Document ID: FDA-2004-P-0205-0006
Agency: fda
Document Type: Rule
Title: Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis
Posted Date: 2008-09-29T04:00Z

[Federal Register: September 29, 2008 (Volume 73, Number 189)]
[Rules and Regulations]               
[Page 56477-56487]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se08-17]                         

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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.

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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

[[Page 56478]]

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 Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  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 Sec.  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

[[Page 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, Sec.  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 Sec.  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 Sec.  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 Sec.  101.72(c)(2)(i)(C) 
because incomplete information is not accurate information.
    (Response) The comment opposing elimination of the requirement in 
Sec.  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, post-menopausal 
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, post-menopausal 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 Sec.  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

[[Page 56480]]

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 non-toxic 
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- observed-
adverse-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 ([mu]g 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 [mu]g per day) is 
well below the 2,000 IU (50 [mu]g 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 Sec.  101.72(c)(2)(i)(E), as proposed.
    (Comment 4) One comment noted that retaining in Sec.  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 Sec.  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 Sec.  
101.72(c)(2)(i)(A) that the claim list sex, race, and age as specific 
risk factors for the development of osteoporosis; (3)

[[Page 56481]]

elimination of the requirement in Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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

[[Page 56482]]

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)
----------------------------------------------------------------------------------------------------------------
                                                                           (2) Non-fat Milk    (3) Low-fat Milk
                      Nutrient                         (1) Orange Juice   (Skim), With Added   (1%), With Added
                                                             Drink             Vitamin A           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
----------------------------------------------------------------------------------------------------------------

[[Page 56483]]

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, [mu]g                                                    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, [mu]g                                                     10                  12                  12
----------------------------------------------------------------------------------------------------------------
Vitamin B-12, [mu]g                                                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 intolerance\1\ 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.
---------------------------------------------------------------------------

    \1\Lactose 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.
---------------------------------------------------------------------------

    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

[[Page 56484]]

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 diet-disease 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 re-
labeling 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              12 Months to Comply, Cost Per Label SKU         24 Months to Comply, Cost Per Label SKU
       NAICS Codes                    Product            -----------------------------------------------------------------------------------------------
                                                             Low Cost        Med Cost        High Cost       Low Cost        Med Cost        High Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
311421                     Fruit Juices                           $7,478         $10,186         $15,282          $5,455          $7,595         $11,897
311411
--------------------------------------------------------------------------------------------------------------------------------------------------------
311514                     Non-fat and Low-fat Milk,             $11,216         $14,086         $20,437          $7,127          $9,236         $14,327
311511                      fluid, dry, powered,
                            condensed, flavored
--------------------------------------------------------------------------------------------------------------------------------------------------------
311513                     Low-fat Cheese, multiple               $6,611          $8,759         $13,758          $5,106          $6,999         $11,489
                            types
--------------------------------------------------------------------------------------------------------------------------------------------------------
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

[[Page 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              Option 4           Option 1
 claims
------------------------------------------------------------------------
Encouraging fortification                    Option 4           Option 1
------------------------------------------------------------------------
Informing consumers                          Option 4           Option 1
------------------------------------------------------------------------
Informing consumers who do not buy           Option 4           Option 1
 dairy products about alternative
 food sources for vitamin D
------------------------------------------------------------------------

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 re-label 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.

[[Page 56486]]

    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. L[aacute]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/lab-flap.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.

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

PART 101--FOOD LABELING

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

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

0
2. Section 101.72 is revised to read as follows:

Sec.  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.

[[Page 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 Sec.  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 Sec.  
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 Sec.  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 well-
balanced 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