Food Labeling; Nutrient Content Claims, Definition of Sodium Levels for the Term “Healthy”, 56828-56849 [05-19511]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 188 (Thursday, September 29, 2005)]
[Rules and Regulations]
[Pages 56828-56849]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19511]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 1991N-0384H and 1996P-0500] (formerly 91N-384H and 96P-
0500)
RIN 910-AC49


Food Labeling; Nutrient Content Claims, Definition of Sodium 
Levels for the Term ``Healthy''

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations concerning the maximum sodium levels permitted for foods 
that bear the implied nutrient content claim ``healthy.'' The agency is 
retaining the currently effective, less restrictive, ``first-tier'' 
sodium level requirements for all food categories, including individual 
foods (480 milligrams (mg)) and meals and main dishes (600 mg), and is 
dropping the ``second-tier'' (more restrictive) sodium level 
requirements for all food categories. Based on the comments received 
about technological barriers to reducing sodium in processed foods and 
poor sales of products that meet the second-tier sodium level, the 
agency has determined that requiring the more restrictive sodium levels 
would likely inhibit the development of new ``healthy'' food products 
and risk substantially eliminating existing ``healthy'' products from 
the marketplace. After reviewing the comments and evaluating the data 
from various sources, FDA has become convinced that retaining the 
higher first-tier sodium level requirements for all food products 
bearing the term ``healthy'' will encourage the manufacture of a 
greater number of products that are consistent with dietary guidelines 
for a variety of nutrients. The agency has also revised the regulatory 
text of the ``healthy'' regulation to clarify the scope and meaning of 
the regulation and to reformat the nutrient content requirements for 
``healthy'' into a more readable set of tables, consistent with the 
Presidential Memorandum instructing that regulations be written in 
plain language.

DATES: This final rule is effective September 29, 2005.

FOR FURTHER INFORMATION CONTACT: Constance Henry, Center for Food 
Safety and Applied Nutrition (HFS-832), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1450.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 10, 1994 (59 FR 24232), FDA 
published a final rule amending Sec.  101.65 (21 CFR 101.65) to define 
the term ``healthy'' as an implied nutrient content claim under section 
403(r) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
343(r)). The 1994 final rule defined criteria for use of the implied 
nutrient content claim ``healthy'' and its derivatives (e.g., 
``health'' and ``healthful'') on individual foods, including raw, 
single-ingredient seafood and game meat, and on meal and main dish 
products. It also established two separate timeframes in which 
different criteria for sodium content would be effective for foods 
bearing a ``healthy'' claim (i.e., before January 1, 1998, and after 
January 1, 1998).
    According to the 1994 final rule, before January 1, 1998, 
individual foods

[[Page 56829]]

could bear the term ``healthy'' or a related term if the food contained 
no more than 480 mg of sodium (first-tier sodium level) per reference 
amount customarily consumed (RACC or reference amount), per labeled 
serving (LS) (serving size listed in the nutrition information panel of 
the packaged product), and if the reference amount was small (i.e., 30 
grams (g) or less or 2 tablespoons or less), per 50 g (Sec.  
101.65(d)(2)(ii)(A) and (d)(2)(ii)(B) and (d)(3)(ii)(A) and 
(d)(3)(ii)(B)). After January 1, 1998, an individual food could bear 
the term ``healthy'' or a related term if it contained 360 mg or less 
of sodium (second-tier sodium level) per reference amount, per labeled 
serving and per 50 g if the reference amount was small (Sec.  
101.65(d)(2)(ii)(C) and (d)(3)(ii)(C)). The agency derived this 360 mg 
sodium level by applying a 25 percent reduction to the original sodium 
disclosure level of 480 mg for individual foods (59 FR 24232 at 
24240).\1\
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    \1\ Under Sec.  101.13(h)(1) (21 CFR 101.13(h)(1)), individual 
foods bearing a nutrient content claim and containing more than 480 
mg sodium per reference amount, per labeled serving or per 50 g (if 
the reference amount is small--i.e., 30 g or less or 2 tablespoons 
or less), must bear a label statement referring consumers to 
information about the amount of sodium in the food. Such disclosure 
statements are required when a food contains more than a certain 
amount of total fat, saturated fat, sodium, or cholesterol and that 
food bears a nutrient content claim. (See section 403(r)(2)(B) of 
the act.) The agency developed disclosure levels based on dietary 
guidelines, and taking into account the significance of the food in 
the total daily diet, based on daily reference values for total fat, 
saturated fat, cholesterol, and sodium (58 FR 2302 at 2307, January 
6, 1993).
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    Similarly, before January 1, 1998, meal and main dish products 
could bear the term ``healthy'' or a related term if they contained no 
more than 600 mg of sodium (first-tier sodium level) per labeled 
serving (Sec.  101.65(d)(4)(ii)(A)), and after January 1, 1998, no more 
than 480 mg of sodium per labeled serving (second-tier sodium level) 
(Sec.  101.65(d)(4)(ii)(B)). The agency selected the 480 mg sodium 
level because it was low enough to assist consumers in meeting dietary 
goals, while simultaneously giving consumers who eat such foods the 
flexibility to consume other foods whose sodium content is not 
restricted; because there were many individual foods and meal-type 
products on the market that contained less than 600 mg of sodium; and 
because comments suggesting other levels did not provide supporting 
data (59 FR 24232 at 24240). Higher levels of sodium were rejected in 
the 1994 final rule (59 FR 24232 at 24239) because the agency 
determined that higher levels would not be useful to consumers wanting 
to use foods labeled as ``healthy'' to limit their sodium intake in 
order to achieve current dietary recommendations.
    On December 13, 1996, FDA received a petition from ConAgra, Inc., 
(the petitioner) requesting that the agency amend Sec.  101.65(d) to 
``eliminate the sliding scale sodium requirement for foods labeled 
`healthy' by eliminating the entire second tier levels of 360 mg sodium 
for individual foods and 480 mg sodium for meals and main dishes'' (FDA 
Docket No. 96P-0500/CP1, p. 3). As an alternative, the petitioner 
requested that the January 1, 1998, effective date for the second-tier 
sodium levels be delayed until such time as food technology ``catches 
up'' with FDA's goal of reducing the sodium content of foods and there 
is a better understanding of the relationship between sodium and 
hypertension.
    FDA responded to ConAgra's petition in the Federal Register of 
April 1, 1997 (62 FR 15390), by announcing a partial stay of the 
second-tier sodium levels in Sec.  101.65(d)(2)(ii)(C) and 
(d)(4)(ii)(B) until January 1, 2000. The stay was intended to allow 
time for FDA to reevaluate the second-tier sodium levels based on the 
data contained in the petition and any additional data that the agency 
might receive; to conduct any necessary rulemaking; and to give 
industry an opportunity to respond to the rule or to any changes in the 
rule that might result from the agency's reevaluation.
    On December 30, 1997 (62 FR 67771), FDA published an advance notice 
of proposed rulemaking (ANPRM) announcing that it was considering 
whether to initiate rulemaking to reevaluate and possibly amend the 
implied nutrient content claims regulations pertaining to the use of 
the term ``healthy'' (the 1997 AMPRM).
    In the Federal Register of March 16, 1999 (64 FR 12886), FDA 
published a final rule extending the partial stay of the second-tier 
sodium requirements in Sec.  101.65 until January 1, 2003. The agency 
noted that it took this action to provide time for the following: (1) 
FDA to reevaluate the supporting and opposing information received in 
response to the ConAgra petition, (2) the agency to conduct any 
necessary rulemaking on the sodium limits for the term ``healthy,'' and 
(3) companies to respond to any changes that may result from agency 
rulemaking. On May 8, 2002 (67 FR 30795), FDA issued another final rule 
to extend the partial stay of the second tier sodium requirements in 
Sec.  101.65 until January 1, 2006.
    While the partial stay was pending, the U.S. Department of 
Agriculture (USDA) and the Department of Health and Human Services 
(HHS) jointly published the ``Dietary Guidelines for Americans 2000'' 
(Ref. 1). This report provides recommendations for nutrition and 
dietary guidelines for the general public and suggests a diet with 
moderate sodium intake, not exceeding 2,400 mg per day. The health 
concerns relating to high salt intake are high blood pressure and loss 
of calcium from bones, which may lead to risk of osteoporosis and bone 
fractures (Ref. 1).
    On February 20, 2003, FDA published a proposed rule (68 FR 8163) to 
amend the ``healthy'' regulation by retaining the current, less 
restrictive first-tier sodium level of 600 mg for meals and main dish 
products while permitting the more restrictive second-tier level of 360 
mg for individual foods to take effect when the partial stay expired 
(the 2003 proposed rule). The agency also proposed to revise the 
regulatory text for the definition of ``healthy'' to clarify the scope 
and meaning of the regulation and to convert the nutrient content 
requirements for ``healthy'' to a more readable table-based format, 
consistent with the Presidential Memorandum instructing Federal 
agencies to use plain language.

II. Summary of the Final Rule

    As proposed, this final rule amends the ``healthy'' definition in 
Sec.  101.65(d) by eliminating the second-tier, more restrictive sodium 
requirement (480 mg) for meal and main dish products, which had been 
stayed until January 1, 2006. The final rule also eliminates the 
second-tier sodium requirement for individual foods instead of allowing 
it to go into effect on January 1, 2006, as proposed. Consequently, 
neither second-tier sodium requirement will take effect when the stay 
expires on January 1, 2006, and the sodium requirements for products 
labeled as ``healthy'' will remain at the current first-tier levels of 
600 mg of sodium for meal and main dish products and 480 mg of sodium 
for individual food products. As proposed, the final rule also revises 
the regulatory text for the definition of ``healthy'' to clarify the 
scope and meaning of the regulation and to convert the nutrient content 
requirements for ``healthy'' to a more readable table-based format.
    As discussed in section III of this document, this action is being 
taken as a result of comments from a variety of stakeholders urging FDA 
to eliminate the more restrictive sodium requirements for individual 
foods as well as for meal and main dish products. The comments 
documented substantial technical difficulties in

[[Page 56830]]

finding suitable alternatives for sodium and demonstrated the lack of 
consumer acceptance of certain ``healthy'' products made with salt 
substitutes and/or lower sodium. Comments from both industry and 
consumer advocates support the conclusion that implementing the second-
tier sodium requirements would risk substantially eliminating existing 
``healthy'' products from the marketplace because of unattainable 
nutrient requirements or undesirable and, thus, unmarketable flavor 
profiles. As a result of these comments, FDA has concluded that it can 
best serve the public health by continuing to permit products that meet 
the first-tier sodium level to be labeled as ``healthy,'' and thereby 
ensure the continued availability of foods that consumers can rely on 
to help them follow dietary guidelines not only for controlling sodium 
but also for limiting total fat, saturated fat, and cholesterol and 
consuming adequate amounts of important nutrients such as fiber, 
protein, and key vitamins and minerals.

III. Summary of Comments from the Proposed Rule

    FDA received a total of 18 responses, each containing one or more 
comments, to the 2003 proposed rule. Of these comments, 5 were about 
topics other than the nutrient content claim ``healthy'' and are not 
considered here because they are outside the scope of this rulemaking. 
The remaining comments were from consumers, industry, a trade 
association, health and nutrition scientists and organizations, and 
consumer groups. The majority of the comments took the view that the 
more restrictive second-tier requirements for both the meal and main 
dish category and individual foods category should be revoked. The 
comments are discussed in detail in this section of the document.
    To make it easier to identify comments and FDA's responses to the 
comments, the word ``Comment'' will appear in parentheses before the 
description of the comment, and the word ``Response'' will appear in 
parentheses before FDA's response. FDA has also numbered each comment 
to make it easier to identify a particular comment. The number assigned 
to each comment is purely for organizational purposes and does not 
signify the comment's value or importance or the order in which it was 
submitted.

A. Sodium and Hypertension

    (Comment 1) Several comments agreed that there is a problem with 
high blood pressure in the United States, citing statistics showing 
that 40 million people in this country are hypertensive and that an 
additional 45 million people are prehypertensive. Most of these 
comments further agreed that excess sodium in the diet is a primary 
cause of the incidence of high blood pressure in the United States. 
Comments pointed out that for two decades the National Institutes of 
Health's (NIH) National Heart Lung and Blood Institute (NHLBI) has 
recommended that Americans cut back on their sodium consumption while 
eating a diet high in fruits and vegetables, low-fat dairy products and 
limited in saturated and total fat (the DASH diet). Some comments, 
including comments from a consumer advocacy group and health advocacy 
groups, stated that it was indisputable that reducing sodium would 
lower blood pressure.
    One comment maintained that there was no evidence that restricting 
sodium consumption will result in improved cardiovascular health 
outcomes. This comment criticized FDA's reliance on studies examining 
the intermediate variables associated with salt intake, such as changes 
in blood pressure, maintaining that the agency should instead focus on 
whether restricting sodium consumption will result in improved 
cardiovascular health outcomes. According to this comment, none of the 
nine studies reported since 1995 that examined health outcomes 
associated with reduced dietary sodium showed a benefit to the general 
population in terms of health outcomes such as reduced incidence of 
heart attacks and strokes; in fact, some studies actually found a 
connection between low sodium diets and adverse health outcomes, i.e., 
a greater incidence of heart attacks. Another comment pointed out that 
too little sodium can actually be harmful, especially for people with 
low blood pressure and those living in hot climates. A few of the 
comments suggested that the NIH/NHLBI study ``Dietary Approaches to 
Stop Hypertension--Sodium,'' known as the DASH-Sodium study, should be 
examined more closely before the agency comes to any conclusion about 
the need to reduce sodium in foods.\2\ As discussed in detail under 
comment 2 of this document, one comment questioned the accuracy and 
objectivity of this study, whose reported conclusions were that both 
hypertensive and nonhypertensive individuals can lower blood pressure 
by reducing dietary sodium.
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    \2\ The primary objective of the DASH-Sodium trial was to test 
the effects of two dietary patterns (a control diet and the DASH 
diet) and three sodium intake levels on blood pressure in adult men 
and women with blood pressure higher than optimal or at stage 1 
hypertension (systolic 120-159 (millimeters of mercury (mm Hg) and 
diastolic 80-95 mm Hg). The DASH diet is rich in fruits, vegetables, 
and low fat dairy products and reduced in saturated and total fat. 
Consequently, it is rich in potassium, magnesium, and calcium.
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    Other comments expressed concern about the lack of scientific data 
to support changes in the sodium level for ``healthy,'' stating that 
the commenters were not aware of any studies showing improved health 
outcomes with reductions of 120 mg of sodium for individual foods. 
Another comment stated that the commenter was not aware of any 
scientific research since 1997 that increased concerns about the sodium 
content of foods or that showed a need for a 25 percent reduction in 
sodium to ensure consumer health. Still other comments suggested that 
before making its decision, the agency should await the outcome of the 
Institute of Medicine (IOM), National Academy of Science's (NAS) report 
on Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, 
and Sulfate (The Electrolyte Report) (Ref. 2), possible revisions of 
the Dietary Guidelines for Americans, 2000 and Food Guide Pyramid, as 
well as the DASH-Sodium study, in the hope that examination of the 
issue through these deliberative processes would shed more light on the 
matter.
    (Response) The effects of sodium on blood pressure are well 
documented. The IOM has recently completed its in-depth evaluation of a 
variety of electrolytes and established dietary reference intakes 
(DRI's) for these nutrients. The other scientific studies and 
evaluations mentioned in comments (the DASH-Sodium study and revisions 
of the Dietary Guidelines for Americans, 2000 and Food Guide Pyramid) 
have also been completed. The IOM's most recent evaluation of the role 
of sodium is summed up in its 2004 report (The Electrolyte Report) 
(Ref. 2). The Summary section of the Sodium and Chloride chapter of the 
Electrolyte Report states in part:
    The major adverse effect of increased sodium chloride intake is 
elevated blood pressure, which has been shown to be an etiologically 
related risk factor for cardiovascular and renal diseases. On 
average, blood pressure rises progressively with increased sodium 
chloride intake. The dose-dependent rise in blood pressure appears 
to occur throughout the spectrum of sodium intake. However, the 
relationship is non-linear in that blood pressure response to 
changes in sodium intake is greater at sodium intakes below 2.3 g 
(100 mmol) per day than above this level. The strongest dose-
response evidence comes from those clinical trials that specifically 
examined the effects of at least 3 levels of sodium intake on blood 
pressure. The range of sodium intake in these studies

[[Page 56831]]

varied from 0.23 g (10 mmol) per day to 34.5 g (1,500 mmol) per day. 
Several trials included sodium intake levels close to 1.5 g (65 
mmol) per day and 2.3 g/day (100 mmol/day).
    While blood pressure, on average, rises with increased sodium 
intake, there is well recognized heterogeneity in the blood pressure 
response to changes in sodium chloride intake. Individuals with 
hypertension, diabetes, and chronic kidney diseases, as well as 
older-age persons and African Americans, tend to be more sensitive 
to the blood pressure raising effects of sodium chloride intake than 
their counterparts. Genetic factors also influence the blood 
pressure response to sodium chloride. There is considerable evidence 
that salt sensitivity is modifiable. The rise in blood pressure from 
increased sodium chloride intake is blunted in the setting of a diet 
high in potassium or that is low in fat, and rich in minerals; 
nonetheless, a dose-response relationship between sodium intake and 
blood pressure still persists. In non-hypertensive individuals, a 
reduced salt intake can decrease the risk of developing hypertension 
(typically defined as a systolic blood pressure >= 140 mm Hg or a 
diastolic blood pressure >= 90 mm Hg).
    The adverse effects of higher levels of sodium intake on blood 
pressure provide the scientific rationale for setting the Tolerable 
Upper Intake Level (UL). Because the relationship between sodium 
intake and blood pressure is progressive and continuous without an 
apparent threshold, it is difficult to precisely set a UL, 
especially because other environmental factors (weight, exercise, 
potassium intake, dietary pattern and alcohol intake) and genetic 
factors also affect blood pressure. For adults, a UL of 2.3 g (100 
mmol) per day is set. In dose-response trials, this level was 
commonly the next level above the AI [Adequate Intake] that was 
tested. It should be noted that the UL is not a recommended intake 
and, as with other ULs, there is no benefit to consuming levels 
above the AI. Among certain groups of individuals who are most 
sensitive to the blood pressure effects of increased sodium intake 
(e.g., older persons, African Americans, and individuals with 
hypertension, diabetes, or chronic kidney disease), their UL may 
well be lower. These groups also experience an especially high 
incidence of blood pressure-related cardiovascular disease. * * *
    It is well-recognized that the current intake of sodium for most 
individuals in the United States and Canada greatly exceeds both the 
AI and UL.
(The Electrolyte Report, pp. 270-272 (footnote omitted).)
    The IOM also looked at cardiovascular disease and high blood 
pressure. Page 323 of the Electrolyte Report states that ``[d]ata from 
numerous observational studies provide persuasive evidence of the 
direct relationship between blood pressure and cardiovascular 
disease,'' citing a recent meta-analysis (Lewington et al., 2002) of 60 
prospective observational studies with almost 1 million enrolled 
adults. Individuals with preexisting vascular disease were excluded. 
With 12.7 million person years of followup and the total number of 
deaths at 122,716, about half of the deaths in these studies occurred 
as a result of cardiovascular disease (11,960 deaths from stroke, 
34,283 from ischemic heart disease, and 10,092 deaths from other 
vascular causes). The IOM further commented (pp. 324-325):
    [S]troke mortality progressively increased with systolic blood 
pressure * * * and diastolic blood pressure * * * in each decade of 
life. Similar patterns were evident for mortality from ischemic 
heart disease and from other vascular diseases. In analyses that 
involved time-dependent correction for regression-dilution bias, 
there were strong, direct relationships between blood pressure and 
each type of vascular mortality. Importantly, there was no evidence 
of a blood pressure threshold--that is, vascular mortality increased 
throughout the range of blood pressures, in both non-hypertensive 
and hypertensive individuals.
    The IOM also looked at the effects of reduced sodium intake on 
blood pressure using evidence from intervention studies in both 
nonhypertensive and hypertensive individuals (page 329). Although the 
studies differed in size (<10 to > 500 persons), duration (range 3 days 
to 3 years), extent of sodium reductions, background diet (e.g., intake 
of potassium), study quality and documentation, the studies provided 
relatively consistent evidence that a reduced intake of sodium lowers 
blood pressure in both hypertensive and nonhypertensive adults. In 
these intervention trials, the extent of blood pressure reduction from 
a lower intake of sodium in hypertensive participants was more 
pronounced than that observed in nonhypertensive participants. (See The 
Electrolyte Report, Tables 6-12 and 6-13.)
    The NIH/NHLBI DASH-Sodium study tested the effects of two dietary 
patterns (a control diet and the DASH diet described previously) and 
three sodium intake levels on blood pressure in adult men and women 
with blood pressure higher than optimal or at stage 1 hypertension. The 
overall blood pressure range for the study was systolic 120-159 mm Hg 
and diastolic 80-95 mm Hg. The reported conclusions of the DASH-Sodium 
study were that both hypertensive and nonhypertensive individuals can 
lower blood pressure by reducing dietary sodium. These conclusions were 
generally consistent with those of the other intervention studies, 
showing a connection between reduced sodium intake and lowered blood 
pressure in both hypertensive and nonhypertensive subjects, with a 
greater effect observed in the hypertensive subjects.
    The IOM considered the DASH-Sodium trial in the Electrolyte Report, 
which describes the results of the subgroup analysis as follows:
    On the control diet, significant blood pressure reduction was 
evident in each subgroup. Reduced sodium intake led to greater 
systolic blood pressure reduction in individuals with hypertension 
compared with those classified as non-hypertensive, African 
Americans compared with non-African Americans, and older individuals 
(> 45 years old compared with those <= 45 years old). On the DASH 
diet, a qualitatively similar pattern was evident; however, some 
sub-group analyses did not achieve statistical significance, perhaps 
as a result of small sample size. Comparing the combined effect of 
the DASH diet with lower sodium with the control diet with higher 
sodium, the DASH diet with lower sodium reduced systolic blood 
pressure by 7.1 mm HG in non-hypertensive persons and by 11.5 mm Hg 
in individuals with hypertension.
(The Electrolyte Report, p. 347.)
    The DASH-Sodium study and the other studies summarized in The 
Electrolyte Report, as evaluated by the IOM, demonstrate that the 
intake of excess sodium in the diet is indeed a public health issue. 
FDA further agrees with the IOM's recommendations for addressing this 
issue:
    It is well-recognized that the current intake of sodium for most 
individuals in the United States and Canada greatly exceeds both the 
AI and the Tolerable Upper Intake Level (UL). Progress in achieving 
a reduced sodium intake will be challenging and will likely be 
incremental. Changes in individual behavior towards salt consumption 
will be required as will replacement of higher salt foods with lower 
salt versions. This will require increased collaboration of the food 
industry with public health officials, and a broad spectrum of 
additional research. The latter includes research designed to 
develop reduced sodium food products that maintain flavor, texture, 
consumer acceptability, and low cost. Such efforts will require the 
collaboration of food scientists, food manufacturers, behavioral 
scientists, and public health officials.
(The Electrolyte Report, pp. 395-396.)
    Consequently, the agency continues to believe that individuals 
should be encouraged to reduce the amount of sodium in their diets and 
that manufacturers should be encouraged to produce sodium controlled 
products which are palatable and otherwise acceptable to consumers.
    Further, the recently published ``Dietary Guidelines for Americans 
2005'' (Ref. 3), recommends that individuals consume less than 2,300 mg 
(approximately 1 teaspoon (tsp) of salt) of sodium per day. This is a 
decrease of 100 mg from FDA's sodium Daily Value of 2,400 mg (Sec.  
109.9(c)(9) (21 CFR

[[Page 56832]]

101.9(c)(9)))) which was cited in the 2000 Dietary Guidelines.
    The new USDA pyramid (https://www.mypyramid.gov) (Ref. 4) encourages 
consumers to use the Nutrition Facts label to determine the amount of 
sodium in processed foods, particularly meats and canned vegetables, 
and to keep sodium consumption below 2,300 mg per day by looking for 
lower sodium foods. (FDA has verified the Web site address, but we are 
not responsible for subsequent changes to the Web site after this 
document publishes in the Federal Register.)
    (Comment 2) One comment argued that FDA should delay consideration 
of the 2003 proposed rule until the NHLBI of NIH responds to a joint 
request for correction filed by the Salt Institute and the U.S. Chamber 
of Commerce under the Information Quality Act (IQA) (Public Law 106-
554, H.R. 5658, Sec.  515, 114 Stat. 2763, 2763A-153 to -154 (2000)), 
and NIH Information Quality Guidelines, https://aspe.hhs.gov/
infoquality/Guidelines/NIHinfo2.shtml. (FDA has verified the Web site 
address, but we are not responsible for subsequent changes to the Web 
site after this document publishes in the Federal Register.) This 
comment questioned the accuracy and objectivity of NHLBI's conclusion, 
based on the DASH-Sodium study, that all segments of the population can 
lower their blood pressure by reducing sodium intake. The comment 
argued that because not all of the data from the DASH-Sodium study were 
made available for review by interested parties and therefore could not 
be evaluated and validated by others, FDA should defer consideration of 
the study until the data are released and any necessary reexamination 
of NHLBI's conclusions about sodium intake and blood pressure has been 
accomplished. A second comment similarly argued that FDA should not 
consider the DASH-Sodium study or any other studies ``until such time 
that they are in accord with the [IQA].''
    (Response) Under the IQA, affected persons must be afforded an 
administrative mechanism through which they may seek and obtain 
correction of information disseminated by Federal agencies (Public Law 
106-554, H.R. 5658, Sec.  515(b)(1)(B)). The joint Salt Institute--
Chamber of Commerce request for correction asked NIH to make publicly 
available the DASH-Sodium data for all study subgroups, but did not ask 
NIH to withdraw or correct any of its public statements recommending 
that consumers reduce sodium intake to lower blood pressure, which 
relied on the DASH-Sodium data. At the time the comments were filed, 
NIH had not yet responded to the joint IQA request for correction. NIH 
denied the request by letter on August 19, 2003 (Ref. 5). See https://
aspe.hhs.gov/infoquality/request&response/reply_8b.shtml. (FDA has 
verified the Web site address, but we are not responsible for 
subsequent changes to the Web site after this document publishes in the 
Federal Register.) The NIH response informed the requesters that the 
appropriate mechanism to request access to data produced in grant-
funded research such as the DASH-Sodium study is a request for 
government records under the Freedom of Information Act rather than a 
request for correction under the IQA; however, the response also stated 
that NHLBI's public statements about sodium intake and blood pressure 
satisfied NIH's information quality standards, pointing out that both 
the DASH-Sodium study itself and NHLBI's public statements based on it 
had been subjected to thorough multiple rounds of review, including 
peer review, and that the DASH-Sodium study was only one piece of 
evidence in a substantial, cumulative body of evidence that shows a 
clear causal relationship between sodium intake and blood pressure.
    The Salt Institute and Chamber of Commerce requested 
reconsideration of the request for correction. NIH's response (Ref. 6) 
(see https://aspe.hhs.gov/infoquality/request&response/8d.shtml) 
affirmed the denial of the original request and gave additional reasons 
why NHLBI's public statements about sodium intake and blood pressure 
complied with the NIH Information Quality Guidelines. (FDA has verified 
the Web site address, but we are not responsible for subsequent changes 
to the Web site after this document publishes in the Federal Register.) 
The Salt Institute and Chamber of Commerce then sued NIH in the U.S. 
District Court for the Eastern District of Virginia, alleging that NIH 
had violated the IQA by failing to disclose the data and methods 
underlying the DASH-Sodium study. The court dismissed the case, ruling 
that an agency response to a request for correction under the IQA is 
not subject to judicial review. (Salt Institute v. Thompson, 345 F. 
Supp.2d 589 (E.D. Va. 2004), appeal docketed, No. 05-1097 (4th Cir. 
Jan. 25, 2005).) Although an appeal of that ruling is pending, FDA does 
not believe that further delay in issuing a final rule is justified by 
the pendency of this appeal.
    FDA is relying on a large and well-established body of evidence 
about sodium and hypertension summarized in The Electrolyte Report, not 
solely on the DASH-Sodium study or NHLBI's conclusions about that study 
expressed in its public statements. Further, as discussed in response 
to comment 1 of this document, the IOM's conclusions about the DASH-
Sodium study data are consistent with those of NHLBI. For the reasons 
discussed in NHLBI's responses to the IQA request for correction and 
request for reconsideration (Refs. 5 and 6), FDA is satisfied that the 
data that were the subject of the IQA request for correction submitted 
to NHLBI, as well as the other data on sodium and blood pressure 
considered in this rulemaking, are objective and reliable.

B. Public Health Goals

    (Comment 3) Comments said that the ``healthy'' claim should be used 
to promote development of foods that are indeed more healthful and to 
encourage consumers to eat such foods. A number of comments cited the 
Secretary of Health and Human Services' statement that food companies 
should be encouraged and rewarded for creating healthy products. They 
also said that FDA should develop criteria that would allow for a 
sufficient number and variety of ``healthy'' products yet would be 
stringent enough for these products to fit within dietary guidelines.
    Many comments expressed concern that making the requirements for 
use of the term ``healthy'' too stringent will run counter to public 
health goals. These comments contended that the lower (second-tier) 
sodium levels will decrease the incentive to develop healthy foods 
because fewer foods will be able to meet these levels and still be 
palatable. They argued that products that can currently meet the 
``healthy'' first-tier criteria for sodium are better nutritionally 
than products that do not bear the ``healthy'' claim and are therefore 
not required to meet any of the various nutrient requirements for 
``healthy''. Consequently, the comments said, it is better overall to 
allow the currently marketed ``healthy'' products with slightly higher 
sodium content to continue to bear the term ``healthy'' than to 
implement the more restrictive sodium requirement and risk losing these 
nutrient controlled products altogether. Comments argued that if 
consumers are disinclined to eat ``healthy'' foods at the current 
first-tier sodium levels, they will be even less likely to eat similar 
foods at the lower sodium levels, thus eliminating many ``good-for-
you'' products. However, another comment argued in favor of 
implementing the second-tier levels, stating that food manufacturers 
did not reformulate their products to reduce

[[Page 56833]]

levels of other nutrients whose consumption should be controlled until 
nutrient content claim regulations forced industry to lower the levels 
to use such claims.
    Several comments argued that, instead of focusing narrowly on 
reducing the sodium content of foods with ``healthy'' claims, the 
agency should direct its efforts toward higher-impact public health 
measures such as reducing the overall level of sodium in the food 
supply and fighting obesity. Several comments pointed out that the 
Surgeon General has targeted obesity and educating people about eating 
a balanced diet as current U.S. health goals. They said that focusing 
limited resources on lowering sodium levels in foods labeled as 
``healthy'' appears to be out of touch with these goals. These comments 
suggested that the best way to combat high blood pressure is by 
offering a reasonable level and balance of all nutrients in foods that 
tempt the palate. Implementing the second-tier sodium levels, they 
said, will do the opposite.
    (Response) The agency agrees with the comments that it is important 
that consumers be encouraged to consume foods that will help them 
achieve a healthy diet. The agency views the ``healthy'' claim as a 
valuable signal that a food that bears the claim is consistent with 
dietary guidelines in that it meets a very strict set of nutrient 
requirements. Such a food must be low in fat and saturated fat (or 
extra lean), have limited amounts of cholesterol and sodium, but 
contain a sufficient amount (10 percent of the Daily Value) of at least 
one of several desirable nutrients. The agency believes that it is 
important to keep the term ``healthy'' as a viable tool to signal these 
desirable nutrient characteristics.
    The intent of the two-tiered sodium levels established by the 1994 
final rule was to encourage industry to be innovative and further lower 
sodium levels in foods bearing the term ``healthy''. However, based on 
comments and other data that have become available since 1994, FDA is 
concerned that this goal will not be realized and that implementing the 
second-tier sodium level requirements for the ``healthy'' claim could 
in fact result in a smaller selection of nutritionally desirable foods 
on the market. The agency agrees with the majority of comments that 
lowering the amount of sodium in ``healthy'' foods to the second-tier 
levels would run counter to public health goals if it discouraged 
manufacturers from producing ``healthy'' foods and consumers from 
eating them.
    With regard to the comments that expressed concern about whether 
the problem of obesity in the United States is being effectively 
addressed, FDA and its parent agency, HHS, are actively working to 
confront this public health problem. FDA's plan of action for tackling 
obesity, which encompasses consumer education, rulemaking to make food 
labels more useful for people who are trying to lose weight, 
enforcement against products with misleading serving sizes or 
unsubstantiated weight loss claims, and research and education 
partnerships with other government agencies and organizations, is 
described in ``Calories Count: Report of the Working Group on Obesity'' 
March 12, 2004 (Ref. 7) (https://www.cfsan.fda.gov/~dms/owg-toc.html).

C. Consumer Understanding

    (Comment 4) Several comments expressed confusion about the current 
regulations for the term ``healthy''. A couple of comments stated that 
consumers and food manufacturers do not understand the requirements for 
using the ``healthy'' claim in food labeling. Comments suggested that 
food labeling can mislead consumers and FDA about the nutritional value 
of food and asked FDA to address this problem. One comment from a 
consumer remarked that the term ``healthy'' is abused, misused, and 
misunderstood on all sides and that there should be a well publicized 
chart showing which foods qualify for the term. This comment added that 
manufacturers believe that only fat and cholesterol content are 
pertinent criteria; this comment questioned whether many ``healthy'' 
products actually meet all the ``healthy'' criteria.
    (Response) FDA's nutritional criteria for foods that bear a 
nutrient content claim ensure that such foods are consistent with the 
dietary guidelines regarding the nutrient that is the subject of the 
claim. Because ``healthy'' is an implied nutrient content claim (versus 
an explicit nutrient content claim such as ``low fat''), the desirable 
nutrient characteristics of a food bearing this claim are less apparent 
to consumers. Nevertheless, the agency believes that the nutrient 
content claim ``healthy'' does send a clear message to the consumer 
that the food is consistent with dietary guidelines and can be used as 
part of a healthy diet. The definition for ``healthy'' as well as other 
nutrient content claims can be easily found on the FDA Web site by 
searching on the word ``definition'' preceded by the word ``nutrient'' 
or the term(s) used in the claim. In response to the comment asking FDA 
to publicize the requirements for ``healthy'' claims, the agency has 
added a direct link to the ``healthy'' definition, which may be 
accessed by clicking on ``healthy'' in the drop down ``Select a Topic-
Labeling'' menu on the Food Labeling and Nutrition page of the FDA 
Center for Food Safety and Applied Nutrition (CFSAN) Web site (https://
www.cfsan.fda.gov/label.html). Finally, the agency has done 
considerable nutrition outreach, including outreach about requirements 
for the ``healthy'' claim and various other nutrient content claims.
    The agency does not agree that manufacturers are unaware of the 
definition of the ``healthy'' claim, as the definitions of this and 
other nutrient content claims are readily available to industry, and 
manufacturers are required to know the laws and regulations that apply 
to products they market. As with any nutrient content claim, any food 
labeled as ``healthy'' that deviates from the requirements in the 
regulation defining that term (Sec.  101.65(d)) is subject to 
enforcement proceedings under the act.

D. Role of Salt in Manufacturing

    (Comment 5) Many comments, particularly from industry, emphasized 
salt's importance as a food ingredient. They stated that salt is 
essential for developing taste, and sometimes also for texture and 
microbiological stability. The comments said that no single substitute 
for the technical functions of salt was likely to be available soon. 
One comment explained that the tongue only recognizes sodium chloride 
(NaCl) as salty and that this makes creating palatable lower sodium 
versions of products difficult. An industry comment identified a number 
of manufacturing and technical issues with lowering the amount of salt 
in a product to the second-tier level. This comment said that hot dogs 
fall apart, processed meats have reduced microbial protection and lose 
their characteristic texture, and consumers will not eat certain 
products with sodium less than 360 mg because the products do not taste 
good or do not taste as expected. Several comments argued that because 
consumers will not buy products that meet the second-tier sodium 
levels, companies will have to discontinue their ``healthy'' products 
if the second-tier sodium levels go into effect. As discussed in the 
response to comment 11 of this document, some comments submitted data 
to support this argument. One comment stated that FDA recognized that 
the second-tier levels may be overly restrictive in

[[Page 56834]]

soliciting comments in the 1997 ANPRM about the technological 
feasibility of reducing sodium and on consumer acceptance of products 
with reduced sodium.
    (Response) The agency acknowledges manufacturers' concerns about 
the technical importance of salt. The agency had anticipated that 
phasing in the lower second-tier sodium level requirement for the term 
``healthy'' would allow the food industry time to develop technically 
and commercially viable alternatives to salt. Although it is 
unfortunate that no viable alternative has been found, FDA understands 
the manufacturing difficulties that are presented by the absence of a 
suitable substitute for salt and has taken them into consideration in 
deciding how to regulate the sodium content of foods bearing the 
``healthy'' claim.

E. Number of ``Healthy'' Products on the Market

    (Comment 6) A comment contended that the agency had miscounted the 
number of products with a ``healthy'' claim in the 2003 proposed rule. 
The comment asserted that in estimating that there were over 800 
products bearing a ``healthy'' claim, the agency had erroneously 
counted certain products in the Food Labeling and Package Survey 
(FLAPS) data. Examples cited in the comment included products like 
chewing gum and sugar substitutes that used the term ``health'' in 
ingredient warnings, such as warnings that saccharin and phenylalanine 
are bad for your health; products that did not use the term ``healthy'' 
as a nutrient content claim; and products that used the ``healthy'' 
claim illegally. The comment also criticized FDA for using 1999 
Information Resources, Inc. (IRI) data\3\ as a basis for the proposed 
rule's estimate of the number of ``healthy'' products on the market, 
and provided the agency with updated 2003 IRI data.
---------------------------------------------------------------------------

    \3\ The IRI InfoScan database contains dollar sales information 
for food and dietary supplement products. InfoScan includes 
information collected weekly from a selected group of grocery, drug, 
and mass merchandiser stores across the continental United States 
with annual sales of $2 million and above (sample store data)--more 
than 32,000 retail establishments. The retail stores are 
statistically selected and meet IRI's quality standards. The 
database contains sales data for all products in these retail stores 
that are scanned (i.e., sold) at checkout. IRI applies projection 
factors to the sample store data to estimate total sales in the 
continental United States from stores that have annual sales of $2 
million and above. The database does not include data from stores 
with annual sales of less than $2 million. The database provides 
information by brand name only and cannot be used to determine the 
number of products with claims outside the brand name.
---------------------------------------------------------------------------

    (Response) The comment is incorrect in suggesting that FDA's 
estimate that over 800 products bore a healthy claim was derived 
primarily from examination of the FLAPS data. In deriving this number, 
the agency looked first to the IRI data, which indicated that at the 
time the data were collected there were over 800 products bearing a 
``healthy'' brand name (Ref. 8). Because the IRI data represented only 
a sampling of the marketplace and captured only ``healthy'' claims that 
were part of the product's brand name, the agency then used the FLAPS 
data to evaluate whether there were additional ``healthy'' claims in 
the marketplace.
    FLAPS is an FDA survey which essentially provides a ``snapshot'' of 
marketed products. The survey involves purchasing representative 
products and examining them for a variety of label statements that are 
recorded in a database. In developing the 2003 proposed rule, FDA 
examined this database to determine the regulatory classification of 
label statements from this sample. One example of an additional 
``healthy'' claim identified using the FLAPS survey is ``Apple sauce is 
a delicious and healthy fruit product which contains no fat, very low 
sodium, and no cholesterol.'' This ``healthy'' claim would not have 
been captured by the IRI data because it is not part of a brand name. 
On the basis of this and other claims identified in FDA's analysis of 
the data collected in the FLAPS survey, the agency concluded that ``it 
is likely that the number of `healthy' individual foods included in the 
1999 market place analysis [using only IRI data] underestimates the 
number of individual food products bearing `healthy' claims'' (68 FR 
8163 at 8166). Thus, rather than using the FLAPS data to augment its 
numerical estimate of products bearing a ``healthy'' claim as the 
comment assumed, FDA used these data only to support its assertion that 
the numerical estimate generated from the IRI data by counting the 
products with ``healthy'' claims in their brand names had likely 
underestimated the number of products bearing a ``healthy'' nutrient 
content claim somewhere in their labeling.
    The comment's criticism of FDA's estimate also reflects a 
misunderstanding of which products identified in the FLAPS survey were 
counted as bearing a ``healthy'' claim. The examples of illegitimate 
``healthy'' claims cited in the comment appear to have come from 
attachment B of reference 4 of the 2003 proposed rule. Reference 4 of 
the 2003 proposed rule (Ref. 9) is a 2001 cover memorandum entitled 
``1997 Food Labeling and Package Survey (FLAPS) Product Label 
Evaluation for `Healthy' Claims''. Attachment B is a list of all label 
statements identified in the 1997 FLAPS survey that included the word 
``healthy'' or a variant (e.g., ``health'' or ``healthful''). Contrary 
to the comment's assumption, however, this list is not the list of 
FLAPS products that FDA counted as bearing a ``healthy'' claim. 
Compiling this list was only a preliminary step in FDA's marketplace 
data analysis. When the proposal was being developed, each statement in 
this list was carefully examined to determine whether or not it was in 
fact a ``healthy'' claim.
    The agency agrees with the comment that label statements about the 
health effects of phenylketonurics and saccharin are not ``healthy'' 
claims and that products with such statements should not be counted as 
products with a ``healthy'' claim. It also agrees that statements in 
labeling such as ``eat healthy, eat well'' should not be counted as 
``healthy'' claims because they do not imply that the food has levels 
of nutrients that meet the ``healthy'' definition. Rather, such 
statements provide dietary guidance to consumers or make general 
statements about health and diet. A careful reading of the 2001 cover 
memorandum (Ref. 9) demonstrates that FDA recognized during the 
development of the 2003 proposed rule that the statements listed in 
Attachment B were not all ``healthy'' claims:
    Some of the statements are dietary guidance statements (e.g., 
``Eat 5 servings of fruits and vegetables every day for better 
health'') or hazard warnings (e.g., ``Phenylketonurics: Contains 
phenylalanine. Use of this product may be hazardous to your 
health.''), neither of which are implied nutrient content claims for 
``healthy.''
    The comment is correct that the 2003 proposed rule did not use the 
most recent IRI data on the number of ``healthy'' individual foods in 
the marketplace; however, the 2003 IRI data submitted with the comment 
only reinforce FDA's ultimate conclusions about the downward trend in 
the number of such products. Due to budget constraints, the 1999 IRI 
data were the most recent available to FDA at the time the 2003 
proposed rule was being developed. The 2003 proposed rule specifically 
asked for additional marketplace data, and the agency received the more 
recent data provided by the comment that further support the difficulty 
of making and marketing products which may be labeled as ``healthy.'' 
As discussed in section III.F.3 of this document, the agency has taken 
these data into consideration in deciding how to regulate the sodium

[[Page 56835]]

content of foods bearing the ``healthy'' claim.
    Further, FDA's analysis of the IRI and FLAPS marketplace data was 
intended to provide only an estimate of the number of ``healthy'' 
products, not an exact count. It would be extremely difficult, if not 
impossible, to get an accurate count of the exact number of products 
that bear and qualify for the ``healthy'' claim. Obtaining an accurate 
count would involve examining all panels of the labels of all FDA-
regulated food products, including those that use ``healthy'' as part 
of their brand name, to determine whether the label bore the term 
``healthy'' as a nutrient content claim. Once products bearing the 
``healthy'' claim were identified, the person responsible for the count 
would have to check the nutrition facts panel to determine if the 
product met the requirements for this claim. Even then, without a 
laboratory analysis of the product, it would be impossible to determine 
conclusively whether the product actually complied with the definition 
of ``healthy.'' Thus, getting an exact count of products legitimately 
labeled with the ``healthy'' claim would be an extremely burdensome and 
resource-intensive task. In light of the need to move forward with the 
2003 proposed rule and other regulatory priorities, the agency was 
justified in using its available resources to make an estimate, rather 
than an exact count, of the number of products bearing the claim 
``healthy.''

F. Sodium Level Requirement for ``Healthy'' Claims

1. Need for Sodium Level
    (Comment 7) One comment argued that sodium content should not be a 
criterion for whether a food can be labeled as ``healthy'' because, 
according to the comment, current nutritional science does not show 
beneficial health outcomes from reducing sodium in the diet. The 
comment recommended that FDA revise the ``healthy'' regulation to 
remove the sodium level requirements entirely.
    (Response) FDA disagrees with the comment that advocated dropping 
all sodium criteria for the ``healthy'' claim. As discussed previously 
in response to comment 1 of this document, there is ample evidence that 
sodium has an adverse impact on cardiovascular disease, particularly 
hypertension, and that as a consequence, the amount of sodium in an 
individual food or meal type product should be controlled in order for 
such a product to be labeled as ``healthy''.
2. Sodium Level for Meal and Main Dish Products
    (Comment 8) Most comments supported or did not object to 
maintaining the current first-tier sodium level of 600 mg for meals (as 
defined in Sec.  101.13(l)) and main dishes (as defined in Sec.  
101.13(m)). Comments emphasized the importance of making sure that 
``healthy'' meals and main dishes, which present a more healthful 
alternative to standard processed foods, can continue to be marketed 
without sacrificing taste and commercial viability. These comments took 
the view that it is better to avoid driving nutritious, controlled-
sodium alternatives to standard processed foods out of the marketplace 
than to bring about the small incremental reduction in sodium that 
would result from allowing the second-tier level for meals and main 
dishes from going into effect. One comment suggested that the current 
regulations have already had a chilling effect on the term ``healthy'' 
on meal and main dish products. According to this comment, the number 
of brands of frozen entrees or dinners bearing the ``healthy'' claim 
decreased from seven to one between 1994 and 2003. The comment 
suggested that maintaining the first-tier sodium levels for meals and 
main dishes would help achieve the goals FDA articulated in the ANPRM 
and 2003 proposed rule: To develop sodium criteria for the definition 
of ``healthy'' that allow a significant number and variety of products 
to be labeled as ``healthy,'' yet that are not so broadly defined as to 
cause the term to lose its value in identifying products that are 
useful for constructing a healthy diet consistent with dietary 
guidelines. See 62 FR 8163 at 8165; 62 FR 67771 at 67772.
    Of the few comments that opposed FDA's proposal to retain the 
first-tier sodium level requirement for meals and main dishes, one 
consumer comment suggested that the rules for sodium content of meals 
and main dishes should be stricter than the first-tier level currently 
in effect but did not specify whether FDA should implement the second-
tier level or an even lower level. Another comment took issue with the 
agency's rationale for proposing to retain the current first-tier 
sodium level of 600 mg for meals and main dishes. This comment argued 
that the agency's concern about driving ``healthy'' meals and main 
dishes from the market by implementing the lower second-tier sodium 
level requirement of 480 mg is not a legitimate reason for retaining 
the more lenient 600 mg sodium requirement and thus allowing unhealthy 
products to be labeled as ``healthy''. The comment argued that because 
the intent of the regulation was to promote health, FDA should not 
retain the current 600 mg sodium level because it would not guide 
individuals to build a diet that meets Federal nutrition 
recommendations. This comment reasoned that the 2000 Dietary Guidelines 
(Ref. 1) recommend that sodium intake not exceed 2,400 mg per day\4\ 
and that the Food Guide Pyramid recommends a minimum of 15 servings of 
food per day to meet nutrient needs. The comment stated that, on 
average, sodium intake should not exceed 160 mg per serving of food. 
Given that a meal contains 2-3 servings of food, the comment reasoned 
that a meal should contain no more than 480 mg sodium. As discussed in 
comment 7 of this document, one comment suggested that the sodium 
requirement for meals should be dropped altogether.
---------------------------------------------------------------------------

    \4\ The current recommendation for sodium for adults in the 
``Dietary Guidelines for Americans 2005'' is 2,300 g per day (Ref. 
3). This is also the UL for sodium found in The Electrolyte Report 
(Ref. 2).
---------------------------------------------------------------------------

    (Response) The agency acknowledges the comments' concerns about the 
amount of sodium in meal and main dish products and agrees that FDA 
should encourage manufacturers to limit the amount of sodium in these 
products. However, the comments presented no data to substantiate the 
technical and commercial feasibility of implementing the second-tier 
sodium criterion for meals and main dishes at the 480 mg per labeled 
serving level. Consequently, the agency has no basis to change its 
position on this issue. In the 2003 proposed rule, the agency described 
the reasons why FDA had tentatively concluded that the first-tier 
sodium level for ``healthy'' meals and main dishes should be retained:
    Based on the marketplace data analysis, the agency found that 
there were a limited number of ``healthy'' meal and main dish 
products that met the current first-tier sodium level. The agency 
further found a general decline in the number of meal and main dish 
products available in 1999 compared to 1993. * * *
    This appears to indicate that providing consumers with a 
palatable ``healthy'' product at the current, first-tier sodium 
level is difficult.
    The limited number of ``healthy'' meal and main dish products 
affects FDA's goal to provide a definition for ``healthy'' that 
permits consumers access to a reasonable number of products that 
bear the ``healthy'' claim. If FDA were to allow the second-tier 
sodium level for ``healthy'' meal and main dish products to take 
effect, there would likely be an even greater reduction in the 
number of available ``healthy'' meal and main dish products in the 
marketplace.

[[Page 56836]]

    Furthermore, some manufacturers of ``healthy'' meal and main 
dish products might choose to limit only fat or calorie levels and 
change to ``lean,'' ``low calorie,'' or ``low fat'' claims. Although 
those claims do provide some assistance to consumers who are trying 
to construct a diet consistent with dietary guidelines, there are 
additional nutritional benefits in products bearing a ``healthy'' 
claim. * * *
    Moreover, FDA finds the petitioner's comment that a number of 
meal and main dish products would ``disappear'' to be persuasive 
because the petitioner is one of only a few manufacturers currently 
producing ``healthy'' meal and main dish products. The marketplace 
data analysis * * * showed that there were a limited number of 
``healthy'' meal and main dish manufacturers, with one manufacturer 
producing most of the ``healthy'' meal and main dish products. * * * 
Five brands that were available for sale in 1993 had completely 
disappeared from the market by 1999. * * * Considering the 
petitioner's expertise in the ``healthy'' frozen meal and main dish 
market, and the trends seen in the marketplace, FDA believes that 
the petitioner raised valid concerns about the second-tier sodium 
level for meal and main dish products * * * .
    Furthermore, the first-tier sodium level proposed for 
``healthy'' meal and main dish products is proportionate to and 
adequately reflects their contribution to the total daily diet while 
remaining consistent with current dietary guidelines. If each meal 
or main dish product has a maximum of 600 mg sodium and if one meal 
or main dish product is consumed at each of three meals during a 
typical day, then this accounts for a total of 1,800 mg sodium from 
meal and main dish products. This is consistent with previous agency 
assumptions that daily food consumption patterns include three meals 
and a snack with about 25 percent of the daily intake contributed by 
each (final rule on nutrient content claims (58 FR 2302 at 2380, 
January 6, 1993)). The 1,800 mg sodium level is well below the 
suggested 2,400 mg recommendation\5\ and allows for flexibility in 
the rest of the daily diet (i.e., the snack). * * *
---------------------------------------------------------------------------

    \5\ The recommendation in the current edition of the Dietary 
Guidelines is 2,300 mg/day. See footnote 4 in this document.
---------------------------------------------------------------------------

    FDA tentatively concludes that the first-tier sodium level for 
meal and main dish products allows a ``healthy'' definition that is 
neither too strictly nor too broadly defined. The first-tier sodium 
level will allow consumers to meet current dietary guidelines for 
sodium intake while still maintaining flexibility in the diet. 
Additionally, the agency believes that by retaining the first-tier 
sodium level, a reasonable number of ``healthy'' meal and main dish 
products will remain available to consumers. Therefore, the agency 
has tentatively concluded that the current first-tier level of 600 
mg sodium per serving size should be retained as the sodium 
criterion for ``healthy'' meal and main dish products. * * *
(68 FR 8163 at 8169-8170 (reference omitted).)
    Having received no data that would justify changing the tentative 
conclusions outlined in the 2003 proposed rule, FDA has decided to 
eliminate the second-tier (480 mg) requirement for ``healthy'' meals 
and main dish products that was adopted in the 1994 final rule and that 
would have gone into effect when the partial stay of that rule expired.
    In addition, although there may be difficulties in formulating 
products that control sodium in addition to other nutrients, the 
marketing of a variety of these nutrient controlled products shows that 
it is possible to limit the sodium level in meal-type products to the 
first-tier level, 600 mg. Consequently, the agency does not see the 
merit or necessity of eliminating the sodium criterion altogether.
    Therefore, as proposed, FDA is amending the requirements for use of 
the term ``healthy'' on meal and main dish products to do the 
following: (1) To make permanent the current first-tier sodium level 
requirement of 600 mg per labeled serving, and (2) to delete the more 
restrictive second-tier sodium level requirement of 480 mg per labeled 
serving that was adopted in the 1994 final rule and would have become 
effective when the partial stay of that rule expired.
3. Sodium Level for Individual Foods
    (Comment 9) A few comments supported implementing the more 
restrictive second-tier sodium level of 360 mg per RACC and per labeled 
serving for individual foods. One comment asserted that promoting good 
health should be a higher priority than manufacturers' difficulties 
with formulating and marketing lower sodium products. This comment 
argued that the fact that truly ``healthy'' products may not be 
available does not justify stamping ``healthy'' on unhealthy products. 
Another comment hypothesized that the number of products qualifying as 
``healthy'' is not extensive because food processors have resisted 
efforts to reduce the sodium content. This comment expressed 
disagreement with the petitioner's contention that the second-tier 
sodium level cannot be met, and asserted that the available data do not 
justify such a conclusion.
    (Response) The agency agrees with the comments that foods labeled 
as ``healthy'' should in fact promote good health. When FDA issued the 
19