[Federal Register Volume 63, Number 119 (Monday, June 22, 1998)]
[Rules and Regulations]
[Pages 34101-34104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16457]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 98N-0423]
Food Labeling: Health Claims; Calcium Consumption by Adolescents
and Adults, Bone Density and The Risk of Fractures
AGENCY: Food and Drug Administration, HHS.
ACTION: Interim final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing this interim
final rule to prohibit the use on foods of a claim relating to the
relationship between calcium, bone density, and the risk of fractures.
This interim final rule is in response to a notification of a health
claim submitted under section 303 of the FDA Modernization Act of 1997
(FDAMA). FDA is prohibiting the claim because section 303 of FDAMA does
not apply when FDA has an existing regulation authorizing a health
claim about the relationship between the nutrient and the disease or
health-related condition at issue. A health claim concerning the
relationship between calcium and osteoporosis is already authorized. As
provided for in section 301 of FDAMA, this rule is effective
immediately upon publication.
DATES: The interim final rule is effective June 22, 1998. Submit
written comments by September 8, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Christine J. Lewis, Center for Food
Safety and Applied Nutrition (HFS-451), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-4168.
SUPPLEMENTARY INFORMATION:
I. The FDA Modernization Act of 1997
On November 21, 1997, the President signed FDAMA into law (Pub. L.
105-115), which amended the Federal Food, Drug, and Cosmetic Act (the
act). Sections 303 and 304 of FDAMA amended section 403(r)(2) and
(r)(3) of the act by adding new paragraphs (r)(2)(G), (r)(2)(H),
(r)(3)(C), and (r)(3)(D) to section 403 of the act (21 U.S.C.
343(r)(2)(G), (r)(2)(H), (r)(3)(C), and (r)(3)(D), respectively), which
provide for the use in food labeling of nutrient content claims and
health claims, respectively, based on authoritative statements. FDAMA
requires that a notification of the prospective nutrient content claim
or the prospective health claim be submitted to FDA at least 120 days
before a food bearing the claim may be introduced into interstate
commerce. FDAMA and its requirements are discussed in more detail in a
companion document published elsewhere in this issue of the Federal
Register (see ``Food Labeling: Health Claims; Antioxidant Vitamins C
and E and the Risk in Adults of Atherosclerosis, Coronary Heart
Disease, Certain Cancers, and Cataracts;'' hereinafter referred to as
``Health Claims; Vitamins C and E''). In particular, aspects of the
requirements for an ``authoritative statement'' that are relevant to
this rulemaking and FDA's review process for notifications are
discussed in sections I.A and I.B, respectively, of that document.
II. The Notification
Section 403(r)(2)(G) and (r)(3)(C) of the act became effective on
February 19, 1998. On February 23, 1998, the agency received a
notification from Weider Nutrition International, Inc., containing nine
prospective claims that were identified in the text of the notification
as health claims (Ref. 1). The notification included statements that
the submitter described as authoritative statements and a scientific
literature review for each claim. FDA has created nine separate
dockets, one for each of the nine claims and is issuing a separate
interim final rule responding to each claim.
This interim final rule addresses the fourth claim in the
notification. The notification included five statements that the
petitioner identified as authoritative statements on which the
following claim is based: ``Calcium consumption by adolescents and
adults increases bone density and may decrease the risk of fractures.
Sources of calcium include dairy products, broccoli, spinach, and
dietary supplements.''
As discussed in greater detail in section III of this document, FDA
has determined that the claim in the first sentence addresses the same
relationship as provided for by an existing authorized health claim,
specifically Sec. 101.72 (21 CFR 101.72), ``Health claims: calcium and
osteoporosis.'' The second sentence, ``Sources of calcium include dairy
products, broccoli, spinach, and dietary supplements,'' is not a health
claim. Given that the notification indicated that it was intended to be
a notification for health claims, this statement was not reviewed by
FDA. The submitter did not separately identify this statement as any
particular type of claim.
Nonetheless, as a point of information, the agency wishes to
highlight that statements that appropriately constitute nutrient
content claims are allowed on labels and in the labeling of foods and
dietary supplements. Moreover, statements that constitute dietary
guidance are also allowed provided the information is truthful and not
misleading as required by sections 403(a) and 201(n) (21 U.S.C. 321(n)
of the act. These aspects of nutrient content claims and dietary
guidance are discussed in more detail in ``Health Claims; Vitamins C
and E,'' which is published elsewhere in this issue of the Federal
Register.
III. Basis for the Action
A. Section 303 of FDAMA as it Relates to Existing Authorized Health
Claims
The claim at issue in this rulemaking raises the question of the
relationship of the notification process established in section
403(r)(3)(C) of the act to the health claims authorization process
provided by section 403(r)(4) and (r)(3)(B). In particular, when FDA
has issued a regulation under section 403(r)(3)(B) of the act that
authorizes claims that characterize the relationship of a nutrient to a
disease or health-related condition, may the notification process of
section 403(r)(3)(C) be used to make a health claim about the same
relationship, thereby effectively modifying the claims already
authorized by regulation?
Section 403(r)(3)(C) of the act, as added by section 303 of FDAMA,
provides that a health claim ``which is not authorized by the Secretary
in a regulation promulgated in accordance with [section 403(r)(3)(B)],
shall be authorized and may be made'' if the requirements of section
403(r)(3)(C) of the act are met. When discussing the effect of section
303 of FDAMA, the Senate Report states: ``Once FDA regulations
governing health claims
[[Page 34102]]
concerning a particular diet/disease relationship (e.g., calcium and
osteoporosis) have become effective, no claim concerning that diet/
disease relationship based on the statement of an authoritative
scientific body could be made unless it is consistent with the FDA
regulation'' (S. Rept. 105-43, at 51 (1997)). Therefore, when a claim
about the relationship between a nutrient and a disease or health-
related condition is authorized by a regulation issued under section
403(r)(3)(B) of the act, section 403(r)(3)(C) does not authorize a
claim about that relationship based on an authoritative statement.
Accordingly, the authoritative statement notification process for
health claims under section 403(r)(3)(C) of the act does not apply when
there is an existing regulation issued under section 403(r)(3)(B) of
the act that authorizes claims about the relationship between a
nutrient and a disease or health-related condition. However, such a
health claim can be made without prior notification provided it is
consistent with the existing health claim regulation.
Because of the nature of the health claim regulations issued under
section 403(r)(3)(B) of the act, a health claim that is ``consistent
with'' such a regulation, whether based on an authoritative statement
or not, is authorized by the regulation itself and may be used on an
appropriate food or dietary supplement without prior notification to
FDA. Manufacturers can make health claims that are consistent with an
existing health claim regulation, and use of health claims that are
inconsistent with an existing health claim regulation would misbrand
the product.
FDA's health claim regulations specify: (1) The relationship
between the nutrient and the disease (e.g., calcium and osteoporosis);
(2) the significance of the nutrient (e.g., calcium) in reducing the
risk of the disease (e.g., osteoporosis); (3) the requirements of the
health claim (i.e., information that must be included in the health
claim and information that must not be included in the health claim);
(4) the nature of foods that are permitted to display the health claim
on their labels; and (5) optional information that may be included in
the health claim. The regulations specify the elements that a health
claim must contain, the elements that it may contain, and the elements
that it may not contain; however, they do not specify the exact words
to be used in a claim. Accordingly, claims with different wording may
be consistent with a health claim regulation provided they meet the
requirements of the regulation.
For example, to be consistent with the currently existing
regulations relating to calcium intake and reduced risk of
osteoporosis, a potential health claim must meet all of the
requirements in Sec. 101.72. If a potential claim meets all of the
requirements in Sec. 101.72 (i.e., it includes all required
information, and it does not include prohibited information), then the
health claim is permitted on appropriate foods and dietary supplements
as specified in Sec. 101.72(c)(2)(ii), and prior notification about the
health claim is not required to use it on an appropriate food or
dietary supplement. If the requirements of Sec. 101.72 are not met, the
claim would not be consistent with FDA's regulations for calcium and
osteoporosis health claims, and such a claim would misbrand any food or
dietary supplement on which it appears.
Accordingly, section 303 of FDAMA does not provide for modification
of an existing health claim regulation through submission under section
403(r)(3)(C) of the act of a notification for a health claim based on
an authoritative statement by a scientific body. A party interested in
amending an existing regulation may instead submit a citizen's petition
in accordance with the provisions in 21 CFR 10.30.
B. The Prospective Health Claim is a Calcium-Osteoporosis Health Claim
that is Not Authorized under Section 403(r)(3)(C) of the Act and is Not
Consistent with the Existing Calcium-Osteoporosis Health Claim
Authorized by Sec. 101.72
The first sentence in the prospective health claim as submitted in
the subject notification, ``Calcium consumption by adolescents and
adults increases bone density and may decrease the risk of fractures,''
is a health claim relating to calcium intake and the bone disease,
osteoporosis. The reference to the risk of fractures may relate to a
number of bone diseases, but a review of the five statements identified
in the notification as ``authoritative statements'' clarifies that the
claim refers to the bone disease known as osteoporosis. As specified in
Sec. 101.72, the authorized health claim for calcium intake and the
risk of osteoporosis is based on the importance of reducing fractures
in older persons due to osteoporosis and on the importance of peak bone
mass during critical developmental stages, notably adolescence.
Statement 1 in the notification includes three sentences, the first
of which reads: ``Although the precise relationship of dietary calcium
to osteoporosis has not been elucidated, it appears that higher intakes
of dietary calcium could increase peak bone mass during adolescence and
delay the onset of bone fractures later in life.'' The other two
sentences state: ``Inadequate dietary calcium consumption in the first
three to four decades of life may be associated with increased risk of
osteoporosis in later life,'' and ``[e]vidence shows that chronically
low calcium intake especially during adolescence and early adulthood,
may compromise development of peak bone mass.'' These three sentences
are excerpted from the Summary and Recommendations section of the 1988
Surgeon General's Report on Nutrition and Health. The Summary and
Recommendations section of the report in which these sentences appear
makes no mention of any other type of bone disease except osteoporosis.
Moreover, FDA notes that it included the recommendations from the
report in its own deliberations in authorizing the health claim related
to the relationship between calcium and osteoporosis.
Statement 2 is from a Department of Health and Human Services's
press release from 1997, and states: ``[S]ecretary Shalala noted that
there is a `window of opportunity' during adolescence to increase bone
density through calcium intake. Bones grow and incorporate calcium most
rapidly during the teen years, and establish approximately 90% of adult
mass by age 17.'' The press release describes an educational program
developed by a coalition of government, private sector, and medical
groups. As stated in the press release, the education program ``is
designed to help prevent the next generation from suffering the
devastating consequences of osteoporosis by reaching teens with the
message of the importance of consuming calcium during the teen years.''
The context of this statement therefore makes it clear that the
statement is about reducing the risk for osteoporosis.
Statement 3 is from a 1997 press release from the National Academy
of Sciences, and states: ``Calcium recommendations were set at levels
associated with maximum retention of body calcium, since bones that are
calcium rich are known to be less susceptible to fractures.'' FDA notes
that the sentence that follows this statement reads: ``In addition to
calcium consumption, other factors that are thought to affect bone
retention of calcium and risk of osteoporosis include high rates of
growth in children during specific periods, hormonal status, exercise,
genetics, and other diet components.'' The context of this
[[Page 34103]]
statement therefore makes it clear that the statement is about risk of
fractures due to osteoporosis.
Statement 4 is from a 1997 press release from one of the institutes
of the National Institutes of Health, and states: ``Supplements of
calcium and vitamin D can significantly reduce bone loss and the risk
of fractures in older people, according to a new report from scientists
at Tufts University.'' This statement is the first sentence of the
press release. The second sentence reads: ``The research, the first to
show these supplements can help older men fight osteoporosis, also
demonstrates that the benefits of these low-cost and easily-available
supplements can be maintained over several years.'' The context of this
statement, therefore, makes it clear that the statement is about risk
of fractures due to osteoporosis.
Statement 5 is from a 1991 FDA Consumer article, and states: ``Both
women and men need enough calcium to build peak (maximum) bone mass
during their early years of life. Low calcium intake appears to be one
important factor in the development of osteoporosis.'' This statement
is also clearly about osteoporosis.
Statements 1 and 5 explicitly refer to osteoporosis. Statements 2,
3, and 4 are adjacent to sentences that explicitly refer to
osteoporosis, or, given their context, are about osteoporosis. Given
that these statements are about osteoporosis, the agency concludes that
this claim characterizes the relationship of calcium to osteoporosis.
Claims characterizing the relationship of calcium to osteoporosis
are authorized under Sec. 101.72, which was issued under section
403(r)(3)(B) of the act. As discussed in section III.A of this
document, the prospective claim may be used only if it is consistent
with the provisions of Sec. 101.72, in which case it can be made on the
label or labeling of appropriate foods and dietary supplements.
The prospective health claim, as stated, is not consistent with,
and is therefore not authorized under, Sec. 101.72. FDA reviewed the
prospective health claim that was submitted with this notification--
``Calcium consumption by adolescents and adults increases bone density
and may decrease the risk of fractures''--and determined that at least
one key element required by Sec. 101.72 is not included in the claim.
The submitted claim mischaracterizes the mechanism by which calcium
consumption reduces the risk of osteoporosis. Although calcium
consumption increases bone density in adolescents and young adults, in
older adults it instead reduces bone loss (see Sec. 101.72(a)). In
addition, the term ``risk of fractures'' is synonymous with neither
osteoperosis nor fractures related to osteoperosis. Accordingly, the
claim is not authorized by Sec. 101.72.
In summary, FDA is issuing this interim final rule to prohibit use
under section 403(r)(3)(C) of the act of the claim, ``Calcium
consumption by adolescents and adults increases bone density and may
decrease the risk of fractures,'' because it addresses the same
nutrient-disease relationship provided for in an existing health claim
regulation (Sec. 101.72), and so its use cannot be authorized under
section 403(r)(3)(C) of the act. The claim may be used if it is
consistent with Sec. 101.72, the regulation that authorizes use of a
calcium-osteoporosis health claim, yet the agency finds that the claim
is not consistent with Sec. 101.72. Use of the prospective claim in the
labeling of a product would, accordingly, misbrand the product.
IV. Issuance of an Interim Final Rule, Immediate Effective Date,
and Opportunity for Public Comment
For the reasons described in this section, FDA is issuing this rule
as an interim final rule, effective immediately, with an opportunity
for public comment. New section 403(r)(7)(B) of the act, added by
section 301 of FDAMA, provides that FDA ``may make proposed regulations
issued under [section 403(r)] effective upon publication pending
consideration of public comment and publication of a final regulation''
if the agency ``determines that such action is necessary * * * to
enable [FDA] to act promptly to ban or modify a claim'' under section
403(r) of the act. For purposes of judicial review, ``[s]uch proposed
regulations shall be deemed final agency action.'' The legislative
history indicates that the agency should issue rules under this
authority as interim final rules (H. Conf. Rept. 105-399, at 98
(1997)).
As described in Section III of this document, FDA has determined
that the prospective health claim that is the subject of this
notification is a health claim about the relationship between calcium
and osteoporosis. Because health claims about the relationship between
calcium and osteoporosis are already authorized by regulation issued
under section 403(r)(3)(B) of the act, FDA has determined that the
prospective health claim is not subject to the authoritative statement
procedure provided by section 403(r)(3)(C). FDA has determined that it
is necessary to act promptly to prohibit the claim's use under section
403(r)(3)(C) of the act, and, accordingly, is issuing this interim
final rule to ban its use under section 403(r)(3)(C).
FDA invites public comment on this interim final rule. The agency
will consider modifications to this rule based on comments made during
the comment period. Interested persons may, on or before September 8,
1998, submit to the Dockets Management Branch (address above) written
comments regarding this interim final rule. Comments must be received
by that date. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
V. Environmental Impact
The agency has determined under 21 CFR 25.30(k) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. Analysis of Economic Impacts
A. Benefit-Cost Analysis
FDA has examined the impacts of this interim final rule under
Executive Order 12866. Executive Order 12866 directs Federal agencies
to assess the 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). According to Executive Order 12866, a regulatory action is
``significant'' if it meets any one of a number of specified
conditions, including having an annual effect on the economy of $100
million; adversely affecting in a material way a sector of the economy,
competition, or jobs; or if it raises novel legal or policy issues. FDA
finds that this interim final rule is not a significant regulatory
action as defined by Executive Order 12866. In addition, it has been
determined that this interim final rule is not a major rule for the
purpose of congressional review.
A health claim relating to the association between calcium and
osteoporosis is authorized under existing regulations. Accordingly,
firms can make a claim about calcium and
[[Page 34104]]
osteoporosis provided that the food is eligible for the claim and the
claim is consistent with the current regulations. The prospective claim
relating to the relationship between calcium and bone disease,
specifically, increased bone density and the risk of fractures, is not
consistent with the existing claim, and would misbrand any food on
which it is used. Because firms can highlight the relationship between
calcium and osteoporosis, that this prospective claim would misbrand
foods does not create any lost opportunities for firms. Therefore, this
interim final rule results in neither costs nor benefits.
B. Small Entity Analysis
FDA has examined the impacts of this interim final rule under the
Regulatory Flexibility Act. The Regulatory Flexibility Act (5 U.S.C.
601-612) requires Federal agencies to consider alternatives that would
minimize the economic impact of their regulations on small businesses
and other small entities. In compliance with the Regulatory Flexibility
Act, FDA finds that this interim final rule will not have a significant
impact on a substantial number of small entities.
A health claim relating to the relationship between calcium and
osteoporosis is authorized under existing regulations. This interim
final rule results in no regulatory changes for firms, and therefore,
this interim final rule will not result in a significant increase in
costs to any small entity. Therefore, this interim final rule will not
have a significant economic impact on a substantial number of small
entities. Accordingly, under the Regulatory Flexibility Act (5 U.S.C.
601-612), the agency certifies that this interim final rule will not
have a significant economic impact on a substantial number of small
entities.
C. Unfunded Mandates Reform Act of 1995
FDA has examined the impacts of this interim final rule under the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). This
interim final rule does not trigger the requirement for a written
statement under section 202(a) of the UMRA because it does not impose a
mandate that results in an expenditure of $100 million or more by
State, local, and tribal governments in the aggregate, or by the
private sector, in any 1 year.
VII. The Paperwork Reduction Act of 1995
This interim final rule contains no collections of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.
VIII. Reference
The following reference has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Notification to Donna E. Shalala, DHHS, from Jonathan W.
Emord et al., Emord & Associates, P.C., Counsel for Weider Nutrition
International, Inc., February 23, 1998.
Dated: June 16, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-16457 Filed 6-19-98; 8:45 am]
BILLING CODE 4160-01-F