared, the types of ingredients that they must
contain (i.e., mandatory ingredients) and that they may contain (i.e.,
optional ingredients), and how those foods must be labeled (Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 341); the Federal Meat
Inspection Act (21 U.S.C. 607(c)); and the Poultry Products Inspection
Act (21 U.S.C. 457(b)));
11. Comments and research on any advantages of sodium to consumers,
including but not limited to, food safety, nutrition, and palatability;
12. Comments and research on the economic impacts of reducing
sodium, including but not limited to, the cost of food, agricultural
production, small businesses, jobs, and the health care system;
13. Comments and research on the impact of sodium reduction
initiatives on consumer food choices and compliance with 2010 Dietary
Guidelines for Americans recommendations;
14. Comments and research related to how consumers respond to
sodium reductions (i.e., adding back salt to foods, consumption of
reformulated products); and
15. Comments and research related to effective methods for
communicating to the public the health benefits associated with the
sodium intake levels recommended by the 2010 Dietary Guidelines for
Americans.
We anticipate that some interested persons may wish to provide FDA
and FSIS with certain comments, research, data, and information that
they consider to be trade secret or confidential commercial information
(CCI) that would be exempt under Exemption 4 of the Freedom of
Information Act (5 U.S.C. 552). You may claim information that you
submit to FDA and FSIS as CCI or trade secret by clearly marking both
the document and the specific information as ``confidential.''
Information so marked will not be disclosed except in accordance with
the Freedom of Information Act (5 U.S.C. 552) and the specific agency's
disclosure regulations (FDA's regulations under 21 CFR part 20; FSIS's
regulations under 9 CFR part 390). For electronic submissions to http://www.regulations.gov, indicate in the ``comments'' box of the
appropriate docket that your submission contains confidential
information. You must also submit a copy of the comment that does not
contain the information claimed as confidential for inclusion in the
public version of the official record. Information not marked
confidential will be included in the public version of the official
record without prior notice.
III. Public Meeting
A Federal Register notice will be published in the near future
announcing a public meeting to discuss the topics set forth in this
notice.
IV. Comments
FDA: Interested persons may submit to FDA's Division of Dockets
Management (see ADDRESSES) either electronic or written comments
regarding this document. It is only necessary to send one set of
comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
FSIS: Interested persons may submit to FSIS's Docket Clerk (see
ADDRESSES) either electronic or written comments regarding this
document. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the FSIS
Docket Room between 8:30 a.m. and 4:30 p.m., Monday through Friday.
Because two docket numbers are associated with this document,
please include with your comments the docket number that corresponds
with the appropriate agency. Comments submitted for inclusion in both
dockets should be separately submitted to each identified docket number
to ensure consideration.
V. References
FDA has placed the following references on display in FDA's
Division of Dockets Management (see ADDRESSES). You may see them
between 9 a.m. and 4 p.m., Monday through Friday. (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.)
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to sodium chloride: A longitudinal study,'' American Journal of
Clinical Nutrition. 1986; 44: 232-243.
Dated: September 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy, Food and Drug Administration.
Dated: September 12, 2011.
Alfred V. Almanza,
Administrator, Food Safety and Inspection Service.
[FR Doc. 2011-23753 Filed 9-13-11; 11:15 am]
BILLING CODE 4160-01-P