Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 34101

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.

2. Letter to Christine Lewis, CFSAN, FDA,

from Eileen Kennedy, USDA, May 7, 1998.

Dated: June 16, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–16456 Filed 6–19–98; 8:45 am]

BILLING CODE 4160–01–F

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.

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 § 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 healthrelated 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
34102 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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

§ 101.72. If a potential claim meets all

of the requirements in § 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

§ 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

§ 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 § 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

§ 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
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 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 § 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 § 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,

§ 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 § 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 § 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 § 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 (§ 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 § 101.72, the

regulation that authorizes use of a

calcium-osteoporosis health claim, yet

the agency finds that the claim is not

consistent with § 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
34104 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N–0424]

Food Labeling: Health Claims;

Chromium and the Risk in Adults of

Hyperglycemia and the Effects of

Glucose Intolerance

AGENCY: Food and Drug Administration,

HHS.

ACTION: Interim final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing an

interim final rule to prohibit the use on

foods of a claim relating to the

relationship between chromium and the

risk in adults of hyperglycemia and the

effects of glucose intolerance. 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 has reviewed statements that the

petitioner submitted in that notification,

and, in conformity with the

requirements of FDAMA, the agency is

prohibiting the claim because the

statements submitted as the basis of the

claim are not ‘‘authoritative statements’’

of a scientific body, as required by

FDAMA; therefore, section 303 of

FDAMA does not authorize use of this

claim. 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; 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)), 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 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

fifth claim in the notification. The

notification included three statements