Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules 66205

a deceased person, and it is later

established that:

(i) the claimant was convicted of a

felony or an act in the nature of a felony

for intentionally causing that person’s

death; or

(ii) If the claimant was subject to the

juvenile justice system, he or she was

found by a court of competent

jurisdiction to have intentionally caused

that person’s death by committing an act

which, if committed by an adult, would

have been considered a felony or an act

in the nature of a felony;

(8) The claimant shows that it is to his

or her advantage to select a later annuity

beginning date and refunds, by cash

payment or setoff, past payments

applying to the period prior to the later

beginning date, subject, however, to the

provisions of subpart D of part 217 and

§ 218.9 of this chapter;

(9) The decision is incorrect because

of a failure to apply a reduction, or the

proper reduction, to the tier I

component of an annuity;

(10) Except as is provided in § 261.4

of this part, the decision is incorrect for

any reason and results in entitlement to

an annuity in a case where if the

decision were correct there would be no

entitlement.

(d) Revision of the amount or

payment of a separation allowance lump

sum amount pursuant to section 6(e) of

the Railroad Retirement Act is limited to

60 days from the date of notification of

the award of the separation allowance

lump sum payment.

§ 261.3 Change of legal interpretation or

administrative ruling.

A change of legal interpretation or

administrative ruling upon which a

decision is based does not render a

decision erroneous and does not

provide a basis for reopening.

§ 261.4 Decisions which shall not be

reopened.

The following decisions shall not be

reopened:

(a) An award of an annuity beginning

date to an applicant later found to have

been in compensated service to an

employer under part 202 of this chapter

on that annuity beginning date and who

is found not to be at fault in causing the

erroneous award; provided, however,

that this exception shall not operate to

permit payment of benefits for any

month in which the claimant is found

to be engaged in compensated service.

(b) An award of an annuity based on

a subsequently discovered erroneous

crediting of months of service and

compensation to a claimant where:

(1) The loss of such months of service

and compensation will cause the

applicant to lose his or her eligibility for

an annuity previously awarded;

(2) The erroneously credited months

of service do not exceed six months; and

(3) The annuitant is found not to be

at fault in causing the erroneous

crediting.

(c) An erroneous award of an annuity

where the error is no greater than one

dollar per month per annuity affected.

(d) An erroneous award of a lump

sum or accrued annuity payment where

the error is no greater than $25.00.

§ 261.5 Late completion of timely

investigation.

(a) A decision may be revised after the

applicable time period in § 261.2(a) or

§ 261.2(b) of this part expires if the

Railroad Retirement Board begins an

investigation into whether to revise the

decision before the applicable time

period expires and the agency diligently

pursues the investigation to the

conclusion. The investigation may be

based on a request by a claimant or on

action by the Railroad Retirement

Board.

(b) Diligently pursued for purposes of

this section means that in view of the

facts and circumstances of a particular

case, the necessary action was

undertaken and carried out as promptly

as the circumstances permitted. Diligent

pursuit will be presumed to have been

met if the investigation is concluded

and, if necessary, the decision is revised

within 6 months from the date the

investigation began.

(c) If the investigation is not diligently

pursued to its conclusion, the decision

will be revised if a revision is applicable

and if it is favorable to the claimant. It

will not be revised if it would be

unfavorable to the claimant.

§ 261.6 Notice of revised decision.

(a) When a decision is revised, notice

of the revision will be mailed to the

parties to the decision at their last

known address. The notice will state the

basis for the revised decision and the

effect of the revision. The notice will

also inform the parties of the right to

further review.

(b) If a hearings officer or the threemember Board proposes to revise a

decision, and the revision would be

based only on evidence included in the

record on which the prior decision was

based, all parties will be notified in

writing of the proposed action. If a

revised decision is issued by a hearings

officer, any party may request that it be

reviewed by the three-member Board, or

the three-member Board may review the

decision on its own initiative.

§ 261.7 Effect of revised decision.

A revised decision is binding unless:

(a) The revised decision is

reconsidered or appealed in accord with

part 260 of this chapter;

(b) The three-member Board reviews

the revised decision; or

(c) The revised decision is further

revised consistent with this part.

§ 261.8 Time and place to request review

of a revised decision.

A party to a revised decision may

request, as appropriate, further review

of the decision in accordance with the

rules set forth in part 260 of this

chapter.

§ 261.9 Finality of findings when later

claim is filed on same earnings record.

If two claims for benefits are filed on

the same record of compensation,

findings of fact made in a decision in

the first claim may be revised in

determining or deciding the second

claim, even though the time limit for

revising the findings made in the fist

claim has passed. However, a finding in

connection with a claim that a person

was fully or currently insured at the

time of filing an application, at the time

of death, or any other pertinent time,

may be revised only under the

conditions stated in § 261.2 of this part.

§ 261.10 Increase in future benefits where

time period for reopening has expired.

If, after the time period for reopening

under § 261.2(b) of this part has expired,

new evidence is furnished showing a

different date of birth or new evidence

is furnished which would cause a

correction in a record of compensation

as provided for in part 211 of this

chapter and, as a result of the new

evidence, increased benefits would be

payable, the Board will pay increased

benefits, but only for the months

following the month the new evidence

is received.

§ 261.11 Discretion of the three-member

Board to reopen or not to reopen a final

decision.

In any case in which the threemember Board may deem proper, the

Board may direct that any decision,

which is otherwise subject to reopening

under this part, shall not be reopened or

direct that any decision, which is

otherwise not subject to reopening

under this part, shall be reopened.

Dated: December 14, 1995.

By authority of the Board.

For the Board

Beatrice Ezerski,

Secretary to the Board.

[FR Doc. 95–31059 Filed 12–20–95; 8:45 am]

BILLING CODE 7905–01–M
66206 Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 94P–0390 and 95P–0241]

Food Labeling: Nutrient Content

Claims, General Principles; Health

Claims, General Requirements and

Other Specific Requirements for

Individual Health Claims

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its regulations on nutrient

content claims and health claims to

provide additional flexibility in the use

of these claims on food products. These

changes are intended to benefit public

health by encouraging manufacturers to

use health claims and nutrient content

claims that will assist consumers in

maintaining a healthy diet. The agency’s

current regulations were issued in

January of 1993 to implement the

Nutrition Labeling and Education Act of

1990. This document proposes

refinements to those regulations to

allow additional synonyms for nutrient

content claims without specific

preclearance by the agency, permit

health claims on certain foods that do

not currently qualify because they do

not contain 10 percent of certain

required nutrients, permit the use of

shortened versions of authorized health

claims under certain circumstances,

eliminate some of the required elements

for health claims, and provide

additional guidance for petitioners

seeking exemption from the

disqualification of some foods from

bearing a health claim because they

contain high levels of certain nutrients.

FDA is proposing these amendments in

response to petitions submitted by the

National Food Processors Association

(NFPA) and the American Bakers

Association (ABA).

DATES: Written comments by March 20,

1996. The agency is proposing that any

final rules that may issue based upon

this proposal become effective on the

date of publication.

ADDRESSES: Written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, 301–443–1751.

FOR FURTHER INFORMATION CONTACT: F.

Edward Scarbrough, Center for Food

Safety and Applied Nutrition (HFS–2),

Food and Drug Administration, 200 C

St. SW., Washington, DC 20204, 202–

205–4561.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Nutrition Labeling and

Education Act of 1990

On November 8, 1990, the President

signed into law the Nutrition Labeling

and Education Act of 1990 (the 1990

amendments) (Pub. L. 101–535). This

new law amended the Federal Food,

Drug, and Cosmetic Act (the act) in a

number of important ways. Among the

more notable aspects of the 1990

amendments were that they confirmed

FDA’s authority to regulate nutrient

content and health claims on food labels

and in food labeling.

Section 403(r)(1)(A) of the act (21

U.S.C. 343(r)(1)(A)), which was added

by the 1990 amendments, provides that

a product is misbranded if it bears a

claim that characterizes the level of a

nutrient of the type required to be

included in nutrition labeling unless the

claim uses terms that are defined and

designated in regulations adopted by

FDA and is made in accordance with all

other regulatory requirements.

Similarly, section 403(r)(1)(B) of the act

provides that a product is misbranded if

it bears a claim that characterizes the

relationship of a nutrient to a disease or

health-related condition unless the

claim is made in accordance with the

requirements of the act.

The 1990 amendments instruct the

Secretary of Health and Human Services

(the Secretary) (and, by delegation,

FDA) to issue regulations defining

nutrient content claims that characterize

levels of nutrients in food. The 1990

amendments also instruct the Secretary

(and, by delegation, FDA) to issue

regulations authorizing health claims

only if he or she 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’’ (section 403(r)(3)(B)(i) of the

act).

Section 403(r)(3)(B)(ii) and

(r)(3)(B)(iii) of the act describe the

information that must be included in

any health claim authorized under the

act. The act provides that the claim shall

be an accurate representation of the

significance of the substance in affecting

the disease or health-related condition,

and that it shall enable the public to

comprehend the information and

understand its significance in the

context of the total daily diet. Section

403(r)(4)(A)(i) of the act also provides

that any person may petition FDA to

issue a regulation authorizing a nutrient

content or health claim.

In addition, the 1990 amendments

directed FDA to consider 10 diseasenutrient relationships as possible

subjects for health claims.

B. FDA’s Implementation of the 1990

Amendments

In the Federal Register of January 6,

1993 (58 FR 2066–2941), FDA adopted

final rules that implemented the 1990

amendments to the act. Among those

final rules, § 101.13 sets out general

principles for nutrient content claims

and provides for their use on food

labels. Other regulations in subpart D of

part 101 (21 CFR part 101) establish

specific requirements for nutrient

content claims. These regulations define

specific terms such as ‘‘free,’’ ‘‘low,’’

‘‘good source,’’ ‘‘high,’’ ‘‘reduced,’’ ‘‘less

(or fewer),’’ ‘‘more,’’ and ‘‘light’’ or

‘‘lite,’’ and establish values for these

terms for various nutrients. They also

designate certain synonyms that can be

used in place of these defined terms (58

FR 2302). In addition, § 101.69

establishes procedures for petitioning

the agency to authorize additional

nutrient content claims and provide for

additional synonyms which, if

authorized, will be listed in the relevant

regulations (§ 101.69) (e.g., ‘‘extra’’ as a

synonym for ‘‘more’’).

FDA also adopted final rules that

implemented the health claims

provisions of the act (58 FR 2478).

Section 101.14 establishes general

principles for health claims. This

regulation prescribes the circumstances

in which a substance is eligible to be the

subject of a health claim (§ 101.14(b)),

sets forth the standard in section

403(r)(3)(B)(i) of the act as the standard

that the agency will apply in deciding

whether to authorize a claim about a

substance-disease relationship

(101.14(c)), sets forth general rules on

how authorized claims are to be made

in food labeling (§ 101.14(d)), and

establishes limitations on the

circumstances in which claims can be

made (§ 101.14(e)). The agency also

adopted § 101.70, which established a

process for petitioning the agency to

authorize health claims about a

substance-disease relationship

(§ 101.70(a)) and sets out the types of

information that any such petition must

include (§ 101.70(f)).

At the same time, the agency

announced its decisions regarding

health claims on the 10 disease-nutrient
Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules 66207

relationships specified in the 1990

amendments. Of the 10, FDA authorized

health claims for calcium and

osteoporosis (58 FR 2665); dietary lipids

and cancer (58 FR 2787); sodium and

hypertension (58 FR 2820); dietary

saturated fat and cholesterol and risk of

coronary heart disease (58 FR 2739);

fiber-containing grain products, fruits,

and vegetables and cancer (58 FR 2537);

fruits, vegetables, and grain products

that contain fiber, particularly soluble

fiber, and risk of coronary heart disease

(58 FR 2552); and fruits and vegetables

and cancer (58 FR 2622). The

regulations on general requirements for

health claims and on the claims

specified above became effective May 8,

1993.

In the Federal Register of January 6,

1993 (58 FR 2066), FDA also issued

‘‘Food Labeling Regulations

Implementing the Nutrition Labeling

and Education Act of 1990; Opportunity

for Comments,’’ (the implementation

final rule). The implementation final

rule provided 30 days for interested

persons to comment on technical issues

arising in any of the final rules

implementing the 1990 amendments. In

the Federal Register of August 18, 1993

(58 FR 44020 to 44096), FDA published

technical amendments to the final rules

in response to the comments it received.

In the Federal Register of October 14,

1993 (58 FR 53254), FDA proposed to

authorize the use of a health claim about

the relationship between folate and the

risk of neural tube defects on the labels

or in labeling of foods in conventional

food form and dietary supplements.

This action was in response to

provisions of the 1990 amendments and

the Dietary Supplement Act of 1992

(Pub. L. 102–571). In the Federal

Register of January 4, 1994 (59 FR 395),

FDA announced that the proposed

regulation to authorize use of the health

claim about the association between

folate and neural tube defects in food

labeling was considered a final

regulation for dietary supplements of

vitamins, minerals, herbs, and other

similar nutritional substances.

II. The Petition of the National Food

Processors Association

The National Food Processors

Association (NFPA) submitted a citizen

petition dated October 25, 1994,

requesting initiation of rulemaking for

the adoption of amendments to the

regulations governing nutrient content

and health claims. This petition was

assigned FDA Docket No. 94P–0390.

For nutrient content claims, NFPA

requested specific amendments to

§§ 101.13 and 101.65 allowing use of

synonyms and implied nutrient content

claims, without FDA preclearance, that

are understood by consumers to have

the same meaning as a defined term,

where such claims are made in

accordance with the requirements for

the defined term, and the defined term

also appears in the product’s labeling.

NFPA also requested several

amendments to the health claim

regulations. Among other changes,

NFPA requested that FDA permit the

use of an abbreviated or implied health

claim with a referral statement directing

consumers to the complete claim

elsewhere in labeling. Currently, all

required information must appear in

one place without other intervening

material.

It also requested that health claims be

permitted for foods with levels of

nutrients that FDA had determined

increase the risk of other diseases to the

general population. Among the general

requirements for health claims, FDA

established in § 101.14(a)(5) levels of

total fat, saturated fat, cholesterol, and

sodium in a food above which the food

is disqualified from making a health

claim. These are identified as

‘‘disqualifying nutrient levels.’’ In its

petition, NFPA suggested that FDA

amend the regulation so that a food with

a nutrient at a disqualifying level would

be prohibited from making a health

claim only if the nutrient is directly and

adversely associated with the disease to

which the claim refers. Absent such an

association, NFPA requested that the

presence of a nutrient above a threshold

level not disqualify a product from

bearing a health claim but instead

require disclosure of that fact in

labeling.

Finally, NFPA requested an

amendment to § 101.14(e)(6), which

prohibits a food in conventional food

form from bearing a health claim unless

the food contains 10 percent or more of

the Reference Daily Intake or Daily

Reference Value for vitamin A, vitamin

C, iron, calcium, protein, or fiber per

reference amount customarily

consumed before any nutrient addition

(the ‘‘10 percent nutrient contribution

requirement’’). NFPA requested that this

prohibition be replaced by a

requirement that any food bearing a

health claim that refers to an added

nutrient disclose the fact of that nutrient

addition in labeling.

FDA issued a letter on May 11, 1995,

granting most of the requests to initiate

rulemaking on the foregoing aspects of

the petition (hereinafter referred to as

the May 11, 1995, letter). However, the

agency denied certain aspects of NFPA’s

petition, including NFPA’s request that

FDA change the levels in § 101.14(a)(5)

from disqualification levels to

disclosure levels. Although the agency

recognized that it has the authority

under section 403(r)(3)(A)(ii) of the act

to exempt any claim from the

disqualifying nutrient levels if it finds

that the claim would ‘‘assist consumers

in maintaining healthy dietary

practices,’’ the agency concluded that a

generic change in its regulations would

not be consistent with the underlying

goals of the NLEA.

FDA acknowledged, however, that

disclosure rather than disqualification

may be appropriate under certain

circumstances. The agency said it will

seek more limited criteria to define the

conditions under which disclosure

rather than disqualification could be

permitted.

III. The Petition of the American Bakers

Association

A citizen petition, dated July 27,

1995, was submitted to FDA by the ABA

(Docket No. 95P–0241/CP 1), requesting

that FDA amend, among other things,

the regulatory provision in

§ 101.14(e)(6) to permit enriched cerealgrain products that conform to the

standards of identity in part 136, 137, or

139 (21 CFR part 136, 137, or 139), and

bread that conforms to the standard of

identity for enriched bread in § 136.115,

except that it contains whole wheat or

other grain products not permitted

under that standard, to bear health

claims. The petition specifically

requested that FDA amend

§ 101.14(e)(6) to read:

Except for dietary supplements, enriched

grain products that conform to a standard of

identity in part 136, 137, or 139, and bread

that conforms to the standard of identity for

enriched bread in § 136.115, except that it

contains whole wheat or other grain products

not permitted under that standard, or where

provided for in other regulations in part 101,

subpart E.

In the alternative, ABA suggested that

the agency expand the list of qualifying

nutrients to include complex

carbohydrates, niacin, or thiamin or

allow the 10 percent nutrient

contribution requirement to apply to all

foods for which the summation of the

Daily Value of the applicable nutrients

is 10 percent rather than requiring that

the 10 percent be based on a single

serving.

Because of the similarities in the

NFPA and ABA petitions regarding the

10 percent nutrient contribution and

health claims, FDA is responding to part

of the ABA petition in this document,

which implements FDA’s May 11, 1995,

letter response to the NFPA petition.

Other issues raised in the ABA petition

will be handled separately.
66208 Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules

IV. The Proposals

As the petitioners have requested, the

agency is reconsidering its position on

several of the issues raised in the NFPA

and ABA petitions. The agency is well

within its legal authority to reconsider

the issues in the NFPA petition and

propose changes to the current food

labeling regulations. ‘‘An agency may

always change its mind and alter its

policies.’’ (See Conference of State Bank

Examiners v. Office of Thrift

Supervision, 792 F. Supp. 837, 845

(D.D.C. 1992)). While the burden is on

the agency to justify the change from the

status quo, that justification need not

consist of an affirmative demonstration

that the status quo is wrong. The agency

need only supply ‘‘a reasoned analysis

for the change.’’ (See Center for Auto

Safety v. Peck, 751 F.2d 1336, 1349

(D.C. Cir 1985) (citing Motor Vehicle

Mfrs. Ass’n v. State Farm Mutual, 463

U.S. 29, 41, 103 S.Ct. 2856, 2865–2866

(1983))). The agency can justify its

departure from past policy ‘‘with

reference to the objectives underlying

statutory scheme it purports to

construe.’’ (See Simmons v. I.C.C., 829

F.2d 150, 156 (D.C. 1987)).

One of the primary purposes of the

1990 amendments was to educate

consumers about healthful dietary

practices. The legislative history states,

‘‘Health claims supported by significant

scientific agreement can reinforce the

Surgeon General’s recommendations

and help Americans to maintain a

balanced and healthful diet’’ (Ref. 1).

If the current regulations hinder food

companies who want to use one of the

FDA-authorized claims, as NFPA has

alleged, this public health objective will

be frustrated. As the agency has stated,

if valid health claims are not being used,

‘‘there is a cost imposed on society in

that some valuable information may not

be conveyed to consumers’’ (58 FR 2927

at 2940). Consumers cannot change their

dietary practices if they do not have the

necessary information.

The agency is pleased that many food

companies are using the health claims

on the labels of their products. While

the agency has not done an extensive

survey, FDA notes that dozens of health

claims have appeared on products such

as cereal, cookies, frozen dessert bars,

egg products, and frozen vegetables.

Nonetheless, the agency is concerned

that health claims are not being used as

extensively as they could be, despite the

fact that many foods qualify for such

claims.

FDA also notes that food companies

are submitting petitions seeking

approval of new claims. Since the final

regulations have been published, the

agency has received two such petitions,

one regarding sugar alcohols and dental

caries and one regarding oat products

and coronary heart disease. A proposed

regulation to authorize a health claim

regarding sugar alcohols and dental

caries was published in the Federal

Register on July 20, 1995 (60 FR 37502)

(hereinafter referred to as the sugar

alcohols proposal). The agency expects

to complete in the very near future its

evaluation of the petition regarding oat

products and coronary heart disease.

Accordingly, the agency is proposing

changes to the regulations regarding the

use of synonyms for nutrient content

claims, the 10 percent nutrient

contribution requirement for health

claims, the use of abbreviated health

claims, the specific requirements for

individual health claims, and

disqualifying levels for health claims to

facilitate additional use of these claims.

A. Synonyms in Nutrient Content

Claims

Section 403(r)(1)(A) and (r)(2) of the

act state that claims that either expressly

or by implication characterize the level

of a nutrient (nutrient content claims)

may be made in the label or labeling of

a food only if the characterization of the

level made in the claim uses terms that

are defined in regulations of the agency.

Based on these provisions, the agency

has defined expressed claims as any

direct statement about the level (or

range) of a nutrient in the food

(§ 101.13(b)(1)). In addition, it has

defined implied claims as nutrient

content claims that describe the food or

an ingredient therein in a manner that

suggests that a nutrient is absent or

present in a certain amount (e.g., ‘‘high

in oat bran’’) (§ 101.13(b)(2)(i)) or that

suggests that the food, because of its

nutrient content, may be useful in

maintaining healthy dietary practices

and is made in association with an

expressed claim or statement about a

nutrient (e.g., ‘‘healthy, contains 3

grams of fat’’) (§ 101.13(b)(2)(ii)).

The agency has specifically defined a

number of expressed nutrient content

claims (‘‘free,’’ ‘‘low,’’ ‘‘reduced,’’

‘‘light,’’ ‘‘good source,’’ ‘‘high,’’ and

‘‘more’’) and provided for their

synonyms, e.g., ‘‘no,’’ ‘‘little,’’

‘‘contains,’’ and ‘‘rich in.’’ The agency

also provided for certain implied

nutrient content claims (§ 101.65(c) and

(d)). Finally, the agency has defined the

implied nutrient content claim

‘‘healthy’’ (§ 101.65(d)(2)).

The agency considered the use of

additional synonyms for the defined

terms in the 1993 nutrient content

claims final rule (58 FR 2302 at 2320).

At that time the agency provided for a

limited number of specific synonyms

and declined to provide for either long

lists of synonyms or conditions for use

of unevaluated terms. The agency

concluded that permitting additional

synonyms to be used in conjunction

with either a defined claim or a

disclosure statement explaining the

synonym’s intended meaning would not

assist consumers in maintaining healthy

dietary practices (58 FR 2302 at 2320).

The agency stated that there is no

provision in the act that allows for the

use of undefined synonyms in the

absence of action by the agency.

Because of time constraints, in

developing the final regulations FDA

was unable to fully study the suggested

schemes for use of terms without

preclearance to determine whether a

scheme could be devised that would

constitute approval by the agency

without preclearance of each term.

The agency also considered but

rejected (58 FR 2302 at 2373) the

suggestion that implied claims that are

defined on the label be permitted. The

agency did provide for certain implied

claims on products that meet the

definition for certain expressed claims

and gave specific examples of some of

these claims in the preamble (58 FR

2302 at 2374) and in the regulations

(§ 101.65(c)(3)) (e.g., ‘‘high in oat bran’’

for foods that are a good source of fiber;

‘‘no oil’’ for fat free foods).

In the October 25, 1994, petition, as

stated above, NFPA requested that the

agency reconsider allowing synonyms

and implied nutrient content claims to

be used without FDA preclearance

under certain circumstances. NFPA

maintained that FDA’s strict

interpretation and application of the

1990 amendments totally frustrated the

achievement of the various statutory

goals of improving consumer education

about diet and health and thereby

reducing the incidence of diet-related

diseases.

NFPA argued that, because the

regulations sharply limit the

terminology that can be used to make

nutrient content claims for food

products and require ‘‘premarket

clearance’’ of terminology that FDA has

not specifically authorized by

regulation, the regulations ban a host of

truthful and nonmisleading labeling

statements. The petitioner requested

that FDA propose amendments that

would permit nonmisleading terms or

statements that are reasonably

understood by consumers to be

synonyms of a term defined in subpart

D of part 101 to be used in product

labeling when the defined term also is

used in the labeling. Requesting similar

amendments for implied claims, NFPA
Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules 66209

stated that such amendments would

ensure that claims characterizing the

level of a nutrient in a food are truthful

and nonmisleading but would give

manufacturers greater freedom to

construct such labeling messages

creatively.

In its May 11, 1995, response, FDA

recognized that there may be some merit

to the argument that more latitude in the

use of truthful, nonmisleading nutrient

content claims may assist consumers in

maintaining healthy dietary practices

because greater flexibility would

provide the food industry with an

increased incentive to develop more

healthful products. Permitting

synonyms for defined terms to be used

on product labels without specific

authorization for the particular

synonyms has the potential to provide

the industry with a greater variety of

ways to convey nutrient information to

the consumer because the nutrient

content claims on the label would not

be restricted to a finite list of terms that

can only be expanded by filing an

appropriate petition. This approach

could facilitate the industry’s efforts to

arrive at terms that not only

appropriately describe the nutrient level

in a food but also effectively catch the

attention of the consumer.

In its May 11, 1995, letter, the agency

noted that while a plethora of

uncontrolled terms would confuse

consumers by diminishing the

usefulness of clearly defined and

limited terms, NFPA’s ‘‘anchoring’’

concept, if properly implemented, could

offer the possibility of increasing the

available terms without confusing

consumers. The agency stated that it

was granting NFPA’s petition to initiate

rulemaking on the use of additional

synonyms anchored to specifically

authorized terms.

Consequently, the agency is proposing

to add new paragraph (r) to § 101.13,

which provides that synonyms may be

used in labeling in accordance with one

of two provisions. First, proposed

§ 101.13(r)(1) reflects the fact that a term

may be used as a synonym when the

agency has specifically listed it as a

synonym for a defined term in one of

the regulations listing authorized

nutrient content claims in subpart D of

part 101 (‘‘listed synonym’’). FDA

included a number of synonyms in the

regulation that it adopted as part of the

1993 nutrient content claims final rule.

It has also adopted synonyms as a result

of a petition filed in accordance with

§ 101.69(n). Additional synonyms may

be added to FDA’s regulations following

this procedure. Second, FDA is

proposing in § 101.13(r)(2) to authorize

the use of synonyms that are not

specifically listed by name in the

regulations in subpart D of part 101, part

105, or part 107 (21 CFR part 105 or part

107) (‘‘unlisted synonyms’’) but are used

in labeling in accordance with the

labeling requirements set out in this

provision.

Specifically, in § 101.13(r)(2), the

agency is proposing a number of

requirements to ensure that the use of

unlisted synonyms will not confuse or

mislead consumers. In particular, FDA

is proposing in § 101.13(r)(2)(i) to

require that an unlisted term be

reasonably understood by consumers to

be a synonym of a term defined in

subpart D of part 101, part 105, or part

107. Such an understanding is necessary

because the agency has, for example,

defined the terms ‘‘high’’ and ‘‘good

source’’ to represent two different levels

of a nutrient.

Consumers can reasonably be

expected to understand that ‘‘without

any [nutrient]’’ is the same as ‘‘free of

[nutrient],’’ and that ‘‘not much’’ of a

nutrient is, in common usage,

synonymous with ‘‘low’’ for that

nutrient since ‘‘not much’’ implies that

some but not a lot of the nutrient is

present. Other ‘‘synonyms’’ however,

may not be so clear. It is important,

therefore, that the use of unlisted

synonyms that FDA is proposing to

authorize under § 101.13(r)(2) be clear

and unambiguous to consumers

regarding the levels to which they

apply. Without such clarity, consumers

may be confused as to the nutrient

content of the food bearing the claim.

Thus, regardless of the prominent use of

a listed term or other explanatory

information discussed below, terms that

are not clearly understood by consumers

to be synonymous with specific listed

terms may still be misleading and

misbrand the food under both section

403(a) and section 403(r)(1)(A) of the

act.

Further, the agency is concerned that

different manufacturers might use the

same term but anchor it to different

nutrient content claims. For example

‘‘plenty of fiber’’ might be anchored to

‘‘good source’’ on one product label and

‘‘high’’ on another. In this event, the

agency reserves the right to call for

petitions to define the term by

regulation or to define the term on its

own initiative.

The agency agrees with NFPA that, in

addition to considering the words of the

individual claim, it is important to

consider the meaning of the unlisted

synonym in the context of the entire

product label. It is possible, for instance,

that other statements such as other

nutrient content claims on the label or

in labeling could establish a context in

which the unlisted synonym would be

misleading. Section 403(a) of the act

states that a food is misbranded if it

bears any labeling statement that is false

or misleading in any particular.

Therefore, proposed § 101.13(r)(2)(i)

requires that the unlisted synonym not

be misleading in the context of the

entire label.

The agency seeks comments as to

whether further requirements should be

imposed to ensure that an unlisted term

is truly synonymous with a listed term.

For example, FDA seeks comments as to

whether it should require companies to

have data in their files demonstrating

that consumers understand the unlisted

term to be synonymous with the listed

term in question as a condition for the

use of the unlisted terms. In addition,

the agency seeks comments on why, if

it includes such a requirement, it should

not also require that such data be

available for review by regulatory

officials.

As stated above, for any term used as

a synonym authorized under proposed

§ 101.13(r)(2) not to be misleading, the

defined term for which it purports to be

a synonym would have to be clear to the

consumer. Proposed § 101.13(r)(2)(ii)(A)

will require that the listed term appear

prominently and conspicuously on the

label.

Proposed § 101.13(r)(2)(ii)(A)(1)

requires the listed term appear

immediately adjacent to (with no

intervening material) the most

prominent (as defined in

§ 101.13(j)(2)(iii)) use of the unlisted

synonym. The agency tentatively

concludes that having a listed term

immediately adjacent to the most

prominent use of each such unlisted

synonym will help to ensure that

consumers understand the claim that is

being made and thus to ascertain the

level of the nutrient that the food

purports to contain.

The agency tentatively concludes that

it is not sufficient for the listed term to

appear anywhere on the label, as

suggested in the NFPA petition. Such a

scheme would not guarantee that the

unlisted synonym is read in conjunction

with a listed term and would hinder the

consumer from ascertaining the level of

the nutrient that the food purports to

have. For example, with such a

provision, the unlisted synonym

authorized under § 101.13(r)(2) could be

very large and prominent, and the listed

term could be a part of the fine print

(i.e., in small print that is in sentence or

paragraph form elsewhere on the label).

Although such defining information

may be read by consumers at some

point, it would be unlikely to be fully

read and comprehended at the same
66210 Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules

time as the unlisted term and thus

would not make clear to the consumer

that the two statements are

synonymous.

The agency’s proposal is consistent

with section 403(f) of the act which

deems a food to be misbranded if any

word, statement, or other information

required by the act to appear on the

label or labeling is not prominently

placed with such conspicuousness (as

compared with other words, statements,

designs, or devices, in the labeling) and

in such terms as to render it likely to be

read and understood by the ordinary

individual under customary conditions

of purchase and use. Section 403(f) of

the act necessitates placement of the

listed term on the label so that it is

likely to be read and understood, and

thereby to eliminate any ambiguity as to

the meaning of the unlisted synonym.

Allowing the listed term to be anywhere

on the label that the manufacturer

chooses would not ensure that this

requirement is met.

There are a number of precedents for

requiring clarifying information in

labeling to be adjacent to the text that

it clarifies. For example, § 101.3(e)

requires that the word ‘‘imitation’’

precede the name of the food imitated;

the term ‘‘artificial’’ is required by

§ 101.22(i)(1)(i), (i)(1)(ii), and (i)(3) to be

adjacent to the name of the flavor; and

§ 102.5(b)(2) (21 CFR 102.5(b)(2))

requires that if the percentage of a

characterizing ingredient is required to

be included in the common or usual

name of the food, it must be adjacent to

the name of the food. Further, several

aspects of the nutrient content claims

regulations require that clarifying

statements such as the referral

statement, ‘‘See [side] panel for

nutrition information’’ (§ 101.13(g)); the

disclosure statement, ‘‘See [side] panel

for information about [sodium] and

other nutrients’’ (§ 101.13(h)); the

percentage reduction and identity of the

reference food for a relative claim

(§ 101.14(j)(2)(ii)); and other clarifying

information about the food in relation to

the claim, e.g., § 101.13(i)(2) and (p)(2),

be immediately adjacent to the claim to

which the statement pertains.

As with accompanying information

for relative claims (i.e., percent

reduction in the nutrient and identity of

the reference food (§ 101.13(j)(2)(i)

through (j)(2)(iii)), the agency considers

the presence of a listed term to be

necessary to ensure that the claim is

understood by, and is not misleading to,

consumers. However, as with

accompanying information, it

recognizes that to require that this

information be included each time an

unlisted synonym is used may

overburden the label. Consequently, as

with relative claims, the agency is

proposing to require only that the

defined term or listed synonym be

placed immediately adjacent to the most

prominent declaration of each unlisted

synonym. Because of the similar

purposes of the two requirements, the

agency believes that the provisions in

§ 101.1(j)(2)(iii) for determining the

order of prominence of relative claims

are also appropriate for determining the

order of prominence of presentations of

an unlisted synonym. The order of

prominence for relative claims is: (1) A

claim on the principal display panel

adjacent to the statement of identity, (2)

a claim elsewhere on the principal

display panel, (3) a claim on the

information panel, or (4) a claim

elsewhere on the label or labeling.

The agency is proposing in

§ 101.13(r)(2)(ii)(A)(2) that the listed

term be at least half as prominent as the

unlisted synonym. If it adopts these

changes, FDA will evaluate prominence

using type size, style, and color. In the

past, FDA has required certain clarifying

information to be in type at least half

the size of that of the statement it is

clarifying. For example, when the term

‘‘light’’ is used to describe a physical or

organoleptic property of a food (e.g.,

‘‘light in color’’), the clarifying

information ‘‘in color’’ is required to be

at least half the type size as the word

‘‘light’’ (§ 101.56(e)(2)). Similarly, when

the term ‘‘light’’ is used on a meal type

product to describe a nutrient reduction,

a clarifying statement as to whether the

food is ‘‘low in calories’’ or ‘‘low in fat’’

is required and must be at least half the

size of the term ‘‘light’’

(§ 101.56(d)(1)(ii)). Further, § 102.5

requires that the percentage declaration

of a characterizing ingredient or

component be no less than half the

height of the largest type appearing in

the common or usual name when it has

a material bearing on the nature of the

product. Further, this information must

appear in bold-faced type. As a final

example, § 101.13(f) requires that any

nutrient content claim not be more than

two times larger than, and not unduly

prominent in type style compared to,

the statement of identity. All of these

provisions are examples of requirements

where clarifying information must be at

least half as large or prominent as the

statement that it is clarifying.

FDA is proposing section

101.13(r)(2)(ii)(A)(1) and (r)(2)(ii)(A)(2)

to ensure that the combination of

unlisted and listed terms that appear on

a food label are understood by

consumers to be making a single claim.

This understanding is crucial because

the act requires that a nutrient content

claim be made ‘‘only if the

characterization of the level made in the

claim uses terms which are defined in

regulations * * *.’’ (Section

403(r)(2)(A)(i) of the act (emphasis

added).) In its petition, NFPA argues

that there is nothing in the act that

defines a claim to mean individual label

statements—as opposed to the overall

message conveyed by labeling for a

product. The petition stated that, in

NFPA’s view, a ‘‘claim’’ is properly

viewed under the statute as referring to

the message about the level of a

particular nutrient in the food conveyed

in the context of the entire product

labeling. NFPA maintained that, while

the labeling should include terms

defined by FDA, other synonyms or

implied statements concerning the

nutrient should be viewed as

components of the single labeling claim.

FDA tentatively concludes that the use

of unlisted synonyms in the manner

proposed will ensure that consumers

understand them to be part of a single

nutrient content claim that uses terms

defined by regulation. As stated in its

May 11, 1995, letter to NFPA, however,

the agency cannot finalize this rule

unless it receives evidence

demonstrating that consumers

understand the terms used in this way.

FDA also recognizes that there may be

some labels on which the listed term is

significantly more prominent than an

unlisted synonym. This would be the

case, for example, if the listed term was

made in a ‘‘burst’’ or in the statement of

identity and the unlisted synonym was

used in a paragraph in smaller sized

type. Such usage might occur if a

manufacturer wanted to use a variety of

ways to express the level of a nutrient

in a discussion about the food. The

agency tentatively finds that, in this

case, the level of the nutrient described

by the listed term would be clearly

understood, and additional clarification

next to the smaller print on the same

label would not be necessary. Therefore,

FDA is proposing in § 101.13(r)(2)(ii)(B)

that if the listed term is more than twice

as prominent on a label as the listed

synonym, such that the claimed nutrient

level is clearly understood, e.g., a bold

faced listed term versus an unlisted

synonym used only in a paragraph in

smaller sized type, the listed need not

be placed adjacent to the unlisted

synonym. The agency requests comment

on whether this approach is consistent

with a nonmisleading label.

The agency is also providing in

proposed § 101.13(r)(2)(iv) that a listed

term may not be used with an unlisted

synonym to form a new term, e.g., extra

low, extra high, especially good source,

or great source. In its review of food
Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules 66211

labels before the passage of the 1990

amendments, the Institute of Medicine

(IOM) stated that consumers were

confused by the plethora of terms on

food labels and recommended that

definitions of nutrient levels for label

claims be severely restricted (Ref. 2).

The IOM recommended that four levels

be defined for explicit claims: Low, very

low, high and very high or their

equivalents. The agency has essentially

done just that in defining, ‘‘low,’’ ‘‘free,’’

‘‘good source’’ and ‘‘high.’’ With the use

of unlisted synonyms, the agency is

concerned that there may be instances

when the use of unapproved modifiers

for these terms (e.g., ‘‘extra low,’’ ‘‘extra

high,’’ ‘‘especially good source,’’ ‘‘great

source’’) would confuse consumers by

unjustifiably suggesting that there is a

distinction between the listed term with

and without the modifier. To avoid this

confusion, the agency tentatively

concludes that it is necessary to prohibit

the use of claims that consist of a term

that modifies an existing listed term.

In the course of developing the

definitions and other requirements for

the use of nutrient content claims, the

agency made a diligent effort to

determine the various meanings and

requirements of the nutrient content

claims it defined. In some cases the

agency determined that, in order for the

label not to be misleading, it was

necessary for certain additional

information to be conveyed to

consumers along with the claim. This

information included referral or

disclosure statements (required by the

statute), additional label statements

such as accompanying information for

foods bearing relative claims

(§ 101.13(j)(2)), and other statements

such as ‘‘not a sodium free food’’ on a

food bearing an ‘‘unsalted’’ claim that

was not ‘‘sodium free’’

(§ 101.61(c)(2)(iii)). Just as this

information is necessary for a listed

term not to be misleading and for a label

bearing such a claim to provide full and

relevant information to the consumer,

the agency tentatively concludes that

such additional information is equally

important and necessary when unlisted

synonyms are used. Consequently, the

agency is proposing in § 101.13(r)(2)(iii)

to require that unlisted synonyms be

used in conformance with all of the

requirements for the use of the listed

terms.

The petitioners also requested that the

agency permit the use of unlisted

synonyms with implied claims such as

terms, statements, or symbols. As with

unlisted synonyms, FDA tentatively

finds that this concept may have some

merit. However, the agency points out

that implied claims that are consistent

with a listed term may currently be used

on a label. Therefore, the agency is not

proposing further provisions for the use

of implied nutrient content claims.

B. Section 101.14(e)(6): The 10 Percent

Nutrient Contribution Requirement

In the Federal Register of January 6,

1993, FDA published a final rule

entitled ‘‘Food Labeling: General

Requirements for Health Claims for

Food’’ (58 FR 2478) (hereinafter referred

to as the 1993 health claims final rule).

Among other things, this rule requires

that, to be eligible to bear a health claim,

a food other than a dietary supplement

contain 10 percent or more of the Daily

Value (DV) for vitamin A, vitamin C,

iron, calcium, protein, or fiber, before

any nutrient addition (§ 101.14(e)(6)).

As explained in that document, FDA

concluded that such a requirement was

necessary to assure that the value of

health claims would not be trivialized

or compromised by their use on foods

of little or no nutritional value.

Furthermore, such a requirement

responded to Congress’s intent that

health claim provisions consider the

role of the nutrients in food in a way

that will enhance the chances of

consumers constructing total daily diets

that meet dietary guidelines. Thus,

foods bearing health claims should be

consistent with current dietary

guidelines. Furthermore, the agency

concluded that fortification of foods of

little or no nutritional value for the sole

purpose of qualifying that food for a

health claim is misleading, especially if

foods such as confections, soda, and

sweet desserts are fortified to qualify for

a health claim, because such foods have

been cited in dietary guidance as those

that should be used sparingly.

In the Federal Register of August 18,

1993 (58 FR 44036), FDA published

technical amendments to the health

claim regulations in response to

comments that the agency received on

the implementation final rule

(hereinafter referred to as the 1993

health claims technical amendment).

One of the comments stated that if a

health claim petition were submitted for

the claim ‘‘useful only in not promoting

tooth decay,’’ virtually none of the

sugar-free products on the market would

be eligible to bear the claim because of

the 10 percent nutrient contribution

requirement.

In the 1993 health claims technical

amendments, FDA acknowledged that

certain food products of limited

nutritional value that have been

specially formulated relative to a

specific disease condition, such as

dental caries, may be determined to be

appropriate foods to bear a health claim.

The agency commented that its

intention was to deal with such

situations within the regulations

authorizing specific health claims.

Therefore, FDA amended § 101.14(e)(6)

to state that:

Except for dietary supplements not in

conventional food form or where provided

for in other regulations in part 101, subpart

E, the food contains 10 percent or more of the

Reference Daily Intake or Daily Reference

Value for vitamin A, vitamin C, iron,

calcium, protein, or fiber per reference

amount customarily consumed prior to any

nutrient addition.

The terminology ‘‘not in conventional

food form’’ was subsequently deleted in

the final rules pertaining to health

claims for dietary supplements

published in the Federal Register on

January 4, 1994 (59 FR 395).

The sugar alcohols proposal proposes

such an exemption from the 10 percent

nutrient contribution requirement.

Following publication of the health

claims final rule, two trade

associations—NFPA and the ABA—

submitted petitions to FDA requesting

that the agency revise the general

requirements for health claims and

reconsider its decision regarding the 10

percent nutrient contribution

requirement. The NFPA petition argued

that the 10 percent nutrient contribution

requirement precludes truthful,

nonmisleading health claims because it

sets an arbitrary nutritional contribution

a food must make to the diet to qualify

for any claim. Consequently, NFPA

argued, the 10 percent nutrient

contribution requirement prohibits

some common fruits, vegetables, and

other wholesome and nutritious foods

from making health claims. While NFPA

agreed that a food bearing a health claim

should contain levels of the nutrient

consistent with the health claim, it

contended that the lack of significant

levels of other nutrients should not

prevent a food from bearing a health

claim. NFPA argued that if other

nutrient levels are deemed to be

material with respect to consumers’

understanding of a health claim, then

such levels should be disclosed in the

Nutrition Facts panel.

Furthermore, NFPA contended that

the 1993 health claims final rule

precludes truthful, nonmisleading

claims because it prohibits a food from

satisfying the 10 percent nutrient

contribution requirement through

fortification. NFPA stressed that even

though fortification of a food to support

a health claim is material information

that should be disclosed in labeling,

added and indigenous nutrients are

equally nutritious, and, therefore,
66212 Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules

prohibiting fortified foods from bearing

a health claim is not justified.

NFPA requested that FDA amend

§ 101.14(e) by revoking the requirement

that foods bearing a health claim

contain 10 percent of the DV of vitamin

A, vitamin C, calcium, protein, iron, or

fiber before any nutrient addition, so

that fruits, vegetables, and other

nutritious foods could bear health

claims.

The ABA petition did not request that

the agency revoke the 10 percent

nutrient contribution requirement.

Rather, it requested that FDA modify the

10 percent nutrient contribution

requirement to permit health claims on

certain enriched grain products. ABA

contended that while some enriched

breads might meet the 10 percent

nutrient contribution requirement for

fiber, most enriched grain products

cannot meet the 10 percent nutrient

contribution requirement for any of the

six listed nutrients because they are

precluded by the standards of identity

from containing 10 percent of the six

listed nutrients. ABA also stated that the

standards of identity require specific

nutrient addition at levels that were

established by FDA as optimal for

reducing the risk of certain diet-related

diseases. These foods, in fact, have been

used for many years to improve the

nutrition of U.S. consumers and to

reduce the risk of diet-related diseases.

Therefore, ABA contended that these

foods are precisely the kinds of foods

that should be permitted to bear health

claims.

ABA argued that the 10 percent

nutrient contribution requirement was

obviously not intended to apply to foods

that conform to the standards of identity

for enriched grain products because it

precludes virtually all enriched grain

products from bearing health claims. It

contended that this exclusion is

inconsistent with the basis of the health

claims because these foods are not only

beneficial in reducing the risk of dietrelated diseases but, more importantly,

are also recommended in current dietary

guidelines as foods whose consumption

should be increased to maintain a

balanced and healthful diet. The

petition noted that the Food Guide

Pyramid recommends that 6 to 11

servings of grain products be consumed

per day. ABA contended that this

recommendation demonstrates the

importance of including these foods in

the diet. ABA argued that the 10 percent

nutrient contribution requirement has

had the unintended effect of precluding

foods that FDA concluded could

appropriately bear a health claim from

bearing the claim. Thus, ABA requested

that the agency amend § 101.14(e) to

exempt from the 10 percent nutrient

contribution requirement enriched grain

products that conform to a standard of

identity in part 136, 137, or 139, and

bread that conforms to the standard of

identity for enriched bread in § 136.115,

except that it contains whole wheat or

other grain products not permitted

under that standard.

In the alternative, ABA suggested that

the agency expand the list of nutrients

that must be present at 10 percent to

include complex carbohydrates, niacin,

or thiamin. Such action, the petition

explained, would permit enriched grain

products to bear health claims because

these products are a significant source

of such nutrients.

As a second alternative, ABA

suggested that FDA amend the 10

percent nutrient contribution

requirement to allow it to apply to a

daily consumption of grain products

rather than to the nutrient profile of a

specific food.

FDA has fully evaluated and

considered the arguments raised in both

petitions. FDA recognizes that the 10

percent nutrient contribution

requirement may have had the

unintended effect of prohibiting health

claims on certain foods that could be

beneficial for consumers and help them

to maintain a balanced and healthful

diet. The agency is concerned, however,

that eliminating the 10 percent nutrient

contribution requirement will permit

misleading health claims on foods with

little or no nutritional value such as

candies and soft drinks or will

encourage overfortification of the food

supply (e.g., vitamin or mineral addition

to soft drinks). The appearance of health

claims on such foods would be

inconsistent with Congress’s intent

when it enacted the health claims

provisions. As discussed in the 1993

health claims final rule, Congress

enacted the health claims provisions of

the 1990 amendments to not only

protect consumers from health claims

that are not scientifically valid but also

to help consumers maintain healthy

dietary practices by providing

information that would be useful in

constructing total daily diets that meet

current dietary guidelines. Thus, an

important part of the significance and

benefit of health claims is that they

appear on foods that are compatible

with current dietary recommendations.

(See H. Rept. 101–538, 101st Cong., 2d

sess. pp. 9–10 (1990).)

During the development of the health

claims final rule, FDA considered other

alternatives that would ensure that

health claims are not trivialized or

rendered meaningless by appearing on

foods of little or no nutritional value.

For example, the agency considered

prohibiting health claims on specific

foods, such as confections, soda, and

snack foods, based on the foods’

categorization or characteristic use.

However, as fully discussed in the 1993

health claims final rule (58 FR 2478 at

2521), the agency was not persuaded

that such action was in keeping with the

intent of the statute. The agency

concluded that Congress did not intend

that specific foods that could be in

general use be prohibited from bearing

a health claim. Thus, the agency

concluded that a prohibition on health

claims for specific categories of foods

was not a viable option.

However, given the requirement in

section 403(r)(3)(B)(iii) of the act that a

claim should enable the public to

comprehend the information in a claim

and understand the relative significance

of that information in the context of a

total daily diet, FDA concluded (as

discussed in the 1993 health claims

final rule (58 FR 2478 at 2521–2522))

that it is appropriate to provide a basis

for health claims that takes into account

the nutritional contribution of the food

beyond its role as a source of calories.

The agency noted that ‘‘Congress

intended that FDA establish provisions

of health claims regulations by

considering the role of the nutrients in

food in a way that will enhance the

chances of consumers constructing total

daily diets that meet dietary guidelines’’

(Id. at 2521). Without such provisions,

foods that are not compatible with

dietary guidelines could bear health

claims. In addition to being inconsistent

with Congress’s intent when it

established the health claim provisions,

and section 403(r) of the act, claims

intended to promote the consumption of

a food that is incompatible with dietary

guidelines would be misleading to

consumers and, therefore, would be in

violation of section 403(a) (id.). Such

claims would be misleading because

consumers would be purchasing the

food, in part, to achieve a more

healthful diet, when, in fact, such foods

are inconsistent with dietary guidelines.

Further, such claims could be damaging

if consumers are encouraged to replace

wholesome and nutritious foods that are

recommended in dietary guidelines

with these foods.

Thus, the agency concluded then, and

reiterates now, that the 10 percent

nutrient contribution requirement is a

necessary component of the health

claims provisions to ensure that such

claims appear on foods that make a

nutritional contribution to the diet and

are consistent with dietary guidelines. If

the agency were to revoke this

requirement, it would have to establish
Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules 66213

an alternative mechanism to ensure that

health claims are not made on

inappropriate foods. The NFPA petition

did not suggest any alternatives to the

10 percent nutrient contribution

requirement to preclude misleading

health claims on inappropriate foods.

The agency also tentatively concludes

that the alternatives suggested in the

ABA petition would not ensure that

health claims were made only on foods

that are consistent with dietary

guidelines. Relying on either of the two

alternatives suggested in the ABA

petition would not adequately assist

consumers in placing foods that bear

health claims in their proper dietary

context.

The ABA’s suggestion that the

nutrients required to be present at 10

percent be expanded to include thiamin,

niacin, or carbohydrates would not

encourage consumers to increase their

intake of vitamins and minerals that

have been identified as those of

continuing public health significance.

Public health concerns for deficient

intakes of thiamin, niacin, or

carbohydrates have lessened

considerably in the last 20 years,

whereas the inadequate intakes of

vitamin A, vitamin C, calcium, and iron

remain a public health concern

especially because of the possible

association between several of these

nutrients and the risk of chronic

disease. Furthermore, expanding the list

of nutrients required to be at 10 percent

to include thiamin, niacin, or

carbohydrates would permit only

certain foods to bear health claims, such

as enriched cereal grain products.

Certain fruit and vegetable products that

are promoted in dietary guidelines but

that are currently prohibited from

bearing health claims would still not be

able to bear a health claim.

Consequently, the agency tentatively

concludes that expanding the list of

nutrients would not sufficiently address

the concern that the current regulation

precludes certain foods that contribute

to a healthful diet, and whose

consumption is encouraged by the

dietary guidelines, from bearing health

claims.

Likewise, permitting the 10 percent

nutrient contribution requirement to be

based on the daily consumption of a

food group would not enhance the

likelihood of consumers achieving

dietary goals. In fact, such a requirement

would be contrary to dietary goals

because it would reduce the likelihood

that a consumer would reach 100

percent of the DV if daily consumption

of an entire food group only supplies 10

percent of one of the listed nutrients.

One reason for requiring that a serving

of the food provide 10 percent of one or

more of the listed nutrients is to assist

the consumer in achieving daily intakes

recommended in current dietary

guidelines. Permitting a food that does

not meet the 10 percent nutrient

requirement to bear a claim on the basis

that the total daily consumption of

foods from that category would provide

10 percent of the nutrient would be

inconsistent with one of the basic

principles of the requirement.

Accordingly, the agency has not been

persuaded by the arguments raised in

the petitions to propose to eliminate the

10 percent nutrient contribution

requirement, to expand the list of

nutrients that will qualify a food to bear

a health claim, or to allow the 10

percent nutrient requirement to apply to

a daily consumption of grain products

rather than to the nutrient profile of a

specific food.

Regarding the request that FDA

permit fortification to meet the 10

percent nutrient contribution

requirement, the agency is concerned

that fortification of foods solely to bear

a health claim could result in deceptive

or misleading labeling and, thereby, be

in violation of section 403(a) of the act.

As fully addressed in the 1993 health

claims final rule (58 FR 2478 at 2522),

fortification of a food of little or no

nutritional value for the purpose of

bearing a health claim has the great

potential of misleading and confusing

consumers if foods like confections,

soda, and sweet desserts are fortified to

qualify for a health claim when, at the

same time, dietary guidance as

contained in the Food Guide Pyramid,

for example, states that ‘‘[T]hese foods

provide calories and little else

nutritionally. Most people should use

them sparingly’’ (Ref. 3). Indiscriminate

fortification of such foods with one

nutrient would not make such foods

consistent with dietary guidelines.

Consequently, FDA has not been

persuaded that foods should be

permitted to be fortified to qualify to

bear a health claim. Accordingly, FDA

is denying NFPA’s request to permit

fortification to specifically qualify a

food to bear a health claim.

The agency notes, as discussed in the

1993 health claims technical

amendments (58 FR 44036 at 44037),

that some foods either have been

traditionally formulated in accordance

with the fortification policy or to meet

standards of identity that include

fortification and, in that form, contain

10 percent or more of one of the six

nutrients listed. In such cases, the

agency notes that the food would not be

precluded by § 101.14(e)(6) from being

fortified to qualify for a health claim.

Although the agency has not been

persuaded that elimination of the 10

percent nutrient contribution

requirement is in order, or that it should

permit fortification so that a food could

qualify to bear a health claim, the

agency has been persuaded by the

arguments raised in the petitions that it

should act to modify the 10 percent

nutrient contribution requirement. As

stated above, the agency acknowledges

that the 10 percent nutrient contribution

requirement has had the unintended

effect of precluding some foods that

contribute to a healthful diet, and whose

consumption is encouraged by the

dietary guidelines, from bearing health

claims. As discussed above, the agency’s

primary goals in establishing the 10

percent nutrient contribution

requirement were to preclude foods of

little or no nutritional value from

bearing health claims and, at the same

time, to enhance the likelihood of

consumers constructing overall daily

diets that conform to current dietary

guidelines.

FDA recognizes that precluding

certain fruits, vegetables, and grain

products from bearing health claims

because of the 10 percent nutrient

contribution requirement is contrary to

that goal. The agency agrees with the

arguments raised in the petitions that

certain fruits, vegetables, and grain

products that otherwise meet the

requirements of the specific health

claim should be able to bear the claim

even though they do not contain 10

percent of one of the six listed nutrients

because these foods comprise a major

part of a balanced and healthful diet,

and because current dietary guidance

promotes consumption of these foods.

Moreover, diets high in fruits,

vegetables, and grain products have

been associated with various specific

health benefits, including lower

occurrence of coronary heart disease

and of some cancers (Refs. 4 and 5) and

therefore, are exactly the types of foods

that should be included in the diet to

reduce the risk of specific diet-related

diseases. Precluding such foods from

bearing health claims could confuse

consumers and undermine the utility of

health claims.

Furthermore, the foods described in

the petitions are not the types of foods

FDA intended to preclude from bearing

health claims when it established the 10

percent nutrient contribution

requirement. In fact, these foods can

contribute significantly to a balanced

and healthful diet and to achieving

compliance with dietary guidelines

even though they do not meet the 10

percent nutrient contribution

requirement. Consequently, the agency
66214 Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules

tentatively concludes that fruit and

vegetable products comprised solely of

fruits and vegetables, enriched grain

products that conform to a standard of

identity, and bread that conforms to the

standard of identity for enriched bread

except that it contains whole wheat or

other grain products not permitted

under that standard, that do not meet

the 10 percent nutrient contribution

requirement but that meet all other

aspects of the health claim should be

permitted to bear a health claim.

Accordingly, the agency is proposing to

amend § 101.14(e)(6) to exempt these

products from the 10 percent nutrient

contribution requirement.

The agency is proposing to limit the

exemption for fruit and vegetable

products to those products comprised

solely of fruits and vegetables because it

is concerned that permitting health

claims on fruit and vegetable products

that do not contain 10 percent of one of

the six listed nutrients, but that contain

ingredients that may raise the level of

certain other nutrients, such as fat,

cholesterol, and sodium, would be

inconsistent with the purpose of the

health claim and incompatible with

current dietary guidelines. While the

agency recognizes that fruit and

vegetable products with added syrups,

sauces, and other ingredients that have

increased levels of fat, cholesterol, or

sodium have an appropriate place in the

diet, the agency tentatively concludes

that to exempt these products from the

10 percent nutrient contribution

requirement would be to promote the

consumption of foods that do not fall

within the recommendations in dietary

guidelines. Accordingly, the agency is

not prepared to extend the exemption to

these products. However, FDA requests

comment on whether the exemption

proposed in this document should be

extended to include fruit and vegetable

products with added oils, sodium,

sauces, syrups, or other ingredients.

The agency also requests comment on

whether other foods, for example, other

types of grain products such as breakfast

cereals, should be exempt from the 10

percent nutrient contribution

requirement. The agency advises that

comments submitted in support of

extending this exemption to other foods

should provide valid data and sound

justification for exempting such foods

from the 10 percent nutrient

contribution requirement. If the

comments persuade the agency that

such foods are being unfairly precluded

from bearing health claims, and that the

foods are consistent with the intent of

the health claims, the agency will

consider including such foods in the

exemption provided in any final

regulation based on this proposal.

C. Abbreviated Health Claims

Current § 101.14(d)(2)(iv) mandates

that all information required to be

included in the claim appear in one

place without other intervening

material. The current rule, however,

does permit a reference statement

‘‘See———— for information about the

relationship between————

and————,’’ with the blanks filled in

with the location of the labeling

containing the health claim, the name of

the substance, and the disease or healthrelated condition (e.g., ‘‘See attached

pamphlet for information about calcium

and osteoporosis’’) with the complete

health claim appearing elsewhere on the

other labeling. The current rule also

permits the use of graphic material,

such as a symbol that constitutes an

expressed or implied health claim, to be

used on the label or labeling of the

product provided that it is accompanied

by the complete claim, an abbreviated

claim, or a referral statement

(§ 101.14(d)(2)(iv)).

In the preamble to its 1993 health

claims final rule, the agency stated that

it did not believe that it is appropriate

to use abbreviated health claims as

referral statements (58 FR 2478 at 2512).

The agency was concerned that an

abbreviated claim did not include facts

that are material in light of the

representation that is made and that are

necessary to understand the claim in the

context of the daily diet. The agency

was concerned that such confusion is

possible ‘‘whenever the full health

claim information appears in a location

different from that of the reference

statement and is especially likely to

occur when a multiplicity of labeling is

associated with a product’’ (Id.). The

agency then described the situation

where the grocer displays an

abbreviated claim on a display (labeling)

near the product but only puts the full

claim on a billboard in a far corner of

the store (labeling) (id.).

In its petition, NFPA requested that

the agency reconsider this position and

permit greater latitude in constructing

and presenting health claims. More

specifically, the petition requested that

FDA permit abbreviated health claims

that are accompanied by a referral

statement directing the consumer to the

label panel where the complete health

claim appears.

The agency has no desire for its

regulations to unnecessarily stand in the

way of the use of health claims and the

presentation of the important

information contained therein. While

health claims are currently being used

on the label and in labeling, the agency

would like to see them used more

extensively. Consequently, the agency

agreed to initiate rulemaking in this

area. The agency stated, however, that it

must have assurance that the claims will

be presented in a scientifically valid,

truthful, and nonmisleading manner.

FDA notes that in this document the

agency is proposing to provide the basis

for shorter health claims by making

optional some of the elements that it has

required to be included in claims. If

those changes are finalized, many of the

complete claims will be brief enough to

permit their use on the principal display

panel. For example, a claim for sodium

and hypertension could be made in 12

words: ‘‘Diets low in sodium may

reduce the risk of high blood pressure.’’

Most other claims would be of a similar

length. The agency believes that these

shortened claims will, for the most part

make this issue moot. Nevertheless, the

agency recognized that some claims may

still remain somewhat complex.

In those cases where the complete

health claim remains long and

somewhat complex, the agency

recognizes that there may be a need to

permit a shortened version of the claim

on the principal display panel.

Although the entire health claim

contains important information

necessary for consumers to fully

understand the subject substancedisease relationship, the agency

recognizes that a short message that

captures the consumer’s attention will

facilitate use of the claim. As a result,

the communication of formation will

assist consumers in achieving healthful

dietary practices.

The agency tentatively concludes that

the use of an abbreviated health claim

on the principal display panel is

consistent with the act. The full health

claim includes information required

under section 403(a) and 403(r)(3)(B)(iii)

of the act. Section 403(r)(3)(B)(iii)

requires that the complete health claim

‘‘enable[] the public to comprehend the

information provided in the claim and

to understand the relative significance

of such information in the context of a

total daily diet.’’ Section 403(a) of the

act requires only that a claim not be

false and misleading. FDA has long

required that all information that is

necessary to make the claim truthful

and not misleading appear in one place,

without any intervening material. (See,

e.g., United States v. An Article of Food

* * * ‘‘Manischewitz * * * Diet Thins’’,

377 F. Supp. 746 (E.D. New York 1974)).

However, there is nothing in the act that

would require that information required

under section 403(r)(3)(B)(iii) appear as
Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules 66215

part of the claim each time it is

presented on the label.

Thus, an abbreviated health claim that

is a scientifically valid representation of

the relationship between a substance

and a diet-related disease may be

permissible under section 403(a) of the

act if it is truthful and not misleading.

If such an abbreviated claim includes a

prominent and immediately adjacent

reference to the full claim elsewhere on

the label, the requirements of section

403(a) and (r)(3)(B)(iii) of the act would

be fulfilled. Consequently, the agency is

proposing to amend § 101.14(d)(2)(iv).

In addition to permitting the current

reference statement to the full claim

(§ 101.14(d)(2)(iv)(A)), the agency is

proposing to permit an abbreviated

health claim to be used on the principal

display panel of the label provided that

it is accompanied by a reference

statement to the complete health claim

on the same label or in the same

labeling (proposed § 101.14(d)(2)(iv)(B)).

It is vital to compliance with the act

that the complete claim appear

elsewhere on the same label or in the

same labeling as the abbreviated claim.

For example, as discussed below for the

calcium and osteoporosis health claim,

the agency is concerned that consumers

might be less likely to read the full

health claim if an abbreviated claim

appears on the principal display panel

of a label, and the full health claim

appears in a separate brochure that

accompanies the product.

The agency is also proposing to

require that the reference statement be

prominent and in immediate proximity

to the abbreviated claim. The agency

notes, of course, that if the proposed

provision is adopted, an abbreviated

claim could not be used unless the food

meets the criteria necessary to make the

complete health claim.

As stated above, in the section D.IV.

of this document, the agency is

proposing to amend the regulations in

subpart E of part 101, where

appropriate, to set forth the elements

that are required to ensure that an

abbreviated health claim complies with

section 403(a) of the act. As stated

above, provision for an abbreviated

claim will not be needed for most of the

nutrient-disease relationships about

which FDA has authorized claims if the

revisions proposed in this document are

adopted. Consumers may benefit,

however, from abbreviated claims for a

few of the longer, more complicated

claims, such as those for calcium/

osteoporosis and folic acid/neural tube

defects.

The agency strongly emphasizes that

the diet-disease relationship may not be

overstated. Even with a prominent

referral to the full claim, the abbreviated

claim must not overemphasize the

importance of the substance in the dietdisease relationship or in the total daily

diet. The concept of risk reduction must

be accurately conveyed.

The agency notes that some of the

diet-disease relationships may already

be well-known by consumers.

Therefore, nutrient content claims such

as ‘‘low sodium’’ and ‘‘reduced

cholesterol’’ on the principal display

panel and elsewhere on the label may

serve as a reminder of the diet-disease

relationship and provide a way to

market a product for its contribution to

a healthy diet.

FDA encourages the use of all

authorized claims by the food industry

in order to educate consumers about the

importance of a healthy diet. The

agency believes that the proposed

changes to § 101.14(d)(2)(iv) will result

in increased use of the authorized

health claims and, consequently, will

fulfill the legislative intent to educate

the public about diet-disease

relationships.

D. Specific Requirements for Health

Claims

To date, FDA has authorized eight

health claims that are codified in the

Code of Federal Regulations, Title 21,

subpart E of part 101 (§§ 101.72 to

101.79). Among the actions requested by

NFPA in its petition is one to ‘‘* * *

modify the regulations in subpart E of

part 101 prescribing the content of

authorized health claims so that they

constitute ‘safe harbors’ rather than

requirements for claims; * * *.’’ To

accomplish this request, NFPA

requested that the health claims

regulations be modified to permit

simplified, nondeceptive claims that are

likely to be more easily understood.

NFPA contended that the specific health

claims regulations contained in subpart

E of part 101 include several provisions

that prescribe the content and form of

health claims to an extent that far

exceeds that necessary to ensure that

claims are truthful and not misleading.

Mentioned as an example was that some

regulations require claims to include

references to specific nondietary factors

even though, in NFPA’s view, this

information is unnecessary to ensure a

claim is stated in a truthful,

nonmisleading manner. Cited as

illustrative of the nature of the problem

was the model claim from the calcium/

osteoporosis regulation (§ 101.72(e))

containing all required elements:

Regular exercise and a healthy diet with

enough calcium helps teen and young adult

white and Asian women maintain good bone

health and may reduce their high risk of

osteoporosis later in life.

Each of the other regulations

authorizing claims in subpart E of part

101 was identified as requiring similar

information.

NFPA requested that the regulations

in subpart E of part 101 governing the

specific information that must appear in

a health claim, and the circumstances in

which a claim could be used, be

amended. Where, for example,

§ 101.14(d)(2)(i) requires that labeling

statements about a health claim be

based on, and consistent with, the

conclusions set forth in the regulations

in subpart E of part 101, NFPA

recommended amending

§ 101.14(d)(2)(i), along with

§ 101.14(d)(1) and the rest of (d)(2), so

that such statements are objective and

either consistent with applicable

guidelines set forth in subpart E of part

101, or a reasonable basis for the claim

is otherwise substantiated. The

petitioner contended that such changes

would operate to allow truthful,

nonmisleading health claims that either

omit information currently required

under the regulations (e.g., nondietary

information) or that include other useful

information not expressly authorized by

the regulations.

Responding to NFPA in the May 11,

1995, letter, FDA acknowledged that,

although use of health claims in food

labeling has increased over the period of

time that they have been in effect, the

number of products bearing such claims

is not as great as the agency had

anticipated. Because of the importance

of the information conveyed to

consumers by health claims, the agency

stated that it would review the

authorizing regulations to determine

whether they contain any unnecessary

barriers to the use of the claims and, if

so, take steps to remove those barriers.

FDA stated that, as part of this

assessment, it would conduct a review

of what are referred to as ‘‘required

elements’’ in each of the eight

authorized health claims to determine

whether any of them are unnecessary or

can be made optional and initiate

rulemaking to propose any changes

identified in its internal review.

The eight authorized health claims in

subpart E of part 101 are codified

following the same format. Thus the

‘‘required elements’’ for each claim are

contained in paragraph (c) of the

respective regulation under the heading

‘‘Requirements.’’ For example, specific

requirements that apply to the calcium/

osteoporosis health claim are contained

in § 101.72(c)(2)(i)(A) through

(c)(2)(i)(E).
66216 Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules

The agency has reviewed all of the

required elements in the eight

authorized claims codified in subpart E

of part 101. This document presents the

results of this review for the following

seven claims: § 101.72 on calcium and

osteoporosis; § 101.73 on dietary lipids

and cancer; § 101.74 on sodium and

hypertension; § 101.75 on dietary

saturated fat and cholesterol and risk of

coronary heart disease; § 101.76 on

fiber-containing grain products, fruits,

and vegetables and cancer; § 101.77 on

fruits, vegetables, and grain products

that contain fiber, particularly soluble

fiber, and risk of coronary heart disease;

and § 101.78 on fruits and vegetables

and cancer. The health claim on folate

and neural tube defects (§ 101.79) will

be dealt with separately but in a manner

consistent with the review of the other

health claims.

Since the final rules on the seven

claims addressed in this document were

published on January 6, 1993 (58 FR

2537 to 2849), new data have become

available allowing FDA to reconsider

the need for some information that, at

the time the specific health claim

regulations were issued, was considered

necessary to preclude a claim from

being misleading. Most notable among

these data are two documents, one a

National Institutes of Health (NIH)

consensus statement on optimal calcium

intake (hereinafter referred to as the

1994 consensus statement) and the other

an FDA report on consumer

understanding of health claims

(hereinafter referred to as the 1995

consumer report) (Refs. 6 and 7,

respectively).

1. The Calcium/Osteoporosis Health

Claim

The 1994 consensus statement is the

result of the Consensus Development

Conference on Optimal Calcium Intake

convened by NIH on June 6 through 8,

1994, which brought together experts in

public education and different

biomedical sciences dealing with

osteoporosis and bone and dental

health. Directly relevant to the calcium/

osteoporosis health claim, this

conference addressed questions and

provided recommendations on optimal

calcium intake for various population

segments, on important cofactors for

achieving optimal intake, on the risks

associated with increased intake, on the

best ways to attain optimal intake, and

on the public health strategies that are

available or are needed to implement

optimal calcium intake

recommendations.

The 1995 consumer report is part of

FDA’s ongoing review of its regulations

governing health claims. The report

evaluated consumer understanding of

four health claims (dietary lipids and

cancer, fruits and vegetables and cancer,

calcium and osteoporosis, and folate

and neural tube defects) and consumer

reaction to possible variations on the

messages. The report describes the

content, the manner of presentation, and

the results of a consumer survey of

knowledge about the four health claims

mentioned above among consumer

groups at eastern, central, and western

locations in the United States.

For the calcium/osteoporosis health

claim, the first required element is

contained in § 101.72(c)(2)(i)(A) and

provides that:

The claim makes clear that adequate

calcium intake throughout life is not the only

recognized risk factor in this multifactorial

bone disease by listing specific factors,

including sex, race, and age that place

persons at risk of developing osteoporosis

and stating that an adequate level of exercise

and a healthful diet are also needed.

The effect of presenting the information

required by this element is to convey

the message that, for any individual,

several factors define the disease risk.

The focus of the 1994 consensus

statement is, as stated in its title,

optimal calcium intake for promotion of

public health. The first of several

significant conclusions in the report is

that a large percentage of Americans fail

to meet currently recommended

guidelines for optimal calcium intake.

Because of the need to correct this

public health shortfall and to improve

bone health in the United States,

thereby reducing the risk of

osteoporosis, FDA tentatively concludes

that a singular focus on achieving and

maintaining adequate calcium intake as

a required element in the calcium/

osteoporosis health claim is important.

Accordingly, FDA is proposing to

simplify § 101.72(c)(2)(i)(A) by limiting

the requirement to a balanced statement

that reflects the importance of the

essential nutrient calcium over a

lifetime in a healthful diet to reduce

osteoporosis risk, but that does not

imply that calcium is the only risk

factor for the development of

osteoporosis. To this end, proposed

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

must make clear that adequate calcium

intake as part of a healthful diet

throughout life is essential to reduce the

risk of osteoporosis.

FDA has included the reference to a

‘‘healthful diet’’ in proposed

§ 101.72(c)(2)(i)(A) for consistency with

the general requirement in

§ 101.14(d)(2)(v) that ‘‘the claim enable[

] the public * * * to understand the

relative significance of such information

[in this case, the relationship between

calcium and osteoporosis] in the context

of a total daily diet.’’ The effect of

adequate calcium intake can only be

realized if the calcium is a part of a

healthy diet that provides all essential

and other nutrients to optimize

nutritional health status.

The proposed revision of

§ 101.72(c)(2)(i)(A) emphasizes the most

important risk factor in the development

of osteoporosis on the label of a food

product, i.e., adequacy of dietary

calcium intake. Nevertheless, the agency

is concerned that such a claim could

lead consumers to believe that adequacy

of dietary calcium intake is the only risk

factor for the disease. In the proposal to

authorize the calcium/osteoporosis

health claim, the following was stated:

Calcium intake is not the only recognized

risk factor in the development of

osteoporosis. Other factors include a person’s

sex, race, hormonal status, family history,

body stature, level of exercise, general diet,

and specific life style choices, such as

smoking and excess alcohol consumption.

(56 FR 60689 at 60698, November 27,

1991). Based on that information in part,

§ 101.72(c)(2)(i)(A) requires a listing of

several specific risk factors, in addition

to dietary calcium intake, in the

calcium/osteoporosis health claim.

As stated above, however, FDA

acknowledges that the number of food

products bearing health claims is not as

great as the agency had anticipated.

FDA is concerned that manufacturers

have been disinclined to use lengthy

health claims on food labels, and that

too many words will detract from the

central consumer message of the claim.

As a result, FDA is concerned that

health claims like the calcium/

osteoporosis claim will continue to be

infrequently used, and that the benefits

of communicating information on dietdisease relationships through such

claims will not be realized.

Because of these concerns, the agency

has reevaluated the requirement in

§ 101.72(c)(2)(i)(A) that a calcium/

osteoporosis health claim ‘‘* * * list[ ]

specific factors, including sex, race, and

age that place persons at risk of

developing osteoporosis and stat[e] that

an adequate level of exercise * * * [is]

also needed.’’ Given the consensus

statement’s central focus on optimal

calcium intake and the agency’s desire

to make health claims as useful and

useable as possible, FDA is proposing to

replace the requirement in

§ 101.72(c)(2)(i)(A) that specific risk

factors and the need for an adequate

level of exercise be stated in any claim

with the more simple requirement that

the claim not imply that adequate

dietary calcium intake is the only

recognized risk factor for a reduced risk
Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules 66217

of osteoporosis. This revision will

ensure that the scientific validity of

claims about osteoporosis is preserved

by recognizing the multifactorial nature

of this disease without adding words to

the claim.

In concert with the proposed change

in § 101.72(c)(2), the agency is

proposing to redesignate § 101.72(d)(2)

as paragraph (d)(5) and to add a new

paragraph (d)(2) that provides for the

provision of the following information

from current § 101.72(c)(2)(i)(A) as

optional information:

The claim may list specific risk factors for

osteoporosis, identifying them among the

multifactorial risks for the disease. Such

factors include a person’s sex, age, and race.

The claim may state that an adequate amount

of exercise is also needed to reduce risk for

the disease.

The 1995 consumer report identified

the calcium/osteoporosis model health

claim as the one most actively disliked

(Ref. 7). This dislike most likely arises

primarily from a misunderstanding one

of the concepts required in

§ 101.72(c)(2)(i)(B), specific

identification of the populations at

particular risk for the disease. The

current regulation states:

The claim does not state or imply that the

risk of osteoporosis is equally applicable to

the general United States population. The

claim shall identify the populations at

particular risk for the development of

osteoporosis. These populations include

white (or the term ‘‘Caucasian’’) women and

Asian women in their bone forming years

(approximately 11 to 35 years of age or the

phrase ‘‘during teen or early adult years’’

may be used). The claim may also identify

menopausal (or the term ‘‘middle-aged’’)

women, persons with a family history of the

disease, and elderly (or ‘‘older’’) men and

women as being at risk.

The 1995 consumer report states that

minority women were unanimous in

objecting to the inference that black

American women do not need calcium.

Accordingly, minority participants

questioned the accuracy of the

information. All of the survey

participants recognized that calcium is

essential for everyone. Although there

was some recognition based on prior

knowledge that younger women need to

be concerned about osteoporosis, no

participant thought the model claim

communicated that concept very well.

For these and other reasons, older

women tended to dismiss the model

claim as incorrect.

The agency did not intend that the

calcium/osteoporosis health claim

imply that calcium is not needed by any

individual or specific population. Given

that calcium is essential for every

person, the agency attempted to craft

requirements for presenting this disease

claim in a truthful, nonmisleading, and

scientifically valid manner. In reviewing

the scientific data supporting the claim,

including the incidence of low-trauma

bone fracture in the elderly, FDA stated

in the preambles to the calcium/

osteoporosis proposed and final rules

(56 FR 60689 and 58 FR 2665,

respectively) that those individuals in

the general population at greatest risk of

developing osteoporosis, and for whom

the health claim would have greatest

benefit, include Caucasian and possibly

Asian women and adolescent girls and

young adult women between 11 and 35

years of age. For this and other reasons,

a requirement for identifying these high

risk groups was included in

§ 101.72(c)(2)(i)(B). In identifying those

at highest risk, there was no intent by

the agency to imply that other

consumers are risk free.

The 1994 consensus statement is

silent in ascribing relative risk for

osteoporosis on the basis of race or

ethnicity of population groups. For

adolescents and young adults of both

sexes, 11 through 24 years of age, the

optimal calcium requirement is given as

a range of 1,200 to 1,500 milligrams

(mg) of calcium daily. The report says

the following about a subset of this

population, 12 to 19 year old females:

Importantly, population surveys of girls

and young women 12–19 years of age show

their average calcium intake to be less than

900 mg/day, which is well below the calcium

intake threshold. The consequences of low

calcium intake during this crucial period of

rapid skeletal accrual raise concerns that

achievement of optimal peak adult peak bone

mass may be seriously compromised. Special

education and public measures aimed at

improving dietary calcium intake in this age

group are essential.

(Ref. 6.)

FDA tentatively concludes that greater

use in food labeling of the calcium/

osteoporosis health claim, articulated in

a manner that will be accepted and

followed by consumers, can help

support significant strides in improving

calcium intake in all segments of the

U.S. population. Accordingly, the

agency is proposing to revise

§ 101.72(c)(2)(i)(B) in several ways.

First, it is proposing to revise

§ 101.72(c)(2)(i)(B) by removing the

requirement to identify by race those

populations at particular risk for the

development of osteoporosis. In neither

the statement cited above nor elsewhere

in the 1994 consensus statement is any

racial or ethnic segment among girls and

young women 12 to 19 years of age

identified as being more at risk for the

consequences of a less than optimal

calcium intake. The 1994 NIH

consensus statement found that the

recommendation for optimal nutrient

requirements for any particular age/sex

population segment to forestall the

impact of a degenerative disease applies

to all members of that segment, although

not necessarily to the same degree for

everyone. Thus, the agency is proposing

not to require mention of race or

ethnicity as a required element but to

permit such information as an option

since it is useful and important to those

to whom it applies.

Nevertheless, retention of teen and

young adult women, irrespective of race

or ethnicity, as the focus of the claim is

important because, as stated succinctly

in the 1994 consensus statement:

Two important factors that influence the

occurrence of osteoporosis are optimal bone

mass attained in the first two or three

decades of life and the rate at which bone is

lost in later years.

Failure to attain optimal bone mass

during the bone-forming years of

adolescence and early adulthood is a

loss that cannot be recovered during

middle age or later in life (Ref. 6). Once

peak adult bone mass is reached at

about age 25, bone turnover is stable in

men and women such that bone

formation and bone resorption

(breakdown) are balanced. In women,

resorption rates increase, and bone mass

declines, beginning with the fall in

estrogen production that is associated

with the onset of menopause. Unlike

hormone replacement therapy,

supplemental calcium during this initial

phase will not slow the decline in bone

mass attributable to estrogen deficiency.

The effects of calcium in reducing the

rate of bone loss can be shown more

clearly in postmenopausal women after

the period when the effects of estrogen

deficiency are no longer dominant (i.e.,

about 10 years after menopause).

Osteoporosis affects more than 25

million people in the United States and

is the major underlying cause of bone

fractures in postmenopausal women and

the elderly (Ref. 6). Given this

tremendous cost to public health, it is

essential that the health claim on

calcium and osteoporosis inform

consumers, particularly those at great

risk for the disease, of the importance of

adequate calcium intake throughout life

for attaining peak adult bone mass and

for reducing the rate of bone resorption

or loss, two processes that occur at

different periods over a lifetime.

Thus, FDA is proposing to retain the

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

the claim not suggest that the risk of

osteoporosis applies equally to the

general U.S. population. However, it is

proposing to remove the required
66218 Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules

reference to any racial or ethnic group

in identifying the at-risk population.

The agency is proposing to identify this

population in the following way:

* * * The claim shall identify the

population at particular risk for the

development of osteoporosis as women in

their bone forming years from approximately

11 to 35 years of age. An optional statement

that further characterizes this and other

populations at risk for developing

osteoporosis may be made in accordance

with paragraph (d)(3) of this section.

FDA is proposing to permit

identification of Caucasian women and

Asian women as among those at

particular risk for the disease as

optional information, along with other

information from § 101.72(c)(2)(i)(B), in

new § 101.72(d)(3). While the 1995

consumer report (Ref. 7) found evidence

that some consumers could be misled by

references in the calcium/osteoporosis

health claim to Caucasian and Asian

women, FDA tentatively concludes that,

if properly qualified, this information

could be helpful in informing such

women who may be unaware of their

risk of developing this disease. By

providing for this information as an

optional element in § 101.72(d), the

agency is attempting to encourage

manufacturers to use this information in

formats where the message can be

phrased in enough detail to clarify its

meaning. For example, ‘‘while all

women may be at risk of osteoporosis,

Caucasian and Asian women are

particularly at risk,’’ may be understood

and not rejected by consumers. While

this statement provides more detail than

seems to be necessary in the basic

health claim, this information could be

useful in a longer discussion of calcium

and osteoporosis, for example in a

paragraph format on a large label or in

a pamphlet. The agency requests

comment, and is particularly interested

in data, on whether its tentative view

that consumer understanding would be

helped is correct.

Section 101.72(c)(2)(i)(C) established

a requirement for identifying the

mechanism whereby adequate dietary

calcium over a lifetime should reduce

the risk of osteoporosis:

The claim states that adequate calcium

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. When reference is made to

persons with a family history of the disease,

menopausal women, and elderly men and

women, the claim may also state that

adequate calcium intake is linked to reduced

risk of osteoporosis through the mechanism

of slowing the rate of bone loss.

The agency concluded in developing

this requirement that it is important for

consumers to have a basic

understanding of the biological and

physiological mechanisms by which

adequate dietary intake of calcium

achieves a reduced risk of osteoporosis.

However, information developed since

the regulation was published indicates

that a health claim may not be the best

way to provide this information. The

1995 consumer survey (Ref. 7) found

that, because participants had learned

elsewhere that calcium intake is related

to general bone health, they thought the

food label was not the right means for

conveying this information. In addition,

this awareness by consumers that

calcium’s ability to ‘‘build and maintain

good bone health’’ is the mechanism

whereby risk of osteoporosis is reduced,

raises a question as to whether there is

a need to state that fact in a health

claim. In the interest of streamlining the

claim, therefore, FDA is proposing to

make the statement of the mechanism

by which calcium intake affects the risk

of osteoporosis optional information.

The agency is proposing to move

§ 101.72(c)(2)(i)(C) to § 101.72(d)(4),

changing only the word ‘‘shall’’ to

‘‘may’’.

Section 101.72(c)(2)(i)(D) requires

that:

The claim does not attribute any degree of

reduction in risk of osteoporosis to

maintaining an adequate calcium intake

throughout life;

This paragraph is consistent with

requirements in regulations for all other

authorized claims that no attribution to

degree of risk reduction for the

respective disease or health-related

condition be made in reference to the

nutrient or substance that is the subject

of the claim (see, for example:

§§ 101.73(c)(2)(i)(E), 101.74(c)(2)(i)(D),

101.75(c)(2)(i)(D), 101.76(c)(2)(i)(E),

101.77(c)(2)(i)(G), 101.78(c)(2)(i)(E), and

101.79(c)(2)(i)(F).

Unlike these other regulations,

§ 101.72 does not contain an express

requirement that the claim state that

adequate calcium intake throughout life

‘‘may’’ or ‘‘might’’ reduce the risk of

osteoporosis (see, for example,

paragraphs (c)(2)(i)(A) in §§ 101.73

through 101.79). However, it is clear

that FDA also intended that this

requirement apply to the calcium/

osteoporosis health claim. This

intention may be inferred from the two

model health claims that use the term

‘‘may’’ in relating calcium intake with a

reduction in risk of osteoporosis.

Accordingly, the agency is proposing to

revise § 101.72(c)(2)(i)(D) and

redesignate it as § 101.72(c)(2)(i)(C) to

read as follows:

The claim does not attribute any degree to

which maintaining adequate calcium intake

throughout life may reduce the risk of

osteoporosis;

This proposed revision retains the

prohibition against attributing the

degree to which adequate calcium

intake is associated with a reduced risk

for osteoporosis while introducing the

concept that, because of the

multifactorial nature of the disease,

maintenance of an adequate calcium

intake throughout life may reduce risk

of developing the disease.

Section 101.72(c)(2)(i)(E) contains the

conditional requirement that a calcium/

osteoporosis health claim include a

statement that reflects the limit on the

benefit derived from dietary calcium

intake as follows:

The claim states that a total dietary intake

greater than 200 percent of the recommended

daily intake (2,000 milligrams (mg) of

calcium) has no further known benefit to

bone health. This requirement does not apply

to foods that contain less than 40 percent of

the recommended daily intake of 1,000 mg of

calcium per day or 400 mg of calcium per

reference amount customarily consumed as

defined in § 101.12(b) or per total daily

recommended supplement intake.

Most conventional foods and many

calcium-fortified foods do not exceed

the threshold of 40 percent of the DV for

calcium for adults and children 4 or

more years of age and, therefore, do not

trigger the required use of the statement

in § 101.72(c)(2)(i)(E). Dietary

supplements containing calcium,

particularly single nutrient supplements

containing 500 or 600 mg of calcium per

tablet, exceed the threshold and are

therefore required to bear the statement

as part of a health claim. The Dietary

Supplement Health and Education Act

of 1994 (the DSHEA) (Pub. L. 103–417)

was enacted on October 25, 1994, and

amends the act (Ref. 8). Among the

findings of Congress for this new law

regarding the benefits of dietary

supplements to health promotion and

disease prevention is one that identifies

a link between ingestion of certain

nutrients or dietary supplements and

reduced risk for several chronic diseases

including osteoporosis. Another finding

states that the Federal Government

should not take any actions to impose

unreasonable regulatory barriers

limiting or slowing the flow of safe

products and accurate information to

consumers.

Among the issues addressed in the

1994 consensus statement is the

question of the ways by which optimal

calcium intake may be attained. The
Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules 66219

document draws the following

conclusion:

The preferred source of calcium is through

calcium-rich foods such as dairy products.

Calcium-fortified foods and calcium

supplements are other means by which

optimal calcium intake can be reached in

those who cannot meet this need by ingesting

conventional foods.

The agency has taken into

consideration the expressed intent of

the DSHEA and this finding from the

1994 consensus statement and

tentatively concludes that revision of

§ 101.72(c)(2)(i)(E) is in order. The

agency is proposing to raise the

threshold for the required statement

from 400 to 1,500 mg of calcium, along

with other changes.

With regard to adverse effects and the

risks associated with increased levels of

calcium intake, the 1994 consensus

statement states the following:

Even at intake levels of less than 4 g/day,

certain otherwise healthy persons may be

more susceptible to developing

hypercalcemia or hypercalciuria. Likewise,

subjects with mild or subclinical illnesses

marked by dysregulation of 1,25-

dihydroxyvitamin D synthesis (e.g., primary

hyperparathyroidism, sarcoidosis) may be at

increased risk from higher calcium intakes.

Nevertheless, in intervention studies (albeit

of relatively short duration--less than 4

years), no adverse effects of moderate

supplementation up to 1500 mg/day have

been reported.

(Ref. 6.)

The same document concludes that

daily calcium intake, up to a total of

2,000 mg, appears to be safe in most

individuals (Ref. 6). For major segments

of the U.S. population the 1994

consensus statement identifies an

optimal calcium requirement of either

1,500 mg or a range of 1,200 to 1,500 mg

of calcium per day. These population

groups include adolescents and young

adults 11 to 24 years of age, pregnant

and lactating women, women over 50

(postmenopausal) who are not on

estrogens, and men over 65 years of age

(Ref. 6). Therefore, the agency

tentatively finds that a level of 1,500 mg

of calcium as the proposed threshold for

the statement in § 101.72(c)(2)(i)(E) is

not only consistent with current

recommendations for dietary calcium

intake but is also well within a range

that is not known to cause adverse

effects.

The agency is consequently proposing

to require that the statement of limited

benefit appear only on foods that

provide more than 1,500 mg of calcium

per day. FDA has expressed this

proposed threshold level as a percentage

of the Daily Values (DV’s) for adults and

children 4 or more years of age and for

pregnant or lactating women. The

agency notes that the calcium DV’s for

adults and children 4 or more years of

age and for pregnant or lactating women

have not changed and are 1,000 and

1,300 mg, respectively. (See

§ 101.9(c)(8)(iv) and 58 FR 2206 at

2213.) The agency intends to

redesignate this requirement as

§ 101.72(c)(2)(i)(D).

A common form of a calcium dietary

supplement in the marketplace is as a

tablet containing either 500 or 600 mg

of calcium as the sole nutrient with

directions for use in labeling that

recommend an intake of one or two

tablets per day. A health claim in the

labeling of such a product would not

require the additional statement in

proposed § 101.72(c)(2)(i)(D). FDA

tentatively concludes that this proposed

change is consistent with the

recommendation from the 1994

consensus statement on dietary sources

for this nutrient.

For consistency with the proposed

revisions in § 101.72(c) and (d), FDA has

revised the model health claims in

proposed § 101.72(e). FDA has used the

phrase ‘‘Especially for teen and young

adult women’’ in example 1, which sets

out how a claim that conforms with

§ 101.72(c) might look to reflect the

effects on the risk of developing

osteoporosis that may be realized by this

population segment without implying

that adequate calcium intake is without

benefit for others.

The agency solicits comment on the

proposed revisions to the calcium/

osteoporosis health claim and is

particularly interested in data on

consumer understanding of this claim,

and how such understanding can be

improved.

2. Other Health Claims

A common requirement in the

authorized claims for dietary fat and

cancer (§ 101.73); sodium and

hypertension (§ 101.74); dietary

saturated fat and cholesterol and risk of

coronary heart disease (§ 101.75); fibercontaining grain products, fruits, and

vegetables and cancer (§ 101.76); fruits,

vegetables, and grain products that

contain fiber, particularly soluble fiber,

and risk of coronary heart disease

(§ 101.77); and fruits and vegetables and

cancer (§ 101.78) is a statement that

development of the particular disease

depends on many factors.

It is well documented over the past 10

years that consumers are generally

aware that development of major

chronic diseases, such as cancer and

coronary heart disease, is dependent on

a number of different factors such as

smoking, excess body weight, family

history of the disease, exposure to

environmental chemicals, and dietary

and other factors (Refs. 9 and 10).

Additionally, the requirement that

authorized claims use the term ‘‘may’’

or ‘‘might’’ to relate the ability of the

substance that is the subject of the claim

to reduce the risk of the corresponding

disease or health-related condition is an

indication to consumers of the

multifactorial nature of the disease or

health-related condition. In responding

to comments on the scientific standard

for health claims as to whether or not

a claim based on preliminary scientific

data would be consistent with that

standard, the agency said:

* * * Further, absolute claims about

diseases affected by diet are generally not

possible because such diseases are almost

always multifactorial. Diet is only one factor

that influences whether a person will get

such a disease. For example, in the case of

calcium and osteoporosis, genetic

predisposition (e.g., where there is a family

history of fragile bones with aging) can play

a major role in whether an individual will

develop the disease. Because of factors other

than diet, some individuals may develop the

disease regardless of how they change their

dietary patterns to avoid the disease. For

those individuals, a claim that changes in

dietary patterns will reduce the risk of

disease would be false. Thus, health claims

must be free to use the term ‘‘may’’ with

respect to the potential to reduce the risk of

disease. However, use of this term would not

be appropriate for health claims on food

labeling where significant scientific

agreement does not exist that there is a high

probability that a reduction in disease risk

will occur.

(58 FR 2478 at 2505.)

Given these facts, as part of its review

of required elements for all health

claims the agency has reconsidered the

need to remind consumers of the

multifactorial nature of hypertension,

heart disease, and cancer. Based on its

review, FDA tentatively concludes that

the statement of that fact in each claim

can be made optional. In place of the

requirement for stating the

multifactorial nature of the disease, the

agency proposes to substitute a

requirement that the claim not imply

that the substance that is the subject of

the health claim is the only recognized

risk factor for the corresponding disease

or health-related condition. Thus, the

agency tentatively concludes that the

concept of the multifactorial nature of

the disease or health-related condition

for each health claim will be preserved

without adding additional words to the

claim. The agency requests comment on

whether consumers will be misled to

believe reduction of risk will be

achieved if the multifactorial nature of
66220 Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules

the disease or health-related condition

is not stated in the claim.

Accordingly, the agency is proposing

to revise §§ 101.73(c)(2)(i)(F),

101.74(c)(2)(i)(E), 101.75(c)(2)(i)(E),

101.76(c)(2)(i)(D), 101.77(c)(2)(i)(F), and

101.78(c)(2)(i)(I) in similar fashion to

ensure that the health claim not imply

that there is only one recognized risk

factor for the development of the

corresponding disease or health-related

condition. The agency is also proposing

to revise §§ 101.73(d)(1), 101.74(d)(1),

101.75(d)(1), 101.76(d)(2), 101.77(d)(1),

and 101.78(d)(2) to state that

development of the disease in question

depends on many factors and to list the

relevant factors for each disease. For

consistency, the agency is also

proposing to revise the model claims to

reflect the proposed revisions to

§§ 101.73, 101.74, 101.75, 101.76,

101.77, and 101.78.

In addition, the agency is proposing to

correct § 101.77(e) by adding the phrase

‘‘and the risk of coronary heart disease’’

which was inadvertently omitted in the

final rule.

The health claim for fruits and

vegetables and cancer (§ 101.78)

contains one additional element that

FDA tentatively concludes could be

optional instead of a mandatory part of

the claim. In § 101.78(c)(2)(i)(D) the

regulation states:

The claim characterizes the food bearing

the claim as containing one or more of the

following, for which the food is a good

source under § 101.54: dietary fiber, vitamin

A, or vitamin C.

This required statement is very similar

to the one required by

§ 101.78(c)(2)(i)(C):

The claim characterizes fruits and

vegetables as foods that are low in fat and

may contain vitamin A, vitamin C, and

dietary fiber.

The agency believes that the

statement required by

§ 101.78(c)(2)(i)(C) is necessary to

describe the relationship between the

food and the disease. In the 1993 health

claims final rule, FDA stated that by

requiring that all characterizing

nutrients be identified as characteristic

of dietary patterns rich in fruits and

vegetables without specifically

attributing reduced cancer risk to a

single nutrient, the claim is consistent

with current scientific knowledge.

However, the requirement in

§ 101.78(c)(2)(i)(D) identifies for the

consumer which of the characterizing

nutrients is contributed by the labeled

food. FDA tentatively concludes that

this information need not be a required

element of the claim because it is

available as part of the nutrition label.

Therefore, the agency has tentatively

concluded that the information in

§ 101.78(c)(2)(i)(D) can be made

optional. Accordingly, the agency is

proposing to remove § 101.78(c)(2)(i)(D);

redesignate § 101.78(d)(3) through (d)(5)

as § 101.78(d)(4) through (d)(6), and add

new § 101.78(d)(3) which reads:

The claim may characterize fruits and

vegetables that meet the requirements

described in paragraph (c)(2)(ii) of this

section as foods that are low in fat and that

contain (or are a good source of) one or more

of vitamin A, vitamin C, or dietary fiber.

FDA is also proposing to revise the

model health claims in § 101.78(e) to

reflect these changes.

3. Abbreviated Health Claims

In addition to eliminating some of the

requirements for a full health claim, as

stated above, NFPA requested that FDA

permit the use of abbreviated health

claims in labeling, such as on the

principal display panel. FDA has

reviewed the health claims as it is

proposing to revise them to determine

whether the required elements can be

reorganized in accordance with

proposed § 101.14(d)(2)(iv) to facilitate

their use on the food label.

With the revisions to §§ 101.73,

101.74, 101.75, 101.76, 101.77, and

101.78 proposed in this document, the

agency tentatively finds that all of the

required elements for each of the claims

are required under section 403(a) of the

act to ensure that the claims are truthful

and not misleading as well as under

section 403(r) to ensure that they are

scientifically valid. Accordingly, the

agency tentatively concludes that there

is no basis upon which it can propose

to permit the splitting of these required

elements between the principal display

panel and another part of the food label.

Using the health claim for dietary fat

and cancer as an example, the agency is

proposing to remove the requirement

that the claim state that cancer is a

multifactorial disease. The remaining

specific requirements in

§ 101.73(c)(2)(i)(A) through (c)(2)(i)(E)

are necessary so that claims on the

relationship between dietary fat and

cancer are truthful, not misleading, and

scientifically valid. A claim consistent

with these requirements can be

expressed in 11 or fewer words (e.g., ‘‘A

low fat diet may reduce the risk of some

cancers’’). These requirements also

ensure that consumers will be able to

understand the relative significance of

the information presented in the claim

in the context of a total daily diet.

Accordingly, the agency tentatively

finds that there is no need to divide the

required elements of § 101.73 into those

that must be included whenever the

claim is presented and those that need

only be included as part of the full

claim. Based on the same reasoning,

FDA has reached the same judgment

about the elements of the claims

authorized by §§ 101.74 through 101.78.

The agency tentatively concludes,

however, that such a split is appropriate

among the required elements of health

claims on calcium and osteoporosis

(§ 101.72). The various proposed

revisions for the specific requirements

in § 101.72(c)(2)(i) would produce a

claim that is shorter than is provided for

in the current regulation. Nonetheless,

even with the proposed revisions, the

length of the claim that would be

required under § 101.72 is such that, to

facilitate use of the claim, FDA is

proposing to distinguish between those

elements necessary to ensure that the

claim is truthful and not misleading,

and those elements that are necessary to

understand the significance of the claim

in the context of the total daily diet.

Section 101.72(c)(2)(i)(A), which the

agency is proposing to revise, sets forth

the most important requirement. It

establishes the essence of the calcium/

osteoporosis claim in that it requires

clarity in a statement that associates

adequacy of dietary calcium intake over

a lifetime with a reduced risk of

osteoporosis, a degenerative disease that

affects more than 25 million Americans,

particularly postmenopausal women

and the elderly, and that is manifested

by an incidence of 1.5 million bone

fractures annually (Ref. 6). This

provision sets out information that is

fundamental if a claim associating

calcium and osteoporosis is to be

truthful and not misleading.

Section 101.72(c)(2)(i)(C), which

requires that the claim not attribute any

particular degree of risk reduction to

adequate calcium intake is also

necessary to ensure that claims are

truthful, not misleading, and

scientifically valid. Compliance with

this requirement, however, does not add

any words to the claim.

For the remaining requirements,

§ 101.72(c)(2)(i)(B) prohibits the

implication that risk for the disease

applies equally across the U.S.

population. Instead, it requires

identification of that segment of the

population that is most at risk for

developing the disease later in life,

women in their bone forming years. The

agency requires this information in

response to section 403(r)(3)(b)(iii) of

the act, which as stated above, requires

that the claim accurately represent the

relationship between calcium and

osteoporosis in a manner that is

comprehensible to the public. It is also

under section 403(r)(3)(b)(iii) of the act
Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules 66221

that FDA is requiring in

§ 101.72(c)(2)(i)(D) that the claim

disclose that further benefit does not

derive from a daily dietary intake of

calcium that exceeds 2,000 mg.

Given these bases for the calcium/

osteoporosis claim, an abbreviated claim

consistent with the principles proposed

earlier in this document may be

developed that sets out the information

required under § 101.72(c)(2)(i)(A) and

(c)(2)(i)(C). To reflect this fact, the

agency is proposing to renumber current

§ 101.72(c)(2)(ii), which deals with the

nature of a food bearing a calcium/

osteoporosis health claim, as

§ 101.72(c)(2)(iii), and it is proposing a

new § 101.72(c)(2)(ii) that describes how

the health claim is to be presented on

the label or in labeling. This proposed

new paragraph states that all of the

elements listed in § 101.72(c)(2)(i) must

be included in one presentation of the

claim on the label or labeling. However,

it also provides that a short, simple

statement of the claim that includes the

elements in § 101.72(c)(2)(i)(A) and

(c)(2)(i)(C), and thus that is truthful, not

misleading, and scientifically valid, may

be used on the principal display panel

as long as the full claim appears on the

label or in the labeling, and, there is a

referral statement to the full claim in

immediate proximity to the abbreviated

statement.

The referral statement that FDA is

proposing accompany the abbreviated

claim is consistent with that provided

for in the general requirements for

nutrient content claims (§ 101.13) and

health claims (§ 101.14(d)(2)(iv)).

Because this referral statement is short,

it is also consistent with the use of an

abbreviated claim.

In the 1993 health claims final rule,

the agency stated that it did not believe

that it is appropriate to use abbreviated

health claims as referral statements (58

FR 2478 at 2512). The agency was

concerned that an abbreviated claim did

not include facts that are material in

light of the representation that is made

and that are necessary to understand the

claim in the context of the daily diet.

The agency was concerned that such

confusion is possible whenever the full

health claim information is in a location

different from that of the reference

statement, and that such confusion is

especially likely to occur when a

multiplicity of labeling is associated

with a product. If these concerns can be

addressed, however, the use of an

abbreviated claim on the principal

display panel would facilitate use of the

claim and, as a result, the

communication of information that will

assist consumers in achieving healthful

dietary practices.

The agency has tentatively concluded

that this proposed rule addresses these

concerns. It is providing for an

abbreviated statement that reflects the

facts that are material under section

201(n) of the act (21 U.S.C. 321(n)) and

that are necessary to ensure that the

claim is scientifically valid. It is also

providing for an accompanying referral

statement to additional information that

is necessary for a full understanding of

the claim. The agency is concerned,

however, about the possibility that

consumers may not read the complete

claim, and thus that they will not have

all the facts necessary to fully

understand the significance of the claim

being made and to comprehend the

claim in the context of the daily diet.

For this reason, the agency is asking for

data to demonstrate that permitting an

abbreviated claim in the manner that

FDA has proposed will not significantly

decrease the likelihood that consumers

will read the full claim.

In § 101.72(c)(2)(ii)(A) and

(c)(2)(ii)(B), the agency is proposing

requirements for the type size and

location of the referral statement that are

consistent with those for nutrient

content claims in § 101.13(g)(1) and

(g)(2).

FDA has long held that accompanying

information should be in a size

reasonably related to that of the

information that it modifies. Section

403(f) of the act requires that

information required under the act be

placed on the label with such

conspicuousness as to render it likely to

be read. Section 403(r)(2)(B) of the act

requires that a referral statement for

nutrient content claims appear

prominently, although it does not

specify requirements such as to type

size or style.

For nutrient content claims, FDA

established type size requirements for

referral and disclosure statements that

are related to the area of the surface

bearing the principal display panel

rather than to the type size used for the

nutrient content claim. The

proportionality between size of the

referral statement and the size of the

label panel ensures that the referral

statement is presented with appropriate

prominence. However, when the claim

is less than twice what the minimum

size of the referral statement would be,

given the size of the label and

§ 101.105(i), the type size of the referral

statement may be less than that required

under § 101.105 for net quantity of

contents. In such circumstances, the

referral statement is of appropriate

prominence if it is at least one-half the

size of the claim and not less than onesixteenth of an inch. This approach to

the type size requirement for the referral

statement provides additional flexibility

to firms in utilizing label space but still

ensures adequate prominence for this

statement.

Because, under this proposal, health

claim referral statements are to be used

in a manner that is similar to how

nutrient content claim referral

statements are used, and because they

are likely to appear on the principal

display panel, the agency tentatively

concludes that a health claim referral

statement should be subject to the same

type size requirements as those for

nutrient content claims. Therefore, the

agency tentatively concludes that the

requirements for the referral statement

set forth in § 101.72(c)(2)(ii)(A) and

(c)(2)(ii)(B) are appropriate when an

abbreviated health claim is used, and it

is including them in this proposed rule.

In concert with the proposed

requirements for an abbreviated health

claim, the agency is including an

abbreviated health claim among the

examples of other model claims in

proposed § 101.72(e).

E. Disclosure Versus Disqualifying

Nutrient Levels for Health Claims

Section 403(r)(3)(A)(ii) of the act

provides that a health claim may only

be made for a food that ‘‘does not

contain, as determined * * * by

regulation, any nutrient in an amount

which increases to persons in the

general population the risk of a disease

or health-related condition which is diet

related, taking into account the

significance of the food in the total daily

diet.’’ This section helps to ensure that

consumers who rely on health claims

will be consuming foods that will assist

them in structuring a healthful diet that

meets dietary guidelines.

As discussed more fully in the

preamble to the 1993 health claims final

rule, the agency implemented this

provision by considering a food’s role in

the total daily diet and calculating

levels of total fat, saturated fat,

cholesterol, and sodium that would

increase the risk of disease or healthrelated conditions in the general

population. FDA calculated these levels

by considering the number of foods

consumed each day, as well as the

number of foods that are likely to

contain significant levels of these

nutrients.

The agency has established different

disqualifying levels for different types of

foods, depending on the role that they

play in the daily diet. Section

101.14(a)(5) defines the disqualifying

level for individual foods as 20 percent

of the DV’s for total fat, saturated fat,

cholesterol, and sodium. These levels
66222 Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules

translate to 13.0 grams (g) of total fat, 4.0

g of saturated fat, 60 mg of cholesterol,

and 480 mg of sodium per reference

amount customarily consumed, per

label serving size, and for foods with

reference amounts customarily

consumed of 30 g or less or 2

tablespoons or less, per 50 g. The

regulations make additional allowances

for main dish products and meal-type

products. The disqualifying levels for

main dish and meal products are 30

percent and 40 percent of the DV,

respectively. These different levels are

consistent with the legislative history,

which states, ‘‘a particular level of fat in

a frozen dinner might not trigger the

provision, whereas the same amount of

fat in a snack food might trigger it.’’

A food that exceeds the disqualifying

level for any of the four disqualifying

nutrients may not bear a health claim

unless the agency has granted an

exemption ‘‘based on a finding that such

a claim would assist consumers in

maintaining healthy dietary practices.’’

(Section 403(r)(3)(A)(ii) of the act.) To

date, the agency has received no

petitions for an exemption from this

provision.

The NFPA petition requested that the

defined disqualification levels be

converted to disclosure levels under

certain circumstances. More

specifically, the petition suggested that

‘‘the presence of one of these nutrients

at the prescribed level would require

disqualification only if the nutrient was

found in another health claim regulation

to be directly and adversely related to

the disease mentioned in the claim.’’

The petition went on to state that ‘‘[i]f

the nutrient is not so directly related to

the disease to which the claim refers,

the regulations would require only

disclosure by an appropriate referral

statement in conjunction with the

health claim on the label, as the

regulations now require for nutrient

content claims.’’

As stated in the May 11, 1995, letter

to NFPA, FDA concludes that a generic

change in its regulations would not be

consistent with the underlying goals of

the NLEA. The current disqualifying

levels assist consumers in constructing

total daily diets that meet dietary

guidelines. The agency considered the

role a food plays in the daily diet when

it calculated the disqualifying levels.

Health claims on foods with levels of

fat, saturated fat, cholesterol, or sodium

that exceed the disqualifying levels

would encourage increased intake of

these foods and would make it difficult

for consumers to follow the Surgeon

General’s recommendations and to

construct a healthful diet. Even with the

current disqualification levels,

consumers could reach the DV’s for total

fat, saturated fat, cholesterol, or sodium

by eating as few as five foods that bear

health claims.

The agency considers the current

disqualification rules to be consistent

with congressional intent. Congress

contemplated that health claims would

be reserved for those foods that can

contribute to a healthful diet. As the

House Report states, ‘‘Health claims

supported by a significant scientific

agreement can reinforce the Surgeon

General’s recommendations and help

Americans to maintain a balanced and

healthful diet.’’ (See H. Rept. 101–538,

101st Cong., 2d sess. pp. 9–10 (1990).)

Nevertheless, the agency tentatively

finds that there may be some instances

where disclosure rather than

disqualification is appropriate. While

FDA continues to believe that

exceptions should be granted on a caseby-case basis, using a petition process,

the agency recognizes that further

guidance on the criteria that it will use

to evaluate petitions for exceptions

would be useful. FDA is, therefore,

proposing to amend its regulations to

give such guidance.

Proposed § 101.70(f) provides

guidance for petitioners requesting an

exception to the prohibition in

§ 101.14(e)(3) against health claims for

foods exceeding the disqualifying levels

identified in § 101.14(a)(5). This

proposed amendment to the petition

procedures sets out some of the factors

that the agency will consider when

evaluating a petition.

The first factor that FDA is proposing

to list is whether the risk of the disease

or health-related condition is of such

public health significance, and the role

of the diet so critical, that

disqualification is not appropriate

(proposed § 101.70(f)(1)). The agency

recognizes that there may be instances

where extraordinary efforts are needed

to address a particular public health

problem. In such cases, the agency

would consider providing for disclosure

rather than disqualification levels.

The second factor is whether the

availability of foods that qualify for a

health claim is adequate to address the

public health concern that is the subject

of the health claim (proposed

§ 101.70(f)(2)). The agency intends to

consider whether the application of the

claim is so limited because of the

disqualification levels that it will not be

possible to meet the public health goal

of the health claim. If only a limited

number of food products qualify to bear

the claim because of the disqualifying

levels, the agency would consider

providing for disclosure rather than

disqualification levels.

The third factor that FDA intends to

consider is whether there is some

evidence that the population to which

the health claim is targeted is not at risk

for the disease or health-related

condition associated with the

disqualifying nutrient (proposed

§ 101.70(f)(3)). Although the current

disqualifying nutrients are associated

with diseases or health-related

conditions that pose risks to the general

population, there may be some

categories of foods that are targeted to

specific subpopulations that are not at

particular risk for the disease or healthrelated condition associated with the

disqualifying nutrient (toddlers, for

example). The agency would be willing

to look at data and to consider whether

an exception to the disqualifying levels

should be made for foods intended for

such subgroups.

Related to this criterion, is the

question of whether there is evidence

that consumers can identify themselves

as being at risk for a particular disease

or health-related condition associated

with the disqualifying levels. For

instance, some individuals can already

identify themselves as being sensitive to

sodium and, therefore, would recognize

the risk of a high sodium food if it were

disclosed. If the ability to self-identify

for these risks becomes widespread,

disclosure might be sufficient to reduce

the risk from the disqualifying nutrient.

FDA would expect to receive data that

demonstrate that this ability exists,

however, before it would be willing to

grant an exemption on this basis.

Finally, the agency intends to

consider whether there are any other

public health reasons for providing for

disclosure rather than disqualification

(proposed § 101.70(f)(4)). The agency

does not consider the above list of

criteria exhaustive. There may be other

criteria that would be useful in

determining whether the agency should

provide for disclosure rather that

disqualification levels for health claims,

and the agency is open to considering

such factors.

The agency requests comments on the

appropriateness of these criteria.

The agency notes that there are ways

to convey important health information

other than through health claims. A

food may still be able to bear a nutrient

content claim or a structure/function

claim in order to highlight a particular

attribute even if it exceeds the

disqualification level for a health claim.

For example, while whole milk may not

be able to bear a calcium and

osteoporosis health claim, it can still

bear a ‘‘high calcium’’ nutrient content

claim, so long as the levels of fat and

saturated fat are disclosed. Similarly,
Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules 66223

cooking oils that are lower in saturated

fat may not be able to bear a ‘‘healthy

heart’’ claim but can still bear a ‘‘low’’

or ‘‘less’’ saturated fat nutrient content

claim.

In addition, some products can make

other truthful and not misleading

claims. For example, the label of whole

milk can state ‘‘Calcium builds strong

bones.’’ While such a claim is not

considered a health claim under the

1990 amendments, it still conveys

important dietary advice useful to

consumers in constructing a healthful

diet.

V. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(11) 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 Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(Pub. L. 96–354). 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 proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

proposed rule is not a significant

regulatory action as defined by the

Executive Order and so is not subject to

review under the Executive Order.

FDA is proposing to: (1) Specify

circumstances under which synonyms

may be used, authorizing the use of

unlisted synonyms provided that they

are properly anchored to a listed term;

(2) exempt certain types of products

from the 10 percent nutrient

contribution requirement; (3) provide

the basis for shorter health claims by

eliminating some of the required

elements; and (4) permit an abbreviated

health claim to be used on the principal

display panel. FDA is also providing

guidance for petitioners requesting an

exception to the prohibition against

health claims for foods exceeding FDA’s

defined disqualifying levels. The agency

anticipates that the costs of this

proposed rule will be minimal. If this

rule is finalized as proposed, it will not

require any manufacturers currently

making claims to change their labels or

labeling. Also, this rule may reduce the

costs of making future claims by

reducing the uncertainty and relaxing

the requirements of the petition process

for claims.

Although many health claims have

appeared on a variety of products, the

agency is concerned that health claims

are not being used as extensively as they

could be. To the extent that valid claims

are not being used, a cost is imposed on

society in that some valuable

information may not be conveyed to

consumers. This proposed rule will

reduce the cost of lost beneficial

information by making it easier for firms

to make nutrient content and health

claims. The agency is aware that the

food label or labeling is a major means

of providing information on foods at the

point-of-purchase. By adopting a less

restrictive approach to claims, the

agency is providing industry with a

method by which the label can be used

to inform consumers of the health

benefits of foods in such a way that will

catch the attention of consumers. As

long as the claims are truthful, not

misleading, and scientifically valid, the

additional information will benefit

consumers by reinforcing the Surgeon

General’s recommendations and helping

consumers maintain healthful dietary

practices. In addition, the greater

flexibility provided to industry will

increase the incentive to develop more

healthful products.

The Regulatory Flexibility Act

requires analyzing options for regulatory

relief for small businesses. The current

claims regulations may have

discouraged small businesses from

making valid nutrient content claims

and health claims. To the extent that

this rule relaxes the restrictions on the

ability of firms to use claims on the

labels or in the labeling of their

products, this rule will benefit small

firms. In accordance with the Regulatory

Flexibility Act, the agency certifies that

the proposed rule will not have a

significant economic impact on a

substantial number of small businesses.

VII. Paperwork Reduction Act

FDA tentatively concludes that this

proposed rule contains no reporting,

recordkeeping, labeling, or other third

party disclosure requirements; thus

there is not ‘‘information collection’’

necessitating clearance by the Office of

Management and Budget. However, to

ensure the accuracy of this tentative

conclusion, FDA is seeking comment on

whether this proposed rule to permit

additional flexibility in the use of health

claims and synonyms for nutrient

content claims on food labels imposes

any paperwork burden.

VIII. Comments

Interested persons may, on or before

March 20, 1996, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. 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.

IX. References

The following references have 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. House Committee on Energy and

Commerce, ‘‘Nutrition Labeling and

Education Act of 1990,’’ 101st Congress, 2d

sess., Report 101–538, pp. 9–10, June 13,

1990.

2. Committee on the Nutrition Components

of Food Labeling, Food and Nutrition Board,

IOM, National Academy of Science,

‘‘Nutrition Labeling, Issues and Directions for

the 1990’s,’’ Washington, DC, National

Academy Press, 1990.

3. United States Department of Agriculture,

Human Nutrition Information Services,

‘‘USDA’s Food Guide Pyramid,’’ Home and

Garden Bulletin No. 249, April, 1992.

4. ‘‘The Surgeon General’s Report on

Nutrition and Health,’’ DHHS, Public Health

Service Publication No. 88–50210

(Government Printing Office Stock No. 017–

001–00465–1), U.S. Government Printing

Office, Washington, DC, 1988.

5. Committee on Diet and Health, Food and

Nutrition Board, Commission on Life

Sciences, National Research Council,

National Academy of Science, ‘‘Diet and

Health: Implications for Reducing Chronic

Disease Risk,’’ National Academy Press,

Washington, DC, 1989.

6. National Institutes of Health, Office of

the Director, ‘‘NIH Consensus Statement,

Optimal Calcium Intake,’’ vol. 12, No. 4, June

6–8, 1994. Available from: NIH Consensus

Program Information Service, P.O. Box 2577,

Kensington, MD 20891, 1–800–644–6627.

7. Levy, A., Food and Drug Administration,

Center for Food Safety and Applied

Nutrition, Division of Market Studies,

‘‘Summary Report on Health Claims Focus

Groups,’’ June 15, 1995.

8. Dietary Supplement Health and

Education Act of 1994 (Pub. L. 103–417),

October 25, 1994.

9. Technical Report—Cancer Prevention

Awareness Survey—Wave II, Office of Cancer

Communications, National Cancer Institute,

National Institutes of Health, Bethesda, MD,

November 1986.

10. Brenda Derby, Memorandum to Victor

Frattali, ‘‘Consumer Understanding of
66224 Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules

Multifactoriality of Disease,’’ October 25,

1995.

List of Subjects in 21 CFR Part 101

Food labeling, Nutrition, Reporting

and recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 101 be amended as follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: Secs. 4, 5, 6 of the Fair

Packaging and Labeling Act (15 U.S.C. 1453,

1454, 1455); secs. 201, 301, 402, 403, 409,

701 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 331, 342, 343, 348, 371).

2. Section 101.13 is amended by

revising the introductory text of

paragraph (b) and adding new paragraph

(r) to read as follows:

§ 101.13 Nutrient content claims—general

principles.

* * * * *

(b) A claim that expressly or

implicitly characterizes the level of a

nutrient (nutrient content claim) of the

type required in nutrition labeling

under § 101.9 with the exception of

such claims on restaurant menus and

except as noted in paragraph (r) of this

section for unlisted synonyms, may not

be made on the label or in labeling of

foods unless the claim is made in

accordance with this regulation and

with the applicable regulations in

subpart D of this part or in part 105 or

part 107 of this chapter.

* * * * *

(r) Expressed synonyms for nutrient

content claims may be used, provided:

(1) The term is listed as a synonym of

a defined term in the regulations in

subpart D of this part or in part 105 or

part 107 of this chapter; or

(2) The term is used in a manner that

complies with the following

requirements:

(i) Such term is not misleading and,

in the context of the entire label, is

reasonably understood by consumers to

be a synonym of a term listed in subpart

D of this part or in part 105 or part 107

of this chapter;

(ii)(A) The term that is listed in

subpart D of this part or in part 105 or

part 107 of this chapter, and for which

the unlisted term is being used as a

synonym, appears prominently and

conspicuously on the label, such that it

is:

(1) Immediately adjacent (with no

intervening material) to the most

prominent use of the unlisted synonym

(as determined in accordance with

§ 101.13(j)(2)(iii)); and

(2) At least half as prominent

(including type size, style, and color) as

the unlisted synonym authorized under

this paragraph.

(B) If the term listed in subpart D of

this part or in part 105 or part 107 of

this chapter is more than twice as

prominent on a label as the synonym

authorized under this paragraph such

that the claimed nutrient level is clearly

understood (e.g., a claim in the

statement of identity versus an unlisted

synonym used only in a paragraph in

small sized type), the term listed in

subpart D of this part or in part 105 or

part 107 of this chapter need not be

placed adjacent to the unlisted synonym

authorized under this paragraph.

(iii) The unlisted synonym is used in

conformance with all the requirements

for the use of the defined term, i.e., the

referral statement required in § 101.13(g)

and any other required label statements

appear in the prescribed manner; and

(iv) This paragraph does not authorize

a term listed in subpart D of this part or

in part 105 or part 107 of this chapter

to be used in conjunction with an

unlisted qualifying term (e.g., ‘‘extra

low,’’ ‘‘extra high,’’ ‘‘especially good

source,’’ or ‘‘great source’’).

3. Section 101.14 is amended by

revising paragraphs (d)(2)(iv) and (e)(6)

to read as follows:

§ 101.14 Health claims: general

requirements.

* * * * *

(d) * * *

(2) * * *

(iv) All information required to be

included in the claim appears in one

place without other intervening

material, except that the principal

display panel of the label or labeling

may bear:

(A) The reference statement,

‘‘See————— for information about

the relationship between———— and

————— ,’’ with the blanks filled in

with the location of the labeling

containing the health claim, the name of

the substance, and the name of the

disease or health-related condition (e.g.,

‘‘See attached pamphlet for information

about calcium and osteoporosis’’), with

the entire claim appearing elsewhere on

the other labeling, Provided that, where

any graphic material (e.g., a heart

symbol) constituting an explicit or

implied health claim appears on the

label or labeling, the reference statement

or the complete claim shall appear in

immediate proximity to such graphic

material; or

(B) As authorized under subpart E of

this part, an abbreviated claim

consisting only of a truthful,

nonmisleading, and scientifically valid

description of the relationship between

the substance and the disease or healthrelated condition, Provided that:

(1) Such an abbreviated claim is

accompanied by a reference statement to

the complete health claim;

(2) The reference statement is

prominent and in immediate proximity

to the abbreviated claim; and

(3) The complete health claim appears

on the same label, or in the same

labeling, in which the abbreviated claim

appears.

* * * * *

(e) * * *

(6) Except for dietary supplements,

fruit or vegetable products composed

solely of fruits and vegetables, enriched

grain products that conform to a

standard of identity in part 136, 137, or

139 of this chapter, and bread which

conforms to the standard of identity for

enriched bread in § 136.115 of this

chapter except that it contains whole

wheat or other grain products not

permitted under that standard, or where

provided for in other regulations in part

101, subpart E, the food contains 10

percent or more of the Reference Daily

Intake or Daily Reference Value for

vitamin A, vitamin C, iron, calcium,

protein, or fiber per reference amount

customarily consumed prior to any

nutrient addition.

* * * * *

4. Section 101.70 is amended in

paragraph (f) by adding in the model

petition new text immediately

preceding the last undesignated

paragraph of section B to read as

follows:

§ 101.70 Petitions for health claims.

* * * * *

(f) * * *

B. * * *

In deciding the merits of a petition

filed for an exception to the prohibition

in § 101.14(e)(3) against health claims

for foods exceeding the disqualifying

levels identified in § 101.14(a)(5), the

agency will consider the following

factors:

1. The public health significance of

the risk of the disease or health-related

condition that is the subject of the claim

and the role that the diet plays in

decreasing that risk;

2. The availability of foods that

qualify for a claim to address the

underlying public health concerns;

3. Evidence demonstrating the

population to which the health claim is

targeted is not at risk for the disease or

health-related condition associated with

the disqualifying nutrient, including,
Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules 66225

but not limited to, the ability of

individuals to identify themselves as

being at risk for the disease or healthrelated condition associated with the

disqualifying nutrient; and

4. All other evidence demonstrating

the public health need for waiving the

disqualification requirements.

* * * * *

5. Section 101.72 is amended by

revising paragraph (c)(2)(i); by

redesignating paragraphs (c)(2)(ii) and

(d)(2) as (c)(2)(iii) and (d)(5),

respectively; by adding new paragraphs

(c)(2)(ii), (d)(2), (d)(3), and (d)(4); and by

revising paragraph (e) to read as follows:

§ 101.72 Health claims: calcium and

osteoporosis.

* * * * *

(c)(2) Specific requirements. (i)

Nature of the claim. A health claim

associating calcium with a reduced risk

of osteoporosis may be made on the

label or labeling of a food described in

paragraph (c)(2)(iii) of this section,

provided that:

(A) The claim makes clear that

adequate calcium intake as part of a

healthful diet throughout life is

essential to reduce the risk of

osteoporosis. The claim does not imply

that adequate dietary calcium intake is

the only recognized risk factor for the

development of osteoporosis;

(B) The claim does not state or imply

that the risk of osteoporosis is equally

applicable to the general United States

population. The claim shall identify the

population at particular risk for the

development of osteoporosis as women

in their bone forming years from

approximately 11 to 35 years of age. An

optional statement that further

characterizes this and other populations

at risk for developing osteoporosis may

be made in accordance with paragraph

(d)(3) of this section;

(C) The claim does not attribute any

degree to which maintaining adequate

calcium intake throughout life may

reduce the risk of osteoporosis; and

(D) The claim states that total dietary

intake of calcium greater than 2,000

milligrams (mg) per day (200 percent of

the DV for calcium for adults and

children 4 or more years of age or 154

percent of the daily value (DV) for

pregnant or lactating women) provides

no further benefit to bone health in

reducing the risk of osteoporosis. This

requirement does not apply to a food

that provides 1,500 mg or less of

calcium per day (150 percent or less of

the DV for calcium for adults and

children 4 or more years of age or 115

percent or less of the DV for pregnant or

lactating women) when used as directed

in labeling.

(ii) Presentation of the claim. All of

the elements listed in paragraph (c)(2)(i)

of this section must be included in one

presentation of the claim displayed

prominently on the label or labeling on

which the claim appears. Other

presentations of the claim on that label

or labeling, including on the principal

display panel, need not include the

information in paragraphs (c)(2)(i)(B)

and (c)(2)(i)(D) of this section provided

that, displayed prominently and in

immediate proximity to such claim, the

following referral statement is used:

‘‘See ———— for more information’’

with the blank filled in with the identity

of the panel on which is presented the

statement of the claim that includes all

of the elements in paragraph (c)(2)(i) of

this section.

(A)The referral statement ‘‘See

[appropriate panel] for more

information’’ shall be in easily legible

boldface print or type, in distinct

contrast to other printed or graphic

matter, that is no less than that required

by § 101.105(i) for net quantity of

contents, except where the size of the

claim is less than two times the required

size of the net quantity of contents

statement, in which case the referral

statement shall be no less than one-half

the size of the claim but no smaller than

one-sixteenth of an inch.

(B) The referral statement shall be

immediately adjacent to any

presentation of the health claim that

does not include all of the elements of

paragraph (c)(2)(i) of this section, and

there may be no intervening material

between the claim and the referral

statement. If the abbreviated health

claim appears on more than one panel

of the label, the referral statement shall

be adjacent to the claim on each panel

except for the panel that bears the full

health claim where it may be omitted.

* * * * *

(d) * * *

(2) The claim may list specific risk

factors for osteoporosis, identifying

them among the multifactorial risks for

the disease. Such factors include a

person’s sex, age, and race. The claim

may state that an adequate amount of

exercise is also needed to reduce risk for

the disease.

(3) The claim may further identify the

population at particular risk for the

development of osteoporosis as

including white (or ‘‘Caucasian’’)

women and Asian women in their bone

forming years (approximately 11 to 35

years of age). The claim may also

identify menopausal (or the term

‘‘middle-aged’’) women, persons with a

family history of the disease, and

elderly (or ‘‘older’’) men and women as

being at risk.

(4) The claim may state that adequate

calcium 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. When

reference is made to persons with a

family history of the disease,

menopausal women, and elderly men

and women, the claim may also state

that adequate calcium intake is linked to

reduced risk of osteoporosis through the

mechanism of slowing the rate of bone

loss.

* * * * *

(e) Model health claims. The

following are examples of model health

claims that may be used in food labeling

to describe the relationship between

calcium and osteoporosis:

(1) Examples 1 and 2. Model health

claims for a food that does not require

the statement specified in paragraph

(c)(2)(i)(D) of this section:

Especially for teen and young adult

women, adequate calcium in a healthful diet

may reduce the risk of osteoporosis later in

life.

A healthful diet with adequate calcium and

regular exercise help teen and young adult

white and Asian women maintain good bone

health and may reduce their high risk of

osteoporosis later in life.

(2) Example 3. Model health claims

for a food labeled for use by adults and

children 4 or more years of age that

requires the statement specified in

paragraph (c)(2)(i)(D) of this section:

Exercise and a healthful diet with enough

calcium may help teen and young adult

women reduce their high risk of osteoporosis

later in life. Adequate calcium is important

for everyone (women and men at all ages) but

daily intakes above 2,000 mg (200 percent of

the DV) may not provide added benefit.

(3) Example 4. Abbreviated model

health claim for use with a full health

claim and that conforms with the

requirements of paragraph (c)(2)(ii) of

this section:

Adequate calcium in a healthful diet may

reduce the risk of osteoporosis. See

[appropriate panel] for more information.

6. Section 101.73 is amended by

revising paragraphs (c)(2)(i)(F), (d)(1),

and (e)(1) to read as follows:

§ 101.73 Health claims: dietary lipids and

cancer.

* * * * *

(c) * * *

(2) * * *

(i) * * *

(F) The claim does not imply that

dietary fat consumption is the only
66226 Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules

recognized risk factor for the

development of cancer.

* * * * *

(d) Optional information. (1) The

claim may indicate that development of

cancer depends on many factors and

identify one or more of the following as

risk factors for the disease: Family

history of a specific type of cancer,

cigarette smoking, alcohol consumption,

overweight and obesity, ultraviolet or

ionizing radiation, exposure to cancercausing chemicals, and dietary factors.

* * * * *

(e) * * *

(1) A low fat diet may reduce the risk

of some cancers.

* * * * *

7. Section 101.74 is amended by

revising paragraphs (c)(2)(i)(E), (d)(1),

(e)(1), and (e)(2) to read as follows:

§ 101.74 Health claims: sodium and

hypertension.

* * * * *

(c) * * *

(2) * * *

(i) * * *

(E) The claim does not imply that

dietary sodium consumption is the only

recognized risk factor for the

development of high blood pressure.

* * * * *

(d) Optional information. (1) The

claim may indicate that development of

high blood pressure depends on many

factors and identify one or more of the

following as risk factors for the disease

in addition to dietary sodium

consumption: Family history of high

blood pressure, growing older, alcohol

consumption, and excess weight.

* * * * *

(e) * * *

(1) A low sodium diet may reduce the

risk of high blood pressure.

(2) [This product] can be part of a low

sodium, low salt diet that might reduce

the risk of hypertension or high blood

pressure.

8. Section 101.75 is amended by

revising paragraphs (c)(2)(i)(E), (d)(1),

(e)(1), and (e)(2) to read as follows:

§ 101.75 Health claims: dietary saturated

fat and cholesterol and risk of coronary

heart disease.

* * * * *

(c) * * *

(2) * * *

(i) * * *

(E) The claim does not imply that

consumption of dietary saturated fat and

cholesterol is the only recognized risk

factor for the development of coronary

heart disease.

* * * * *

(d) Optional information. (1) The

claim may indicate that coronary heart

disease risk depends on many factors

and identify one or more of the

following in addition to saturated fat

and cholesterol about which there is

general scientific agreement that they

are major risk factors for this disease: A

family history of coronary heart disease,

elevated blood total and LDLcholesterol, excess body weight, high

blood pressure, cigarette smoking,

diabetes, and physical inactivity.

* * * * *

(e) * * *

(1) Diets low in saturated fat and

cholesterol may reduce the risk of heart

disease;

(2) Your risk of heart disease might be

reduced by a diet low in saturated fat

and cholesterol and a healthy lifestyle;

* * * * *

9. Section 101.76 is amended by

revising paragraphs (c)(2)(i)(D), (d)(2),

(e)(1), and (e)(2) to read as follows:

§ 101.76 Health claims: fiber-containing

grain products, fruits, and vegetables and

cancer.

* * * * *

(c) * * *

(2) * * *

(i) * * *

(D) The claim does not imply that

consumption of diets low in fat and

high in fiber-containing grain products,

fruits, and vegetables is the only

recognized risk factor for a reduced risk

of developing cancer.

* * * * *

(d) * * *

(2) The claim may indicate that

development of cancer depends on

many factors and identify one or more

of the following as risk factors for the

disease: Family history of a specific type

of cancer, cigarette smoking, alcohol

consumption, overweight and obesity,

ultraviolet or ionizing radiation,

exposure to cancer-causing chemicals,

and dietary factors.

* * * * *

(e) * * *

(1) Low fat diets rich in fibercontaining grain products, fruits, and

vegetables may reduce the risk of some

types of cancer.

(2) A diet low in fat and high in grain

products, fruits, and vegetables that

contain fiber may reduce your risk of

some cancers.

* * * * *

10. Section 101.77 is amended by

revising paragraphs (c)(2)(i)(F), (d)(1),

and (e) to read as follows:

§ 101.77 Health claims: fruits, vegetables,

and grain products that contain fiber,

particularly soluble fiber, and risk of

coronary heart disease.

(c) * * *

(2) * * *

(i) * * *

(F) The claim does not imply that

consumption of diets low in saturated

fat and cholesterol and high in fruits,

vegetables, and grain products that

contain fiber, particularly soluble fiber,

is the only recognized risk factor for a

reduced risk of developing coronary

heart disease.

* * * * *

(d) Optional information. (1) The

claim may indicate that development of

coronary heart disease depends on

many factors and identify one or more

of the following as risk factors for the

disease: A family history of coronary

heart disease, elevated blood-, total- and

LDL-cholesterol, excess body weight,

high blood pressure, cigarette smoking,

diabetes, and physical inactivity.

* * * * *

(e) Model health claims. The

following model health claims may be

used in food labeling to characterize the

relationship between diets low in

saturated fat and cholesterol and high in

fruits, vegetables, and grain products

that contain soluble fiber and the risk of

coronary heart disease:

(1) Diets low in saturated fat and

cholesterol and rich in fiber-containing

fruits, vegetables, and grain products

may reduce the risk of heart disease.

(2) A diet low in saturated fat and

cholesterol and high in fruits,

vegetables, and grain products that

contain fiber may lower blood

cholesterol levels and reduce your risk

of heart disease.

11. Section 101.78 is amended by

removing paragraph (c)(2)(i)(D); by

redesignating paragraphs (c)(2)(i)(E)

through (c)(2)(i)(J) and (d)(3) through

(d)(5) as (c)(2)(i)(D) through (c)(2)(i)(I)

and (d)(4) through (d)(6), respectively;

by revising newly redesignated

paragraph (c)(2)(i)(I), paragraphs (d)(2),

(e)(1), and (e)(2); and by adding new

paragraph (d)(3) to read as follows:

§ 101.78 Health claims: fruits and

vegetables and cancer.

* * * * *

(c) * * *

(2) * * *

(i) * * *

(I) The claim does not imply that

consumption of diets low in fat and

high in fruits and vegetables is the only

recognized risk factor for a reduced risk

of developing cancer.

* * * * *
Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules 66227

(d) * * *

(2) The claim may indicate that

development of cancer depends on

many factors and identify one or more

of the following as risk factors for the

disease: Family history of a specific type

of cancer, cigarette smoking, alcohol

consumption, overweight and obesity,

ultraviolet or ionizing radiation,

exposure to cancer-causing chemicals,

and dietary factors.

(3) The claim may characterize fruits

and vegetables that meet the

requirements described in paragraph

(c)(2)(ii) of this section as foods that are

low in fat and that contain (or are a good

source of) one or more of vitamin A,

vitamin C, or dietary fiber.

* * * * *

(e) * * *

(1) Low fat diets rich in fruits and

vegetables (foods that are low in fat and

may contain dietary fiber, vitamin A

and vitamin C), may reduce the risk of

some types of cancer.

(2) A diet low in fat and high in

certain fruits and vegetables, foods that

are low in fat and that may contain

vitamin A and vitamin C, may reduce

your risk of some cancer.

Dated: December 13, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–31008 Filed 12–20–95; 8:45 am]

BILLING CODE 4160–01–F

Food and Drug Administration

21 CFR Part 888

[Docket No. 95N–0176]

Orthopedic Devices: Classification,

Reclassification, and Codification of

Pedicle Screw Spinal Systems;

Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting

certain statements in the preamble to a

proposed rule that appeared in the

Federal Register of October 4, 1995 (60

FR 51946). The document proposed to

classify certain unclassified

preamendments pedicle screw spinal

systems into class II (special controls),

and to reclassify certain

postamendments pedicle screw spinal

systems from class III (premarket

approval) to class II. The document

states further that FDA is issuing for

public comment the recommendations

of the Orthopedic and Rehabilitation

Devices Panel (the Panel) concerning

the classification/reclassification of

pedicle screw spinal systems, and the

agency’s tentative findings on the

Panel’s recommendations. The

document is being corrected to reflect

an accurate description of the formation,

membership, and activities of the Spinal

Implant Manufacturers Group (SIMG),

and the Scientific Committee, two

separate entities established by the

spinal implant manufacturers and

medical professional societies to collect

and submit to FDA all available valid

scientific data on the performance of

pedicle screw spinal devices.

FOR FURTHER INFORMATION CONTACT:

Mark N. Melkerson, Center for Devices

and Radiological Health (HFZ–410),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2036.

In the FR Doc. 95–24686, appearing

on page 51946 in the Federal Register

of Wednesday, October 4, 1995, the

following corrections are made:

1.On page 51947, in the second

column, in the fourth paragraph,

beginning in line 7, the second, third,

and fourth sentences are removed and

the following text is added in their place

to read as follows:

In response, two groups were

founded: The Spinal Implant

Manufacturers Group (SIMG), and the

Scientific Committee. SIMG, founded by

16 medical device manufacturers,

agreed to provide the funding that

would be required to conduct a

nationwide study of pedicle screw

devices. The Scientific Committee was

formed by five professional medical

societies, including the North American

Spine Society, the American Academy

of Orthopedic Surgeons, the Scoliosis

Research Society, the Congress of

Neurosurgeons, and the American

Association of Neurological Surgeons.

The Scientific Committee was formed to

develop and implement a uniform

research protocol to gather clinical

experience from the use of the device.

The Scientific Committee consisted of

four surgeons and two nonvoting SIMG

representatives, a biostatistician, and a

clinical/regulatory affairs professional.

2. On page 51947, in the third

column, in the first paragraph,

beginning in the fifteenth line, the

fourth and fifth sentences are removed

and the following text is added in their

place to read as follows:

At this meeting, the Scientific

Committee presented clinical data from

its nationwide ‘‘Historical Cohort Study

of Pedicle Screw Fixation in Thoracic,

Lumbar, and Sacral Spinal Fusions’’

(Cohort Study). FDA presented a

comprehensive review of the medical

literature, an analysis of the medical

literature, an analysis of the Cohort

study conducted by the Scientific

Committee, and a summary of the

clinical data that had been released by

IDE sponsors.

3. On page 51950, in the first column,

in the fourth paragraph, in the first line,

the abbreviation ‘‘SIMG’’ is corrected to

read ‘‘Scientific Committee’’.

Dated: December 8, 1995.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 95–31047 Filed 12–20–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[INTL–52–86]

RIN 1545–AL99

Statements to Recipients of Dividends

and Patronage Dividends

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Partial withdrawal of a notice of

proposed rulemaking.

SUMMARY: This document withdraws a

portion of the notice of proposed

rulemaking under sections 6042 and

6044 of the Internal Revenue Code that

was published in the Federal Register

on February 29, 1988, as proposed to be

amended on September 27, 1990. The

proposed regulations prescribed rules

for official statements to recipients of

dividends and patronage dividends paid

after December 31, 1983.

DATES: This withdrawal is effective on

December 21, 1995.

FOR FURTHER INFORMATION CONTACT:

Renay France, (202)622–4910 (not a tollfree number).

SUPPLEMENTARY INFORMATION:

Background

On February 29, 1988, the IRS issued

proposed regulations on backup

withholding (INTL–52–86, 53 FR 5991).

The proposed regulations related, in

part, to official statements to recipients

of dividends and patronage dividends

under sections 6042 and 6044,

respectively (proposed §§ 1.6042–5 and

1.6044–6). On September 27, 1990, the

IRS issued additional proposed

regulations on backup withholding (IA–

224–82, 55 FR 39427). Those proposed