Food Labeling: Health Claims; Calcium Consumption by Adolescents and Adults, Bone Density and The Risk of Fractures

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]

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