Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 56477 

of Proposed Rulemaking is not required 

for this action. 

Alaskan Low Altitude Reporting 

Points are listed in paragraph 7004 of 

FAA Order 7400.9R signed August 15, 

2007, and effective September 15, 2007, 

which is incorporated by reference in 14 

CFR 71.1. Alaskan High Altitude 

Reporting Points are listed in paragraph 

7005 of FAA Order 7400.9R signed 

August 15, 2007, and effective 

September 15, 2007, which is 

incorporated by reference in 14 CFR 

71.1. The Reporting Points listed in this 

document will be revised subsequently 

in the Order. 

The Rule 

This action amends Title 14 Code of 

Federal Regulations (14 CFR) part 71 by 

revising the Low Altitude Reporting 

Points; CRACK, GARRS, and MOCHA; 

and the High Altitude Reporting Points; 

GARRS, and MOCHA to match the 

published description with their actual 

locations. The high and low altitude 

reporting point FLUKE is being revoked. 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. Therefore, this regulation: (1) Is 

not a ‘‘significant regulatory action’’ 

under Executive Order 12866; (2) is not 

a ‘‘significant rule’’ under Department of 

Transportation (DOT) Regulatory 

Policies and Procedures (44 FR 11034; 

February 26, 1979); and (3) does not 

warrant preparation of a regulatory 

evaluation as the anticipated impact is 

so minimal. Since this is a routine 

matter that will only affect air traffic 

procedures and air navigation, it is 

certified that this rule, when 

promulgated, will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the United States Code. 

Subtitle I, section 106 describes the 

authority of the FAA Administrator. 

Subtitle VII, Aviation Programs, 

describes in more detail the scope of the 

agency’s authority. 

This rulemaking is promulgated 

under the authority described in 

Subtitle VII, Part A, Subpart I, section 

40103. Under that section, the FAA is 

charged with prescribing regulations to 

assign the use of the airspace necessary 

to ensure the safety of aircraft and the 

efficient use of airspace. This regulation 

is within the scope of that authority as 

it amends Low and High Altitude 

Compulsory Reporting Points in Alaska. 

Environmental Review 

The FAA has determined that this 

action qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with FAA 

Order 1050.1E, Environmental Impacts: 

Policies and Procedures. This airspace 

action is not expected to cause any 

potentially significant environmental 

impacts, and no extraordinary 

circumstances exist that warrant 

preparation of an environmental 

assessment. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

Adoption of the Amendment 

■ In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for part 71 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 

1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order 7400.9R, 

Airspace Designations and Reporting 

Points, signed August 15, 2007, and 

effective September 15, 2007, is 

amended as follows: 

Paragraph 7004 Alaskan Low Altitude 

Reporting Points. 

* * * * * 

CRACK: [Amended] 

Lat. 57°20′48′′ N., long. 159°24′19′′ W. (INT 

King Salmon, AK, LOM 226°, Port Heiden, 

AK, NDB 314° bearings). 

GARRS: [Amended] 

Lat. 58°19′06′′ N., long. 161°20′32′′ W. (INT 

King Salmon, AK, LOM 262°, Cape 

Newenham, AK, NDB 131° bearings). 

MOCHA: [Amended] 

Lat. 54°30′24′′ N., long. 133°01′15′′ W. (INT 

Nichols, AK, NDB 236°, Sandspit, BC, 

Canada, NDB 331° bearings). 

FLUKE: [Revoked] 

* * * * * 

Paragraph 7005 Alaskan High Altitude 

Reporting Points. 

* * * * * 

GARRS: [Amended] 

Lat. 58°19′06′′ N., long. 161°20′32′′ W. (INT 

King Salmon, AK, LOM 262°, Cape 

Newenham, AK, NDB 131° bearings). 

MOCHA: [Amended] 

Lat. 54°30′24′′ N., long. 133°01′15′′ W. (INT 

Annette Island, AK, 237°, Sandspit, BC, 

Canada, 331° radials). 

FLUKE: [Revoked] 

* * * * * 

Issued in Washington, DC, on September 

12, 2008. 

Edith V. Parish, 

Manager, Airspace & Rules Group. 

[FR Doc. E8–22648 Filed 9–26–08; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket No. FDA–2004–P–0205] (formerly 

Docket No. 2004P–0464) 

Food Labeling: Health Claims; Calcium 

and Osteoporosis, and Calcium, 

Vitamin D, and Osteoporosis 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

labeling regulation authorizing a health 

claim on the relationship between 

calcium and a reduced risk of 

osteoporosis to include vitamin D so 

that, in addition to the claim for calcium 

and osteoporosis, an additional claim 

can be made for calcium and vitamin D 

and osteoporosis; eliminate the 

requirement that the claim list sex, race, 

and age as specific risk factors for the 

development of osteoporosis; eliminate 

the requirement that the claim does not 

state or imply that the risk of 

osteoporosis is equally applicable to the 

general U.S. population, and that the 

claim identify the populations at 

particular risk for the development of 

osteoporosis; eliminate the requirement 

that the claim identify the mechanism 

by which calcium reduces the risk of 

osteoporosis and instead make it 

optional; eliminate the requirement that 

the claim include a statement that a 

total dietary intake greater than 200 

percent of the recommended daily 

intake (2,000 milligrams (mg) of 

calcium) has no further benefit to bone 

health when the food contains 400 mg 

or more of calcium per reference 

amount customarily consumed or per 

total daily recommended supplement 

intake; and allow reference for the need 

of physical activity in either of the 

health claims to be optional rather then 

required. This final rule is, in part, in 


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56478 Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 

response to a health claim petition 

submitted by The Beverage Institute for 

Health and Wellness, LLC. 

DATES: This final rule is effective 

January 1, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Jillonne Kevala, Center for Food Safety 

and Applied Nutrition (HFS–830), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740– 

3835, 301–436–1450. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 5, 

2007 (72 FR 497), FDA published a 

proposed rule (the calcium and vitamin 

D proposed rule) to amend § 101.72 (21 

CFR 101.72), which authorizes a health 

claim regarding the relationship 

between calcium and osteoporosis. The 

agency proposed the following five 

amendments: (1) Inclusion of vitamin D 

so that, in addition to the claim for 

calcium and osteoporosis, an additional 

claim can be made for calcium and 

vitamin D and osteoporosis; (2) 

elimination of the requirement in 

§ 101.72(c)(2)(i)(A) that the claim list 

sex, race, and age as specific risk factors 

for the development of osteoporosis; (3) 

elimination of the requirement in 

§ 101.72(c)(2)(i)(B) that the claim does 

not state or imply that the risk of 

osteoporosis is equally applicable to the 

general U.S. population, and that the 

claim identify the populations at 

particular risk for the development of 

osteoporosis; (4) elimination of the 

requirement in § 101.72(c)(2)(i)(C) that 

the claim identify the mechanism by 

which calcium reduces the risk of 

osteoporosis and instead make it 

optional; and (5) elimination of the 

requirement in § 101.72(c)(2)(i)(E) that 

the claim include a statement that 

reflects the limit of the benefits derived 

from dietary calcium intake, when the 

level of calcium in the food exceeds a 

set threshold level. FDA issued this 

proposed rule in response to a health 

claim petition submitted on July 12, 

2004, by the Beverage Institute for 

Health and Wellness under section 

403(r)(4) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

343(r)(4)) (Ref. 1). Section 403(r)(3)(B)(i) 

of the act states that the Secretary of 

Health and Human Services (Secretary) 

(and, by delegation, FDA) shall issue a 

regulation authorizing a health claim 

only if the Secretary determines, based 

on the totality of publicly available 

scientific evidence (including evidence 

from well-designed studies conducted 

in a manner which is consistent with 

generally recognized scientific 

procedures and principles), that there is 

significant scientific agreement, among 

experts qualified by scientific training 

and experience to evaluate such claims, 

that the claim is supported by such 

evidence (see also 21 CFR 101.14(c)). 

Section 403(r)(4) of the act sets out the 

procedures that FDA is to follow upon 

receiving a health claim petition. FDA 

filed the petition for comprehensive 

review in accordance with section 

403(r)(4) of the act on October 20, 2004. 

II. Summary of Comments and the 

Agency’s Response 

FDA solicited comments on the 

calcium and vitamin D proposed rule. 

The comment period closed on March 

21, 2007. The agency received 27 

responses, each containing one or more 

comments, to the calcium and vitamin 

D proposed rule. The comments were 

from trade associations, health-related 

organizations, academia, and 

consumers. Most of the comments 

supported the proposed amendments. A 

few comments expressed personal 

opinions on the use of health claims and 

labeling in general. These comments did 

not raise any issues about the calcium 

and vitamin D proposed rule, and 

therefore, we consider these to be 

outside the scope of this rulemaking and 

do not discuss them in this document. 

Another comment asserted that the 

standard of significant scientific 

agreement was not met and provided 

some citations and studies as support 

for its assertion. However, the studies 

that were submitted were not the type 

of studies that could resolve a question 

about the relationship between vitamin 

D and calcium, or calcium only, and 

osteoporosis that is the subject of the 

claim. The remaining comments and the 

agency’s responses are discussed below. 

(Comment 1) FDA received two 

comments opposing the elimination of 

the requirement in § 101.72(c)(2)(i)(A) 

that the claim list sex, race, and age as 

specific risk factors for the development 

of osteoporosis. One of these comments 

did not give a reason for its opposition 

to the elimination of this requirement. 

The comment also asserted that high 

levels of calcium will inhibit the intake 

of manganese, and that the primary 

cause of osteoporosis in the United 

States is manganese deficiency. The 

other comment stated that the 

‘‘published docket’’ did not provide 

adequate support to eliminate references 

to age, sex, race, and the need for an 

adequate level of exercise. The comment 

noted that studies have linked calcium 

and vitamin D to bone health only in 

specific demographic categories. 

(Response) The comment opposing 

the elimination of listing sex, race, and 

age as specific risk factors in the claim 

language failed to provide any 

explanation, data, or evidence to 

support its opposition to eliminating the 

listing of these risk factors in the claim. 

Without such explanation, data, or 

evidence, FDA has no basis upon which 

to revise its analysis. As such, FDA will 

continue to rely on the analysis as set 

forth in the calcium and vitamin D 

proposed rule (72 FR 497 at 506–507). 

As to the comment’s concern about 

manganese, the agency is not aware of, 

nor did the comment provide, any data 

or evidence to substantiate the 

statement that high levels of calcium 

intake will inhibit the intake of 

manganese or that the primary cause of 

osteoporosis in the United States is 

manganese deficiency. 

FDA disagrees with the comment that 

information in the docket does not 

provide adequate evidence to eliminate 

the requirement that the claim reference 

age, sex, and race. The information in 

the record of this proceeding 

demonstrates that benefits of adequate 

calcium and vitamin D in reducing the 

risk of osteoporosis is not confined to 

any particular subpopulation in the 

United States. The scientific evidence 

from both the 2004 Surgeon General’s 

Report on Bone Health and Osteoporosis 

and the 2000 National Institutes of 

Health (NIH) Consensus Statement 

concludes that osteoporosis occurs in all 

populations and at all ages (72 FR 497 

at 506). Moreover, both the 2000 NIH 

Consensus Statement and the 2004 

Surgeon General’s Report on Bone 

Health and Osteoporosis conclude that 

achieving and maintaining optimal bone 

health is a process that is important in 

both men and women throughout the 

lifespan and is not a specific need to 

any particular subpopulation in the 

United States (72 FR 497 at 506–507). 

Given that the risk of osteoporosis 

applies to the general U.S. population, 

the benefits of adequate calcium and 

vitamin D in terms of reducing risk of 

disease apply to both sexes at all ages 

and race categories. Accordingly, 

because these benefits do not apply only 

to specific demographic groups, the 

language of the health claim in question 

should not state or suggest otherwise. 

For this reason, FDA is eliminating the 

requirement that the calcium and 

osteoporosis health claim or the 

calcium, vitamin D, and osteoporosis 

health claim list sex, race, and age as 

specific risk factors for the development 

of osteoporosis. 

In any discussion about osteoporosis 

and bone health, it is important to 

recognize the difference between risk of 

bone disease, including osteoporosis, 

and the prevalence of the disease in 

various subpopulations in the United 


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Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 56479 

States. Risk measures the probability 

that a disease will occur whereas 

prevalence measures the number of 

cases of a disease that are documented 

in a given population or subpopulation. 

Both the 2000 NIH Consensus Statement 

and the 2004 Surgeon General’s Report 

on Bone Health and Osteoporosis state 

that all populations in the United States 

are at risk of osteoporosis, although the 

prevalence of the disease is not equally 

distributed among all subpopulations. 

Specifically, osteoporosis is most 

prevalent in White postmenopausal 

women. However, as noted, the disease 

often goes unrecognized in other age 

and ethnic groups as well as in men (72 

FR 497 at 508). 

In sum, while the prevalence of 

osteoporosis varies in different 

subpopulations in the United States, all 

populations are at risk of osteoporosis 

and, in fact, the disease does occur in 

all populations. Thus, the benefits of 

calcium or calcium and vitamin D on 

reducing the risk of bone diseases, 

including osteoporosis, apply to both 

sexes at all ages and in all race 

categories (72 FR 497 at 507). For this 

reason, FDA is eliminating the 

requirement that the calcium and 

osteoporosis health claim or the 

calcium, vitamin D, and osteoporosis 

health claim list sex, race, and age as 

specific risk factors for the development 

of osteoporosis. 

Importantly, however, although this 

final rule eliminates the requirement 

that the claim reference age, sex, and 

race for the development of 

osteoporosis, § 101.72(d)(4) allows the 

claim to include optional information 

related to the prevalence of 

osteoporosis. In particular, the claim 

could include information about the 

number of people in the United States, 

including the number of people in 

certain subpopulations in the United 

States, who have osteoporosis or low 

bone density. For example, under 

§ 101.72(d)(4), a claim could include a 

statement that, according to the National 

Osteoporosis Foundation, 20 percent of 

non-Hispanic Caucasian and Asian 

women aged 50 and older are estimated 

to have osteoporosis. 

(Comment 2) FDA received two 

comments opposing the elimination of 

the requirement in § 101.72(c)(2)(i)(C) 

that the calcium and osteoporosis health 

claim identify the mechanism by which 

calcium reduces the risk of osteoporosis. 

One comment did not give a reason for 

its opposition to the elimination of this 

requirement. The other comment noted 

that building a strong bone matrix relies 

on proper mineral balance and that 

science is continually evolving to 

elucidate the specific mechanisms 

involved. This comment further stated 

that although calcium is required to 

develop and sustain proper bone health 

and to prevent osteoporosis, the 

scientific community recognizes that 

calcium alone is not adequate, and a 

balance of normal minerals and 

hormones are also critical for bone 

health. Thus, this comment suggested 

that there is not enough scientific 

evidence either to eliminate or make 

optional the requirement in 

§ 101.72(c)(2)(i)(C) because incomplete 

information is not accurate information. 

(Response) The comment opposing 

elimination of the requirement in 

§ 101.72(c)(2)(i)(C) failed to provide any 

explanation, data, or evidence to 

support its position. Without any 

explanation, data, or evidence provided 

in the comment, we have no basis upon 

which to revise our analysis or to alter 

our conclusion to eliminate the 

requirement that the health claim 

identify the mechanism by which 

calcium reduces the risk of osteoporosis; 

thus we will continue to use the 

analysis as set forth in the calcium and 

vitamin D proposed rule (72 FR 497 at 

508–509). 

FDA agrees with the comment that 

stated: Building a strong bone matrix 

relies on proper mineral balance and 

that science is continually evolving to 

elucidate specific mechanism(s) 

involved. Calcium is an important 

nutrient for achieving and maintaining 

good skeletal health. FDA discussed the 

findings that many nutrients are 

involved in bone health, and tentatively 

concluded in the proposed rule that a 

well-balanced diet is important for bone 

health throughout life (72 FR 497 at 

507). Thus, the agency proposed that the 

claim make clear the importance of 

calcium intake or calcium and vitamin 

D intake in a healthful well-balanced 

diet over a lifetime. Conveying the 

information about calcium intake in the 

context of a healthful, well-balanced 

diet recognizes that calcium alone is not 

sufficient for bone health. Furthermore, 

results from a 1995 health claims report 

showed that consumers had learned 

elsewhere that calcium intake is related 

to bone health and that they thought the 

food label was not the right means for 

conveying this information (72 FR 497 

at 509). This consumer awareness of 

calcium’s ability to ‘‘build and maintain 

good bone health,’’ as well as the 

observation that the food label is not 

necessarily the most appropriate means 

to convey this information, prompted 

the agency to request comment in the 

calcium and vitamin D proposed rule on 

whether to make information of the 

mechanism by which calcium reduces 

the risk of osteoporosis optional in the 

health claim. Therefore, for the reasons 

set forth previously in this document, 

FDA is eliminating the requirement that 

the claims identify the mechanism by 

which calcium reduces the risk of 

osteoporosis, and instead is making 

such information optional. FDA is also 

revising the language from the proposed 

rule for use of the optional statement 

about slowing the rate of bone loss, by 

removing the following phrase: ‘‘When 

reference is made to persons with a 

family history of the disease, postmenopausal women, and elderly men 

and women * * *’’ so the language now 

reads: ‘‘The claim may also state that 

adequate intake of calcium, or when 

appropriate, adequate intake of calcium 

and vitamin D, is linked to reduced risk 

of osteoporosis through the mechanism 

of slowing the rate of bone loss for 

persons with a family history of the 

disease, post-menopausal women, and 

elderly men and women.’’ This change 

makes the use of the optional language 

related to the mechanism of slowing the 

rate of bone loss consistent with the 

final rule to remove reference to specific 

targeted populations as to risk of 

osteoporosis, but allows reference to 

family history of the disease, postmenopausal women, and elderly men 

and women in the context of the 

mechanism of slowing the rate of bone 

loss. 

(Comment 3) Several comments 

opposed the elimination of the 

conditional requirement in 

§ 101.72(c)(2)(i)(E) that the calcium and 

osteoporosis health claim include a 

statement that a total dietary intake 

greater than 200 percent of the 

recommended daily intake (2,000 mg of 

calcium) has no further known benefit 

to bone health. Some of the comments 

were concerned that eliminating this 

requirement could potentially mislead 

consumers because there will be 

nothing on the label to remind them that 

‘‘more is not always better when it 

comes to nutrients, especially in the 

form of supplements or fortification.’’ 

One comment stated that withholding 

this information could encourage 

consumers to over consume calcium 

products while other comments were 

concerned that withholding this 

information could be potentially 

harmful for those individuals who may 

be taking high doses of supplemental 

calcium, along with high amounts of 

vitamin D. One comment highlighted its 

concern regarding the elimination of 

this conditional requirement by 

pointing out that the Institute of 

Medicine (IOM) of the National 

Academy of Sciences (NAS) has found 

that the toxic effects of excess calcium 


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56480 Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 

increased the risk of kidney stone 

formation and that this condition 

affected 12 percent of individuals in the 

United States, as well as renal 

insufficiency and decreased absorption 

of other essential minerals (iron, zinc, 

magnesium and phosphorus) (72 FR 497 

at 502). Another comment questioned 

how FDA could be assured that 

cumulative vitamin D intake from all 

dietary sources would remain ‘at nontoxic levels’ (e.g., less than the Tolerable 

Upper Intake Level (UL) for vitamin D) 

when supplementation is encouraged in 

a variety of foods, including staples 

such as milk, cereal, and bread. 

(Response) FDA’s decision to 

eliminate the conditional requirement 

was made, in part, in response to the 

IOM’s 1997 report on ‘‘Dietary 

Reference Intakes (DRIs) for Calcium, 

Phosphorus, Magnesium, Vitamin D and 

Fluoride,’’ which was not available at 

the time the calcium and osteoporosis 

health claim was authorized in 1993 (72 

FR 497 at 510). IOM conducted a major 

review of bone-related nutrients to 

determine the level of nutrient intake 

for normal, healthy individuals that 

would prevent the development of a 

chronic condition (e.g., osteoporosis) 

associated with calcium (Ref. 2). IOM 

set the UL for calcium at 2,500 mg per 

day for all individuals ages 1 and above. 

The UL, as defined by IOM, is the 

highest level of nutrient intake that is 

likely to pose no risks of adverse effects 

to all individuals in the general 

population. When IOM set the UL for 

calcium it divided the lowest- observedadverse-effect level (LOAEL) of calcium 

by an uncertainty factor of two to take 

into account the relatively high 

prevalence of kidney (renal) stones in 

the U. S. population, which is 12 

percent, and the potential increased risk 

of hypercalciuria and depletion of other 

minerals among susceptible individuals 

(72 FR 497 at 502). An increased risk of 

kidney stone formation from toxic 

effects of excess calcium, as noted in 

one of the comments, was addressed 

when IOM established the UL for 

calcium. 

Furthermore, inclusion of the 

conditional requirement was based, in 

part, on a concept that calcium was a 

threshold nutrient, which means that 

there is a level of calcium intake below 

which bone health is jeopardized and 

above which no further benefit to bone 

health occurs (72 FR 497 at 510). 

Neither IOM in its 1997 report, the 2000 

NIH Consensus Statement, nor the 2004 

Surgeon General’s Report on Bone 

Health and Osteoporosis discusses a 

threshold level of calcium beyond 

which no further bone benefit occurs; 

instead these reports discuss scientific 

evidence that is useful for establishing 

a desirable level of intake for calcium as 

well as intake levels of calcium that 

pose no risk of adverse health effects (72 

FR 497 at 510). 

Moreover, contrary to concerns 

expressed by some of the comments, the 

lack of calcium in the American diet is 

more of a concern than the potential 

over consumption of the nutrient. For 

example, the 2005 Dietary Guidelines 

for Americans identified calcium as a 

‘‘nutrient of concern’’ due to low 

calcium consumption in the U.S. 

population (Ref. 3). 

FDA also notes that a ‘‘high’’ level of 

calcium and vitamin D is at least 20 

percent of the Reference Daily Intake 

(RDI) of calcium and vitamin D per 

reference amount customarily 

consumed (RACC). Since the RDI for 

calcium is 1,000 mg per day and the RDI 

for vitamin D is 400 IU (10 micrograms 

per day (μg per day)), 20 percent of the 

RDI for calcium (200 mg per day) is well 

below the UL of 2,500 mg per day intake 

level of calcium that poses no risk of 

adverse health effects and 20 percent of 

the RDI for vitamin D (80 IU (2 μg per 

day) is well below the 2,000 IU (50 μg 

per day) intake level of vitamin D that 

poses no risk of adverse health effects. 

To evaluate potential maximum 

intake levels of calcium and vitamin D 

in the United States, FDA examined the 

most recent nationally representative 

data available from the National Health 

and Nutrition Examination Survey on 

median intake values for calcium and 

vitamin D and common dietary 

supplement products that contain 

calcium, or calcium and vitamin D in 

the calcium and vitamin D proposed 

rule (72 FR 497 at 500 to 502). Results 

from this evaluation suggested that 

consumers who choose foods that bear 

the calcium, or the calcium and vitamin 

D, and osteoporosis health claim would 

be able to incorporate such foods into 

the diet in a manner that would likely 

keep their total intake of calcium well 

below the UL of 2,500 mg per day and 

their total intake of vitamin D below the 

UL of 2,000 IU per day (72 FR 497 at 

502). Further, FDA determined that 

consumers who choose conventional 

foods that bear the calcium or the 

additional calcium and vitamin D claim 

and that consume up to 1,500 mg of 

calcium per day from supplements (the 

maximum daily intake of calcium 

suggested in commonly found 

supplements) and that consume up to 

400 IU of vitamin D per day from 

supplements (the most common daily 

intake of vitamin D suggested in 

supplements) would also likely keep 

their total intake of calcium and vitamin 

D below the ULs of calcium and vitamin 

D (id.). None of the comments 

questioned these findings. Finally, the 

agency is not aware of any basis for why 

the elimination of the conditional 

requirement would be misleading or 

encourage over-consumption of calcium 

products. 

For these reasons, FDA is eliminating 

the conditional requirement in 

§ 101.72(c)(2)(i)(E), as proposed. 

(Comment 4) One comment noted that 

retaining in § 101.72(e) and (f) physical 

activity as part of the calcium and 

osteoporosis health claim as well as the 

calcium, vitamin D and osteoporosis 

health claim, might have the 

unintended consequence of leading 

consumers to believe that the benefits to 

bone health (or reduced risk of 

osteoporosis) of consuming adequate 

amounts of calcium or calcium and 

vitamin D can only be achieved by 

regularly engaging in physical activity. 

(Response) FDA agrees with this 

comment. The agency’s tentative 

decision to retain physical activity as 

part of the calcium and osteoporosis 

claim as well as the calcium, vitamin D 

and osteoporosis health claim was based 

primarily on the 2000 NIH Consensus 

Statement and the 2004 Surgeon’s 

General Report (72 FR 497 at 507), 

which indicate that physical activity is 

beneficial to bone health and can have 

an additive effect on increasing bone 

mineral density (BMD) in conjunction 

with adequate intake of calcium and 

vitamin D. On the other hand, several 

studies show that consuming adequate 

levels of calcium and vitamin D 

supports bone health and reduces the 

risk of osteoporosis in the absence of 

physical activity (Refs. 4 to 12). Since 

consumption of adequate amounts of 

calcium and vitamin D reduces the risk 

of osteoporosis without physical 

activity, FDA will not require physical 

activity to remain as part of the claim 

language for the calcium and 

osteoporosis or the calcium, vitamin D 

and osteoporosis health claim. However, 

since the importance of physical activity 

to bone health is well established, FDA 

will allow optional reference to physical 

activity in the health claim. 

Given the information discussed in 

the preamble to the calcium and vitamin 

D proposed rule and the absence of 

contrary information in the comments, 

FDA is adopting the following 

amendments to § 101.72: (1) Inclusion of 

vitamin D so that, in addition to the 

claim for calcium and osteoporosis, a 

claim can be made for calcium and 

vitamin D and osteoporosis; (2) 

elimination of the requirement in 

§ 101.72(c)(2)(i)(A) that the claim list 

sex, race, and age as specific risk factors 

for the development of osteoporosis; (3) 


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Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 56481 

elimination of the requirement in 

§ 101.72(c)(2)(i)(B) that the claim does 

not state or imply that the risk of 

osteoporosis is equally applicable to the 

general U.S. population, and that the 

claim identify the populations at 

particular risk for the development of 

osteoporosis; (4) elimination of the 

requirement in § 101.72(c)(2)(i)(C) that 

the claim identify the mechanism by 

which calcium reduces the risk of 

osteoporosis, and instead make it 

optional; (5) elimination of the 

conditional requirement in 

§ 101.72(c)(2)(i)(E) that the claim 

include a statement that a total dietary 

intake greater than 200 percent of the 

recommended daily intake (2,000 

milligrams (mg) of calcium) has no 

further benefit to bone health, when the 

level of calcium in the food exceeds a 

set threshold level; and (6) elimination 

of the provision in § 101.72(c)(2)(i)(A) 

about physical activity, and instead 

make it optional. Therefore, FDA is not 

including the term ‘‘physical activity’’ 

in some of the model health claims as 

proposed. Moreover, FDA is revising 

§ 101.72(e) and (f) by removing the term 

‘‘regular exercise’’ in the model health 

claims. 

III. Analysis of Economic Impacts 

A. Final Regulatory Impact Analysis 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and 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). The agency 

believes that this final rule is not a 

significant regulatory action as defined 

by the Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant economic impact of a rule on 

small entities. The final rule amends the 

current calcium and osteoporosis health 

claim language and will require changes 

to the claim language on products 

currently bearing the health claim. 

Thus, the only mandatory costs of this 

final rule will be the costs to update the 

current wording of the calcium and 

osteoporosis health claim on those 

products that currently bear the claim. 

Based on FDA’s 2001 Food Label and 

Package Survey (FLAPS) (see discussion 

in section III.A.2 ‘‘Background’’ of this 

document), very few products bear the 

calcium and osteoporosis health claim. 

Therefore, because of the limited use of 

the current calcium and osteoporosis 

health claim, the agency certifies that 

the final rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which 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 $130 

million, using the most current (2007) 

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 and has determined that 

this final rule does not constitute a 

significant rule under the Unfunded 

Mandates Reform Act. 

1. Need for This Regulation 

Current regulations do not permit 

food producers to claim health benefits 

for products by linking the intake of 

vitamin D, when combined with the 

intake of calcium, with a reduced risk 

of osteoporosis. However, current 

regulations do permit food producers to 

claim health benefits for products by 

linking calcium intake with a reduced 

risk of osteoporosis only if they also list 

the specific risk factors and at-risk 

subpopulations for osteoporosis, the 

mechanism by which calcium reduces 

the risk of osteoporosis, and the limit of 

the benefits of dietary calcium at certain 

levels. 

Health claims can inform consumers 

about diet-disease relationships and 

encourage producers to produce more 

healthful foods. This final rule will 

allow producers to make more nutrition 

information related to osteoporosis 

available to consumers (linking the 

intake of calcium and vitamin D to the 

risk of osteoporosis), while eliminating 

other information currently required to 

be given to consumers when claiming 

health benefits relating to the 

relationship between calcium intake 

and the risk of osteoporosis. 

2. Background 

Osteoporosis represents a major 

public health problem in the United 

States. This disease affects more than 10 

million individuals and causes 

approximately 1.5 million fractures 

annually. Every year, these lead to more 

than 2.6 million physician office visits, 

over 800,000 emergency room visits, 

and more than 500,000 hospitalizations, 

and the placement of nearly 180,000 

people into nursing homes. The direct 

care expenditures for osteoporotic 

fractures alone range from 12 to 18 

billion dollars each year (measured in 

2002 dollars) (Ref. 13). The indirect 

health costs of osteoporosis, such as 

pain, suffering, and lost mobility, are 

also large. Average calcium and vitamin 

D intakes are below recommended 

levels for many consumers (Refs. 13, 14 

and 15). Even though many consumers 

are not achieving recommended intakes 

of calcium, producers have rarely 

placed the calcium and osteoporosis 

health claim on products that qualify for 

the claim. FDA’s 2001 FLAPS (the most 

recently available data) showed only 1 

out of the 87 shelf-stable juice products 

surveyed, a fortified orange juice, 

bearing the calcium and osteoporosis 

health claim. None of the 10 milk 

products surveyed bore the claim (Ref. 

16). 

3. Regulatory Options 

FDA identified four regulatory 

options for this final rule: (1) Take no 

new regulatory action; (2) reduce the 

required language in the existing 

calcium and osteoporosis health claim; 

(3) expand the existing calcium and 

osteoporosis health claim to include 

vitamin D; or (4) reduce the required 

language in the existing calcium and 

osteoporosis health claim and include 

vitamin D as an option to the claim, as 

described in this final rule. 

4. Changes in Market Behavior in 

Response to Options 

This final rule will require that any 

food manufacturers wishing their 

products’ labels to make the calcium, or 

calcium and vitamin D, and 

osteoporosis health claim be redesigned. 

Labels must be redesigned in order for 

a food to carry the health claim since 

information on populations at particular 

risk for osteoporosis would no longer be 

required or allowed for the claim (see 

§ 101.72(c)(2)(A) and (c)(2)(B)). 

Manufacturers that wish to continue 

making a calcium and osteoporosis 

health claim on their products will not 

need to reformulate their products 

under the final rule. The nature of the 

food eligible to make a calcium and 

osteoporosis health claim remains food 

that meets or exceeds a ‘‘high’’ level of 

calcium (as defined in 21 CFR 

101.54(b)). Manufacturers wishing to 

take advantage of the expanded calcium, 

vitamin D, and osteoporosis health 


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claim may voluntarily choose to 

reformulate their products. If some 

producers choose to reformulate their 

products to take advantage of the 

calcium, vitamin D, and osteoporosis 

health claim, they reveal that they 

expect the private benefit that the 

claims give them to exceed the expense 

of making the claims. If this is not the 

case, no producer will voluntarily 

choose to use the claims. Likewise, 

consumers who choose to purchase the 

products with the amended health 

claims reveal that they value the 

products more highly than other 

alternatives, including not purchasing 

the products. 

We considered five potential effects in 

estimating the relative public health 

benefits of the options: (1) The extent to 

which the option encourages producers 

to use the health claims on their food 

labels; (2) the extent to which the option 

encourages producers to reformulate 

their products to make the health 

claims; (3) the extent to which the 

option provides information to 

consumers; (4) potential risk-risk 

tradeoffs (where the action taken to 

reduce the risk posed by one hazard 

causes an increase in the risk posed by 

another hazard) with each option; and 

(5) the availability of information on the 

relationship between osteoporosis and 

calcium and vitamin D to consumers 

who do not consume dairy products. 

a. Producer responses. There are four 

likely responses to this final rule from 

producers: (1) Make no changes (i.e., 

continue not making the calcium or 

calcium and vitamin D health claim; (2) 

create new product labels to continue 

making the calcium and osteoporosis 

health claim (for products already 

making the existing claim); (3) add the 

health claims to their products that 

qualify for the health claims (increase 

usage of the claim due to the new 

wording requirements); and (4) 

reformulate their products (by fortifying 

with calcium or vitamin D, for example) 

to qualify for the health claims. 

Several factors affect whether 

producers choose to use health claims, 

including the flexibility of the health 

claims and how appealing the health 

claims are to consumers. Revising the 

existing calcium and osteoporosis 

health claim language to make it shorter 

will make it more appealing to put the 

health claims on labels. Package space 

is limited, so more flexible and shorter 

claims are easier to use. Also, Wansink, 

et al. (2004) found that shorter health 

claims on the front of the package led 

to more favorable beliefs about the 

product and a more positive image of 

the product among consumers (Ref. 17). 

Approving a calcium, vitamin D, and 

osteoporosis health claim should 

encourage the manufacturers of foods 

that are eligible for fortification with 

vitamin D to do so because they will be 

able to publicize the relationship 

between calcium, vitamin D, and 

osteoporosis on their labels. If producers 

fortify more products with vitamin D, 

consumers can get more vitamin D in 

their diet without making changes in 

their dietary choices. 

b. Consumer responses. Providing 

information about the relationship 

between calcium, vitamin D, and 

osteoporosis on food packages provides 

a number of benefits to consumers, 

including: (1) Informing them about the 

nutrient-disease relationship; (2) 

helping them identify products that are 

high in calcium and vitamin D; and (3) 

helping them make dietary choices that 

reduce their risk of osteoporosis. The 

extent to which consumers realize these 

benefits will depend on the consumer’s 

knowledge of the relationship between 

calcium, vitamin D, and bone health; 

how many products bear the calcium or 

calcium and vitamin D health claims; 

how many consumers read the health 

claims; and how much they change their 

behavior to include such products in 

their diets. There is evidence that 

consumers who read nutrition 

information on packages eat healthier 

diets (Refs. 18 and 19). However, there 

is a great deal of uncertainty about how 

much consumers change their behavior 

in response to label information. 

c. Risk-risk tradeoffs. A potential 

concern is that allowing these 

osteoporosis health claims on juice 

drinks will result in consumers 

switching away from milk to juice 

drinks, which are higher in calories, for 

dietary sources of calcium and vitamin 

D. Table 1 of this document presents the 

caloric and nutrient profile of non-fat 

and low-fat milk products and an orange 

juice drink product as reported in the 

U.S. Department of Agriculture (USDA) 

National Nutrient Database for Standard 

Reference. Orange juice drinks are 

higher in calories and contain less of 

some important nutrients than either 

non-fat or low-fat milk (table 1 of this 

document). 

TABLE 1—PROFILES OF SELECTED NUTRIENTS IN NON-FAT AND LOW-FAT MILK AND ORANGE JUICE DRINK (PER 8-OUNCE

SERVING) 

Nutrient (1) Orange Juice 

Drink 

(2) Non-fat Milk 

(Skim), With Added 

Vitamin A 

(3) Low-fat Milk 

(1%), With Added 

Vitamin A 

Energy, kilocalorie (kcal) 134 83 102 

Protein, gram (g) 0 .5 8 .25 8 .22 

Total Fat, g 0 0 .2 2 .37 

Saturated Fat, g 0 0 .286 1 .545 

Carbohydrate, g 33 .36 12 .14 12 .18 

Total Dietary Fiber, g 0 .5 0 0 

Total Sugars, g 23 .29 12 .46 12 .69 

Calcium, mg 5 306 290 

Iron, mg 0 .27 0 .07 0 .07 

Magnesium, mg 7 27 27 

Phosphorus, mg 10 247 232 


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1Lactose intolerance is a condition in which 

individuals cannot metabolize lactose, the main 

sugar found in milk and other calcium-rich dairy 

products. Information in the Surgeon General’s 

2004 Report on Bone Health and Osteoporosis 

indicates that an estimated 30 to 50 million 

Americans are affected by lactose intolerance, 

although to varying degrees. 

TABLE 1—PROFILES OF SELECTED NUTRIENTS IN NON-FAT AND LOW-FAT MILK AND ORANGE JUICE DRINK (PER 8-OUNCE

SERVING)—Continued 

Nutrient (1) Orange Juice 

Drink 

(2) Non-fat Milk 

(Skim), With Added 

Vitamin A 

(3) Low-fat Milk 

(1%), With Added 

Vitamin A 

Potassium, mg 104 382 366 

Sodium, mg 5 103 107 

Zinc, mg 0 .05 1 .03 1 .02 

Copper, mg 0 .045 0 .032 0 .024 

Manganese, mg 0 .017 0 .007 0 .007 

Selenium, μg 0 7 .6 8 .1 

Vitamin C, mg 37 .3 0 0 

Thiamin, mg 0 .945 0 .11 0 .049 

Riboflavin, mg 1 .07 0 .446 0 .451 

Niacin, mg 12 .44 0 .23 0 .227 

Pantothenic acid, mg 0 .149 0 .874 0 .881 

Vitamin B–6, mg 1 .244 0 .091 0 .09 

Folate, μg 10 12 12 

Vitamin B–12, μg 0 1 .3 1 .07 

Vitamin A, IU 109 499 478 

Vitamin D, IU 0 101 .46 126 .77 

Cholesterol, mg 0 5 12 

The likelihood of consumers 

switching from non-fat or low-fat milk 

or to higher caloric juice drinks because 

of this rule is expected to be small 

because non-fat and low-fat milk and 

juice drinks that are eligible can already 

make the existing calcium and 

osteoporosis health claim. Permitting 

the same set of products to make the 

final, simpler calcium and osteoporosis 

health claim should not change the 

relative appeal of the claim to producers 

of one type of beverage over another. 

The allowance of the new calcium, 

vitamin D, and osteoporosis health 

claim could expand the set of products 

making an osteoporosis health claim; 

however, the relative appeal of the new 

claim (calcium and vitamin D) to 

producers of non-fat and low-fat milk 

and juice drinks should be similar to the 

appeal of the existing calcium and 

osteoporosis health claim. 

There is little evidence to support that 

consumers would switch from non-fat 

or low-fat milk to juice drinks as a result 

of this final rule. As stated in the 

Surgeon General’s Report on Bone 

Health and Osteoporosis, consuming 

adequate levels of calcium and vitamin 

D throughout life are critically 

important to an individual’s bone 

health. However, the report’s review of 

national surveys suggests that the 

average calcium intake of individuals is 

far below the levels recommended for 

optimal bone health. One reason cited 

by the report for these low levels of 

calcium intake relates to current 

lifestyle and food preferences, which 

have resulted in reduced intake of dairy 

products and other naturally occurring 

calcium-rich foods. The report also 

posits that for some individuals lactose 

intolerance1 may also play a role in not 

consuming adequate levels of calcium. 

Given this information on the current 

preference and tolerance for dairy 

products, expanding the calcium and 

osteoporosis health claim to include 

vitamin D as a result of this final rule 

should only lead to an increase in the 

overall consumption of these essential, 

under consumed nutrients. 

In addition, according to the 

American Beverage Association, U.S. 

sales of calcium-fortified orange juice 

have grown dramatically over recent 

years, reaching nearly $1 billion in 2003 

(Ref. 20), while overall sales of juice 

have not grown. Therefore, FDA expects 

that the nutritional profile of diets 

would most likely improve as a 

consequence of changes in consumption 

resulting from this final rule. Switching 

from unfortified to fortified juices 

would increase needed consumption of 

calcium and vitamin D. 

5. Benefits and Costs of Regulatory 

Options 

The simplification of the current 

health claim for calcium and 

osteoporosis, along with the additional 

health claim for calcium, vitamin D, and 

osteoporosis should increase and 

expand the current usage of the health 

claim and therefore improve the U.S. 

population’s intake of these two 

important nutrients. Therefore, all the 

options considered below would 

improve public health relative to the 

baseline of taking no new regulatory 

action. In our analysis of the benefits 

and costs of the options, we compare 


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the benefits and costs of each option 

with each other option based on their 

relative effects on consumer and 

producer behavior. 

Option 1: Take no new regulatory 

action. 

This option would result in no change 

to the current situation. This is the 

baseline for comparison of options and 

entails no costs or benefits. 

Option 2: Reduce the required language 

in the existing calcium and 

osteoporosis health claim. 

Compared with Option 1, this option 

would increase the appeal of the claim 

for producers, increase the use of the 

claim on products, and thereby provide 

consumers with more information on 

the calcium and osteoporosis dietdisease relationship. It could encourage 

more reformulation of products to 

fortify with calcium than has occurred 

with the existing claim. Like Option 1, 

this option provides consumers with no 

information about the relationship of 

vitamin D to osteoporosis. 

With this option, manufacturers of 

some products making the current 

calcium and osteoporosis health claim 

may have to re-label their products to 

reflect the updated wording provided by 

the claim. The potential costs associated 

with a required label change will vary 

depending on when the new effective 

compliance date is established. Table 2 

of this document shows the possible 

range of costs by product type of having 

to re-label to be in compliance with the 

revised calcium and osteoporosis health 

claim. The product re-labeling costs 

were estimated using the FDA Labeling 

Cost Model (Ref. 21). The costs of relabeling included are administrative, 

graphic, prepress, engraving, and 

inventory costs. Re-labeling costs are 

shown for both a 12-month and 24- 

month compliance period. 

TABLE 2.—COST OF LABEL CHANGES FOR OPTION 2 

NAICS Codes Product 

12 Months to Comply, Cost Per Label SKU 24 Months to Comply, Cost Per Label SKU 

Low Cost Med Cost High Cost Low Cost Med Cost High Cost 

311421 

311411 

Fruit Juices $7,478 $10,186 $15,282 $5,455 $7,595 $11,897 

311514 

311511 

Non-fat and Low-fat 

Milk, fluid, dry, powered, condensed, flavored 

$11,216 $14,086 $20,437 $7,127 $9,236 $14,327 

311513 Low-fat Cheese, multiple types $6,611 $8,759 $13,758 $5,106 $6,999 $11,489 

311511 Yogurt-like products $4,554 $6,490 $10,857 $4,140 $5,900 $9,880 

325412 Dietary Supplements $9,728 $13,345 $22,834 $8,540 $11,739 $20,266 

Average cost of label change regardless 

of product type 

$7,917 $10,573 $16,633 $6,074 $8,294 $13,572 

Option 3: Expand the existing calcium 

and osteoporosis health claim to include 

vitamin D. 

Failing to shorten the existing calcium 

and osteoporosis health claim will not 

make the health claim as appealing to 

producers and consumers as Option 2, 

leading to less claim use and 

reformulation and less information 

provided to consumers than Option 2. 

This option would provide consumers 

with more information on vitamin D 

than Option 2, should producers decide 

to voluntarily re-label and/or 

reformulate their products to make use 

of the added vitamin D language. 

Option 4: Reduce the required language 

in the existing calcium and osteoporosis 

health claim and include vitamin D as 

an option to the claim, as described in 

this final rule. 

Like Option 2, this option would 

increase the appeal of the calcium and 

osteoporosis health claim for producers 

and thereby provide consumers with 

more information on the calcium and 

osteoporosis diet-disease relationship. 

Also like Option 2, producers of 

products with existing calcium and 

osteoporosis health claim labeling will 

have to revise their labeling in order to 

comply with the revised claim language. 

Like Option 3, this option would 

provide consumers with more 

information on vitamin D than Option 2 

because the new, simplified calcium 

and osteoporosis health claim can now 

contain information about vitamin D as 

well. It could also encourage more 

reformulation of products to fortify with 

vitamin D than would Option 2 and as 

many products to fortify with calcium 

as Option 2. 

Summary 

FDA is unable to quantify the benefits 

of this final rule due to uncertainty 

about the degrees of changes in 

consumer and producer behavior. 

However according to information 

compiled in the Surgeon General’s 2004 

Report on Bone Health and 

Osteoporosis, there are about 1.5 million 

osteoporotic fractures in the United 

States each year that carry annual direct 

care expenditures of 12 to 18 billion 

dollars per year (2002 dollars). These 

fractures cause more than half a million 

hospitalizations, over 800,000 

emergency room encounters, more than 

2.6 million physician office visits, and 

the placement of nearly 180,000 

individuals into nursing homes 

annually (Ref. 13). The direct costs of 

other complications from osteoporosis, 

and the indirect costs of these fractures 

and other osteoporotic ailments (e.g., 

the value of functional disability to the 

patient, the value of the pain and 

suffering to the patient, the costs 

experienced by the care giver) if 

calculated, would add substantially to 

the annual costs of this disease. Any 

increase in calcium and vitamin D 

intake by consumers insufficient in 

these nutrients as a result of this final 

rule could possibly lower the incidence 

of osteoporosis and therefore the annual 

costs associated with the disease. 

Table 3 of this document provides a 

summary of the effects of the rule, and 

which options create the smallest and 

largest behavior changes for consumers 

and producers. All options should 

produce positive net benefits, with the 

largest net benefit arising from Option 4, 

the final rule. With Option 4, the largest 

number of products and labels would 


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Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 56485 

change, leading to the largest reduction 

in the risk of osteoporosis. 

TABLE 3.—SUMMARY OF EFFECTS OF OPTIONS

Effect Largest Effect Smallest Effect 

Encouraging producer use of the claims Option 4 Option 1 

Encouraging fortification Option 4 Option 1 

Informing consumers Option 4 Option 1 

Informing consumers who do not buy dairy products about alternative food sources for vitamin D Option 4 Option 1 

B. Small Entity Analysis (or Initial 

Regulatory Flexibility Analysis) 

FDA has examined the economic 

implications of this final rule as 

required by the Regulatory Flexibility 

Act (5 U.S.C. 601–612). If a rule has a 

significant economic impact on a 

substantial number of small entities, the 

Regulatory Flexibility Act requires 

agencies to analyze regulatory options 

that would lessen the economic effect of 

the rule on small entities consistent 

with statutory objectives. FDA does not 

believe that this final rule will have a 

significant economic impact on a 

substantial number of small entities 

because the only mandatory costs of this 

rule are the costs to update the current 

wording of the calcium and osteoporosis 

health claim for manufacturers of 

products that currently make the claim 

and wish to continue doing so. Also 

previously mentioned, FDA’s 2001 Food 

Label and Package Survey showed only 

1 out of 87 shelf-stable juice products 

surveyed bore the current calcium and 

osteoporosis health claim while none of 

the 10 milk products surveyed bore the 

claim. This implies that not many 

products eligible to bear the current 

claim would need to be re-labeled as a 

result of this final rule. 

In addition, FDA establishes uniform 

compliance dates for final food labeling 

regulations in 2-year intervals. 

Therefore, companies whose products 

currently make the calcium and 

osteoporosis health claim and wish to 

continue doing so will have between 1 

and 2 years to use existing label 

inventory and expense the costs of 

designing revised labeling. FDA 

estimates that on average, the cost to relabel a product according to the revised 

health claim language will be $7,900 to 

$16,600 per product if the compliance 

period is 12 months; and $6,100 to 

$13,600 per product if the compliance 

period is 24 months. In the calcium and 

vitamin D proposed rule, FDA requested 

comments on whether the rule would 

have a significant impact on a 

substantial number of small entities. 

FDA received no comments on the issue 

of significant impacts on any size 

business. Manufacturers that wish to 

begin using the revised calcium and 

osteoporosis health claim or the new 

calcium, vitamin D, and osteoporosis 

health claim will only do so if the 

benefits of labeling their products to 

inform consumers of the claim outweigh 

the costs of doing so. 

IV. Environmental Impact 

FDA has determined under 21 CFR 

25.32(p) 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. Paperwork Reduction Act 

FDA concludes that the labeling 

provisions of this final rule are not 

subject to review by the Office of 

Management and Budget because they 

do not constitute a ‘‘collection of 

information’’ under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). Rather, the food labeling health 

claims on the association between 

calcium and osteoporosis or calcium, 

vitamin D, and osteoporosis is a ‘‘public 

disclosure of information originally 

supplied by the Federal Government to 

the recipient for the purpose of 

disclosure to the public.’’ (5 CFR 

1320.3(c)(2)). 

VI. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule will have a 

preemptive effect on State law. Section 

4(a) of the Executive Order requires 

agencies to ‘‘construe * * * a Federal 

statute to preempt State law only where 

the statute contains an express 

preemption provision or there is some 

other clear evidence that the Congress 

intended preemption of State law, or 

where the exercise of State authority 

conflicts with the exercise of Federal 

authority under the Federal statute.’’ 

Section 403A of the act (21 U.S.C. 343– 

1) is an express preemption provision. 

Section 403A(a)(5) of the act (21 U.S.C. 

343–1(a)(5)) provides that: ‘‘* * * no 

State or political subdivision of a State 

may directly or indirectly establish 

under any authority or continue in 

effect as to any food in interstate 

commerce—* * * (5) any requirement 

respecting any claim of the type 

described in section 403(r)(1) made in 

the label or labeling of food that is not 

identical to the requirement of section 

403(r) * * *.’’ 

This final rule amends the existing 

food labeling regulations on health 

claims for calcium and osteoporosis. 

Although this rule has a preemptive 

effect in that it precludes States from 

issuing any health claim labeling 

requirements for calcium and 

osteoporosis or calcium, vitamin D, and 

osteoporosis that are not identical to 

those required by this final rule, this 

preemptive effect is consistent with 

what Congress set forth in section 403A 

of the act. Section 403A(a)(5) of the act 

displaces both State legislative 

requirements and State common law 

duties. Riegel v. Medtronic, 128 S. Ct. 

999 (2008). 

FDA believes that the preemptive 

effect of the final rule is consistent with 

Executive Order 13132. Section 4(e) of 

the Executive order provides that ‘‘when 

an agency proposes to act through 

adjudication or rulemaking to preempt 

State law, the agency shall provide all 

affected State and local officials notice 

and an opportunity for appropriate 

participation in the proceedings.’’’ On 

February 17, 2006, FDA’s Division of 

Federal and State Relations provided 

notice by fax and e-mail transmission to 

State health commissioners, State 

agriculture commissioners, food 

program directors, and drug program 

directors as well as FDA field personnel, 

of FDA’s intended amendments to the 

calcium and osteoporosis health claim 

(21 CFR 101.72). FDA received no 

comments in response to this notice. 


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56486 Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 

In addition, the agency sought input 

from all stakeholders through 

publication of the proposed rule in the 

Federal Register on January 5, 2007 (72 

FR 497). FDA received no comments 

from any States on the proposed 

rulemaking. 

In conclusion, the agency believes 

that it has complied with all of the 

applicable requirements under the 

Executive order and has determined that 

the preemptive effects of this rule are 

consistent with Executive Order 13132. 

VII. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20857, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site addresses, but FDA is not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. The Beverage Institute for Health and 

Wellness, ‘‘Petition for Vitamin D, Calcium 

and Osteoporosis,’’ (Docket No. 2004P–0464, 

CP1), July 12, 2004. 

2. Standing Committee on the Scientific 

Evaluation of Dietary Reference Intakes, Food 

and Nutrition Board, Institute of Medicine, 

‘‘Dietary Reference Intakes for Calcium, 

Phosphorus, Magnesium, Vitamin D and 

Fluoride,’’ Chapter 4, National Academy 

Press, Washington, DC, 1997. 

3. U.S. Department of Health and Human 

Services and U.S. Department of Agriculture. 

‘‘Dietary Guidelines for Americans, 2005,’’ 

6th ed., Washington, DC: U.S. Government 

Printing Office, chapter 2, January 2005. 

4. Baeksgaard, L., K. P. Andersen, and L. 

Hyldstrup, ‘‘Calcium and Vitamin D 

Supplementation Increases Spinal BMD in 

Healthy, Postmenopausal Women,’’ 

Osteoporosis International, 8:255–260, 1998. 

5. Chapuy, M. C., M. E. Arlot, F. Duboeuf, 

et al., ‘‘Vitamin D3 and Calcium to Prevent 

Hip Fractures in Elderly Women,’’ The New 

England Journal of Medicine, 327:1637–1642, 

1992. 

6. Chapuy, M. C., M. E. Arlot, P. D. Delmas, 

et al., ‘‘Effect of Calcium and Cholecalciferol 

Treatment for Three Years on Hip Fractures 

in Elderly Women,’’ British Medical Journal, 

308:1081–1082, 1994. 

7. Dawson-Hughes, B., G. E. Dallal, E. A. 

Krall, S. Harris, L. J. Sokoll, and G. Falconer, 

‘‘Effect of Vitamin D Supplementation on 

Wintertime and Overall Bone Loss in Healthy 

Postmenopausal Women,’’ Annuals of 

Internal Medicine, 115:505–512, 1991. 

8. Dawson-Hughes, B., S. S. Harris, E. A. 

Krall, et al., ‘‘Effect of Calcium and Vitamin 

D Supplementation on Bone Density in Men 

and Women 65 Years of Age or Older,’’ The 

New England Journal of Medicine, 337:670– 

676, 1997. 

9. Dawson-Hughs, B., S. S. Harris, E. A. 

Krall, et al., ‘‘Effect of Withdrawal of Calcium 

and Vitamin D Supplements on Bone Mass 

in Elderly Men and Women,’’ American 

Journal of Clinical Nutrition, 72:745–750, 

2000. 

10. Krieg, M. A., A. F. Jacquet, M. 

Bremgartner, et al., ‘‘Effect of 

Supplementation with Vitamin D3 and 

Calcium on Quantitative Ultrasound of Bone 

in Elderly Institutionalized Women: A 

Longitudinal Study,’’ Osteoporosis 

International, 9:483–488, 1999. 

11. Sosa, M., P. La ́inez, A. Arbelo, et al., 

‘‘The Effect of 25-dihydroxyvitamin D on the 

Bone Mineral Metabolism of Elderly Women 

with Hip Fracture,’’ Rheumatology, 39:1263– 

1268, 2000. 

12. Jackson, R. D., et al., ‘‘Calcium Plus 

Vitamin D Supplementation and the Risk of 

Fractures, The Women’s Health Initiative,’’ 

The New England Journal of Medicine, 

354:669–683, 2006. 

13. ‘‘Bone Health and Osteoporosis: A 

Report of the Surgeon General,’’ Rockville, 

MD: U.S. Department of Health and Human 

Services, Office of the Surgeon General, 

Executive Summary, 2004. 

14. Calvo, M. S., S. J. Whiting, and C. N. 

Barton, ‘‘Vitamin D Fortification in the 

United States and Canada: Current Status and 

Data Needs,’’ American Journal of Clinical 

Nutrition, 80(suppl):1710S–1716S, 2004. 

15. Moore, C., M. M. Murphy, D. R. Keast, 

et al., ‘‘Vitamin D Intake in the United 

States,’’ Journal of the American Dietetic 

Association, 104(6):980–983, 2004. 

16. U.S. Food and Drug Administration, 

Center for Food Safety and Applied 

Nutrition, Office of Nutritional Products, 

Labeling, and Dietary Supplements, ‘‘Food 

Label and Package Survey 2000–2001,’’ 

http://www.cfsan.fda.gov/~dms/labflap.html, August 2004. 

17. Wansink B., S. T. Sonka, and C. M. 

Hasler, ‘‘Front-Label Health Claims: When 

Less is More,’’ Food Policy, 29(6):659–667, 

2004. 

18. Kim, S., R. M. Nayga, Jr., and O. Capps 

Jr., ‘‘The Effect of Food Label Use on Nutrient 

Intakes: An Endogenous Switching 

Regression Analysis,’’ Journal of Agricultural 

and Resource Economics, 25(1):215–231, 

2000. 

19. Neuhouser, M. L., A. R. Kristal, and R. 

E. Patterson, ‘‘Use of Food Nutrition Labels 

Associated With Lower Fat Intake,’’ Journal 

of the American Dietetic Association, 

99(1):45–50, 53, 1999. 

20. American Beverage Association, Press 

Release, September 17, 2004 (http:// 

www.ameribev.org/news-detail/ 

index.aspx?nid=32). 

21. ‘‘Food and Drug Administration 

Labeling Cost Model,’’ Health, Social, and 

Economics Research, Research Triangle Park, 

NC, January 2003 (http://www.cfsan.fda.gov/ 

~dms/lab-flap.html). 

List of Subjects in 21 CFR Part 101 

Food labeling, Nutrition, Reporting 

and recordkeeping requirements. 

■ 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 to read 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 101.72 is revised to read as 

follows: 

§ 101.72 Health claims: calcium, vitamin D, 

and osteoporosis. 

(a) Relationship between calcium, 

vitamin D, and osteoporosis. An 

inadequate intake of calcium or calcium 

and vitamin D contributes to low peak 

bone mass, which has been identified as 

one of many risk factors in the 

development of osteoporosis. Peak bone 

mass is the total quantity of bone 

present at maturity, and experts believe 

that it has the greatest bearing on 

whether a person will be at risk of 

developing osteoporosis and related 

bone fractures later in life. Another 

factor that influences total bone mass 

and susceptibility to osteoporosis is the 

rate of bone loss after skeletal maturity. 

Vitamin D is required for normal 

absorption of calcium and to prevent the 

occurrence of high serum parathyroid 

hormone (PTH) concentration, which 

stimulates mobilization of calcium from 

the skeleton and can lower bone mass. 

Calcium, along with vitamin D and 

several other nutrients, is required for 

normal bone mineralization. While 

vitamin D is required for optimal bone 

mineralization, it is more effective when 

calcium intake is adequate. An adequate 

intake of calcium and vitamin D is 

thought to exert a positive effect during 

adolescence and early adulthood in 

optimizing the amount of bone that is 

laid down. However, the upper limit of 

peak bone mass is genetically 

determined. The mechanism through 

which adequate intakes of calcium and 

vitamin D and optimal peak bone mass 

reduce the risk of osteoporosis is 

thought to be as follows. All persons 

lose bone with age. Hence, those with 

higher bone mass at maturity take longer 

to reach the critically reduced mass at 

which bones can fracture easily. The 

rate of bone loss after skeletal maturity 

also influences the amount of bone 

present at old age and can influence an 

individual’s risk of developing 

osteoporosis. Maintenance of adequate 

intakes of calcium and vitamin D later 

in life is thought to be important in 

reducing the rate of bone loss 

particularly in the elderly and in 

women during the first decade 

following menopause, but a significant 

protective effect is also seen among men 

and younger women. 


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Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 56487 

(b) Significance of calcium or calcium 

and vitamin D. Adequate calcium 

intake, or adequate calcium and vitamin 

D intake, is not the only recognized risk 

factor in the development of 

osteoporosis, which is a multifactorial 

bone disease. Maintenance of adequate 

calcium and vitamin D intakes 

throughout life is necessary to achieve 

optimal peak bone mass and to reduce 

the risk of osteoporosis in later life. 

However, vitamin D is most effective in 

this regard when calcium intake is 

adequate. Increasing intake of calcium 

has been shown to have beneficial 

effects on bone health independent of 

dietary vitamin D. 

(c) Requirements. (1) All requirements 

set forth in § 101.14 shall be met. 

(2) Specific requirements—(i) Nature 

of the claim. A health claim associating 

calcium or, when appropriate, calcium 

and vitamin D with a reduced risk of 

osteoporosis may be made on the label 

or labeling of a food described in 

paragraphs (c)(2)(ii) and (d)(1) of this 

section, provided that: 

(A) The claim makes clear the 

importance of adequate calcium intake, 

or when appropriate, adequate calcium 

and vitamin D intake, throughout life, in 

a healthful diet, are essential to reduce 

osteoporosis risk. The claim does not 

imply that adequate calcium intake, or 

when appropriate, adequate calcium 

and vitamin D intake, is the only 

recognized risk factor for the 

development of osteoporosis; 

(B) The claim does not attribute any 

degree of reduction in risk of 

osteoporosis to maintaining an adequate 

dietary calcium intake, or when 

appropriate, an adequate dietary 

calcium and vitamin D intake, 

throughout life. 

(ii) Nature of the food. (A) The food 

shall meet or exceed the requirements 

for a ‘‘high’’ level of calcium as defined 

in § 101.54(b); 

(B) The calcium content of the 

product shall be assimilable; 

(C) Dietary supplements shall meet 

the United States Pharmacopeia (USP) 

standards for disintegration and 

dissolution applicable to their 

component calcium salts, except that 

dietary supplements for which no USP 

standards exist shall exhibit appropriate 

assimilability under the conditions of 

use stated on the product label; 

(D) A food or total daily 

recommended supplement intake shall 

not contain more phosphorus than 

calcium on a weight per weight basis. 

(d) Optional information. (1) The 

claim may include the term ‘‘vitamin D’’ 

if the food meets or exceeds the 

requirements for a ‘‘high’’ level of 

vitamin D as defined in § 101.54(b); 

(2) The claim may include 

information from paragraphs (a) and (b) 

of this section. 

(3) The claim may make reference to 

physical activity. 

(4) The claim may include 

information on the number of people in 

the United States, including the number 

of people in certain subpopulations in 

the United States, who have 

osteoporosis or low bone density. The 

sources of this information must be 

identified, and it must be current 

information from the National Center for 

Health Statistics, the National Institutes 

of Health, or the National Osteoporosis 

Foundation. 

(5) The claim may state that the role 

of adequate calcium intake, or when 

appropriate, the role of adequate 

calcium and vitamin D intake, 

throughout life is linked to reduced risk 

of osteoporosis through the mechanism 

of optimizing peak bone mass during 

adolescence and early adulthood. The 

phrase ‘‘build and maintain good bone 

health’’ may be used to convey the 

concept of optimizing peak bone mass. 

The claim may also state that adequate 

intake of calcium, or when appropriate, 

adequate intake of calcium and vitamin 

D, is linked to reduced risk of 

osteoporosis through the mechanism of 

slowing the rate of bone loss for persons 

with a family history of the disease, 

post-menopausal women, and elderly 

men and women. 

(e) Model health claims. The 

following model health claims may be 

used in food labeling to describe the 

relationship between calcium and 

osteoporosis: 

Adequate calcium throughout life, as 

part of a well-balanced diet, may reduce 

the risk of osteoporosis. 

Adequate calcium as part of a healthful 

diet, along with physical activity, may 

reduce the risk of osteoporosis in later 

life. 

(f) Model additional health claims for 

calcium and vitamin D. The following 

model health claims may be used in 

food labeling to describe the 

relationship between calcium, vitamin 

D, and osteoporosis: 

Adequate calcium and vitamin D 

throughout life, as part of a wellbalanced diet, may reduce the risk of 

osteoporosis. 

Adequate calcium and vitamin D as part 

of a healthful diet, along with physical 

activity, may reduce the risk of 

osteoporosis in later life. 

Dated: September 11, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22730 Filed 9–26–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 314 

[Docket No. FDA–2008–N–0341] 

Applications for Food and Drug 

Administration Approval to Market a 

New Drug; Postmarketing Reports; 

Reporting Information About 

Authorized Generic Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations to require that the holder of 

a new drug application (NDA) submit 

certain information regarding 

authorized generic drugs in an annual 

report. We are taking this action as part 

of our implementation of the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA). FDAAA requires that 

FDA publish a list of all authorized 

generic drugs included in an annual 

report since 1999, and that the agency 

update the list quarterly. We are using 

direct final rulemaking for this action 

because the agency expects that there 

will be no significant adverse comment 

on the rule. In the proposed rule section 

of this issue of the Federal Register, we 

are concurrently proposing and 

soliciting comments on this rule. If 

significant adverse comments are 

received, we will withdraw this final 

rule and address the comments in a 

subsequent final rule. FDA will not 

provide additional opportunity for 

comment. 

DATES: This direct final rule is effective 

February 11, 2009. Submit written or 

electronic comments on or before 

December 15, 2008. If we receive no 

timely significant adverse comments, 

we will publish a notice in the Federal 

Register before January 12, 2009, 

confirming the effective date of the 

direct final rule. If we receive any 

timely significant adverse comments, 

we will publish a notice of significant 

adverse comment in the Federal 

Register withdrawing this direct final 

rule before February 11, 2009. 


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