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March 25, 2008

Division of Dockets Management (HFA-305)

Food and Drug Administration

5360 Fishers Lane, Room 1061

Rockville, Maryland 20852

**Re: Docket No. 2005P-0450:** **Salt and Sodium; Petition to Revise the
Regulatory Status of Salt and Establish Food Labeling Requirements
Regarding Salt and Sodium; Public Hearing; Request for Comments**

Dear Sir or Madam:

Founded in 1919, the National Restaurant Association ("Association") is
the leading business association for the restaurant industry. The
Association\'s mission is to represent, educate and promote a rapidly
growing industry that is comprised of 945,000 restaurant and foodservice
outlets employing 13.1 million people. As such, nutrition is a priority
for our ever-growing industry. We would like to take this opportunity to
comment on the Food and Drug Administration's (FDA's) request for
comments on the Petition to Revise the Regulatory Status of Salt and
Establish Food Labeling Requirements Regarding Salt and Sodium.

While it is true that more Americans than in years past seem to express
awareness of the important role that balance, moderation and physical
activity play in a healthy lifestyle, we as a nation still have a long
way to go. Many consumers are demanding more nutritious options, but
there is still a great deal of the public who do not have the foundation
of knowledge and education to use the nutrition information provided to
them.

We believe that it is important that as FDA examines its role and
responsibilities in addressing the major public health problems facing
our nation, you keep in mind that our diverse population is much in need
of recommendations that are understandable and relevant to how they live
their lives. The clear need is for a consistent message that promotes
healthier thinking and lifestyles.

It is also important that FDA understands the progress that the industry
has made in reducing the sodium content of its foods. Virtually all
restaurants provide healthful options, and many items can be customized
to reduce calories, sodium, and/or fat content. In addition, many
national chain restaurants already provide nutrition information in ways
that have proven to be most effective for that restaurant and their
patrons.

Although sodium is an essential ingredient that contributes to the
safety, quality and taste of foods, we have heard from our members that
they are working to reduce sodium in their cuisines. Several examples
include:

-   Using different spices and ingredients as substitutes for salt and
    other condiments;

-   Chef education (i.e., not relying on salt for flavor);

-   Offering more fruits and vegetables on menus;

-   Switching to only reduced-sodium (i.e., soy sauce), and/or
    no-salt-added ingredients (i.e., diced tomatoes);

-   Working with suppliers to reformulate and gradually decrease sodium;
    and

-   Looking for new solutions, such as using value added produce with a
    custom packed sauce (that is lower in sodium), rather than using
    some of the higher sodium "convenience" heat and serve products
    available.

Our members have also told us that much of the foodservice world is
being pushed to rely more and more on convenience products due to client
mandated labor cutbacks and a shortage of skilled labor/equipment to
cook \"from scratch\". These convenience products are for the most part
higher in sodium; thus for much of the foodservice world to reduce
sodium in our menu items, we must look to our manufacturers and
suppliers of convenience products to reformulate first.

While the restaurant industry is working closely with our partners
throughout the entire food chain on this effort, it is important to
remember that this is not something that can happen overnight. It takes
time to reformulate recipes and this is a gradual process that must be
done with care. The Association's answers to the questions FDA posed in
its Notice on October 23, 2007 are provided below.

**Issue 1: FDA considered revoking the Generally Recognized as Safe
(GRAS) status of salt and declaring it to be a food additive in 1982,
but rejected this approach for several reasons.**

GRAS status is a scientific evaluation that must take place within a
well-defined legal framework. There is no basis for revoking the present
status of salt. The plain language of the Federal Food, Drug, and
Cosmetic Act (FFDCA) directly supports the GRAS status of salt because
salt has been commonly used in food prior to 1958. Indeed, the statute
mandates that ingredients may be GRAS based on common use in food. The
statute exempts GRAS substances from the meaning of a food additive and
provides that general recognition of safety may be established through
either scientific procedures or, in the case of a substance used in food
prior to January 1, 1958, through experience based on common use in
food. [^1]/

When assessing whether general recognition of safety has been
demonstrated based on common use in food, the regulations and
corresponding rulemaking history similarly state that GRAS may be proven
based only on an ingredient's use prior to 1958. Specifically, the
regulations provide that "general recognition of safety through
experience based on common use in food prior to January 1, 1958 shall be
based solely on food use of the substance prior to January 1,
1958." [^2]/

It is well-established that salt has been commonly used in foods prior
to 1958. Indeed salt has been used by all civilizations for thousands of
years. FDA even noted in its 1982 Policy Notice regarding the GRAS
Safety Review of Sodium ("Policy Notice"): "Historically, salt has been
considered an essential part of the diet. The traditional foods of many
cultures contain salt. Salt is found in almost every home and restaurant
as a condiment." [^3]/ Indeed, FDA has recognized that "salt occupies a
special place in our food supply." [^4]/ The legislative history of the
FFDCA further reinforces FDA's comments. For example, during the
Congressional Food Additive Hearings of 1958 ("Hearings"), former FDA
commissioners and senators commented on the history of salt. For
example, FDA Commissioner George Larrick when probed regarding the scope
of the common use exception, stated that it "would include staple foods
such as salt, sugar, vinegar, caramel and many other that are common in
our food supply."  [^5]/ As such, salt is the first example in the
regulations that FDA provides of a food that is generally recognized as
safe. [^6]/

Concern over the role of salt and other dietary factors relating to the
nutrients/foods we consume is important. We should address such issues
directly rather than try to force an unfounded change in the law to
severely restrict or prohibit the use of a common food ingredient.

**Question 1.**

**Could a food additive regulation be constructed to prescribe
limitations for uses of salt? If so, how might the regulation be
constructed?**

The Association does not support establishing a food additive regulation
for salt because it would require tremendous agency resources and is
simply not practical. FDA similarly rejected issuing a food additive
regulation for salt in its 1982 Policy Notice and many of the same
logistical and practical concerns FDA noted in 1982 are still valid in
2008. When FDA visited this issue in 1982, it declared that "The
American food supply is too diverse and complex for the Federal
government to be able to regulate successfully an individual's sodium
consumption." [^7]/ FDA noted that "It would be extremely difficult to
prescribe and enforce fair use limitations for salt that would be safe
for all consumers." [^8]/ FDA recognized that not only would it be
difficult, promulgating and enforcing salt limitations "would constitute
an extraordinary regulatory burden." [^9]/ Since that time, no obvious,
efficient mechanisms for determining appropriate levels of salt across
the food supply have been established.

In effect, FDA would have to set unique limits for each technical effect
of salt and may need to set separate limits for different food
categories, particularly in those cases in which salt acts as a
preservative. The difficulty lies in the fact that salt is often used
for a variety of different technical effects in a single food and any
limits on the use of salt as a flavoring agent would be extremely
subjective. The challenge to FDA would be to determine a level of salt
that is of minimal concern to the majority of consumers, and to rely
upon nutritional labeling to warn those consumers who must limit sodium
in their diets. Unfortunately, there are too many uncontrolled variables
in the American diet for any salt restrictions mandated by regulation to
be effective. Furthermore, it is important to keep in mind that
limitations in a food additive regulation are intended to provide
protection against unintended adverse effects from consuming the food
additive rather than regulating dietary objectives. Many of the concerns
expressed here and by other comments are tied to the inherent disconnect
that can arise from the use of a food safety tool as a means for
implementing nutrition policy.

**Question 2.**

**Would reducing the salt content of food, even in a modest way, impact
the safety or quality of various foods given the wide variety of
technical functions for which salt is used in food? How feasible would
it be to mitigate this impact if true? Could it be mitigated by, for
example, the addition of other ingredients?**

Sodium has various beneficial functions in the food supply and is also
an essential nutrient. Beyond the fact that salt is naturally occurring
in a number of foods, salt serves a critical role in the safety and
quality of the food supply. Among other things, salt plays an important
function by suppressing undesirable taste attributes. As such, the
industry must be cognizant of consumers' desire for tasteful foods.
Beyond taste, salt is also used as a preservative, to control
fermentation, and as a processing tool. In addition, salt is a required
ingredient in a number of foods, including chemically leavened products,
cheese (salting is part of the cheese-making process), smoked fish (salt
levels must be maintained to prevent disease), cured meats (require salt
ingredients for microbial control), and others.

FDA has similarly recognized that "In the food industry, salt is widely
employed for a number of different purposes: e.g., as a seasoning agent
and flavor enhancer, a preservative and curing agent, a formulating and
processing aid, a nutritional supplement, and a dough
conditioner." [^10]/ FDA has also noted that "Foods in which salt is
important for preparation or preservation are a prominent component of
many diets." [^11]/ Although other ingredients could serve similar
functions, there would likely be a negative impact on flavor and
quality. At this time, there is a shortage of salt alternatives that
meet the same taste, qualities, and functions of salt. Consequently,
there is a great need for additional research on viable alternatives and
Government incentives for the industry to develop salt alternatives.

Finally, the nature of the question further illustrates the
impracticality of the approach. A "modest" reduction in salt content
cannot be evaluated outside the context of specific foods. The
question's answer requires a case-by-case approach. A modest reduction
in salt could have a significant food safety impact, or no such effect
at all.

**Question 3.**

**If you agree with the underlying premise of CSPI's petition (i.e.,
that the sodium content of processed foods should be reduced), but
disagree with one or more of the specific actions requested by CSPI,
what other actions would you recommend?**

The Association does not agree with the underlying premise of CSPI's
petition. These written comments provide the Association's primary
reasons for disagreement.

**Question 4.**

**How could FDA partner with interested stakeholders regarding the
development of appropriate recommendations or other information to
reduce the salt content of processed foods?**

There is certainly a great opportunity for FDA to partner with
interested stakeholders, such as manufacturers, retailers, consumer
groups, health professionals, and other government agencies to develop
appropriate recommendations to further reduce the salt content of
processed foods. FDA should also work with these groups towards greater
consumer education along with implementing a strategy to reduce the
population's overall caloric intake. Partnerships with interested
stakeholders would allow FDA to understand the challenges that the
industry faces. For example, in order to get the taste customers desire,
there are not always substitutes available, and if the food doesn't
taste the way they want, customers will not return to establishments or
purchase the food again. Even with alternatives, reduced sodium products
still may not provide the same flavor that consumers expect. There is no
benefit to consumers if a lower sodium product is unacceptable because
the consumer will simply select a tastier, higher sodium alternative or
add their own salt to the food.

Although it is important that FDA be involved in such key partnerships,
it is also critical to keep in mind that FDA has limited resources.
There are many avenues that FDA has and should support to educate
consumers (e.g., Dietary Guidelines). The Association is concerned that
a significant shift in agency resources necessary to address the tangled
web of issues arising from a change in salt's GRAS status would prevent
FDA from addressing more significant issues.

**Issue 2: Food labeling initiatives introduced by FDA during the last
25 years have been designed to provide consumers with more information
about the sodium content of foods.**

**Question 5.**

**How would you describe the effectiveness of the following FDA
regulations in reducing salt intake by the public? (1) Declaration of
sodium content in the Nutrition Facts panel; (2) sodium content claims;
and (3) "healthy" claims: How would you change these labeling
requirements to make them more effective?**

The Association believes that the current scheme of nutrition labeling
and defined nutrient content claims for salt and sodium provide helpful
information to consumers. FDA's regulations have been effective in terms
of providing data for consumers to make informed decisions when
purchasing packaged foods.

Sodium in the context of other nutrient intake was discussed more
broadly by members of the Association. Eating patterns such as DASH and
MyPyramid that address the broad relationship between diet and chronic
disease should be FDA's main objective rather than focusing on a single
nutrient, which the Association believes is counter-productive. Salt is
just one single component of the diet and FDA policy should focus on
overall improvement of food choices and dietary patterns as this will
benefit consumer health more generally. The Association encourages a
holistic policy where the public is advised and educated on how to make
informed choices that advance their health and well-being.

**Question 6.**

**What, if any, data, such as consumer studies, are available regarding
the potential for label statements about the health effects of salt to
reduce salt intake?**

The Association has not conducted any studies and does not have such
data available. However, the Association believes that consumer research
on how to communicate messages about sodium on food packages and ways to
create positive behavior change need to be explored. There is certainly
a gap in understanding consumer acceptance and use of such information.

**Question 7.**

**To what extent could FDA's labeling policies provide incentives to
manufacturers to reduce the salt content of processed foods? For
example, would there be an incentive to manufacturers to reduce the salt
content of processed foods if FDA used enforcement discretion to permit
a claim about a reduction in salt or sodium when that claim does not
satisfy the criteria for a defined nutrient content claim? Would there
be an incentive to manufacturers to reduce the salt content of processed
foods if FDA encouraged the use of health messages to identify products
with reduced salt? How would such incentives differ from the incentives
provided by currently authorized label statements?**

Because consumer acceptance is critical, some designations beyond
current authorized claims could be helpful. For example, expanded
nutrient content claims that would allow manufacturers to label small
changes in sodium reduction such as 5, 10, or 20 percent could be
beneficial. Due to the fact that sodium reduction needs to be a gradual
process, allowing manufacturers to highlight small changes would
encourage them to make these changes. If the permitted claims for sodium
are too restrictive, the industry may not attempt to lower sodium
content in order to make nutrient content claims because drastically
changing formulations and reducing sodium content could negatively
impact consumer acceptance of products.

\*\*\*\*\*\*

The Association appreciates this opportunity to present its views on
these matters and welcomes the chance to discuss these matters further
if helpful to the agency. We believe that our communication on this
important topic has set the stage for valuable work ahead. Our shared
commitment to nutrition and healthy lifestyles give us many
opportunities to work together in the near future which we look forward
to. The Association appreciates the opportunity to submit these comments
and commends the agency for the questions posed and its open
consideration of these issues. While important public health goals
relate to many of the questions, the Association urges FDA to address
such concerns directly and not entertain the bar of an ingredient used
for centuries to advance the shared goals of healthier, more active
American adults and children. Please feel free to call us with any
questions you may have regarding this issue, at (202) 331-5900.

Sincerely,

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![](media/image3.jpeg){width="1.2979166666666666in"
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Dawn Sweeney John Gay

President and CEO Senior Vice President

Government Affairs and Public Policy

[^1]: / 21 U.S.C. § 321(s).

[^2]: / 21 C.F.R. §170.30(c)(1).

[^3]: / 47 Fed. Reg. 26590 (June 18, 1982).

[^4]: / *Id.* at 26592.

[^5]: / Food Additive Hearings, 85^th^ Congress, 2d Sess. 429 at 460
    (1958).

[^6]: / *See* 21 C.F.R. 182.1(a).

[^7]: / 47 Fed. Reg. at 26593.

[^8]: / *Id.*

[^9]: / *Id.*

[^10]: / *Id.* at 26590.

[^11]: / *Id.* at 26592.