56828 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 

restriction, the extension will be 

effective on September 29, 2005. 

To assist us in our ongoing 

consideration of Section 404 of the 

Sarbanes-Oxley Act in the context of 

smaller public companies, we are 

including a list of questions below to 

solicit public comment on some 

substantive issues regarding the 

application of our internal control over 

financial reporting requirements to 

these companies. We also are soliciting 

public comment on the amount of time 

and expense that companies that are not 

accelerated filers have incurred to date 

to prepare for compliance with the 

internal control reporting requirements. 

These comments will assist us in any 

future proposals regarding our rules 

under Section 404. We would expect to 

provide formal notice and an additional 

opportunity for public comment on any 

such proposals. 

In this regard, we note that the 

Advisory Committee recently also has 

solicited public input on a range of 

issues related to the current securities 

regulatory system for smaller 

companies, including the impact on 

smaller public companies of the internal 

control reporting requirements 

mandated by Section 404 of the 

Sarbanes-Oxley Act of 2002. In 

formulating any possible proposed 

revisions to the internal control 

reporting requirements that would affect 

smaller reporting companies, we intend 

to consider relevant recommendations 

made to the Commission by the 

Advisory Committee. 

Request for Comment 

• Should there be a different set of 

internal control over financial reporting 

requirements that applies to smaller 

companies than applies to larger 

companies? Would it be appropriate to 

apply a different set of substantive 

requirements to non-accelerated filers, 

or for management of non-accelerated 

filers to make a different kind of 

assessment? Why or why not? If you 

think that there should be a different set 

of requirements for companies that are 

not accelerated filers, what should those 

requirements be? What would be the 

impact of any such differences in the 

requirements on investors? 

• Would a public float threshold that 

is higher or lower than the $75 million 

threshold that we use to distinguish 

accelerated filers from non-accelerated 

filers be more appropriate for this 

purpose? If so, what should the 

threshold be and why? Would it be 

better to use a test other than public 

float for this purpose, such as annual 

revenues, number of segments or 

number of locations or operations? If so, 

why? 

• Should the independent auditor 

attestation requirements be different for 

smaller public companies? If so, how 

should the requirements differ? 

• Should the same standard for 

auditing internal control over financial 

reporting apply to auditors of all public 

companies, or should there be different 

standards based on the size of the public 

company whose internal control is 

being audited? If the latter, how should 

the standards differ? 

• How can we best assure that the 

costs of the internal control over 

financial reporting requirements 

imposed on smaller public companies 

are commensurate with the benefits? 

• We solicit comment describing the 

actions that non-accelerated filers 

already have taken to prepare for 

compliance with the internal control 

over financial reporting requirements. 

Specific time and cost estimates would 

be particularly helpful. We also would 

be interested in receiving additional 

information about the compliance 

burdens incurred this year by smaller 

accelerated filers that included internal 

control reports in their Form 10–K 

annual reports. 

Dated: September 22, 2005. 

By the Commission. 

Jonathan G. Katz, 

Secretary. 

[FR Doc. 05–19426 Filed 9–28–05; 8:45 am] 

BILLING CODE 8010–01–U 

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. 

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 firsttier 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 § 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 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 56829 

1Under § 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). 

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 

(§ 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 (§ 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

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 (§ 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) 

(§ 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 mealtype 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 § 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 

§ 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 

§ 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 

§ 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 § 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 

56830 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 

2The 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. 

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. 

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 indepth 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 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 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 doseresponse relationship between sodium intake 

and blood pressure still persists. In nonhypertensive 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 DASHSodium 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 nonAfrican 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 nonhypertensive 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 (§ 109.9(c)(9) (21 CFR 

56832 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 

101.9(c)(9)))) which was cited in the 

2000 Dietary Guidelines. 

The new USDA pyramid (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, § 515, 

114 Stat. 2763, 2763A–153 to -154 

(2000)), and NIH Information Quality 

Guidelines, 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, § 515(b)(1)(B)). The joint 

Salt Institute—Chamber of Commerce 

request for correction asked NIH to 

make publicly available the DASHSodium 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://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:// 

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 wellestablished 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 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 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 higherimpact 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:// 

www.cfsan.fda.gov/~dms/owgtoc.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:// 

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 

(§ 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 secondtier 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 

56834 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 

3The 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. 

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) data3

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. 

(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 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 56835 

4The 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). 

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 

§ 101.13(l)) and main dishes (as defined 

in § 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 

day4 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. 

(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. 

56836 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 

5The recommendation in the current edition of 

the Dietary Guidelines is 2,300 mg/day. See 

footnote 4 in this document. 

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 recommendation5 and allows for 

flexibility in the rest of the daily diet (i.e., the 

snack).*** 

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 secondtier 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 

§ 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. 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 56837 

6The comment did not include a copy of this 

reference, and FDA was unable to locate it. 

7FDA 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). 

(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

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 

56838 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 

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). 

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 ‘‘goodfor-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 firsttier 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 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 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 § 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 § 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 § 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 § 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 tablebased format for the ‘‘healthy’’ nutrient 

criteria. In addition, proposed 

§ 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 § 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., § 101.62(b), defining nutrient 

criteria for ‘‘fat free’’). LS refers to the 

serving size that is determined 

according to the rules in § 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 (§ 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 § 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 § 101.13(l) and (m) respectively, must 

have sodium levels no higher than 600 

mg per labeled serving (either a large 

56840 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 

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 firsttier sodium levels for some or all 

products): 

1. Implement the current rule (i.e., 

§ 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 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 56841 

8One 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. 

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 firsttier 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 sodiumcontrolled 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. 

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 

56842 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 

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 secondtier 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 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 56843 

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. 

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 secondtier 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). 

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 Webbased 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 firsttier 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. 

56844 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 

10As 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. 

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

Scenario 

Healthy Brand Claim Brand 1 Claim Brand 2 Other 

Sodium 

(Market Share) 

Sodium 

(Market Share) 

Sodium 

(Market Share) 

Average Sodium (mg) 

1. Market Before 2003 Proposed Rule 551 

(.45) 

593 

(.52) 

722 

(.03) 

856 

(0) 

579 

2. Perfect Reformulation (option 1) 476 

(.45) 

593 

(.52) 

722 

(.03) 

856 

(0) 

544 

3. Switch Point, Random Share Loss (option 1) 476 

(.45-.142) 

593 

(.52+.047) 

722 

(.03+.047) 

856 

(.047) 

579 

4. Switch Point, Equal Share Loss to Health (option 1) 476 

(.45-.193) 

593 

(.52+.097) 

722 

(.03+.097) 

856 

(0) 

579 

5. Reformulation Up (option 2b) 600 

(.45) 

593 

(.52) 

722 

(.03) 

856 

(0) 

600 

6a. Combined Response to option 1 480 

(.45-.113) 

593 

(.52+.056) 

722 

(.03+.056) 

856 

(0) 

566 

6b. Combined Response to option 2b 580 

(.45+.04) 

593 

(.52-.02) 

722 

(.03-.02) 

856 

(0) 

588 

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. 

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 (§ 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 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 56845 

11Note 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. 

12Again, these are numbers from 1999, before this 

rulemaking began. Some products may have been 

reformulated since then. 

13A stress test is performed to see if the model 

results hold using a different data sample. 

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 FirstTier 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. 

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 (onefourth 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. 

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 test13 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. 

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 

56846 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 

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 firsttier 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 firsttier 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. 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 56847 

Net Benefits of Option 2c. The net 

benefits of option 2c, retaining the firsttier 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 firsttier 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 

www.healthierus.gov/dietaryguidelines. 

4. MyPyramid.gov, U.S. Department of 

Agriculture first available 2005 at 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://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://aspe.hhs.gov/infoquality/ 

request&response/reply_8d.shtml. 

7. Calories Count Report of the Working 

Group on Obesity March 12, 2004, 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://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. 

56848 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 

■ 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 

■ 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. 

■ 2. Section 101.65 is amended by 

revising paragraph (d) to read as 

follows: 

§ 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: 

If the food is... The fat level must be... The saturated fat level 

must be... 

The cholesterol level 

must be... 

The food must contain... 

(A) A raw fruit or vegetable Low fat as defined in 

§ 101.62(b)(2) 

Low saturated fat as 

defined in 

§ 101.62(c)(2) 

The disclosure level for 

cholesterol specified 

in § 101.13(h) or less 

N/A 

(B) A single-ingredient or a mixture of 

frozen or canned fruits and vegetables1

Low fat as defined in 

§ 101.62(b)(2) 

Low saturated fat as 

defined in 

§ 101.62(c)(2) 

The disclosure level for 

cholesterol specified 

in § 101.13(h) or less 

N/A 

(C) An enriched cereal-grain product 

that conforms to a standard of identity in part 136, 137 or 139 of this 

chapter 

Low fat as defined in 

§ 101.62(b)(2) 

Low saturated fat as 

defined in 

§ 101.62(c)(2) 

The disclosure level for 

cholesterol specified 

in § 101.13(h) or less 

N/A 

(D) A raw, single-ingredient seafood 

or game meat 

Less than 5 grams (g) 

total fat per RA2 and 

per 100 g 

Less than 2 g saturated 

fat per RA and per 

100 g 

Less than 95 mg cholesterol per RA and 

per 100 g 

At least 10 percent of 

the RDI3 or the 

DRV4 per RA of one 

or more of vitamin A, 

vitamin C, calcium, 

iron, protein, or fiber 

(E) A meal product as defined in 

§ 101.13(l) or a main dish product 

as defined in § 101.13(m) 

Low fat as defined in 

§ 101.62(b)(3) 

Low saturated fat as 

defined in 

§ 101.62(c)(3) 

90 mg or less cholesterol per LS5At least 10 percent of 

the RDI or DRV per 

LS of two nutrients 

(for a main dish 

product) or of three 

nutrients (for a meal 

product) of: vitamin 

A, vitamin C, calcium, iron, protein, or 

fiber 

(F) A food not specifically listed in this 

table 

Low fat as defined in 

§ 101.62(b)(2) 

Low saturated fat as 

defined in 

§ 101.62(c)(2) 

The disclosure level for 

cholesterol specified 

in § 101.13(h) or less 

At least 10 percent of 

the RDI or the DRV 

per RA of one or 

more of vitamin A, 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 (§ 101.12(b)). 3 RDI means Reference Daily Intake (§ 101.9(c)(8)(iv)). 4 DRV means Daily Reference Value (§ 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 (§ 101.9(b)). 

Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Rules and Regulations 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 greater than 

30 g or 2 tablespoons (tbsp.) 

480 mg or less sodium per RA and 

per LS 

(B) A food with a RA 

that is equal to or 

less than 30 g or 2 

tbsp. 

480 mg or less sodium per 50 g1

(C) A meal product as 

defined in 

§ 101.13(l) or a 

main dish product 

as defined in 

§ 101.13(m) 

600 mg or less sodium per LS 

1For dehydrated food that is typically reconstituted with water or a liquid that contains insignificant amounts per RA of all nutrients (as 

defined in § 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 § 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 

DEPARTMENT OF THE INTERIOR 

Minerals Management Service 

30 CFR Parts 216 and 218 

RIN 1010–AD28 

Royalty Payment and Royalty and 

Production Reporting Requirements 

Relief for Federal Oil and Gas Lessees 

Affected by Hurricane Katrina or 

Hurricane Rita 

AGENCY: Minerals Management Service 

(MMS), Interior. 

ACTION: Final rule. 

SUMMARY: The Minerals Management 

Service (MMS) is publishing a final rule 

to provide immediate temporary relief 

to reporters in the aftermath of 

Hurricanes Katrina and Rita. The final 

rule provides an extension to pay 

royalties owed on Federal oil and gas 

leases and report corresponding royalty 

and production reports. On August 29, 

2005, Hurricane Katrina struck the Gulf 

of Mexico coast of the United States. 

Subsequently, in late September 2005, 

Hurricane Rita struck the Gulf Coast. 

Both hurricanes caused extensive 

damage to areas in which a number of 

Federal oil and gas lessees, particularly 

lessees of offshore leases, have their 

offices and principal operations. This 

final rule extends the due date for 

monthly royalty payments and reports 

and monthly operations reports for 

Federal oil and gas lessees, royalty 

payors, and operators whose operations 

have been disrupted by one or both of 

the hurricanes to the extent that the 

lessee, payor, or operator is prevented 

from submitting accurate payments or 

accurate reports. Extending the due date 

for royalty payments means that late 

payment interest will not accrue for the 

period between the original due date 

and the new due date established by 

this rule. 

DATES: Effective date: September 29, 

2005. 

FOR FURTHER INFORMATION CONTACT: 

Sharron L. Gebhardt, Lead Regulatory 

Specialist, Minerals Revenue 

Management (MRM), Minerals 

Management Service, P.O. Box 25165, 

MS 302B2, Denver, Colorado 80225; 

telephone (303) 231–3211; FAX (303) 

231–3781; e-mail 

sharron.gebhardt@mms.gov. The 

principal authors of this final rule are 

Geoffrey Heath of the Office of the 

Solicitor and Robert Prael of MRM, 

MMS, U.S. Department of the Interior. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Lease Royalty Reporting, Royalty 

Payment and Production Reporting 

Obligations 

Applicable regulations and the terms 

of Federal oil and gas leases prescribe 

the dates by which lessees must pay 

royalty and by which they must submit 

required royalty reports. Specifically, 30 

CFR 218.50(a) requires: 

Royalty payments are due at the end 

of the month following the month 

during which the oil and gas is 

produced and sold except when the last 

day of the month falls on a weekend or 

holiday. In such cases, payments are 

due on the first business day of the 

succeeding month. * * * 

The terms of almost all onshore and 

offshore Federal oil and gas leases 

likewise provide that royalty is due at 

the end of the month following the 

month of production. 

Section 111(a) of the Federal Oil and 

Gas Royalty Management Act of 1982 

(FOGRMA), 30 U.S.C. 1721(a), 

prescribes that lessees must pay interest 

on royalty payments received after the 

due date. Section 1721(a) provides in 

relevant part: 

(a) In the case of oil and gas leases 

where royalty payments are not received 

by the Secretary on the date that such 

payments are due, or are less than the 

amount due, the Secretary shall charge 

interest on such late payments or 

underpayments at the rate applicable 

under section 6621 of the Internal 

Revenue Code * * *. (Emphasis added.) 

Implementing MMS regulations at 30 

CFR 218.54 prescribe in relevant part: 

(a) An interest charge shall be 

assessed on unpaid and underpaid 

amounts from the date the amounts are 

due. 

* * * * * 

(c) Interest will be charged only on 

the amount of the payment not received. 

Interest will be charged only for the 

number of days a payment is late. 

(Emphasis added.) 

Title 30 CFR 210.52 prescribes similar 

requirements for the reports that 

accompany royalty payments. It 

provides in relevant part: 

(a) You must submit a completed 

Form MMS–2014 (Report of Sales and 

Royalty Remittance) to MMS with: 

(1) All royalty payments * * * 

* * * * * 

(c) Completed Forms MMS–2014 for 

royalty payments are due by the end of 

the month following the production 

month. 

Thus, for all Federal oil and gas leases 

onshore and on the Outer Continental 

Shelf, both royalty payments and 

royalty reports are due at the end of the 

month following the month of 

production. 

Title 30 CFR 216.53 prescribes similar 

requirements for production reporting. 

It provides in relevant part: 

(a) You must file an Oil and Gas 

Operations Report [OGOR], Form MMS–

4054, if you operate one of the following 

that contains one or more wells that are 

not permanently plugged or abandoned: 

(1) An OCS lease or federallyapproved agreement; or 

(2) An onshore Federal or Indian lease 

or federally-approved agreement for 

which you elected to report on a Form 

MMS–4054 instead of a Form MMS–

3160. 

* * * * * 

(c) * * *