[Federal Register: October 23, 2007 (Volume 72, Number 204)]
[Proposed Rules]
[Page 59973-59979]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc07-14]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; notice of availability of citizen
petition; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing concerning FDA's policies regarding salt (sodium chloride) and
sodium in food. FDA also is announcing the availability for comment of
a citizen petition, submitted by the Center for Science in the Public
Interest (CSPI), requesting that FDA make changes to the regulatory
status of salt, require limits on salt in processed foods, and require
health messages related to salt and sodium. The purpose of the hearing
is for FDA to share its current framework of policies regarding salt
and sodium and to solicit information and comments from interested
persons on this current framework and on potential future approaches,
including approaches described in the citizen petition.
DATES: The public hearing will be held on November 29, 2007, from 9
a.m. to 4:30 p.m. Registration begins on October 22, 2007. See section
V of this document for other dates associated with participation in the
hearing. Submit written or electronic comments (i.e., submissions other
than notices of participation and written material associated with an
oral presentation) by March 28, 2008. The administrative record of the
hearing will remain open until March 28, 2008.
ADDRESSES: Public hearing. The public hearing will be held at the
Harvey W. Wiley Federal Building, Food and Drug Administration, Center
for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College
Park, MD, 20740-3835 (Metro stop: College Park on the Green Line).
Registration. Submit electronic notices of participation for the
hearing to http://www.cfsan.fda.gov/register.html. We encourage you to
use this method of registration, if possible. Submit written notices of
participation by mail, fax, or e-mail to Isabelle Howes, U.S.
Department of Agriculture Graduate School, 600 Maryland Ave., SW, suite
270, Washington, DC 20024-2520, FAX: 202-479-6801, or e-mail:
Isabelle_Howes@grad.usda.gov. You may also submit oral notices of
participation by phone to Isabelle Howes, U.S. Department of
Agriculture Graduate School (see FOR FURTHER INFORMATION CONTACT).
Written material associated with an oral presentation. Submit
written material associated with an oral presentation by mail, fax or
e-mail to Isabelle Howes.
Comments. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
For additional information on submitting
comments, see section VI in this document.
FOR FURTHER INFORMATION CONTACT:
For questions about registration or written material associated
with an oral presentation, or to register orally: Isabelle Howes, 202-
314-4713.
For all other questions about the hearing or if you need parking or
special accommodations due to a disability: Juanita Yates, Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 301-
436-1731, e-mail: Juanita.Yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. Salt
1. Salt in the Human Diet
Salt (sodium chloride) is an essential part of the diet. Both the
sodium and chloride ions are required, for example, to maintain
extracellular volume and serum osmolality (Ref. 1). Salt is found
naturally in foods such as milk and shellfish (Ref. 1). Salt also is
added intentionally as a food ingredient for multiple technical effects
in foods, e.g., as a seasoning agent and flavor enhancer, a
preservative and curing agent, a formulating and processing aid, and a
dough conditioner (47 FR 26590, June 18, 1982 (the 1982 policy
notice)).
The Dietary Guidelines for Americans, 2005 (Dietary Guidelines)
(Ref. 2), a joint publication of the Department of Health and Human
Services and the U.S. Department of Agriculture (USDA), forms the basis
for the Federal Government's nutrition programs and policies. Chapter 8
of the Dietary Guidelines reports that, on average, the natural salt
content of food accounts for only about 10 percent of total intake,
while discretionary salt use (i.e., salt added at the table or while
cooking) provides another 5 to 10 percent of total intake. Chapter 8 of
the Dietary Guidelines also reports that approximately 75 percent of
total salt intake is derived from salt added to processed food by
manufacturers.
2. Adverse Health Effects of Salt
Excessive sodium has been cited by the scientific community as a
contributory factor in the development of hypertension and
cardiovascular disease (47 FR 26580). In general, there is a dose-
dependent relationship between sodium intake and blood pressure that
has been observed to occur throughout the range of levels of sodium
intake (Ref. 1). Blood pressures among individuals in certain
populations (e.g., persons with hypertension, diabetes, kidney disease,
older persons, and African Americans) are more responsive to dietary
sodium than blood pressures among the general population (Ref. 1). The
Dietary Guidelines recommend that the general population consume no
more than 2,300 milligrams/day (mg/d) and that persons with
hypertension, blacks, and middle-aged and older
[[Page 59974]]
adults consume no more than 1,500 mg/d (Ref. 2).
3. Regulatory Status of Salt (1959-1982)
The definition of ``food additive'' in section 201(s) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s)) is a
multistep definition that first broadly includes any substance, the
intended use of which results or may reasonably be expected to result,
directly or indirectly, in its becoming a component or otherwise
affecting the characteristics of food. However, the definition then
excludes substances that are generally recognized, among experts
qualified by scientific training and experience to evaluate their
safety as having been adequately shown through scientific procedures
(or, in the case of a substance used in food prior to January 1, 1958,
through either scientific procedures or through experience based on
common use in food) to be safe under the conditions of their intended
use. The definition also excludes certain other substances from the
definition of food additive. In particular, under section 201(s)(4) of
the act, any substance used in accordance with a sanction or approval
granted prior to September 6, 1958, under the act, the Poultry Products
Inspection Act (21 U.S.C. 451 et seq.) or the Federal Meat Inspection
Act (21 U.S.C. 601 et seq.) is excluded from the definition of food
additive. Under the act, substances that are not food additives are not
subject to the requirements in section 409 of the act (21 U.S.C. 348)
for premarket review. Prior-sanctioned substances remain subject,
however, to the general adulteration provisions in section 402 of the
act (21 U.S.C. 342). These provisions prohibit, among other things, the
use of added deleterious substances that ``may render [the food]
injurious to health.''
In the Federal Register of November 20, 1959 (24 FR 9368), FDA
clarified the regulatory status of a multitude of food substances that
were used in food prior to 1958 and amended its regulations to include
an initial list of food substances that, when used for the purposes
indicated and in accordance with current good manufacturing practice,
are generally recognized as safe (GRAS). This initial list (the ``GRAS
list'') is currently published in part 182 (21 CFR part 182). Section
182.1(a) provides in part:
``[I]t is impracticable to list all substances that are
generally recognized as safe for their intended use. However, by way
of illustration, the Commissioner regards such common food
ingredients as salt, pepper, vinegar, baking powder, and monosodium
glutamate as safe for their intended use.''
In the early 1970s, FDA announced that the agency was conducting a
comprehensive study of substances presumed to be GRAS (35 FR 18623,
December 8, 1970; and 36 FR 20546; October 23, 1971). FDA also issued
several regulations regarding GRAS substances and procedures associated
with its comprehensive review of GRAS substances. These regulations are
currently in part 170 (21 CFR part 170) and include: (1) Criteria that
could be used to establish whether substances presumed to be GRAS
should be listed as GRAS, become the subject of a food additive
regulation, or be listed in an interim food additive regulation pending
completion of additional studies (Sec. 170.30) (36 FR 12093, June 25,
1971); (2) procedures that the agency could use, on its own initiative,
to affirm the GRAS status of substances that were the subject of its
comprehensive review and were found to satisfy the established criteria
(Sec. 170.35(a) and (b)) (37 FR 25705, December 2, 1972); and (3) the
general process that the agency would use to review ingredients
included in the original GRAS list (Sec. 170.30(e)) (41 FR 53600,
December 7, 1976). Under Sec. 170.30(e):
``[f]ood ingredients were listed as GRAS [in 21 CFR part 182]
during 1958-1962 without a detailed scientific review of all
available data and information relating to their safety. Beginning
in 1969, [FDA] has undertaken a systematic review of the status of
all ingredients used in food on the determination that they are GRAS
or subject to a prior sanction. All determinations of GRAS status or
food additive status or prior sanction status pursuant to this
review shall be handled pursuant to [21 CFR 170.35, 170.38, and
180.1] * * *''
As part of FDA's approach to the comprehensive review of GRAS
substances, FDA contracted with the Federation of American Societies
for Experimental Biology (FASEB) for a committee of scientific experts
to summarize the available scientific literature regarding substances
presumed to be GRAS, including salt. FASEB provided FDA with a
tentative report containing its findings and recommendations, held
public hearings to provide an opportunity for interested persons to
submit additional information and to express their views about the
tentative report, and then submitted a final report (47 FR 26590).
In the 1982 policy notice, FDA described the uses of salt in food,
reviewed the statutory framework for food ingredients, and described
its comprehensive review of GRAS substances. FDA also discussed the
findings and conclusions in FASEB's final report on salt. The FASEB
report recognized that there are many variables and uncertainties in
determining an individual's healthy salt intake. However, the FASEB
report also raised concerns about salt consumption levels and concluded
that:
``The evidence on sodium chloride is insufficient to determine
that the adverse effects reported are not deleterious to the health
of a significant proportion of the public when it is used at levels
that are now current and in the manner now practiced.''
The FASEB report recommended the development of guidelines for
restricting the amount of salt in processed foods and adequate labeling
of the salt content of foods.
In the 1982 policy notice, FDA encouraged food manufacturers to
reduce voluntarily the amount of added salt and other sodium-containing
substances in processed foods and requested comment on this approach.
FDA also announced its tentative decision to defer any revision in the
regulatory status of salt until the agency could assess the impact in
light of proposed sodium labeling regulations that would respond to
health concerns about the levels of use of salt in the food supply. We
discuss the proposed labeling regulations in section I.A.5 of this
document.
In the 1982 policy notice, FDA described evidence that some uses of
salt were granted sanction or approval prior to September 6, 1958, and
therefore would be excluded from the definition of a food additive
under section 201(s)(4) of the act (47 FR 26590). In part, this
evidence relates to the inclusion of salt as an ingredient in several
food standards issued before September 6, 1958. We discuss food
standards in section I.A.4 of this document.
4. Food standards
Section 401 of the act (21 U.S.C. 341) gives FDA the authority to
issue regulations fixing and establishing food standards, whenever it
is the judgment of the Secretary of Health and Human Services that such
action will promote honesty and fair dealing in the interest of
consumers. Food standards are established to define the basic nature,
and describe the essential characteristics, of a food consistent with
consumer beliefs and expectations, and to establish its common or usual
name. The process to amend existing standards requires either notice
and comment rulemaking or formal rulemaking, depending on the specific
standard.
Among other things, food standards establish the name of the food
and the ingredients that are mandatory (i.e., required ingredients) or
permitted (i.e.,
[[Page 59975]]
optional ingredients) in the manufacture of the food. Foods that are
marketed under the standardized name must conform to all the
requirements of the relevant standard(s) of identity. Conversely, foods
that do not meet the requirements of the relevant standard(s) of
identity cannot be marketed under the standardized name. Rather, such
foods must be named using descriptors that accurately and adequately
describe the food and that sufficiently distinguish it from the
standardized food. Examples of foods subject to standards of identity
include cheeses and related cheese products (part 133 (21 CFR part
133)); bakery products (part 136 (21 CFR part 136)); and cereal flours
and related products (part 137 (21 CFR part 137)).
Salt is a required or optional ingredient in many standardized
foods. For example, salt is a required ingredient in ``self rising
flour'' (Sec. 137.180), ``self rising white corn meal,'' (Sec.
137.270) and ``cheddar cheese'' (Sec. 133.113). In addition, salt is
an optional ingredient in bakery products such as ``bread, rolls and
buns'' (Sec. 136.110) and ``dry curd cottage cheese'' (Sec. 133.129).
However, such standardized foods do not require a specific amount of
salt and, thus, there is flexibility for food companies to lower salt
concentrations by adjusting their formulations regarding the amount of
salt added in the preparation of these standardized foods. The primary
consideration for lowering salt concentrations in standardized foods
where it is required is to ensure that the intended technical effect of
the salt ingredient is accomplished.
The provisions in Sec. 130.10 (21 CFR 130.10) allow standardized
foods to deviate from certain requirements of a standard of identity to
make the food eligible to bear a FDA-defined nutrient content claim. (A
``nutrient content claim'' (defined in section 403(r)(1)(A) of the act
(21 U.S.C. 343(r)(1)(A))) is a claim that characterizes the level of a
nutrient in a food. We have established regulations implementing
section 403(r)(1)(A) of the act with respect to nutrient content claims
(Sec. 101.13 (21 CFR 101.13 and subpart D)).) Under Sec. 130.10, the
levels of sodium or salt in standardized foods can be altered to make
the food eligible to bear a FDA-defined sodium- or salt-related claim
such as ``sodium free,'' ``low sodium,'' ``reduced sodium,'' ``salt
free,'' and ``unsalted'' (See Sec. 101.61 (21 CFR 101.61)). For
example, although the standard of identity for ``self rising flour'' in
Sec. 137.180 requires the addition of salt in the manufacture of a
food named ``self rising flour,'' manufacturers may deviate from this
requirement for the specific purpose of making the food eligible for
the ``unsalted'' claim in accordance with the provisions of Sec.
101.61(c)(2). Similarly, other standardized foods can be modified to
eliminate or reduce the sodium content of the food to manufacture
sodium-free or lower sodium versions of the standardized food, such as
``low sodium bread'' or ``salt free cottage cheese.''
5. Sodium Labeling
In 1984, as a followup to the 1982 policy notice, FDA established
in Sec. 101.13 definitions for terms related to sodium content, e.g.,
``sodium free,'' ``low sodium,'' and ``no added salt'' and required
that information about sodium be included with other nutritional
information wherever it appears on food labels (49 FR 15510, April 18,
1984). FDA later revised and redesignated Sec. 101.13 as nutrient
content regulations at Sec. Sec. 101.56 (21 CFR 101.56) (Nutrient
content claims for ``light'' and ``lite'') and 101.61 (Nutrient content
claims for the sodium content of food) (58 FR 2302 at 2414 and 2417;
January 6, 1993) in response to the Nutrition Labeling and Education
Act of 1990 (NLEA). Section 101.61 addresses the use of terms such as
``sodium free,'' ``low sodium,'' ``reduced sodium,'' and ``no added
salt'' (58 FR 2302 at 2417) and Sec. 101.56 addresses the use of the
terms ``light'' and ``lite,'' including the use of those terms in
relation to sodium content (58 FR 2302 at 2414).
FDA also published a number of other labeling regulations in the
January 6, 1993 Federal Register in response to NLEA, which bears on
how sodium is declared on the label; namely, the agency's revised
nutrition labeling regulations that required nutrition labeling of
sodium content on virtually all processed food products (Sec.
101.9(c)(4) (21 CFR 101.9(c)(4))) (58 FR 2079 at 2176) and established
a reference value or ``Daily Value'' (DV) for sodium (Sec.
101.9(c)(9)) (58 FR 2206 at 2227), and the agency's new regulation
(Sec. 101.74 (21 CFR 101.74)) establishing a health claim regarding
low sodium diets and reduced risk of hypertension (58 FR 2820). FDA
subsequently established regulations (Sec. 101.65 (21 CFR 101.65))
requiring that foods labeled as ``healthy'' contain less than specified
amounts of certain food components, including sodium (59 FR 24232, May
10, 1994; amended at 70 FR 56828, September 29, 2005).
B. CSPI's Prior Challenges to the GRAS Status of Salt
In 1978, CSPI submitted a citizen petition requesting that FDA
establish limits for sodium in processed foods and reclassify salt as a
food additive. In a letter dated August 18, 1982 (Ref. 3), FDA denied
the petition, stating that the agency had decided to leave salt in part
182. In 1984, CSPI sought review of FDA's actions in the United States
District Court of the District of Columbia. (See Center for Science in
the Pub. Interest v. Novitch, Food, Drug, and Cosm. L. Rep. (CCH)
38,275 (No. 83-801) (D.D.C. June 11, 1984)). CSPI argued that FDA's
denial of its petition was arbitrary and capricious because it violated
FDA's procedures for reviewing substances on the initial GRAS list.
CSPI also argued that FDA's decision to defer any change to the GRAS
status of salt constituted unreasonable delay in violation of the
Administrative Procedures Act (5 U.S.C. 706(1)). The district court
concluded that FDA's decision was consistent with its regulations and
the act and rejected the argument that FDA had unreasonably delayed
reconsideration of the GRAS status of salt. CSPI did not appeal.
In 2005, CSPI sought a writ of mandamus, in the United States Court
of Appeals for the District of Columbia, compelling FDA to publish in
the Federal Register a proposed rule either affirming or denying the
GRAS status of salt and providing an opportunity for comment on the
proposal. The court dismissed CSPI's petition for lack of jurisdiction,
explaining that CSPI had not sought a remedy from FDA or initiated any
proceeding in FDA before resorting to the court. (See In re Center for
Science in the Public Interest, 2005 U.S. App. (No. 05-1057) (D.C. Cir.
2005)).
C. CSPI's Prior Citizen Petitions Regarding Label Requirements for Salt
The 1978 CSPI citizen petition also requested that FDA require
sodium content labeling on packaged foods and require a special symbol
on the labels of high-sodium foods. FDA denied the petition in a letter
dated August 18, 1982 (Ref. 3). In that denial letter, FDA considered
that mandatory labeling for all processed foods was not justified and
noted that the 1982 sodium labeling proposed rule would affect
approximately one third of all processed food at that time. In
addition, FDA considered a decision regarding special symbols for
sodium-containing products to be premature because FDA was researching
the utility of such symbols and vignettes.
In 1981, CSPI submitted a citizen petition requesting that FDA
require warning labels on packages of salt weighing half an ounce or
more. FDA denied that petition in a letter dated
[[Page 59976]]
October 7, 1982 (Ref. 4). In that denial letter, FDA considered an
isolated warning appearing on the label of one class of food products
to be inappropriate given that many foods contribute to an individual's
sodium intake.
D. Citizen Petition Submitted by CSPI in 2005 (Docket No. 2005P-0450)
In a citizen petition dated November 8, 2005, CSPI requested that
the agency take certain regulatory actions regarding salt.
Specifically, CSPI requested that FDA initiate rulemaking to revoke the
GRAS status for salt, amend prior sanctions for the use of salt,
require food manufacturers to reduce the amount of sodium in all
processed foods, require a health message on retail packages of salt
one-half ounce or larger, and reduce the DV for sodium from its current
level of 2,400 mg/d to 1,500 mg/d. CSPI also requested that FDA take
regulatory action to reduce the amount of sodium in processed foods
sold directly to restaurants, e.g., by regulating salt in precooked
French fries that are purchased by restaurants who then add more salt.
In its petition, CSPI acknowledges that FDA has implemented several
labeling requirements related to the sodium content of food through the
NLEA as well as other labeling provisions, but asserts that these
measures have not done enough to reduce sodium consumption.
CSPI summarizes several published clinical and population-based
studies regarding the effect of sodium on blood pressure to support its
view that the link between cardiovascular disease and excessive sodium
intake has been clearly defined in the scientific community (Refs. 5 to
8). CSPI discusses the potential impact on public health of reductions
in blood pressure, citing published estimates that reductions in blood
pressure and resultant reductions in the incidence of hypertension
would reduce the risk of stroke and heart disease significantly,
resulting in fewer deaths from cardiovascular disease (Refs. 9 to 13).
CSPI provides a table summarizing various estimates of the average
consumption of sodium collected between 1971 and 2000. CSPI argues that
the data show that per capita sodium consumption has increased from
2,800 mg/d in the years 1976-1980 to 3,400 mg/d in the years 1999-2000.
(CSPI reports that it derived these estimates from dietary recall
surveys conducted by the Centers for Disease Control and Prevention
(i.e., the National Health and Nutrition Examination Surveys) and USDA
(i.e., the Continuing Survey of Food Intakes of Individuals)). CSPI
also cites a clinical study, based on urinary sodium excretion,
estimating an average sodium intake of 4,000 mg/d in the United States
(Ref. 14). CSPI compares these estimates to the current DV for sodium
(i.e., 2,400 mg/d) and to recommendations in the Dietary Guidelines
(Ref. 2) for the general population (i.e., no more than 2,300 mg/d) and
for persons with hypertension, blacks, and middle-aged and older adults
(i.e., no more than 1,500 mg/d). CSPI concludes that the available data
demonstrate current intake of sodium is significantly higher than the
intake recommended by governmental and scientific organizations around
the world.
CSPI discusses the sources of sodium in the food supply, noting
that some of the salt in the diet occurs naturally as an inherent
component of foods, such as in milk. CSPI acknowledges that one reason
for the increased consumption of sodium by the U.S. population in
recent years is increased consumption of food in general. However, CSPI
notes that the Dietary Guidelines estimate that 75 percent of the
sodium in the diet is derived from processed foods. CSPI states that
regulatory action to reduce the sodium content of the diet should
therefore focus on these foods. CSPI discusses the feasibility of
reducing salt levels in foods, stating that reductions can be made
without adversely affecting public health or taste. CSPI also describes
the activities of the British government's Food Standards Agency, which
has introduced voluntary goals for the reduction of sodium in processed
foods by food category (Ref. 15).
Based on the health effects of salt cited in its petition, CSPI
asserts that salt should no longer be considered ``safe.'' As a result,
CSPI argues that salt should not be considered as a GRAS food
ingredient and that prior sanctions for certain uses of salt should be
revoked.
CSPI also asserts that FDA has authority to require the labeling
requested in its petition under several provisions of the act and FDA's
regulations in Title 21 of the Code of Federal Regulations. These
include the misbranding provisions of section 403(a) of the act
(together with the associated definition in section 201(n) of the act
and the associated regulation in 21 CFR 1.21) and the premarket
approval provisions of section 409 of the act.
In August 2006, FDA issued a tentative response to CSPI's citizen
petition, indicating the need for additional information before a final
response could be rendered (Ref. 16).
II. Purpose and Scope of the Hearing
The purpose of the hearing is for the agency to solicit comment,
information and discussion from interested persons on the regulatory
status of salt, and food labeling requirements regarding salt and
sodium, particularly with respect to the feasibility and potential
effectiveness of the regulatory actions requested in CSPI's citizen
petition. FDA is aware that other organizations are in general
agreement with some of the recommendations in CSPI's petition. For
example, at the July 2006 annual meeting of the American Medical
Association (AMA), the AMA announced recommendations, in the form of a
report issued by the AMA's Council on Science and Health, to the agency
echoing many of the regulatory actions suggested by CSPI (Ref. 17). The
agency is very much interested in hearing the views of other interested
parties, including the AMA.
The agency also is interested in discussions regarding other
potential approaches for reducing salt intake. Because FDA has separate
plans to issue an advanced notice of proposed rulemaking that would
address DVs, including the DV for sodium (Ref. 18), comments regarding
the DV for sodium are outside the scope of the public hearing announced
in this document.
The scope of this hearing is determined by this notice. FDA invites
general comments on the citizen petition (other than the requested
actions regarding DVs) as well as comments on the issues and questions
listed in section III of this document.
III. Issues and Questions for Discussion
The following issues and questions will be discussed at the public
hearing:
Issue 1: FDA considered revoking the GRAS status of salt and
declaring it to be a food additive in 1982, but rejected this approach
for several reasons, including the following: (1) The agency would have
to establish a limitation for each technical effect for which salt is
used in each food category, and it would be extremely difficult to
prescribe and enforce ``fair use'' limitations for salt that would be
safe and effective for all consumers (including those hypertensive
patients on severe sodium restrictions) given the fact that salt has
numerous technical functions in a wide variety of processed foods and
may often be used for several different technical effects in a single
food and (2) many uses of salt are prior sanctioned and the agency
would have to show that salt in food is a ``poisonous or
[[Page 59977]]
deleterious substance'' for it to take regulatory action against a
prior sanctioned ingredient. Failing to do this, the practical effect
of regulating those remaining uses of salt not authorized by prior
sanction might be quite small and the issuance and enforcement of
limitations for uses of salt would therefore constitute an
extraordinary regulatory burden for FDA. These facts and the
uncertainty about the precise role of salt as a basic causative factor
in essential hypertension left unclear whether the use of salt in a
particular food would render that food uniformly injurious to health.
Therefore, FDA concluded in 1982 that informative labeling would be
more responsive to the health concerns about sodium (47 FR 26590). FDA
is not aware of any fundamental changes to these considerations since
it published the 1982 policy notice.
Question 1. Could a food additive regulation be constructed to
prescribe limitations for uses of salt? If so, how might the regulation
be constructed?
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?
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?
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?
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. For example, our
regulations currently require declarative statements on the label about
the sodium content of processed food (Sec. 101.9(c)(4)), define
nutrient content claims for foods based on their salt content
(Sec. Sec. 101.61 and 101.56), provide for a health claim regarding
low sodium diets and reduced risk of hypertension (Sec. 101.74), and
stipulate maximum sodium concentrations for foods that are to be
labeled as ``healthy'' (Sec. 101.65(d)(2)). In addition to the goal of
providing information to consumers, these labeling initiatives are also
intended to encourage food manufacturers to reduce the salt content of
foods and to provide incentives to manufacturers to produce lower
sodium foods. CSPI argues that these measures have not ultimately
served to reduce salt intake and that further, more aggressive
regulatory action is needed.
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 (Sec.
101.9(c)); (2) sodium content claims (Sec. Sec. 101.61 and 101.56);
health claims (Sec. 101.74); and (4) ``healthy'' claims (Sec.
101.65(d)(2))? How would you change these labeling requirements to make
them more effective?
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?
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?
IV. Notice of Hearing Under 21 CFR Part 15
By delegation from the Commissioner of Food and Drugs (the
Commissioner) (Staff Manual Guide 1410.21 paragraph 1.f.(5)), the
Assistant Commissioner for Policy finds that it is in the public
interest to permit persons to present information and views at a public
hearing regarding the regulatory framework for salt and sodium,
particularly with respect to CSPI's petition to revise the regulatory
status of salt and establish food labeling requirements regarding salt
and sodium and is announcing that the public hearing will be held in
accordance with part 15 (21 CFR part 15). The presiding officer will be
the Commissioner or his designee. The presiding officer will be
accompanied by a panel of FDA employees with relevant expertise.
Persons who wish to participate in the hearing (either by making a
presentation or as a member of the audience) must file a notice of
participation (see DATES, ADDRESSES, FOR FURTHER INFORMATION CONTACT,
and section V of this document). By delegation from the Commissioner
(Staff Manual Guide 1410.21 paragraph 1.f.(5)), the Assistant
Commissioner for Policy has determined under Sec. 15.20(c) that
advance submissions of oral presentations are necessary for the panel
to formulate useful questions to be posed at the hearing under Sec.
15.30(e), and that the submission of a comprehensive outline or summary
is an acceptable alternative to the submission of the full text of the
oral presentation. For efficiency, we request that individuals and
organizations with common interests consolidate their requests for oral
presentation and request time for a joint presentation through a single
representative. After reviewing the notices of participation and
accompanying information, we will schedule each oral presentation and
notify each participant of the time allotted to the presenter and the
approximate time that the presentation is scheduled to begin. If time
permits, we may allow interested persons who attend the hearing but did
not submit a notice of participation in advance to make an oral
presentation at the conclusion of the hearing. The hearing schedule
will be available at the hearing.
After the hearing, the schedule and a list of participants will be
placed on file in the Division of Dockets Management (see ADDRESSES)
under the docket number listed in brackets in the heading of this
notice.
To ensure timely handling of any mailed notices of participation,
written material associated with presentations, or comments, any outer
envelope should be clearly marked with the docket number listed in
brackets in the heading of this notice along with the statement ``Salt
and Sodium; Petition to Revise the Regulatory Status of Salt and
Establish Food Labeling Requirements Regarding Salt and Sodium; Public
Hearing.''
Under Sec. 15.30(f), the hearing is informal, and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10 (21 CFR part 10, subpart C)). Under Sec. 10.205,
representatives of the electronic media may be permitted,
[[Page 59978]]
subject to the procedures and limitations in Sec. 10.206, to
videotape, film, or otherwise record FDA's public administrative
proceedings, including presentations by participants. The hearing will
be transcribed as stipulated in Sec. 15.30(b). For additional
information about transcripts, see section VII in this document.
Any handicapped persons requiring special accommodations to attend
the hearing should direct those needs to the appropriate contact person
(see FOR FURTHER INFORMATION CONTACT).
To the extent that the conditions for the hearing, as described in
this notice, conflict with any provisions set out in part 15, this
notice acts as a waiver of these provisions as specified in Sec. Sec.
10.19 and 15.30(h). In particular, Sec. 15.21(a) states that the
notice of hearing will provide persons an opportunity to file a written
notice of participation with the Division of Dockets Management within
a specified period of time. If the public interest requires, e.g., if a
hearing is to be conducted within a short period of time, the notice
may name a specific FDA employee and telephone number to whom an oral
notice of participation may be given. If the public interest requires,
the notice may also provide for submitting notices of participation at
the time of the hearing. In this document, the conditions for the
hearing specify that notices of participation be submitted
electronically to an agency Web site, to a contact person who will
accept notices of participation by mail, telephone, fax, or e-mail, or
in person on the day of the hearing (as space permits). In addition,
the conditions for the hearing specify that written material associated
with an oral presentation be provided to a contact person who will
accept it by mail, fax, or e-mail rather than to the Division of
Dockets Management. We are using these procedures to facilitate the
exchange of information between participants and the agency. By
delegation from the Commissioner (Staff Manual Guide 1410.21 paragraph
1.f.(5)), the Assistant Commissioner for Policy finds under Sec. 10.19
that no participant will be prejudiced, the ends of justice will
thereby be served, and the action is in accordance with law if notices
of participation are submitted by any of the procedures listed in this
notice.
V. How to Participate in the Hearing
Registration by submission of a notice of participation is
necessary to ensure participation and will be accepted on a first-come,
first-served basis. Registration begins on October 22, 2007. The notice
of participation may be submitted electronically, orally, or by fax,
mail, or e-mail (see ADDRESSES and FOR FURTHER INFORMATION CONTACT). We
encourage you to submit your notice of participation electronically. A
single copy of any notice of participation is sufficient.
The notice of participation must include your name, title, business
affiliation (if applicable), address, telephone number, fax number (if
available), and e-mail address (if available). If you wish to request
an opportunity to make an oral presentation during the open public
comment period of the hearing, your notice of participation also must
include the title of your presentation, the sponsor of the oral
presentation (e.g., the organization paying travel expenses or fees),
if any; and the approximate amount of time requested for the
presentation. Presentations will be limited to the questions and
subject matter identified in section III of this document and,
depending on the number of requests received, we may be obliged to
limit the time allotted for each presentation (e.g., 5 minutes each).
Under Sec. 15.20(c), if you request an opportunity to make an oral
presentation you must submit your presentation (either as the full text
of the presentation, or as a comprehensive outline or summary). You may
submit your presentation by e-mail, fax, or mail. A single copy of your
presentation is sufficient. See ADDRESSES and FOR FURTHER INFORMATION
CONTACT for information on where to send your presentation.
Persons who wish to request an opportunity to make an oral
presentation must submit a notice of participation by November 8, 2007,
and also must submit either the full text of the oral presentation, or
a comprehensive outline or summary of the oral presentation, by
November 21, 2007. All other persons wishing to attend the hearing must
submit a notice of participation by November 21, 2007. Persons
requiring special accommodations due to a disability must submit a
notice of participation by November 21, 2007, and should inform the
contact person of their request (see FOR FURTHER INFORMATION CONTACT).
Persons wishing to park onsite should inform the contact person of
their request by November 26, 2007. Individuals who request an
opportunity to make an oral presentation will be notified of the
scheduled time for their presentation prior to the hearing.
We will also accept notices of participation onsite on a first-
come, first served basis; however, space is limited and registration
will be closed when the maximum seating capacity is reached. Requests
for an opportunity to make a presentation from individuals or
organizations that did not make such a request in advance may be
granted if time permits.
Persons who submit a notice of participation in advance of the
hearing should check in at the onsite registration desk between 8 a.m.
and 9 a.m. Persons who wish to submit a notice of participation onsite
on the day of the hearing may do so at the registration desk between 8
a.m. and 9 a.m. We encourage all participants to attend the entire
hearing. Because the hearing will be held in a Federal building,
hearing participants must present photo identification and plan
adequate time to pass through the security system.
All submissions and comments received may be posted without change
to http://www.fda.gov/ohrms/dockets/default.htm, including any personal
information provided.
VI. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments for consideration at or
after the hearing in addition to, or in place of, a request for an
opportunity to make an oral presentation (see section V of this
document). Submit two paper copies of any written comments, except that
individuals may submit one copy. Comments are to be identified 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.
VII. Transcripts
Transcripts of the hearing will be available for review at the
Division of Dockets Management (see ADDRESSES) and on the Internet at
http://www.fda.gov/ohrms/dockets approximately 30 days after the
hearing. You may place orders for copies of the transcript through the
Freedom of Information Office (HFI-35), Food and Drug Administration,
5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, at a cost of 10 cents
per page.
VIII. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified Web site addresses, but FDA is not responsible for
any subsequent changes
[[Page 59979]]
to the Web sites after this document publishes in the Federal
Register.)
1. Dietary Reference Intakes for Water, Potassium, Sodium,
Chloride, and Sulfate, Chapter 6, ``Sodium and Chloride'' pp. 1, 2,
43. Food and Nutrition Board, Institute of Medicine of the National
Academies, The National Academies Press, 2004.
2. Department of Health and Human Services and Department of
Agriculture, Dietary Guidelines for Americans, 2005. (Available at
http://www.healthierus.gov/dietaryguidelines, accessed and printed
on June 21, 2007.)
3. Letter from Joseph P. Hile, Associate Commissioner for
Regulatory Affairs, FDA to Michael F. Jacobson, August 18, 1982.
4. Letter from Joesph P. Hile, Associate Commissioner for
Regulatory Affairs, FDA to M.F. Jacobson, B. Liebman, B.
Silverglade, October 7, 1982.
5. Sacks, F.M., Svetkey L.P., Vollmer W.M., et al., ``Effects on
Blood Pressure of Reduced Dietary Sodium and the Dietary Approaches
to Stop Hypertension (DASH) Diet,'' The New England Journal of
Medicine, 344: 3-10, 2001.
6. Whelton, P.K., Appel L.J., Espeland M.A., et al. ``Sodium
Reduction and Weight Loss in the Treatment of Hypertension in Older
Persons (TONE).'' The Journal of the American Medical Association,
279: 839-846, 1998.
7. Kumanyika, S.K., Cook N.R., Cutler J.A., et al. ``Sodium
Reduction for Hypertension Prevention in Overweight Adults: Further
Results From the Trials of Hypertension Prevention Phase II,''
Journal of Human Hypertension, 19: 33-45, 2005.
8. Khaw, K.T., Bingham S., Welch A., et al., ``Blood Pressure
and Urinary Sodium in Men and Women: The Norfolk Cohort of the
European Prospective Investigation Into Cancer (EPIC-Norfolk),'' The
American Journal of Clinical Nutrition, 80: 1397-1403, 2004.
9. Cook, N.R., Cohen J., Hebert P.R., et al., ``Implications of
Small Reductions in Diastolic Blood Pressure for Primary
Prevention,'' Archives of Internal Medicine, 155: 701-709, 1995.
10. He, F.J. and MacGregor, G.A., ``How Far Should Salt Intake
be Reduced?'' Hypertension, 42: 1093-1009, 2003.
11. Stamler, J., Stamler R., Neaton J.D., ``Blood Pressure,
Systolic and Diastolic, and Cardiovascular Risks,'' Archives of
Internal Medicine, 153: 598-615, 1993.
12. Tuomilehto, J., Jousilahti P., Rastenyte D., et al.,
``Urinary Sodium Excretion and Cardiovascular Mortality in Finland:
A Prospective Study,'' Lancet 357: 848-51, 2001.
13. Havas, S., Roccella E.J., Lenfant C., ``Reducing the Public
Health Burden From Elevated Blood Pressure Levels in the United
States by Lowering Intake of Dietary Sodium,'' American Journal of
Public Health, 94: 19-22, 2004.
14. Zhou, B.F., Stamler J., Dennis B., et al., ``Nutrient
Intakes of Middle-Aged Men and Women in China, Japan, United
Kingdom, and United States in the Late 1990s: The INTERMAP Study,''
Journal of Human Hypertension, 17:623-630, 2003.
15. ``Salt in Processed Foods'' Food Standards Authority (UK),
2005 (Available at http://www.food.gov.uk/healthiereating/salt/saltmodel
, accessed and printed on June 21, 2007.)
16. Letter from Laura M. Tarantino, Director of the Office of
Food Additive Safety, FDA, to Michael F. Jacobson, June 5, 2006.
17. American Medical Association, Report 10 of the Council on
Science and Public Health (A-06), Promotion of Healthy Lifestyles I:
Reducing the Population Burden of Cardiovascular Disease by Reducing
Sodium Intake, Action of the AMA House of Delegates 2006 Annual
Meeting, 2006.
18. Food and Drug Administration, Center for Food Safety and
Applied Nutrition, CFSAN FY 2007 Report to Stakeholders, June 2007,
available at http://www.cfsan.fda.gov/~dms/cfsan607.html#fy07pp.
Dated: October 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-5216 Filed 10-19-07; 10:35 am]
BILLING CODE 4160-01-S
Meeting and Registration Information October 19, 2007