[Federal Register: September 29, 2005 (Volume 70, Number 188)]
[Rules and Regulations]               
[Page 56828-56849]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se05-8]                         

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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 (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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) (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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 (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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 
1994 final rule providing for a phased-in second-tier sodium level of 
360 mg per RACC and per labeled serving, the agency had anticipated 
that with the passage of time, there would be sufficient technological 
progress to make it feasible to implement this lower sodium level 
requirement for foods labeled as ``healthy.'' However, in both the 1997 
ANPRM and the 2003 proposed rule, the agency recognized that 
technological and safety concerns might justify reconsidering the 
second-tier sodium level. For example, in the ANPRM FDA said (62 FR 
67771 at 67773):
    If the petitioner is correct that the technology does not yet 
exist that will permit manufacturers, by January 1, 1998, to produce 
certain types of low fat foods at the lower levels of sodium 
required in Sec.  101.65(d) that are still acceptable to, and safe 
for, consumers, then the possibility exists that ``healthy'' will 
disappear from the market for such foods. This result would force 
consumers who are interested in foods with restricted fat and sodium 
levels to choose among foods in which an effort has been made to 
lower the level of one or the other of these nutrients but not 
necessarily both. * * * Therefore, the agency has decided that, 
before allowing the new sodium levels for ``healthy'' to go into 
effect, it needs to explore whether it has created an unattainable 
standard * * * .
    The 2003 proposal summarized the technological and safety 
considerations presented in the 1997 ANPRM, including consumer 
acceptance of foods at the second-tier sodium levels, availability of 
sodium substitutes, difficulties in manufacturing foods with reduced 
sodium levels, and the impact of lower sodium levels on the shelf-life, 
stability, and safety of the food (68 FR 8163 at 8164). In addition, 
the proposed rule reiterated FDA's goal of ensuring continued 
availability of ``healthy'' foods for consumers to purchase (68 FR 8163 
at 8165):
    The fundamental purpose of a ``healthy'' claim is to highlight 
those foods that, based on their nutrient levels, are particularly 
useful in constructing a diet that conforms to current dietary 
guidelines * * * . To assist consumers in constructing such a diet, 
a reasonable number of ``healthy'' foods should be available in the 
marketplace.
    [FDA's] goal was to establish sodium levels for the definition 
of ``healthy'' that are not so restrictive as to preclude the use of 
the term ``healthy'' * * * .
    In keeping with this goal, FDA solicited comments on the potential 
impact of the second-tier sodium level on specific categories of 
individual foods (68 FR 8163 at 8167). As discussed in comment 11 of 
this document, the majority of comments opposed the agency's proposal 
to allow the second-tier sodium level to go into effect. Some of these 
comments included data supporting their position. In contrast, the 
proponents of the second-tier sodium requirement did not provide 
supporting data as to why this lower level is appropriate and how it 
could be technologically accomplished.

[[Page 56837]]

    (Comment 10) One comment that did not agree with implementing the 
second-tier sodium levels suggested an alternative. This comment 
suggested that FDA set sodium level requirements for ``healthy'' 
individual foods on a case by case basis instead of applying the 
second-tier sodium level to all types of individual foods. For example, 
the comment suggested that the sodium requirement for soups be lowered 
from the first-tier requirement by 30-50 mg per serving rather than 120 
mg as required by the second-tier sodium level, to retain the 
palatability of ``healthy'' soups. To create broad incentives for 
companies to lower the sodium content of processed foods, this comment 
recommended that FDA take a similar approach for other categories of 
foods and set appropriate sodium levels (higher than the second-tier 
level, but lower than the first-tier level) on a category-by-category 
basis. According to the comment, modest reductions in sodium across a 
wide range of individual processed foods in the total diet could have a 
significant effect.
    (Response) Although the alternative suggested in this comment has 
some appeal as a compromise between the first- and second-tier levels, 
the comment did not include supporting data, unlike comments advocating 
that FDA retain the first-tier level for individual foods. With regard 
to the comment's specific recommendation to lower the sodium level 
requirement for ``healthy'' soups by 30-50 mg per reference amount and 
per labeled serving below the first-tier level (rather than the 120 mg 
reduction required by the second-tier level), the comment provided no 
data on the benefits of reducing the sodium requirement by 6-10 percent 
as opposed to the 25 percent reduction that would result from the 
second-tier sodium requirement, on whether a 6-10 percent reduction 
would be feasible, or on the effect that such a reduction would have on 
the overall amount of sodium in soups that currently use ``healthy'' 
claims or that have used ``healthy'' claims in the past. In contrast to 
the absence of data supporting this alternative regulatory approach, 
FDA has enough data about the feasibility of formulating and selling 
``healthy'' foods at the current first-tier sodium level to be 
confident that retaining this level will promote the continued 
availability of nutritious processed foods that will assist consumers 
in following dietary guidelines.
    Moreover, this comment advocates a regulatory approach based on 
product categories (i.e., different sodium level requirements for 
different product categories like soups and cheeses); such an approach 
would not be consistent with the principles of consistency and 
uniformity that have always guided FDA's regulation of nutrient content 
claims. Although FDA does vary the criteria for nutrient content claims 
somewhat for broad classes of products (such as meals and main dishes, 
seafood and game meat, and foods with small servings) to accommodate 
inherent differences in the nutrient characteristics of different 
classes of foods, the agency has never created food-specific exemptions 
or nutrient criteria to accommodate the making of a nutrient content 
claim for an individual food category, such as soups, that otherwise 
could not qualify for the claim.
    When the nutrient content claims requirements were being developed, 
the agency rejected the notion of having variable nutrient requirements 
for various commodities. In the proposed rule on general requirements 
for nutrient content claims in food labeling, FDA explained its view as 
follows:
    The use of different criteria for different food categories has 
several disadvantages that affect both consumers and the food 
industry. When different criteria are used for different categories 
of foods, consumers cannot use the descriptors to compare products 
across categories and will likely find it difficult to use the 
descriptors for substituting one food for another in their diets.
     * * * [T]he agency believes that such a system would have a 
high potential for misleading the consumers about the nutrient 
content of foods * * * . [W]ith different criteria for different 
food categories, it would be possible that some foods that did not 
qualify to use the descriptor would have a lower content of the 
nutrient than foods in other categories that did qualify. * * *
    FDA has received many comments asking for increased consistency 
among nutrient content claims to aid consumers in recalling and 
using the defined terms. In addition, the IOM report recommended 
that ``low sodium,'' for example, should have the same meaning 
whether it is applied to soup, frozen peas, or meat. Accordingly, 
the agency concludes that establishing different cutoff levels for 
each nutrient content claim for different food categories would 
greatly increase the complexity of using such claims to plan diets 
that meet dietary recommendations. * * *
(56 FR 60421 at 60439, November 27, 1991 (reference omitted).)
    Further, as stated in the comments on consumer understanding 
summarized in section II.C of this document, there may already be some 
confusion as to what the term ``healthy'' means. This confusion could 
worsen if the definition for ``healthy'' meant different sodium levels 
for different foods. Consequently, the agency is not establishing a 
different sodium criterion for ``healthy'' for soups or other 
individual product categories.
    (Comment 11) A majority of the comments supported retaining the 
less restrictive, first-tier sodium level for individual foods. 
Comments argued that if the lower second-tier sodium level for 
``healthy'' individual foods takes effect, many foods that meet the 
current criteria for ``healthy'' would disappear from the marketplace 
because the second-tier standard is difficult or impossible to meet 
while maintaining palatability. They expressed the view that although 
the first-tier level for sodium is not perfect, it is preferable to 
seeing products labeled as ``healthy'' disappear from the marketplace.
    Several comments stated that consumers will not accept or purchase 
foods that meet the second-tier level for sodium, explaining that 
consumers want good taste and that these lower sodium products do not 
taste as good as products with more sodium. Some of these comments 
pointed out that lowering the sodium content of a food can affect its 
texture, which in turn may also affect whether consumers are willing to 
purchase the food. One comment from a food manufacturer stated that 
even under the current, less restrictive first-tier sodium criterion, 
production and consumer acceptance are difficult. This comment cited 
data showing that consumers buy relatively few ``healthy'' products; 
for example, ``Healthy Choice'' makes up less than 1/10th of 1 percent 
of all food products (Ref. 10). This comment also asserted that eating 
trends had changed between 1994 and 2003. The comment stated that 
according to National Eating Trends 2003 data, consumption of foods 
free of or low in salt or sodium was currently 1.5 percent, down from 
3.3 percent in 1994.\6\
---------------------------------------------------------------------------

    \6\ The comment did not include a copy of this reference, and 
FDA was unable to locate it.
---------------------------------------------------------------------------

    According to the comment, a 1994 Prevention Magazine article 
entitled ``Eating in America: Perception and Reality'' reported data 
from the Food Marketing Institute showing that of 597 shoppers 
surveyed, 89 percent said that taste was the most important factor in 
food selection.\7\ The comment also asserted that taste tests conducted 
in 2003 by the manufacturer who

[[Page 56838]]

submitted the comment found that modern ``salt enhancers'' and bitter 
blockers (substances that block bitter tastes in foods) were not 
sufficient to make soup containing only 360 mg sodium appealing to 
consumers, while the manufacturer's current soup version at 480 mg 
sodium was found to be acceptable to consumers (Ref. 12).
---------------------------------------------------------------------------

    \7\ FDA determined that this information, though accurate, did 
not come from the Prevention article cited in the comment but rather 
from a report summarizing data collected for the Food Marketing 
Institute by Abt Associates. The report ``Trends in the United 
States--Consumer Attitudes and the Supermarket, 1996'' states that 
in each year from 1991 to 1996, taste ranked highest in importance 
(89-91 percent) of various factors (e.g., nutrition, product safety, 
and price) in food selection (Ref. 11).
---------------------------------------------------------------------------

    The comment also cited IRI data on soup sales (Ref. 13). These data 
showed that the soup category currently has $ 2.7 billion in sales, of 
which only $ 19 million is for soup with 360 mg or less sodium. The 
comment calculated that soups with 360 mg or less sodium account for 
only 1.7 percent of ``Ready to Serve'' soup sales. ``Low sodium'' soups 
(less than 140 mg) make up less than 0.4 percent of the ready to serve 
market, and sales of these soups are falling. Further, there are no low 
sodium condensed soups on the market.
    In addition, this comment included a graph of the market sales of a 
leading manufacturer of soups labeled as ``healthy.'' This graph shows 
a drop in sales of roughly 75 percent from 1999 to 2003, when the 
sodium level in the soups was reportedly reduced from 480 mg to 360 mg. 
The comment cited a case of another major manufacturer marketing 
``healthy'' soups that reportedly increased the sodium in its products 
by 1/3 to 1/2; this increase in sodium content was followed by an 
increase in product sales.
    The comment further stated that there are very few manufacturers 
left that produce foods that qualify to bear the term ``healthy.'' The 
comment asserted that in eight of the nine food categories in which the 
manufacturer that submitted the comment competes, its product is the 
only product with the term ``healthy'' in its brand name.
    Other comments also focused on the limited selection and dwindling 
numbers of ``healthy'' products. One comment stated that in the past 5 
years there has not been a significant number of new ``healthy'' 
product offerings (only 80 such new products, or about 16 per year). 
The comment added that of these new products, 76 percent of them were 
under the same brand name, ``Healthy Choice.'' In contrast, there are 
approximately 20,000 ``non-healthy'' new product offerings each year. 
The comment said that certain product categories such as ``healthy'' 
cheese had already disappeared and expressed concern that if the lower 
second-tier sodium level for a ``healthy'' claim was implemented, even 
more products would disappear from the market. Another comment took a 
different view, suggesting that the absence from the market of 
``healthy'' cheese could have a positive impact by encouraging 
consumers to switch to more healthful whole foods such as fruits, 
vegetables, grains, and legumes.
    One comment added that consumer acceptance of food products with 
sodium content low enough to meet the second-tier sodium requirement 
has not been encouraging and that lowering the sodium level will 
decrease flavor and reinforce the concept that healthy foods taste bad. 
Another comment contended that implementing the lower sodium level 
requirement for ``healthy'' would be counterproductive to the goal of 
encouraging the creation of more foods that qualify for the ``healthy'' 
claim. This comment argued that if consumers will not eat current 
``healthy'' foods, they are less likely to eat new ones with even lower 
sodium. According to the comment, by disqualifying many ``good-for-
you'' products from being labeled as ``healthy,'' FDA risks less 
development and commercialization of similarly healthful products.
    A number of comments stated that lowering the sodium level by 120 
mg for already reduced sodium products will not have a positive effect. 
Several comments asserted that reducing the number of ``healthy'' 
products further will force products off the shelves, leaving only 
higher sodium alternatives.
    A comment from a consumer group concurred, suggesting that the 
``Healthy Choice'' brand has an incentive effect on the market. If the 
``Healthy Choice'' products disappear from the market because of the 
second-tier sodium requirement, there will be no more incentive. 
Consumers will be left with higher sodium alternatives, will not be 
likely to search for the next best alternative, and will return to full 
sodium soups at 800-1000 mg of sodium per serving. An industry comment 
stated that the first-tier level requirement had brought down the 
average sodium level for all soups by 32 mg per serving from 882 to 
850. This comment predicted that if the level required to bear the term 
``healthy'' is dropped further, the average sodium level will go back 
up.
    As evidence that the second-tier sodium level is too restrictive, 
another comment pointed out that some products that qualify for a 
coronary heart disease health claim or American Heart Association's 
(AHA's) heart check program, such as ready to eat cereals with fiber, 
would not be able to qualify for the term ``healthy'' under the more 
restrictive second-tier sodium requirement.
    In summary, many comments stated that the potential benefit of 
having ``healthy'' products with a slightly lower sodium level was not 
worth the risk of losing currently marketed ``healthy'' products. These 
comments emphasized that while the current option is not perfect, 
``healthy'' products are better than their standard alternatives even 
at the higher first-tier sodium level. They believe that lowering the 
sodium limit could reverse progress made since the term ``healthy'' was 
defined in 1994.
    (Response) The agency has taken into account these comments and the 
supporting data provided. FDA believes it is essential that low fat, 
nutritious products that are also reduced in sodium be available for 
consumers who wish to control both fat and sodium. The agency finds 
persuasive the information on technological barriers to reducing sodium 
in processed foods and the data demonstrating the difficulty in 
achieving palatable products that meet the second-tier sodium 
requirement. Without consumer acceptance of ``healthy'' foods, public 
health goals of reducing dietary sodium and fat (as well as saturated 
fat and cholesterol) will not be met, and the ``healthy'' claim will 
not foster better dietary practices in the long run. FDA has also taken 
into account the data on decreased market shares of existing 
``healthy'' products and the dearth of new ``healthy'' products as 
companies have begun preparing to comply with the second-tier sodium 
requirements. These data make a persuasive case that, rather than 
encouraging the development of new products, allowing the second-tier 
sodium requirement for individual foods to go into effect would have 
the opposite effect on the market.
    Therefore, the agency has decided to eliminate the second-tier 
sodium level requirement for ``healthy'' individual foods that was 
adopted in the 1994 final rule and would have gone into effect when the 
partial stay of that rule expired. For consistency across all 
categories of individual foods (see response to comment 10 of this 
document), the agency has also decided to eliminate the second-tier 
sodium level requirement for ``healthy'' raw, single ingredient seafood 
and game meat.
    Therefore, FDA is amending the requirements for use of the term 
``healthy'' on individual foods and raw, single ingredient seafood and 
game meat (1) to make permanent the current first-tier sodium level 
requirement of 480 mg per reference amount customarily consumed and per 
labeled serving or, if the serving size is small (30 g or less or 2 
tablespoons or less), per 50 g; and (2) to delete the more restrictive 
second-tier sodium level requirement of 360 mg that was adopted in the 
1994 final rule and

[[Page 56839]]

that would have become effective when the partial stay of that rule 
expired.

G. Legal Issues

    (Comment 12) A few comments raised legal objections to FDA's 
proposal to implement the second-tier sodium level requirement for 
individual foods labeled as ``healthy.'' Specifically, comments alleged 
that allowing the second-tier sodium level to go into effect would 
facilitate the use of a false and misleading statement in food labeling 
in violation of the act, would be arbitrary and capricious in violation 
of the Administrative Procedure Act, would violate manufacturers' 
commercial speech rights under the First Amendment to the United States 
Constitution, and would effect an unconstitutional regulatory taking 
under the Fifth Amendment.
    (Response) Because FDA is not adopting the proposal to allow the 
second-tier sodium level requirement for ``healthy'' individual foods 
to go into effect, but instead is removing that requirement from the 
``healthy'' regulation, these comments are moot and need not be 
addressed.

H. Clarification in Regulatory Text

    In the 2003 proposed rule (68 FR 8163 at 8171), FDA proposed to 
amend the ``healthy'' definition in Sec.  101.65(d)(1) to specify that 
a claim that suggests that a food, because of its nutrient content, may 
be useful in maintaining healthy dietary practices, is an implied 
nutrient content claim if it is made in connection with either an 
explicit or implied claim or statement about a nutrient. The purpose of 
this proposed change was to clarify the scope of ``healthy'' claims 
covered under Sec.  101.65(d) and to make the regulatory text 
consistent with preamble discussions in the 1993 proposed rule (58 FR 
2944 at 2945, January 6, 1993) and 1994 final rule (59 FR 24232 at 
24235), where FDA made clear that claims made in connection with an 
implied claim or statement about a nutrient would be covered by the 
``healthy'' regulation.
    FDA received no comments on this provision of the proposed rule and 
is adopting it as proposed.

I. Plain Language

    In the 2003 proposed rule, FDA proposed changes to the format and 
regulatory text of the ``healthy'' regulation to be consistent with the 
Presidential Memorandum on Plain Language (Ref. 14) and to make the 
regulation easier to understand and follow. The proposed changes 
consisted of converting the nutrient requirements in Sec.  101.65(d) 
for foods labeled as ``healthy'' from a text-based format to a table-
based format. The agency also proposed several minor changes in the 
wording of Sec.  101.65(d) to make the regulation more concise and 
easier to understand.
    (Comment 13) There was only one comment concerning plain language. 
This comment took issue with the length and complexity of the preamble, 
but not the content of the codified.
    (Response) As there were no suggestions as to how the codified 
might be revised to more closely comply with the Presidential 
Memorandum instructing Federal agencies to use plain language, the 
agency is making no changes in response to this comment.
    FDA is adopting the proposed table-based format for the ``healthy'' 
nutrient criteria. In addition, proposed Sec.  101.65(d)(2)(iv) and 
(d)(2)(v) have been incorporated into the first table in this final 
rule.
    For the most part, the agency is also adopting the proposed changes 
to the regulatory text itself. However, on further consideration, the 
agency has decided to return to the original language of Sec.  
101.65(d) in a few instances to avoid creating inconsistencies with the 
language of existing nutrient content claims regulations. For example, 
the agency has decided not to change the term ``labeled serving'' to 
``serving size'' (SS) to clarify that there is no difference in meaning 
from other nutrient content claim regulations that specify nutrient 
criteria for the claim using ``labeled serving'' (e.g., Sec.  
101.62(b), defining nutrient criteria for ``fat free''). LS refers to 
the serving size that is determined according to the rules in Sec.  
101.9(b) and specified in the Nutrition Facts or Supplement Facts panel 
on the product label.
    As FDA explained in the 2003 proposed rule (68 FR 8163 at 8171), 
the new format and other plain language changes are not intended to 
affect the meaning of the ``healthy'' regulation.

J. Effective Date

    Under the Administrative Procedure Act (5 U.S.C. 553(d)), and FDA's 
regulations (Sec.  10.40(c)(4) (21 CFR 10.40(c)(4)), publication of a 
rule must normally take place 30 days before the rule's effective date. 
However, exceptions to this requirement are permissible in the case of 
``a substantive rule which grants or recognizes an exemption or 
relieves a restriction'' (5 U.S.C. 553(d)(1); see also Sec.  
10.40(c)(4)(i).
    This rule is a substantive rule that relieves a restriction. If FDA 
did not issue this rule, the second-tier sodium level requirements for 
the ``healthy'' claim would go into effect on January 1, 2006, when the 
stay of these requirements expires (see 67 FR 30795). The second-tier 
sodium level requirements are more restrictive than the first-tier 
sodium level requirements and would allow fewer products to bear the 
``healthy'' claim. By revoking the more stringent second-tier sodium 
level requirements for the ``healthy'' claim and making permanent the 
less stringent first-tier sodium level requirements for this claim, 
this rule relieves a restriction.

IV. Analysis of Environmental Impact

    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded under 21 CFR 25.30(k) that 
this action is of a type that does not individually or cumulatively 
have a significant effect on the human environment. Therefore, neither 
an environmental assessment nor an environmental impact statement is 
required.

V. Analysis of Impacts

A. Regulatory Impact Analysis

    FDA has examined the impacts of this final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Executive Order 12866 
classifies a rule as significant if it meets any one of a number of 
specified conditions, including: Having an annual effect on the economy 
of $100 million or adversely affecting in a material way a sector of 
the economy, competition, or jobs. A regulation is also considered a 
significant regulatory action if it raises novel legal or policy 
issues. The Office of Management and Budget has determined that this 
rule is a significant regulatory action under Executive Order 12866, 
although it is not economically significant.
1. The Need for Regulation
    To bear the term ``healthy,'' products must not exceed established 
levels for fat, saturated fat, cholesterol, and sodium. The existing 
regulation states that meals and main dishes, as defined in Sec.  
101.13(l) and (m) respectively, must have sodium levels no higher than 
600 mg per labeled serving (either a large

[[Page 56840]]

portion of a meal or the entire meal) in the first-tier compliance 
period, and sodium levels no higher than 480 mg per labeled serving in 
the second-tier compliance period, which was originally scheduled to 
begin on January 1, 1998. The regulation also states that ``healthy'' 
foods other than meals and main dishes must have sodium levels no 
higher than 480 mg per reference amount and per labeled serving or, if 
the serving size is small (30 g or less or 2 tablespoons or less), per 
50 g, in the first-tier compliance period, and sodium levels no higher 
than the second-tier 360 mg per reference amount and per labeled 
serving thereafter. The agency initially stayed the second-tier sodium 
levels until January 1, 2000 (62 FR 15390, April 1, 1997). FDA has 
since extended the stay twice: First until January 1, 2003 (64 FR 
12886, March 16, 1999), and more recently until January 1, 2006 (67 FR 
30795, May 8, 2002).
    This rule modifies the definition of the term ``healthy'' by making 
permanent the first-tier sodium levels of 600 mg per labeled serving 
for meals and main dishes and 480 mg per reference amount and per 
labeled serving (or per 50 g if the serving size is small) for 
individual foods. Making the first-tier levels permanent will help 
preserve the ``healthy'' claim as a signal that products bearing that 
claim in their labeling are nutritious and will help contribute to a 
healthy diet. Without this modification, the second-tier sodium levels 
would take effect; as a result, many producers would likely cease using 
the ``healthy'' claim (or perhaps cease marketing the product), leading 
to a reduction in the eating options and health-related information 
available to consumers.
2. Regulatory Options
    FDA identified several options in the 2003 proposed rule (68 FR 
8163 at 8171 to 8172): (1) Make no change to the current rule, which 
would allow the second-tier sodium levels to go into effect; (2) amend 
the definition of ``healthy'' to eliminate the second-tier sodium 
levels for some or all products; (3) continue the stay to give 
producers time to develop technological alternatives to sodium; or (4) 
consider different second-tier sodium limits. Analyzing probable 
technological change (option 3) is beyond the scope of this analysis; 
innovation is difficult to predict. Also, analyzing alternative second-
tier sodium limits in terms of net benefits (option 4) is not feasible 
in this analysis because FDA has no way of differentiating health 
effects or manufacturing costs due to marginal differences in the 
allowable sodium content of ``healthy'' food products.
    The optimum sodium level for individual foods, meals, and main 
dishes balances the health benefits of limiting sodium intake with the 
cost to the food industry of making product preparation more 
complicated and the cost to consumers of limiting product choice. In 
the analysis that follows, we conclude that the first-tier sodium level 
strikes that balance better than the second-tier level for all 
categories of FDA-regulated foods.
    The options we consider in this analysis are option 1 (allow 
second-tier levels to take effect) and 3 versions of option 2 (adopt as 
permanent the first-tier sodium levels for some or all products):
    1. Implement the current rule (i.e., Sec.  101.65(d)) without 
modification, which would make the second-tier sodium levels 
effective on January 1, 2006.
    2a. Amend the current rule, adopting as permanent the first-tier 
sodium level for all or specific ``healthy'' individual foods.
    2b. Amend the current rule, adopting as permanent the first-tier 
sodium level for ``healthy'' meals and main dishes.
    2c. Amend the current rule, adopting as permanent the first-tier 
sodium levels for ``healthy'' meals and main dishes and for all or 
specific ``healthy'' individual foods.
The final rule adopts option 2c.
    The baseline in this case is the current rule, or option 1, so the 
benefits of the other options are the reformulation, rebranding, and 
relabeling costs avoided by retaining the first-tier sodium content 
requirements for individual foods or meals and main dishes. The costs 
of the other options are the negative health effects associated with 
the potential net increases in sodium intake under options 2a, 2b, and 
2c.
    Since the baseline is the current rule, or option 1, the market 
data used to analyze the marginal and total costs and benefits of 
options 2a, 2b, and 2c are a snapshot of the market before the 2003 
proposed rule was published. Predicting an amendment to the current 
rule, based on the publication of the 2003 proposed rule, some 
manufacturers of meals and main dishes may have already reacted by 
reformulating or changing their product lines (e.g., manufacturers who 
had begun preparing for the effective date of the second-tier sodium 
level by producing ``healthy'' meals and main dishes with sodium 
content below the first-tier level may have reformulated these products 
back to the first-tier level for taste and texture after FDA proposed 
to make the first-tier level permanent for meals and main dishes). To 
estimate the net effects of this final rule compared with the scheduled 
second-tier levels adopted in the 1994 final rule, it is necessary to 
use data from before the 2003 proposed rule so as not to incorporate 
changes made in anticipation of this final rule. Therefore, the data 
used to calculate the baseline are from before the publication of the 
2003 proposed rule.
    Option 2a: Retain the First-Tier Sodium Level for All or Specific 
``Healthy'' Individual Foods.
    Costs of Option 2a. The principal costs of this option are 
associated with the deterioration of ``healthy'' as a signal of foods 
with strictly controlled levels of sodium and the consequent potential 
increase in overall sodium intake. These costs would in large part be 
mitigated by the countervailing risks avoided by retaining a larger 
selection of ``healthy'' products. ``Healthy'' products are not only 
controlled in sodium, but also low in fat and saturated fat, controlled 
in cholesterol, and have at least 10 percent of the DV of one of the 
following: Vitamin A, vitamin C, calcium, iron, protein, or fiber. If 
products were forced off the market by a more restrictive sodium 
requirement, consumers would have fewer choices not only among products 
that are controlled in sodium, but also among products that are low in 
fat and saturated fat, and controlled in cholesterol.
    According to information provided in the comments, it appears that 
most ``healthy'' individual foods other than soups and cheeses could 
meet the second-tier sodium limit without substantial adverse changes 
in taste or texture. Retaining the first-tier sodium level for all 
individual foods would diminish the effectiveness of the ``healthy'' 
controlled sodium signal compared with option 2b (retaining the first-
tier sodium level for meals and main dishes) because there are more 
individual foods on the market than meals and main dishes. 
Alternatively, if FDA retained the first-tier ``healthy'' sodium level 
only for soups and cheeses, this inconsistency would diminish the 
usefulness of the term ``healthy'' as a signal to identify individual 
foods with uniformly controlled levels of sodium.
    In addition, retaining the first-tier level for individual foods 
under option 2a would be less consistent with the ``healthy'' 
definition for meals and main dishes than allowing the second-tier 
sodium level to go into effect under option 1. The first-tier sodium 
level for combinations of ``healthy'' individual foods allows more 
sodium than when those same foods are combined into meals and main 
dishes. ``Healthy'' meal and main dish products must contain at least 
three and two non-condiment food groups respectively, and still can 
only

[[Page 56841]]

contain 600 mg sodium per meal or main dish under the first-tier sodium 
level. By contrast, two ``healthy'' individual foods combined in 
exactly the same way could contain 720 mg sodium under the stayed 
second-tier level, and up to 960 mg sodium under option 2a (first-tier 
level), or 40 percent of the Daily Reference Value (DRV). This 
difference in sodium levels between a meal and two individual foods 
could have a health effect if consumers are using ``healthy'' 
specifically as a signal to identify foods with strictly controlled 
levels of sodium. However, because consumers, under option 2a, could 
consume three ``healthy'' meal or main dish products plus a ``healthy'' 
snack (individual food), or five servings of ``healthy'' individual 
foods, and still remain within the DRV for sodium, the agency concludes 
that the ``healthy'' signal, though somewhat less effective due to the 
discrepancy described previously in this document, would still be 
useful under option 2a.
    Sodium intake from soups could either increase or decrease under 
this option. If consumers of ``healthy'' soups at the current first-
tier sodium level will not eat ``healthy'' soups at the more 
restrictive second-tier sodium levels, they will either switch to 
another type of soup or to another food category altogether. If most 
former consumers of ``healthy'' soup, under a more restrictive sodium 
requirement, simply switch to other brands of soup, which have an 
average of 850 mg of sodium per serving, sodium consumption could 
actually increase under this option despite the more restrictive sodium 
level requirement for products labeled as ``healthy.'' If most former 
consumers of ``healthy'' soups choose to substitute a different type of 
controlled or low sodium food for soup, however, sodium consumption 
could decrease under this option. Since the agency has no data 
concerning what products consumers will choose if ``healthy'' soups 
disappear from the market, the change in sodium intake from soup (or 
products substituted for it) under this option is indeterminate.
    Under option 2a, sodium intake from other individual foods is 
likely to increase slightly. Since most products other than cheeses and 
soups would be able to meet the second-tier sodium requirement, sodium 
levels of some of these products may increase relative to what would 
happen under option 1, which would require individual foods to stay 
within the lower second-tier sodium level. For most types of individual 
foods (ice cream and bread, for instance), neither the first-tier nor 
the second-tier sodium level requirement for the ``healthy'' claim 
would be a limiting factor because these product categories do not 
require much sodium to taste good. Therefore, most ``healthy'' 
individual food products would be expected to contain similar levels of 
sodium under either the first-tier or second-tier sodium level 
requirement. Manufacturers of products for which the second-tier sodium 
levels would be difficult to meet, such as pasta sauce and microwave 
popcorn, may use more sodium in their products under option 2a than 
under option 1. However, as with soups, the net effect on sodium 
consumption is indeterminate. If the more restrictive second-tier 
sodium requirement caused fewer ``healthy'' options in these product 
categories to be available and consumers reacted by substituting 
towards higher sodium alternatives, sodium consumption could actually 
be lower under option 2a (first-tier sodium level) than under option 1 
(second-tier sodium level). On the other hand, if consumers reacted by 
substituting toward other low sodium or sodium-controlled products, 
sodium consumption under option 2a would likely be similar to or higher 
than under option 1. As with soups, without data allowing a prediction 
of consumer response, the change in sodium consumption under option 2a 
relative to baseline, though likely to be small, is indeterminate.
    It is also important to recall the other requirements for the 
``healthy'' claim. ``Healthy'' products are not only controlled in 
sodium, but also limit fat, saturated fat, and cholesterol, and are 
significant sources of at least one important nutrient. If ``healthy'' 
soups and other ``healthy'' individual foods are forced off the market 
by a more restrictive sodium requirement, there will be fewer 
relatively healthy food choices for consumers.
    The costs of an increased health risk due to a potential increase 
in average daily intake of sodium are uncertain, although they are 
likely to be small. The costs of an increased health risk due to a 
potential increase in average daily intake of sodium are uncertain, 
although they are likely to be small for three reasons: (1) The 
increase in sodium intake, as explained previously in this document, is 
likely to be small; (2) the increased health risk associated with a 
small increase in sodium consumption is small; and (3) any increased 
health risk due to increased sodium intake will be offset somewhat by 
the continued consumption of products that limit fat, saturated fat, 
and cholesterol, and that are significant sources of at least one 
important nutrient.
    Benefits of Option 2a. The benefits of this option are the 
reformulation, rebranding, and relabeling costs avoided by 
manufacturers if they do not have to modify their products to meet the 
second-tier sodium level for individual foods. The benefits of avoiding 
these costs under this option are substantial. In the market analysis, 
FDA identified 870 individual food products among 69 brands that make a 
``healthy'' claim (Ref. 8).\8\ The FLAPS survey also identified several 
additional individual foods that make a ``healthy'' claim but are not 
from a ``healthy'' brand (Ref. 9). According to the comments and 
subsequent analysis by FDA, only 3 of the over 80 food product 
categories would have material trouble meeting the second-tier 
``healthy'' sodium level: Soups, cheeses, and meats (primarily 
frankfurters and ham). Of these three food product categories affected 
by this option, ``healthy'' meats are regulated by USDA and therefore 
are not part of this analysis, and discussions on cheese and soup 
categories follow in this section of the document.
---------------------------------------------------------------------------

    \8\ One comment on the 2003 proposed rule criticized this 
estimate. See comment 10 in section II.E of this document for a 
detailed summary of the comment and FDA's response.
---------------------------------------------------------------------------

    Other individual foods in other categories may have costs 
associated with meeting the second-tier sodium level, but FDA has no 
specific information concerning costs for those other individual foods.
    Cheese. Reformulating cheeses to meet the second-tier sodium level 
would be difficult. However, as of May 2001, every ``healthy'' cheese 
product had apparently been taken off the market. FDA identified 32 
``healthy'' cheeses, under one brand, on the market in 1999 according 
to the marketplace data analysis (Ref. 8). In an informal telephone 
inquiry, FDA confirmed that by May 2001, there were no longer 
``healthy'' cheeses produced under this brand (Ref. 15).
    With no products to analyze, FDA cannot assess the potential impact 
of the second-tier sodium level on cheese. ``Healthy'' cheeses could 
have been taken off the market for any one of three different reasons, 
each with different implications for the effects of option 2a. First, 
characteristics of the products in addition to or unrelated to sodium 
content (e.g. lower fat requirements) could have led to low product 
demand and eventual product withdrawal. If so, option 2a would not lead 
to any societal benefits through influencing the market for cheese. 
Second, firms may not be

[[Page 56842]]

able to create an acceptable ``healthy'' cheese product even under the 
first-tier sodium level for individual foods, so there would be no cost 
or benefit difference between the first and second tiers of sodium 
content. Third, if ``healthy'' cheeses were taken off the market in 
anticipation of being unable to comply with the second-tier sodium 
level, adopting option 2a would probably encourage producers to 
reintroduce ``healthy'' cheese products.
    Sodium content was probably not the primary factor in the decision 
to take ``healthy'' cheeses off the market. Many light mozzarella 
cheeses, for example, currently have sodium content lower than the 
second-tier sodium level--between 167 and 357 mg sodium per 50 g cheese 
in our examples from Washington, DC, area grocery stores (Ref. 15). The 
``healthy'' version of this cheese was among the most popular sellers 
among all ``healthy'' cheeses but was still pulled from the market 
(Ref. 8).
    Soups. Costs associated with the current rule, and therefore 
benefits of avoiding these costs under option 2a, would be substantial 
for soups. According to a comment on the 2003 proposed rule, 
``healthy'' soups had about a 7 percent share of market sales in 2003, 
and a major producer of ``healthy'' soups stated that its products 
would likely be discontinued under the second-tier levels. The producer 
provided evidence in the form of taste tests and survey results for 
soups containing 360 mg of sodium per serving. The taste tests and 
survey results indicated that the products would be unsuccessful. 
Further, ``healthy'' soups with sodium levels near or at 480 mg/serving 
held around 8 times the market share of ``healthy'' soups with sodium 
levels near 360 mg per serving. This evidence shows that major 
producers of ``healthy'' soups would probably either cease producing 
some or all of their ``healthy'' soups or remove the ``healthy'' claim 
from product labels rather than reformulate down to 360 mg sodium per 
serving.
    Producers would have to spend resources to reformulate their 
products to meet the second-tier sodium level. Lost market share due to 
product reformulation would not be a net loss, but rather a transfer 
from one company to another. Reformulation costs themselves are the 
lower limit of the cost to society of allowing the second-tier levels 
to take effect. If producers could reformulate perfectly, without 
altering any characteristic of the product other than sodium content, 
then reformulation would be the total cost of the second-tier levels. 
But if they could not replicate the desirable characteristics of their 
product, consumers would also suffer the utility loss of a market with 
fewer product choices for those who want to buy processed foods that 
contribute to better nutrition and health in several ways, not solely 
with respect to sodium content.
    FDA lacks data needed to predict how ``healthy'' soup producers 
would respond to the implementation of the second-tier level of sodium 
for individual foods. However, a comment to the proposal provided data 
showing that in 2003, two brands making up more than 90 percent of the 
``healthy'' soup market had significantly more than the second-tier 
levels of sodium in their products. Each of these soups had sodium 
content at or near the first-tier level of 480 mg/serving. One of these 
producers stated that it could achieve taste parity for soups 
reformulated to meet the second-tier sodium level; the other said that 
it would be forced to discontinue its line of ``healthy'' soups if the 
second-tier sodium level went into effect. Both of these producers had 
a similar market share in their respective markets (one in ready-to-eat 
soup and the other in condensed soup). Therefore, FDA assumes that 50 
percent of the 30 products produced by these brands would be 
reformulated to meet the second-tier level. The other 50 percent of the 
``healthy'' soups in these brands would be marketed without the 
``healthy'' claim (and possibly also reformulated to increase the 
sodium content of the soups) or would be discontinued completely. 
Because the assumption of 50 percent reformulation is uncertain, we 
also show the costs for 25 percent reformulation and 75 percent 
reformulation in table 1 of this document.

                       Table 1.--Benefits of Avoided Costs Due to Option 2a (in millions)
----------------------------------------------------------------------------------------------------------------
            Level of Reformulation                       50%                   25%                   75%
----------------------------------------------------------------------------------------------------------------
Initial Annual Costs Avoided (First 2 Years)                  $20.77                $27.97                $13.80
----------------------------------------------------------------------------------------------------------------
Long Run Annual Costs Avoided                                 $17.47                $26.21                 $8.74
----------------------------------------------------------------------------------------------------------------

    We do not have detailed reformulation cost estimates for each food 
category. The following reformulation cost estimations are based on a 
detailed example of tortilla chip reformulation (see 64 FR 62745 at 
62781 to 62782, November 17, 1999), but the steps are typical of food 
reformulation in general.
    Reformulation typically starts in a laboratory, where researchers 
develop a new, lower sodium formula for their product. Then the company 
investigates availability and price of new ingredients (herbs, for 
example) and new equipment. If the reformulated food passes these 
obstacles, it moves to the test kitchen, where researchers produce the 
product in small batches. If approved at this level, the product 
graduates to a pilot plant. Cooking the product in large runs at the 
pilot plant may prove unsuccessful and require a manufacturer to 
restart the reformulation process, incurring additional expense. 
However, if pilot plant tests go well, full scale plant trials 
commence.
    For reformulation of an individual food, FDA assumes 5,000 hours of 
professional time at $30 per hour, $190,000 for development and pilot 
plant operating expenses, and $100,000 for market testing per product, 
based on this industry example. Since this reformulation would be 
undertaken to keep the ``healthy'' claim on an existing product, we 
assume negligible relabeling or marketing costs. The total 
reformulation costs are therefore $440,000 per product, or $6.60 
million for the 15 products assumed to be reformulated if ``healthy'' 
soup producers reformulate 50 percent of their products (reformulation 
costs are $3.52 million for 8 products under 25 percent reformulation 
and $10.12 million for 23 products under 75 percent reformulation). 
This cost would be incurred in the first year or two after the 
effective date of the rule. Assuming 50 percent of the cost is incurred 
per year for 2 years, and ignoring the time discount, the cost is $3.3 
million per year.
    Regardless of the relative costs of reformulation, FDA assumes that 
a substantial number of market participants will choose to rebrand or 
relabel their products out of the ``healthy'' category if it becomes 
too restrictive. This shift has already happened in some product 
categories

[[Page 56843]]

under the current first-tier level: The number of ``healthy'' meals and 
main dish products dropped from 210 to 148 from 1993 through 1999, and 
the number of ``healthy'' brands dropped from 13 to 10. This time 
period spans the adoption of the current definition of ``healthy'' in 
1994.
    If producers remove ``healthy'' from product labels as a result of 
the second-tier sodium levels, the direct costs of relabeling the 
product and conducting a marketing campaign are social costs, since 
they represent extra investment that does not increase or improve the 
choice of products for consumers. Although FDA has no information about 
the costs of this type of rebranding activity to the manufacturer, they 
are most likely substantial.
    The market puts a premium on ``healthy'' brands and products. This 
premium reflects what consumers are willing to pay for the ``healthy'' 
signal. Since consumers would presumably be paying less for a less 
valuable product, the total effect of rebranding on consumer utility is 
negative but limited. However, firms have made an investment in the 
``healthy'' brand based on an expected return closely related to the 
``healthy'' premium consumers are willing to pay, and this investment 
would now be worthless if the product cannot use the ``healthy'' 
claim.\9\ In the impacts analysis of the original regulation defining 
``healthy'' (59 FR 24232 at 24247, May 10, 1994), FDA estimated that 
the average premium (measured as the selling price difference) that the 
market placed on ``healthy'' brand goods was $0.57 per 16 ounce (oz) 
equivalent. FDA used a Washington, DC store sample of 106 frozen meals 
and main dishes referred to earlier to reestimate this premium using 
data collected in 2000, with similar results (Ref. 15).
---------------------------------------------------------------------------

    \9\ If the new definition of ``healthy'' with the second-tier 
sodium level is no more useful a health signal than the old 
definition, this lost investment is a cost to society. However, as 
we explain under the Costs of Option 2a, the health signal may be 
better under the second-tier sodium level for individual foods. This 
health signal strength may have significant value, and its loss 
should be netted out of the ``willingness to pay'' premium. However, 
FDA believes the loss in value of healthy products due to decreased 
strength of signal, though possibly significant, is not substantial. 
Therefore the ``willingness to pay'' premium estimated here, though 
an upper bound, should closely resemble the actual benefit of 
keeping these products on the market by retaining the first-tier 
sodium levels.
---------------------------------------------------------------------------

    According to the analysis in FDA's technical memorandum (Ref. 15), 
the ``healthy'' brand competitor had a significant $0.32 premium over 
the other major health positioned producer in this market, and at least 
as high a premium over the other major claims producer. Adjusting for 
serving size (10 oz in the products sampled), the $0.32 premium 
translates to a $0.51 premium per 16 oz, which is very close to the 
$0.57 premium estimated in 1994.
    We estimate the total value of each brand by multiplying the 
premiums and average sales volumes. According to a comment on the 2003 
proposed rule, sales of ``healthy soups'' still on the market were 
approximately 3.64 million units per product in 2003. Under the 
assumption of 50 percent loss of ``healthy'' soups if the second-tier 
sodium level requirement were to go into effect, 15 products would be 
taken off the market, either by rebranding or relabeling them out of 
the ``healthy'' category or by discontinuing them altogether, with a 
total lost premium of $17.47 million per year (15 products x $0.32 
premium lost x average sales of 3.64 million units per product per 
year).
    Adding this lost utility to the cost of reformulating the other 15 
``healthy'' soup products yields a total cost estimate of $20.77 
million for years one and two, and a residual of the lost premium of 
$17.47 million for what would have been the rest of the normal life 
cycle of the lost ``healthy'' claim. These costs and the costs under 25 
percent and 75 percent reformulation assumptions are shown in table 1 
of this document. Avoiding these costs represents a large benefit of 
option 2a.
    Option 2b: Retain the First-Tier Sodium Level for Meals and Main 
Dishes.
    Costs of Option 2b. The cost of this option, as in option 2a for 
individual foods, is the increased health risk due to higher sodium 
intake. However, FDA finds that option 2b will not significantly affect 
the average amount of sodium consumed in an overall diet. The net 
increase in sodium intake under option 2b is insubstantial even under 
the most favorable assumptions of the effects of the current rule. 
Under some plausible scenarios, the average amount of sodium consumed 
could remain the same or actually increase if the current rule were 
implemented without amendment (i.e., under option 1).
    To gather data for our impact analysis, in 1999 we took a sample of 
106 frozen meals and main dishes from a Washington, DC area grocery 
store (Ref. 15). This sample was intended to be reasonably 
representative of the U.S. prepared dinner market, although it may not 
encompass all meal and main dish choices available nationwide. We also 
tested these results with a second Web-based sample in 2000 (Ref. 15). 
Based on data collected in the grocery store sample, the market for 
meals and main dishes can be characterized as having three segments. 
The first is the bargain segment, with two or three producers that 
offer basic meals, usually priced from $1 to $1.50 lower than the 
average product on the market. The second segment, or ``normal'' 
market, also has two or three major producers, with prices ranging from 
slightly lower to the same as the health-positioned goods in the third 
segment. Products in the second segment appear to compete mainly on 
taste or price rather than health attributes, although such products 
sometimes make health-related or dietary claims (e.g., ``low fat''). 
The third segment is the ``claims'' segment, which includes the 
``healthy'' branded products, low fat products, and more expensive 
specialty products such as organic meals and main dishes. Many of these 
products prominently display fat and calorie information on the front 
of the package; these products clearly use nutritional content as a 
marketing tool.
    According to our analysis set forth in a technical memorandum (Ref. 
15), the ``healthy'' branded goods have the lowest average sodium 
content among the ``claims'' brands and the lowest average sodium 
content on the market. On average, they have 42 mg less sodium per meal 
than their next lowest competitor. Both the ``healthy'' branded goods 
and their main competitor that does not make ``healthy'' claims have 
average sodium levels under the first-tier limit of 600 mg for meals 
and main dishes.
    We explored several possible consumer and producer responses to 
option 2b (retaining the first-tier sodium level for meals and main 
dishes only) as compared with option 1 (allowing the second-tier sodium 
level to go into effect for all foods) in the following scenarios. If 
FDA adopted option 1, firms would respond to the imposition of the 
second-tier sodium level for meals and main dishes in a strategic way. 
Producers of ``healthy'' brands would either reformulate their products 
to meet the second-tier level, or relabel their products without the 
``healthy'' claim or the ``healthy'' brand name. The concern here is 
the consumer response to these actions. Reformulated products may be 
less palatable or more expensive, leading to a loss of market share. 
Rebranded (or relabeled) products would no longer carry the ``healthy'' 
claim and therefore would not be subject to a sodium limit. Indeed, 
several comments expressed concern that lowering the sodium requirement 
to the second-tier level could encourage consumers to switch to higher 
sodium alternatives.
    The possible scenarios are summarized in table 2 of this document.

[[Page 56844]]

The first number in each cell is the average amount of sodium in mg and 
the second number in parentheses is the market share for each brand. 
The average sodium content amounts of 551 mg, 593 mg, 722 mg, and 856 
mg per meal come from an analysis explained in the technical memorandum 
(Ref. 15). The ``healthy'' brand has slightly over 9 percent of the 
total frozen dinner meal market when measured by sales volume, and the 
non-``healthy'' brand 1 in the ``claims'' segment of the market has 
10.5 percent. Nonfrozen meals and main dishes, including chili, are 
also important in the overall market, but 99 percent of the sales of 
the ``healthy'' brand and 100 percent of the sales of ``claims'' brand 
2 are in the frozen meal category. The ``other'' brands in table 2 of 
this document represent the normal and bargain market segments 
previously described in this document. We assume that the three 
``claims'' brands in this analysis are a reasonable approximation to 
the ``claims'' market segment as previously described in this analysis. 
Each of their shares in the total market is divided by the sum of the 
shares of the three brands in the total market, which makes their 
market shares in the ``claims'' segment of the market (45 percent + 52 
percent + 3 percent) equal to 100 percent.

 Table 2.--Sodium Consumption Scenario Analyses for 1999 Sample of Meals
              and Main Dishes as Estimated in Proposed Rule
------------------------------------------------------------------------
                      Healthy     Claim      Claim     Other
                       Brand     Brand 1    Brand 2  -------------------
                    ---------------------------------
      Scenario         Sodium     Sodium     Sodium             Average
                      (Market    (Market    (Market              Sodium
                       Share)     Share)     Share)               (mg)
------------------------------------------------------------------------
1. Market Before     551        593        722        856      579
 2003 Proposed Rule  (.45)      (.52)      (.03)      (0)
------------------------------------------------------------------------
2. Perfect           476        593        722        856      544
 Reformulation       (.45)      (.52)      (.03)      (0)
 (option 1)
------------------------------------------------------------------------
3. Switch Point,     476        593        722        856      579
 Random Share Loss   (.45-      (.52+.047  (.03+.047  (.047)
 (option 1)           .142)      )          )
------------------------------------------------------------------------
4. Switch Point,     476        593        722        856      579
 Equal Share Loss    (.45-      (.52+.097  (.03+.097  (0)
 to Health (option    .193)      )          )
 1)
------------------------------------------------------------------------
5. Reformulation Up  600        593        722        856      600
 (option 2b)         (.45)      (.52)      (.03)      (0)
------------------------------------------------------------------------
6a. Combined         480        593        722        856      566
 Response to option  (.45-      (.52+.056  (.03+.056  (0)
 1                    .113)      )          )
------------------------------------------------------------------------
6b. Combined         580        593        722        856      588
 Response to option  (.45+.04)  (.52-.02)  (.03-.02)  (0)
 2b
------------------------------------------------------------------------
Total Effect (6b--6a)                                          22
------------------------------------------------------------------------

    Since option 1, or not amending the current rule, is the baseline 
for exploring the effect of option 2b, the first five scenarios are 
designed to demonstrate how different responses to option 1 (the 
current rule) and option 2b (the proposed rule) affect the average 
amount of sodium consumed in meals and main dishes. Scenarios 6a and 6b 
combine the responses in the previous scenarios in an attempt to 
capture the total effect of option 2b. The last row, in the last 
column, is the total change in sodium when comparing the response to 
option 2b (6b) to the response to option 1 (6a) (scenario 6-``total 
effect'').
    Scenario 1: The Market Before the 2003 Proposed Rule. The first-
tier sodium level applies until 2006, but firms, particularly before 
publication of the 2003 proposed rule, may have been trying to prepare 
for the second-tier sodium level, causing the average amount of sodium 
in the ``healthy'' products to be lower than it will be under the final 
rule.\10\ The average ``claims'' segment meal, as reported in the last 
column of table 2 of this document, contained 579 mg sodium, the 
average ``healthy'' brand meal contained 551 mg sodium, and several 
``healthy'' brand meals in this sample were under the second-tier 
sodium level of 480 mg sodium.
---------------------------------------------------------------------------

    \10\ As already described in detail in this document, the 
baseline market conditions for the purpose of the regulatory 
analysis are those that existed prior to the publication of the 2003 
proposed rule. Costs and benefits accrued during the rulemaking 
process, e.g. as a result of the publication of the 2003 proposed 
rule, must be accounted for in the analysis.
---------------------------------------------------------------------------

    Scenario 2: Perfect Reformulation. Under the very optimistic 
perfect reformulation assumption, where the ``healthy'' manufacturer 
could replicate every aspect of its product except the sodium level, 
the sodium level of the average ``claims'' segment meal would decrease 
to 544 mg ((476 * 45 percent) + (593 * 52 percent) + (722 * 3 percent)) 
under option 1. The difference between this and the current market is 
1.5 percent of the DRV for sodium, which is 2,400 mg per day (Sec.  
101.9(c)(9)).
    Scenario 3: Random Loss of Market Share. Some ``healthy'' brand 
consumers may switch to other products if manufacturers of ``healthy'' 
products cannot perfectly reformulate their products. In this scenario, 
the ``healthy'' brand loses market share to each of its competitors and 
to the rest of the market (``other'' brands) in equal amounts. If the 
loss of market share is small, sodium levels will still decline under 
option 1. However, the average sodium level per meal and per main dish 
would not change if the ``healthy'' brand lost 32 percent of its market 
(14 percent of the ``claims'' market) under these assumptions.
    Scenario 4: Loss of Market Share to Claims Competitors. Consumers 
are likely to switch from ``healthy'' products to other products 
bearing claims. For example, consumers concerned with the sodium 
content of what they eat might switch to a product

[[Page 56845]]

labeled as ``low sodium'' or ``reduced sodium.'' Since these 
alternatives have less sodium than the rest of the frozen foods market, 
the amount of ``healthy'' business lost that would still leave average 
sodium levels lower or unchanged would be higher than in scenario 3 
under option 1. If the ``healthy'' brand lost 43 percent of its market 
share (which is smaller than the 45 percent of their products one major 
producer of ``healthy'' products stated the second-tier level would 
adversely affect) equally to both ``claims'' competitors, the average 
``claims'' segment meal's sodium content would be unchanged at 579 mg.
    Scenario 5: Reformulation Up to First-Tier Limit. Here, we assume 
only the possibility that the second-tier restrictions will become 
effective discourages the ``healthy'' product from increasing the 
amount of sodium up to the first-tier limit. Therefore, under option 
2b, every ``healthy'' meal and main dish would contain 600 mg of sodium 
per meal.\11\ The average meal and main dish in the ``claims'' market 
would increase to 600 mg as well, which is 21 mg per meal more than the 
current amount and 56 mg more than the total under scenario 2, the most 
optimistic, perfect reformulation total.
---------------------------------------------------------------------------

    \11\ Note that since the publication of the 2003 proposed rule, 
in which FDA proposed to make the first-tier sodium level for meals 
and main dishes permanent, many meal and main dish products may have 
already been reformulated to contain exactly or nearly 600 mg of 
sodium per meal.
---------------------------------------------------------------------------

    Scenario 6: Total Effect. Scenario 6, which is scenario 6a 
(combined total response to option 1) subtracted from scenario 6b 
(combined total response to option 2b), represents the agency's 
estimate of the total effects of option 2b, which would adopt as 
permanent the first-tier sodium level for ``healthy'' meals and main 
dishes. In scenarios 6a and 6b, we make behavioral assumptions for both 
option 1 and option 2b.
    Scenario 6a: Combined Total Response to Option 1. Of the 
``healthy'' meals and main dishes in this sample, 75 percent are above 
and 25 percent are below the second-tier sodium level of 480 mg.\12\ If 
the second-tier sodium level were to take effect, we assume that the 
meals and main dishes already below 480 mg (25 percent of the total) 
would be reformulated up to 480 mg. Based on comments to the 1997 
ANPRM, we assume that 37.5 percent of all ``healthy'' meals and main 
dishes (one-half of the 75 percent of ``healthy'' meals and main dishes 
currently above 480 mg) would be reformulated down to 480 mg of sodium 
without a loss of taste. An additional 19 percent of all ``healthy'' 
meals and main dishes (one-fourth of the 75 percent of ``healthy'' 
meals and main dishes currently above 480 mg) would be reformulated 
even though the reformulation would lead to some loss of taste. The 
remaining 19 percent of all healthy meals and main dishes (one fourth 
of the 75 percent of ``healthy'' meals and main dishes currently above 
480 mg) would either have ``healthy'' removed from the label or cease 
being produced.
---------------------------------------------------------------------------

    \12\ Again, these are numbers from 1999, before this rulemaking 
began. Some products may have been reformulated since then.
---------------------------------------------------------------------------

    The total response of producers to the second-tier level of 480 mg 
would therefore be:
     Producers increase the sodium level to 480 mg for the 25 
percent of ``healthy'' meals and main dishes that are currently below 
480 mg of sodium.
     Producers reduce the sodium level to 480 mg for 56 percent 
of ``healthy'' meals and main dishes (37.5 percent with no loss of 
taste, 19 percent with some loss of taste).
     Producers either drop ``healthy'' from the label or cease 
producing 19 percent of all ``healthy'' meals and main dishes.
    In this scenario, consumers respond to the loss of taste and 
disappearance of products by switching choices within the ``claims'' 
segment of the market, which includes ``healthy'' and similar meals and 
main dishes. They switch with equal probability to any one of the three 
brands in the ``claims'' segment, which means that one-third will 
switch to another ``healthy'' branded product and two-thirds will 
switch to products outside the ``healthy'' brand. The market share loss 
of the ``healthy'' brand is therefore 25 percent of its market, or two-
thirds of the 37.5 percent of the market that experiences loss of 
taste, or disappearance of products. This is 11.3 percent of the total 
``claims'' market. The average sodium intake implied by the market 
activity in this scenario under option 1 is 566 mg per meal.
    Scenario 6b: Combined Total Response to Option 2b. We assume that 
producers will reformulate most, but not all, of the ``healthy'' 
products to the first-tier limit. We believe producers of ``healthy'' 
products will choose to position themselves as a slightly lower sodium 
alternative in this market, as they are currently positioned, but 
reformulate to increase sodium to improve taste. Because of improved 
taste, these producers increase their market share by 10 percent under 
this scenario, so the average sodium intake under the proposed 
amendment would be 588 mg per meal.
    The difference between scenarios 6a and 6b gives us the difference 
in average sodium consumption between option 2b and option 1, the 
baseline. This amount, 22 mg sodium per meal, is the best estimate of 
the ``sodium cost'' of option 2b.
    FDA's technical memorandum (Ref. 15) repeats the basic parts of 
this analysis for a second sample of products from the Web sites of a 
producer of ``healthy'' products and a ``claims'' segment producer, 
which we performed as a stress test\13\ of the first sample 
conclusions. The result from this different sample of meal products is 
quite close to the 22 mg ``sodium cost'' calculated in scenario 6 of 
table 2 of this document.
---------------------------------------------------------------------------

    \13\ A stress test is performed to see if the model results hold 
using a different data sample.
---------------------------------------------------------------------------

    According to our analysis, the sodium increase under option 2b 
would be insubstantial. Almost all studies linking sodium's influence 
on hypertension, coronary heart disease, and stroke consider the effect 
of a change in sodium consumption two orders of magnitude larger than 
these changes. A 100 millimole (mmol) (2,300 mg) difference per day is 
typical in both clinical and epidemiological studies; these studies do 
not address the relative dose-response relationship of the small sodium 
intake differences found in the scenarios. Even if the effect were 
linear (i.e., even if the health risk associated with the mg change per 
day in sodium under option 2b were a simple percentage of the 2,300 mg 
risk), the total statistical lives saved by implementing the second-
tier sodium level for meals and main dishes would be less than 1 under 
the total effects calculation in table 2 of this document and in the 
results of the second sample (Ref. 15). Since FDA does not assume a 
linear health response to sodium intake, however, the agency concludes 
that the health effects from this low level of sodium increase are 
negligible.
    Benefits of Option 2b. In the analysis of market data for the 2003 
proposed rule, FDA identified 148 meals and main dishes labeled 
``healthy'' among 10 brands (see 68 FR 8163 at 8169). Under option 1 
(no amendment to the current rule), manufacturers would have to 
reformulate their products (meals and main dishes in this case) to meet 
the second-tier sodium level when the stay expires. Reformulation costs 
would be the lower limit of the cost to society of the current rule. If 
producers could reformulate perfectly, without altering any property 
other than sodium content, then reformulation would be the total cost 
of option 1. But if they could not

[[Page 56846]]

replicate the desirable characteristics of their product, consumers 
would also suffer the utility loss of a market with fewer meal choices.
    In the product samples used for the scenario analyses regarding the 
cost of the second-tier sodium level for meals and main dishes, a 
significant percentage (around 75 percent in the store-based sample and 
50 percent in the Web site sample) of the major ``healthy'' producer's 
products were above the second-tier sodium levels. If this sample 
represents the market as a whole, then approximately 74 to 111 products 
would need to reduce their sodium to meet the second-tier level. In 
estimating the total effects of the second-tier sodium level on meals 
and main dishes, we assumed that 56 percent, or 83 of the 148 products 
on the market (see scenario 6a in table 2 of this document), would be 
reformulated.
    Preliminary testing costs incurred in the first stage of 
reformulation--according to comments on the ANPRM received from a 
frozen meal ``healthy'' brand producer that had begun investigating 
possible reformulation--were well over $1 million, but we do not have 
detailed reformulation cost estimates for meals and main dishes. 
Consistent with its estimate for individual foods (see discussion under 
``Benefits of Option 2a''), FDA assumes that reformulating a meal or 
main dish would require 5,000 hours of professional time at $30 per 
hour, $190,000 for development and pilot plant operating expenses, and 
$100,000 for market testing per product. Since this reformulation would 
be undertaken to keep the ``healthy'' claim on an existing product, we 
assume negligible relabeling or marketing costs. The total 
reformulation costs are therefore $440,000 per product, or $36,520,000 
for the 83 meals assumed to be reformulated if adopting the second-tier 
sodium levels for meals and main dishes under scenario 6a. Assuming 50 
percent of the cost is incurred per year for 2 years, and ignoring the 
time discount, the cost is $18,260,000 per year.
    The agency assumes that a substantial number of market participants 
would choose to rebrand or relabel their products out of the 
``healthy'' category if it becomes too restrictive. As with option 2a, 
the direct costs of relabeling the product and conducting a marketing 
campaign would be social costs, since they represent extra investment 
that will not increase or improve the choice of products for consumers. 
Although FDA has no information about the costs of this type of 
rebranding activity, they are probably substantial. As discussed in the 
analysis of the benefits of option 2a in this document, there will also 
be a $0.32 per unit premium loss on ``healthy'' products no longer on 
the market. Sales of the brands still in the market were approximately 
1.3 million units per product in 1999 (Ref. 8). Under the assumption of 
19 percent loss of ``healthy'' meals and main dishes if the second-tier 
sodium level goes into effect (scenario 6a), 28 products would be taken 
off the market, either by rebranding or relabeling them out of the 
``healthy'' category or by discontinuing them altogether, with a total 
lost premium of $11,648,000 per year (28 products x $0.32 premium lost 
x average sales of 1.3 million units per year).
    Adding this cost to the reformulation costs of the 83 products 
yields a total cost estimate of $29.90 million for years one and two, 
and a residual of the lost premium of $11.65 million for what would 
have been the rest of the normal life cycle of the lost ``healthy'' 
brand. Avoiding these costs represents a large benefit of option 2b.
    Option 2c: Retain the First-Tier Sodium Levels for ``Healthy'' 
Meals and Main Dishes and Individual ``Healthy'' Foods (the Final 
Rule). The benefits and costs of option 2c are close to the sum of the 
benefits and costs associated with options 2a and 2b. However, as 
explained in the discussion of option 2a, retaining the first-tier 
sodium levels for ``healthy'' individual foods would decrease the 
consistency, relative to option 2b, between sodium levels in 
``healthy'' meals and main dishes and the sodium levels in meals put 
together by combining ``healthy'' individual foods.
    Costs of Option 2c. The cost of this option, as with option 2a for 
individual foods and option 2b for meals and main dishes, is the 
increased risk due to higher sodium intake and the diminishing 
effectiveness of the ``healthy'' claim as a signal to identify products 
that contain strictly controlled levels of sodium. Since option 2c is 
essentially combining options 2a and 2b, the costs associated with a 
higher sodium intake are roughly the sum of the costs associated with 
options 2a and 2b.
    As explained in detail in the discussion of option 2b of this 
document, the average increase in sodium intake occurring under option 
2b relative to option 1 is insubstantial (roughly 22 mg per meal), and 
the health effects from this low level of sodium increase are 
negligible. Even under the conservative assumption of a linear dose 
response, the statistical lives saved by decreasing allowable sodium in 
``healthy'' meals and main dishes to second-tier levels would be less 
than 1.
    As discussed in detail under option 2a of this document, the 
potential change in sodium intake occurring under option 2a (relative 
to option 1) due to retaining the less restrictive first-tier level of 
sodium allowable in individual foods labeled as ``healthy,'' is 
uncertain. Because most individual foods are not restricted in formula 
under either sodium level, and because consumers may turn to higher 
sodium alternatives if the sodium level requirement becomes too 
restrictive for certain products (soups, cheeses, pasta sauces), the 
net increase in sodium will probably be small. Furthermore, the health 
costs due to a small increase in sodium intake will be largely 
mitigated by retaining a greater number of choices of relatively 
healthy foods (low in fat and saturated fat, controlled in cholesterol 
and sodium, and a good source of one or more beneficial nutrients).
    Therefore, the costs of option 2c resulting from the reduced 
effectiveness of the ``healthy'' claim as a signal of foods with 
strictly controlled sodium and the health risks due to a potential 
increase in total sodium intake, though uncertain, are likely to be 
small.
    Benefits of Option 2c. The benefits of avoiding reformulation, 
rebranding, and relabeling costs under this option are roughly the sum 
of the benefits associated with options 2a and 2b.
    As discussed in the benefits section of option 2a of this document, 
the benefits of avoiding reformulation, rebranding, and relabeling 
costs by retaining first-tier sodium levels for ``healthy'' individual 
foods are substantial. FDA estimates the total cost avoided under 
option 2a to be $20.77 million for years one and two, and a residual of 
the lost premium of $17.47 million for what would have been the rest of 
the normal life cycle of the lost ``healthy'' products.
    The benefits of avoiding reformulation, rebranding, and relabeling 
costs by retaining first-tier sodium levels for ``healthy'' meals and 
main dishes are also substantial. FDA estimates the total cost of 
reformulation and relabeling avoided under option 2b is $29.90 million 
for years one and two, and $11.65 million per year thereafter.
    The total benefits of option 2c from the avoided reformulation and 
relabeling costs associated with implementing the second-tier sodium 
levels for both ``healthy'' meal and main dish products and ``healthy'' 
individual foods are equal to the sum of the benefits of options 2a and 
2b: $50.67 million for years one and two, and $29.12 million per year 
thereafter.

[[Page 56847]]

    Net Benefits of Option 2c. The net benefits of option 2c, retaining 
the first-tier level of sodium for both ``healthy'' meal and main dish 
products and ``healthy'' individual foods, are roughly the sum of the 
net benefits of options 2a and 2b.
    Since the net benefits of retaining the first-tier sodium level for 
both ``healthy'' individual foods and ``healthy'' meal and main dish 
products are substantial and positive, FDA concludes that the net 
benefits of 2c, roughly the sum of the net benefits associated with 2a 
and 2b, are substantial and positive, and higher than the net benefits 
of the other options. Therefore, net benefits are maximized by option 
2c, the final rule, which adopts the first-tier sodium levels for both 
individual foods and for meals and main dishes.
3. Summary of Benefits and Costs
    This analysis attempts to use limited data to illustrate in some 
detail what would take place in the market under this final rule 
(option 2c) and other regulatory alternatives. The analysis for both 
``healthy'' meals and main dishes and ``healthy'' individual foods 
shows that while the benefits of retaining the first-tier sodium level 
(the costs foregone) are substantial for companies that would need to 
reformulate to comply with the second-tier sodium level or rebrand and 
relabel themselves out of the ``healthy'' market, the health costs 
associated with retaining the first-tier sodium level are both 
unquantifiable and most likely insubstantial. The benefits of the 
foregone reformulation, rebranding, and relabeling costs, and the 
health benefits of keeping available a greater choice of goods that are 
simultaneously low in fat and saturated fat, controlled in cholesterol 
and sodium, and a good source of beneficial nutrients, clearly outweigh 
the costs due to a small loss in the strength of the ``healthy'' sodium 
signal and a small increase in average daily sodium intake. Therefore, 
the net benefits of the rule, which would adopt as permanent the first-
tier sodium level for all foods, are positive.

B. Small Entity Analysis

    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. FDA finds that this final rule would not have a 
significant economic impact on a substantial number of small entities.
    This final rule makes permanent the first-tier sodium level of 600 
mg for meals and main dishes and 480 mg for individual foods. Without 
this final rule, the more restrictive second-tier sodium levels would 
raise the costs of making a ``healthy'' claim on such products. If a 
small business were to market a ``healthy'' meal, main dish, or 
individual food, it would be able to do so at lower cost under the 
final rule than if FDA left the current rule unmodified. FDA therefore 
certifies that this final rule will not have a significant impact on a 
substantial number of small entities.

C. Unfunded Mandates Reform Act of 1995

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public 
Law 104-4) requires that agencies prepare a written statement that 
includes an assessment of anticipated costs and benefits before 
proposing ``any rule that includes any Federal mandate that may result 
in the expenditure by State, local, and tribal governments, in the 
aggregate, or by the private sector, of $100,000,000 or more (adjusted 
annually for inflation) in any one year.'' The current threshold after 
adjustment for inflation is $115 million, using the most current (2003) 
Implicit Price Deflator for the Gross Domestic Product. FDA does not 
expect this final rule to result in any 1-year expenditure that would 
meet or exceed this amount.

VI. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no collections of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852 and may be seen by interested persons between 9 a.m. and 4 
p.m., Monday through Friday.
    1. U.S. Department of Agriculture and Department of Health and 
Human Services, ``Dietary Guidelines for Americans'' 5th ed., U.S. 
Government Printing Office, Washington, DC, 2000.
    2. Dietary Reference Intakes for Water, Potassium, Sodium, 
Chloride, and Sulfate, chapter 6, ``Sodium and Chloride'' pp 269-
423. Panel on Dietary Reference Intakes for Electrolytes and Water, 
Standing Committee on the Scientific Evaluation of Dietary Reference 
Intakes, Food and Nutrition Board, Institute of Medicine of the 
National Academies, The National Academies Press 2004.
    3. ``Dietary Guidelines for Americans 2005'' U.S. Department of 
Health and Human Services, U.S. Department of Agriculture 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.healthierus.gov/dietaryguidelines.

    4. MyPyramid.gov, U.S. Department of Agriculture first available 
2005 at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.mypyramid.gov
    5. Letter from Carl A. Roth, Associate Director for Scientific 

Program Operation, to William Kovaks, Vice President Environment, 
Technology, & Regulatory Affairs, Chamber of Commerce of the United 
States of America, and Richard Hanneman, President, The Salt 
Institute, August 19, 2003, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://aspe.hhs.gov/infoquality/request&response/reply_8b.shtml
.

    6. Letter from Barbara Alving, Acting Director to William 
Kovaks, Vice President Environment, Technology, & Regulatory 
Affairs, Chamber of Commerce of the United States of America, and 
Richard Hanneman, President, The Salt Institute, February 11, 2004, 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://aspe.hhs.gov/infoquality/request&response/reply_8d.shtml.

    7. Calories Count Report of the Working Group on Obesity March 
12, 2004, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/~dms/owg-toc.html.

    8. Anderson, Ellen M., memorandum to file, September 3, 2002.
    9. Anderson, Ellen M. and Heili Kim, memorandum to file, August 
30, 2001.
    10. ``Healthy Choice Total Franchise Sales vs. Total Food Sales 
(IRI)'' Exhibit 3A to ConAgra Comment C 127 to 91N-384H.
    11. ``Trends in the United States, Consumer Attitudes and the 
Supermarket 1996,'' Conducted for the Food Marketing Institute By 
Abt Associates Inc., Published by The Research Department, Food 
Marketing Institute, Washington, DC.
    12. ``Healthy Choice Soup 2003 Taste Test Results'' Exhibit 4 to 
ConAgra Comment C 127 91N-384H.
    13. ``Soup Category Sales Breakdown'' Exhibit 5 to ConAgra 
Comment C 127 to 91N-384H.
    14. National Partnership for Reinventing Government, Plain 
Language Action Network, Presidential Memorandum on Plain Language, 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.plainlanguage.gov/whatisPL/govmandates/memo.cfm.

    15. Mancini, Dominic, memorandum to file, May 23, 2002.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

[[Page 56848]]


0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
101 is amended as follows:

PART 101--FOOD LABELING

0
1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
2. Section 101.65 is amended by revising paragraph (d) to read as 
follows:


Sec.  101.65  Implied nutrient content claims and related label 
statements.

* * * * *
    (d) General nutritional claims. (1) This paragraph covers labeling 
claims that are implied nutrient content claims because they:
    (i) Suggest that a food because of its nutrient content may help 
consumers maintain healthy dietary practices; and
    (ii) Are made in connection with an explicit or implicit claim or 
statement about a nutrient (e.g., ``healthy, contains 3 grams of 
fat'').
    (2) You may use the term ``healthy'' or related terms (e.g., 
``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,'' 
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'') as 
an implied nutrient content claim on the label or in labeling of a food 
that is useful in creating a diet that is consistent with dietary 
recommendations if:
    (i) The food meets the following conditions for fat, saturated fat, 
cholesterol, and other nutrients:

------------------------------------------------------------------------
                                    The           The
   If the food      The fat      saturated    cholesterol     The food
      is...        level must    fat level     level must       must
                     be...      must be...       be...       contain...
------------------------------------------------------------------------
(A) A raw fruit   Low fat as   Low           The            N/A
 or vegetable      defined in   saturated     disclosure
                   Sec.         fat as        level for
                   101.62(b)(   defined in    cholesterol
                   2)           Sec.          specified in
                                101.62(c)(2   Sec.
                                )             101.13(h) or
                                              less
------------------------------------------------------------------------
(B) A single-     Low fat as   Low           The            N/A
 ingredient or a   defined in   saturated     disclosure
 mixture of        Sec.         fat as        level for
 frozen or         101.62(b)(   defined in    cholesterol
 canned fruits     2)           Sec.          specified in
 and                            101.62(c)(2   Sec.
 vegetables\1\                  )             101.13(h) or
                                              less
------------------------------------------------------------------------
(C) An enriched   Low fat as   Low           The            N/A
 cereal-grain      defined in   saturated     disclosure
 product that      Sec.         fat as        level for
 conforms to a     101.62(b)(   defined in    cholesterol
 standard of       2)           Sec.          specified in
 identity in                    101.62(c)(2   Sec.
 part 136, 137                  )             101.13(h) or
 or 139 of this                               less
 chapter
------------------------------------------------------------------------
(D) A raw,        Less than 5  Less than 2   Less than 95   At least 10
 single-           grams (g)    g saturated   mg             percent of
 ingredient        total fat    fat per RA    cholesterol    the RDI\3\
 seafood or game   per RA\2\    and per 100   per RA and     or the
 meat              and per      g             per 100 g      DRV\4\ per
                   100 g                                     RA of one
                                                             or more of
                                                             vitamin A,
                                                             vitamin C,
                                                             calcium,
                                                             iron,
                                                             protein, or
                                                             fiber
------------------------------------------------------------------------
(E) A meal        Low fat as   Low           90 mg or less  At least 10
 product as        defined in   saturated     cholesterol    percent of
 defined in Sec.   Sec.         fat as        per LS\5\      the RDI or
   101.13(l) or    101.62(b)(   defined in                   DRV per LS
 a main dish       3)           Sec.                         of two
 product as                     101.62(c)(3                  nutrients
 defined in Sec.                )                            (for a main
   101.13(m)                                                 dish
                                                             product) or
                                                             of three
                                                             nutrients
                                                             (for a meal
                                                             product)
                                                             of: vitamin
                                                             A, vitamin
                                                             C, calcium,
                                                             iron,
                                                             protein, or
                                                             fiber
------------------------------------------------------------------------
(F) A food not    Low fat as   Low           The            At least 10
 specifically      defined in   saturated     disclosure     percent of
 listed in this    Sec.         fat as        level for      the RDI or
 table             101.62(b)(   defined in    cholesterol    the DRV per
                   2)           Sec.          specified in   RA of one
                                101.62(c)(2   Sec.           or more of
                                )             101.13(h) or   vitamin A,
                                              less           vitamin C,
                                                             calcium,
                                                             iron,
                                                             protein or
                                                             fiber
------------------------------------------------------------------------
\1\ May include ingredients whose addition does not change the nutrient
  profile of the fruit or vegetable.
\2\ RA means Reference Amount Customarily Consumed per Eating Occasion
  (Sec.   101.12(b)).
\3\ RDI means Reference Daily Intake (Sec.   101.9(c)(8)(iv)).
\4\ DRV means Daily Reference Value (Sec.   101.9(c)(9)).
\5\ LS means Labeled Serving, i.e., the serving size that is specified
  in the nutrition information on the product label (Sec.   101.9(b)).


[[Page 56849]]

    (ii) The food meets the following conditions for sodium:

------------------------------------------------------------------------
         If the food is...               The sodium level must be...
------------------------------------------------------------------------
(A) A food with a RA that is          480 mg or less sodium per RA and
 greater than 30 g or 2 tablespoons   per LS
 (tbsp.)
------------------------------------------------------------------------
(B) A food with a RA that is equal   480 mg or less sodium per 50 g\1\
 to or less than 30 g or 2 tbsp.
------------------------------------------------------------------------
(C) A meal product as defined in     600 mg or less sodium per LS
 Sec.   101.13(l) or a main dish
 product as defined in Sec.
 101.13(m)
------------------------------------------------------------------------
\1\ For dehydrated food that is typically reconstituted with water or a
  liquid that contains insignificant amounts per RA of all nutrients (as
  defined in Sec.   101.9(f)(1)), the 50 g refers to the ``prepared''
  form of the product.

    (iii) The food complies with the definition and declaration 
requirements in this part 101 for any specific nutrient content claim 
on the label or in labeling, and
    (iv) If you add a nutrient to the food specified in paragraphs 
(d)(2)(i)(D), (d)(2)(i)(E), or (d)(2)(i)(F) of this section to meet the 
10 percent requirement, that addition must be in accordance with the 
fortification policy for foods in Sec.  104.20 of this chapter.

    Dated: September 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19511 Filed 9-28-05; 8:45 am]

BILLING CODE 4160-01-S