23624 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N–0044]

RIN 0910–AA59

Regulations on Statements Made for

Dietary Supplements Concerning the

Effect of the Product on the Structure

or Function of the Body

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing

regulations defining the types of

statements that can be made concerning

the effect of a dietary supplement on the

structure or function of the body. The

proposed regulations also establish

criteria for determining when a

statement about a dietary supplement is

a claim to diagnose, cure, mitigate, treat,

or prevent disease. This action is

intended to provide direction to the

dietary supplement industry and to

respond to guidance on this issue

provided by the Commission on Dietary

Supplement Labels (the Commission).

DATES: Written comments and

recommendations by August 27, 1998.

ADDRESSES: Submit written comments

and recommendations to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Jeanne Latham, Center for Food Safety

and Applied Nutrition (HFS–456), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4697.

SUPPLEMENTARY INFORMATION:

I. Introduction

The Dietary Supplement Health and

Education Act of 1994 (the DSHEA)

authorizes manufacturers of dietary

supplements to make certain types of

statements about the uses of their

products. Among the types of permitted

statements are certain claims that, prior

to enactment of the DSHEA, could have

rendered the product a ‘‘drug’’ under

the Federal Food, Drug, and Cosmetic

Act (the act). Specifically, section

403(r)(6) of the act (21 U.S.C. 341(r)(6)),

added by the DSHEA, allows dietary

supplement labeling to bear a statement

that ‘‘describes the role of a nutrient or

dietary ingredient intended to affect the

structure or function in humans’’ or that

‘‘characterizes the documented

mechanism by which a nutrient or

dietary ingredient acts to maintain such

structure or function.’’ These types of

claims are generally referred to as

‘‘structure/function claims.’’

Certain other types of statements

about dietary supplements continue,

under the DSHEA, to cause the product

to be regulated as a drug. Statements

permitted under section 403(r)(6) of the

act ‘‘may not claim to diagnose,

mitigate, treat, cure, or prevent a

specific disease or class of diseases,’’

except that such statements may claim

a benefit related to a classical nutrient

deficiency disease, provided that they

also disclose the prevalence of the

disease in the United States. Such

statements are generally referred to as

‘‘disease claims.’’ FDA notes that certain

statements that pertain to a disease or

health-related condition are permitted

on food products, including dietary

supplements. These statements are

known as health claims (see section

403(r)(1)(B) of the act) and describe the

relationship between a nutrient and a

disease or health-related condition.

Unlike structure/function claims, health

claims must be authorized by FDA

before they may be used on the label or

in the labeling of a food or dietary

supplement (see section 403(r)(3) and

(r)(4) and 21 CFR 101.14 and 101.70).

Thus, certain claims about disease may

be made for foods and dietary

supplements without causing these

products to be regulated as drugs,

provided the claim has been authorized

for use by FDA in accordance with the

applicable regulations. FDA also notes

that a dietary supplement for which

only structure/function claims are made

in the label or labeling in accord with

section 403(r) of the act may

nevertheless be subject to regulation as

a drug if the agency has other evidence

(see 21 CFR 201.128) that the intended

use of the product is for the diagnosis,

cure, mitigation, treatment, or

prevention of disease.

A dietary supplement manufacturer

who wishes to make a permitted

structure/function statement under

section 403(r)(6) of the act must have

substantiation that the statement is

truthful and not misleading, and must

include in the statement the following

disclaimer: ‘‘This statement has not

been evaluated by the Food and Drug

Administration. This product is not

intended to diagnose, treat, cure, or

prevent any disease.’’ The DSHEA

requires the manufacturer of a dietary

supplement bearing a statement under

section 403(r)(6) of the act to notify

FDA, no later than 30 days after the first

marketing of the dietary supplement

with the statement, that such a

statement is being made for the product.

Regulations implementing these

requirements were published in the

Federal Register of September 23, 1997,

and are codified at § 101.93 (21 CFR

101.93) (62 FR 49859 at 49883,

September 23, 1997, OMB Control

Number 0910–0351).

Diseases, by definition, adversely

affect some structure or function of the

body, and it is possible to describe most

products intended to treat or prevent

disease in terms of their effects on the

structure or function of the body. The

DSHEA, thus, does not authorize the use

of all claims that describe the effect of

a dietary supplement on the structure or

function of the body. Instead, section

403(r)(6) of the act authorizes only those

structure/function claims that describe

an effect of a product on the structure

or function of the body but that are not

also disease claims. Because the

distinction between allowable structure/

function claims and disease claims is

not always obvious, the dietary

supplement industry has requested

clarification from FDA on structure/

function claims that can be made for

dietary supplements under section

403(r)(6) of the act. To develop

clarifying criteria for such claims, FDA

has reviewed the notification letters that

have been submitted to FDA under

section 403(r)(6) of the act. In addition,

FDA has reviewed the report of the

Commission, which was established by

the DSHEA to provide guidance and

recommendations for the regulation of

label claims and statements for dietary

supplements.

The Commission issued a draft report

(the draft report) on June 24, 1997,

among other things, the report included

the Commission’s views on ‘‘what

constitutes an acceptable statement

* * * of the structure/function type’’

(the draft report, p. 36). The

Commission received public comment

on the draft report and issued a final

report (the report) on November 24,

1997. Guidance in the report

‘‘represents advice to specific agencies,

groups, or individuals. Guidance should

be considered by the identified

recipients as they develop or implement

activities related to the availability of

dietary supplements in the

marketplace’’ (the report, p. vi).

The Commission’s final report

contains the following guidance (the

guidance) on the scope of permissible

structure/function claims:

GUIDANCE

• While the Commission recognizes that

the context of a claim has to be considered

on a case-by-case basis, the Commission

proposes the following general guidelines:
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations 23625

1The report refers to statements under section

403(r)(6) of the act as ‘‘statements of nutritional

support.’’ As noted in a September 23, 1997 final

rule regarding labeling claims for dietary

supplements, FDA no longer uses the term

‘‘statements of nutritional support’’ because many

of the substances that can be the subject of this type

of claim have no nutritional value. Thus, the term

‘‘statement of nutritional support’’ is not accurate

in all instances (62 FR 49859 at 49863).

1. Statements of nutritional support should

provide useful information to consumers

about the intended use of a product.

2. Statements of nutritional support should

be supported by scientifically valid evidence

substantiating that the statements are truthful

and not misleading.

3. Statements indicating the role of a

nutrient or dietary ingredient in affecting the

structure or function of humans may be made

when the statements do not suggest disease

prevention or treatment.

4. Statements that mention a body system,

organ, or function affected by the supplement

using terms such as ‘‘stimulate,’’ ‘‘maintain,’’

‘‘support,’’ ‘‘regulate,’’ or ‘‘promote’’ can be

appropriate when the statements do not

suggest disease prevention or treatment or

use for a serious health condition that is

beyond the ability of the consumer to

evaluate.

5. Statements should not be made that

products ‘‘restore’’ normal or ‘‘correct’’

abnormal function when the abnormality

implies the presence of disease. An example

might be a claim to ‘‘restore’’ normal blood

pressure when the abnormality implies

hypertension.

6. Health claims are specifically defined

under NLEA as statements that characterize

the relationship between a nutrient or a food

component and a specific disease or healthrelated condition. Statements of nutritional

support should be distinct from NLEA health

claims in that they do not state or imply a

link between a supplement and prevention of

a specific disease or health-related condition.

7. Statements of nutritional support are not

to be drug claims. They should not refer to

specific diseases, disorders, or classes of

diseases and should not use drug-related

terms such as ‘‘diagnose,’’ ‘‘treat,’’ ‘‘prevent,’’

‘‘cure,’’ or ‘‘mitigate.’’

(The report, pp. 38–39).

The guidance thus focuses on the

distinction between allowable structure/

function claims and claims that a

product can diagnose, treat, prevent,

cure, or mitigate disease (disease

claims), and makes clear that structure/

function claims made for dietary

supplements should not imply

treatment or prevention of disease. The

guidance also provides examples of

types of structure/function claims that

do and do not imply disease claims. In

its findings, the Commission expressed

the view that ‘‘guidance by FDA to

manufacturers making statements

[under section 403(r)(6) of the act]1 is

appropriate and helpful in clarifying the

appropriate scope of these statements’’

(the report, p. 38).

FDA agrees with the Commission that

an acceptable structure/function claim

must not imply prevention or treatment

of disease. FDA believes that the

Commission’s guidelines provide a

useful framework for clarifying the

sometimes difficult distinction between

structure/function claims and disease

claims. Based upon the Commission’s

advice and the agency’s experience in

reviewing notification letters submitted

under section 403(r)(6) of the act, FDA

has developed proposed regulations to

define the types of claims that are

‘‘disease claims’’ and thus not

acceptable as structure/function claims.

II. Provisions of the Proposed Rule and

Guidance

As described in section I of this

document, the manufacturer of a dietary

supplement may make a truthful,

nonmisleading labeling statement

claiming that the product affects the

structure or function of the body, unless

the statement expressly or implicitly

claims an effect on a disease or class of

diseases (other than a classical nutrient

deficiency disease). Therefore, to

determine the scope of structure/

function claims that may be made for a

dietary supplement, it is necessary to

define the types of claims about the

effects of a product that are prohibited

disease claims. The proposed rule is

designed to provide criteria for

determining when a statement about a

product constitutes a disease claim.

The agency used several methods and

sources to develop the proposed criteria

for discerning which categories of

labeling statements constitute express or

implied claims that a product can

diagnose, cure, mitigate, treat or prevent

disease. To establish what types of

claims the agency had already

determined to be disease claims, FDA

reviewed the letters it has sent in

response to notifications from dietary

supplement manufacturers, listing

specific claims the agency regards as

disease claims, as well as other

regulatory actions taken in response to

dietary supplement claims. FDA also

reviewed the Commission Report’s

guidance on distinguishing structure/

function claims and disease claims. In

addition, the agency developed a

definition of ‘‘disease.’’ As described

below, the agency relied upon standard

medical and legal definitions of disease

as a basis for a proposed regulatory

definition. The agency then used the

proposed definition of disease to

generate workable criteria, by applying

the proposed definition to a wide

variety of statements currently made by

dietary supplement manufacturers to

determine whether the statements

claimed an effect on ‘‘disease,’’ as

tentatively defined. Based upon the

information derived from these reviews,

the agency developed the general

criteria below.

The proposed rule applies only to

structure/function claims and disease

claims within the meaning of section

403(r)(6) of the act. DSHEA generally,

and section 403(r)(6) of the act

specifically, apply only to dietary

supplements for human consumption,

and were enacted to provide a unique

regulatory regime for these products.

Thus, the proposed rule is not intended

to apply to products other than dietary

supplements for human consumption

nor to interpret other provisions of the

act.

A. Permitted Structure/Function Claims

Under proposed § 101.93(f), dietary

supplement labels and labeling may

bear structure/function statements that

are not disease claims within the

meaning of proposed § 101.93(g) and

that otherwise comply with the

notification and disclaimer provisions

of § 101.93 (a) through (e), including the

requirement that any structure/function

statement be substantiated.

B. Definition of Disease

To assist in describing what

constitutes a disease claim, the

proposed rule contains a definition of

‘‘disease.’’ The proposed definition is

based on standard medical and legal

definitions of the term (Refs. 1, 2, 3 and

4). Under proposed § 101.93(g)(1), a

‘‘disease’’ is any deviation from,

impairment of, or interruption of the

normal structure or function of any part,

organ, or system (or combination

thereof) of the body that is manifested

by a characteristic set of one or more

signs or symptoms. For purposes of this

definition, ‘‘signs or symptoms’’ include

laboratory or clinical measurements that

are characteristic of a disease, such as

elevated cholesterol fraction, uric acid,

blood sugar, and glycosylated

hemoglobin, and characteristic signs of

disease, such as elevated blood pressure

or intraocular pressure.

To eliminate any inconsistency

between this definition of ‘‘disease’’ and

the definition of ‘‘disease or healthrelated condition’’ found in

§ 101.14(a)(6) and used for purposes of

the agency’s regulation of health claims,

the proposal would also amend

§ 101.14(a)(6). That section defines

‘‘disease or health-related condition’’ as

‘‘damage to an organ, part, structure, or

system of the body such that it does not

function properly (e.g., cardiovascular

disease), or a state of health leading to

such dysfunctioning (e.g. hypertension);
23626 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations

except that diseases resulting from

essential nutrient deficiencies (e.g.,

scurvy, pellagra) are not included in this

definition * * *’’ Under the proposed

amendment to 101.14(a)(6), ‘‘disease or

health-related condition’’ would be

defined, in relevant part, as:

‘‘any deviation from, impairment of, or

interruption of the normal structure or

function of any part, organ, or system (or

combination thereof) of the body that is

manifested by a characteristic set of one or

more signs or symptoms (including

laboratory or clinical measurements that are

characteristic of a disease), or a state of

health leading to such deviation, impairment,

or interruption; except that diseases resulting

from essential nutrient deficiencies (e.g.,

scurvy, pellagra) are not included within this

definition * * *.

FDA believes that the proposed

amendment of § 101.14(a)(6) is

appropriate because experience since

the issuance of the health claims

regulations has shown that the current

definition is too narrow in some

respects. The term ‘‘damage’’ can be

interpreted as limiting the definition to

serious or long-term diseases, and as

excluding certain conditions that are

medically understood to be diseases,

such as headaches. The proposed

amendment, which covers both

‘‘damage’’ to an organ, part, structure, or

system leading to dysfunction, and

other deviations from, impairments of,

or interruptions of the normal

functioning of an organ, part, or system,

more accurately covers the range of

conditions that are medically

understood to be diseases. FDA notes

that the definition in § 101.14(a)(6) is

intended to cover both diseases and

‘‘health-related conditions.’’ As

amended, the proposed definition in

§ 101.14(a)(6) would remain broader

than the proposed definition of

‘‘disease’’ in proposed § 101.93(g)(1)

because proposed § 101.14(a)(6)

includes the phrase ‘‘or a state of health

leading to such deviation, impairment,

or interruption.’’

C. Criteria for Identifying Disease

Claims

Based upon the definition of disease

in proposed § 101.93(g)(1), § 101.93(g)(2)

of the proposed rule lists criteria for

determining whether a statement about

a product is a disease claim. To

illustrate these criteria, FDA has

provided examples of statements that

would be considered disease claims

under the proposed rule. FDA has also

provided examples of statements that

would not, by themselves, be

considered disease claims. FDA

emphasizes that in determining whether

a statement about a product constituted

a disease claim under these criteria,

FDA would also consider the context in

which the statement appeared. A

statement that by itself would be

considered an acceptable structure/

function claim could become a disease

claim if, in context, an effect on disease

were expressed or implied. FDA seeks

comment on the examples and the

provisions of the proposed rule. To

assist the industry, and especially small

businesses, if the agency issues a final

rule, it will issue an accompanying

guidance providing examples of claims

that would and would not be considered

disease claims under the final rule.

1. Under proposed § 101.93(g)(2)(i), a

statement would be considered a

disease claim if it explicitly or

implicitly claimed an effect on a

specific disease or class of diseases.

Examples of such disease claims

include: ‘‘protective against the

development of cancer,’’ ‘‘reduces the

pain and stiffness associated with

arthritis,’’ ‘‘decreases the effects of

alcohol intoxication,’’ or ‘‘alleviates

constipation.’’ Claims that do not refer

explicitly or implicitly to an effect on a

specific disease state would not be

disease claims under this criterion.

Examples include: ‘‘helps promote

urinary tract health,’’ ‘‘helps maintain

cardiovascular function and a healthy

circulatory system,’’ ‘‘helps maintain

intestinal flora,’’ and ‘‘promotes

relaxation.’’ FDA has tentatively

concluded that these examples do not

contain express or implied references to

specific diseases. Instead, they refer

broadly to body systems or functions

without sufficient reference to specific

abnormalities or symptoms to be

understood as references to particular

diseases.

2. Proposed § 101.93(g)(1) defines

disease as any one of several types of

abnormalities that are ‘‘manifested by a

characteristic set of one or more signs or

symptoms.’’ FDA believes that reference

to a characteristic set of signs or

symptoms, even in the absence of the

name of the disease, can be understood

as a reference to the disease itself.

Under proposed § 101.93(g)(2)(ii), a

statement would be considered a

disease claim if it explicitly or

implicitly claimed an effect (using

scientific or lay terminology) on one or

more signs or symptoms that are

recognizable to health care professionals

or consumers as being characteristic of

a specific disease or of a number of

diseases. Examples of such disease

claims include: ‘‘improves urine flow in

men over 50 years old’’ (characteristic

symptoms of, e.g., benign prostatic

hypertrophy); ‘‘lowers cholesterol’’

(characteristic sign of, e.g.,

hypercholesterolemia); ‘‘reduces joint

pain’’ (characteristic symptom of, e.g.,

arthritis); and ‘‘relieves headache’’

(characteristic symptom of, e.g.,

migraine or tension headache). In each

of these cases, the symptoms described

are sufficient to characterize one or

more specific diseases. To determine

whether a reference to a set of signs and

symptoms constituted a disease claim,

FDA would interpret the reference in

context. Claims of an effect on

symptoms that are not recognizable as

characteristic of a specific disease or

diseases would not constitute disease

claims. Examples include: ‘‘reduces

stress and frustration,’’ ‘‘inhibits platelet

aggregation,’’ and ‘‘improves

absentmindedness.’’ In these examples,

the signs or symptoms noted may be

broadly associated with a number of

diseases, but are not, by themselves,

sufficient to characterize a specific

disease or diseases. If the context did

not suggest treatment or prevention of a

disease, a claim that a substance helps

maintain normal function would not

ordinarily be a disease claim. Examples

include: ‘‘helps maintain a healthy

cholesterol level,’’ or ‘‘helps maintain

regularity.’’

FDA requests comment on the

distinction between maintaining normal

function, which is potentially the basis

for an allowable structure/function

claim, and preventing or treating

abnormal function, which is potentially

a disease claim. This can be a difficult

distinction conceptually, especially if

the only reason for maintaining normal

function is to prevent a specific disease

or diseases associated with abnormal

function. According to the report,

‘‘Commission members who were

troubled about the wording of structure/

function statements suggested that the

most problematic wording is seen in

statements ostensibly relating to ‘normal

healthy function’ that actually imply the

need to remedy an underlying abnormal

or unhealthy state * * *’’ (the report,

pp. 36–37).

The Commission concluded that

‘‘statements that mention a body system,

organ, or function affected by the

supplement using terms such as

‘‘stimulate,’’ ‘‘maintain,’’ ‘‘support,’’

‘‘regulate,’’ or ‘‘promote’’ can be

appropriate when the statements do not

suggest disease prevention or treatment

or use for a serious health condition that

is beyond the ability of the consumer to

evaluate‘‘ (the report, p. 38). This is

consistent with the criterion proposed

by FDA. As the report illustrates,

however, there can be disagreement

about the circumstances in which a

reference to maintaining normal

function implies disease treatment or

prevention. Therefore, FDA welcomes
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations 23627

comment on the basis for the distinction

between maintaining normal function

and preventing or treating abnormal

function and on factors that help

distinguish between claims relating to

normal, healthy function that do not

imply disease treatment or prevention

and those that do. Because of the

Commission’s concerns that claims

relating to maintaining healthy

cholesterol levels raise particularly

difficult issues (the report, p. 37), FDA

seeks comment on these claims.

3. Certain natural states, such as

pregnancy, aging, or the menstrual

cycle, that are themselves not

‘‘diseases,’’ are sometimes associated

with abnormalities that are

characterized by a specific set of signs

or symptoms, and thus meet the

proposed definition of disease. Under

proposed § 101.93(g)(2)(iii), a statement

would be considered a disease claim if

it explicitly or implicitly claimed an

effect on a consequence of a natural

state that presents a characteristic set of

signs or symptoms recognizable to

health care professionals or consumers

as constituting an abnormality of the

body, such as toxemia of pregnancy,

premenstrual syndrome, or

abnormalities associated with aging

such as presbyopia, decreased sexual

function, Alzheimer’s disease, or hot

flashes. Claims that did not refer to a

recognizable abnormality resulting from

a natural state or to its signs or

symptoms (e.g., ‘‘for men over 50 years

old,’’ and ‘‘to meet nutritional needs

during pregnancy’’) would not be

disease claims under this criterion.

These examples do not include

references to specific abnormalities or

symptoms. FDA thus believes that they

would not be understood as references

to particular diseases.

4. Various aspects of a product’s

labeling may be used to express or

imply that the product will diagnose,

cure, mitigate, treat, or prevent disease.

Under proposed § 101.93(g)(2)(iv), a

statement would be considered a

disease claim if it explicitly or

implicitly claimed an effect on disease

through one or more of the following

factors:

(a) The name of the product (e.g.,

‘‘Carpaltum’’ (carpal tunnel syndrome),

‘‘Raynaudin’’ (Raynaud’s phenomenon),

‘‘Hepatacure’’ (liver problems)). Names

that did not imply an effect on a disease,

such as ‘‘Cardiohealth’’ and ‘‘Heart

Tabs,’’ would not constitute disease

claims;

(b) Statements about the formulation

of the product, including a claim that

the product contained an ingredient that

has been regulated primarily by FDA as

a drug and is well known to consumers

for its use in preventing or treating a

disease (e.g., aspirin, digoxin, or

laetrile). FDA notes that this proposed

rule is not intended to interpret section

201(ff)(3)(A) of the act (21 U.S.C.

321(ff)(3)(A)), and that a product may be

included in or excluded from the

definition of ‘‘dietary supplement’’

under that provision regardless of

whether the statement made for the

product under section 403(r)(6) of the

act meets the criteria specified here;

(c) Citation of a title of a publication

or other reference, if the title refers to

a disease use. For example, labeling for

a vitamin E product that included a

citation to an article entitled ‘‘Serial

Coronary Angiographic Evidence That

Antioxidant Vitamin Intake Reduces

Progression of Coronary Artery

Atherosclerosis,’’ would create a disease

claim under this criterion;

(d) Use of the term ‘‘disease’’ or

‘‘diseased;’’ or

(e) Otherwise suggesting an effect on

disease by use of pictures, vignettes,

symbols, or other means (e.g.,

electrocardiogram tracings, pictures of

organs that suggest prevention or

treatment of a disease state, the

prescription symbol (Rx), or any

reference to prescription use). A picture

of a body would not constitute a disease

claim under this criterion.

5. Certain product class names are so

strongly associated with diagnosis, cure,

mitigation, treatment or prevention of a

disease or diseases, that a claim that a

product belonged to such a class would

be understood as a disease claim. Under

proposed § 101.93(g)(2)(v), a statement

would be considered a disease claim if

it claimed that the product belonged in

a class of products recognizable to

health care professionals or consumers

as intended for use to diagnose,

mitigate, treat, cure, or prevent a disease

(e.g., claims that the product was an

‘‘antibiotic,’’ a ‘‘laxative,’’ an

‘‘analgesic,’’ an ‘‘antiviral,’’ a ‘‘diuretic,’’

an ‘‘antimicrobial,’’ an ‘‘antiseptic,’’ an

‘‘antidepressant,’’ or a ‘‘vaccine’’). The

foregoing examples do not constitute an

exclusive list of product class names

that convey disease claims. Claiming

that a product was in a class that is not

recognizable to health care professionals

or consumers as intended for use to

diagnose, mitigate, treat, cure or prevent

disease (e.g., an ‘‘energizer,’’ a

‘‘rejuvenative,’’ a ‘‘revitalizer,’’ or an

‘‘adaptogen’’) would not constitute a

disease claim under this criterion.

6. A statement may imply that a

dietary supplement has an effect on

disease by claiming that the effect of the

dietary supplement is the same as that

of a recognized drug or disease therapy.

A statement may also imply an effect on

disease by suggesting that the dietary

supplement should be used as an

adjunct to a recognized drug or disease

therapy in the treatment of a disease. In

both cases, the statement implies that

the dietary supplement is intended for

the same purpose as the drug or disease

therapy, i.e., for the diagnosis, cure,

mitigation, treatment, or prevention of

disease. Under proposed

§ 101.93(g)(2)(vi) and (g)(2)(vii), a

statement would be considered a

disease claim if it explicitly or

implicitly claimed that the product was

a substitute for another product that is

a therapy for a disease (e.g., ‘‘Herbal

Prozac’’) or that it augmented a

particular therapy or drug action (e.g.,

‘‘use as part of your diet when taking

insulin to help maintain a healthy blood

sugar level’’). A claim that did not

identify a specific drug, drug action, or

therapy (e.g., ‘‘use as a part of your

weight loss plan’’) would not constitute

a disease claim under this criterion.

7. A statement may contain an express

or implied disease claim if it suggests

that the product cures, mitigates, treats

or prevents a disease or diseases by

augmenting the body’s own diseasefighting capabilities. Under proposed

§ 101.93(g)(2)(viii), a statement would

be considered a disease claim if it

explicitly or implicitly claimed a role in

the body’s response to a disease or to a

vector of disease. A vector of disease is

an organism or object that is able to

transport or transmit to humans an

agent, such as a virus or bacterium, that

is capable of causing disease in man. A

claim that a product ‘‘supports the

body’s antiviral capabilities’’ or

‘‘supports the body’s ability to resist

infection’’ would constitute a disease

claim under this criterion. Infections are

well-known disease states that result

from the action of pathogenic (diseasecausing) microorganisms, such as

bacteria and viruses, and are deviations

from and impairments of the normal

structure and/or function of the body

with characteristic signs and symptoms.

Claims that a product is intended to

affect the body’s ability to kill or

neutralize pathogenic microorganisms,

or to mitigate the consequences of the

action of pathogenic microorganisms on

the body (i.e., the signs and symptoms

of infection) are disease claims because

they are claims exclusively associated

with the body’s ability to prevent or

respond to infectious diseases. A more

general reference to an effect on a body

system that has several functions, only

one of which is resistance to disease,

would not constitute a disease claim

under this criterion (e.g., ‘‘supports the

immune system’’).
23628 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations

8. Many adverse reactions to drugs or

medical procedures meet the proposed

definition of disease because they are

abnormalities of structure or function

manifested by a characteristic set of

signs or symptoms. In addition, the

clinical management of adverse events

that are consequences of medical

intervention is an integral part of the

overall medical management of the

underlying disease state for which the

therapeutic intervention is intended.

Therefore, claims that a product is

intended to counter adverse events

resulting from medical intervention are

claims that the product is intended as a

part of the treatment program and, as

such, are claims that the product is to

mitigate, treat, or cure the disease state.

Under proposed § 101.93(g)(2)(ix), a

statement would be considered a

disease claim if it explicitly or

implicitly claimed to treat, prevent, or

mitigate adverse events associated with

a medical therapy or procedure and

manifested by a characteristic set of

signs or symptoms (e.g., ‘‘reduces

nausea associated with chemotherapy,’’

‘‘helps avoid diarrhea associated with

antibiotic use,’’ and ‘‘to aid patients

with reduced or compromised immune

function, such as patients undergoing

chemotherapy’’). A claim that did not

mention a therapy for disease (e.g.,

‘‘helps maintain healthy intestinal

flora’’) would not constitute a disease

claim under this criterion.

9. Under proposed § 101.93(g)(2)(x), a

statement would be considered a

disease claim if it otherwise suggested

an effect on a disease or class of

diseases.

III. Legal Authority

This proposed rule is authorized

under sections 201, 403(r), and 701(a) of

the act (21 U.S.C. 321, 343(r), and

371(a)).

IV. Effective Date and Implementation

Plan

The agency proposes that any final

rule based on this proposal will become

effective 30 days after the date of

publication of the final rule in the

Federal Register. However, for a

product marketed by a small business

(as defined below) that was on the

market as of the date of publication of

the final rule, the agency is proposing to

allow an additional 17 months within

which claims made about such product

as of the date of publication of the final

rule must be brought into compliance

with the final rule, provided that the

small business has notified FDA of the

claim as required by section 403(r)(6) of

the act and § 101.93(a) and that FDA has

not objected to the claim. A ‘‘small

business’’ for purposes of this proposal

is a business with total annual revenues

of less than $20 million. For all other

products that were on the market as of

the date of publication of the final rule,

the agency is proposing to allow an

additional 11 months within which

claims made about such products as of

the date of publication of the final rule

must be brought into compliance, again

provided that the firm has notified FDA

of the claim as required by section

403(r)(6) of the act and § 101.93(a) and

that FDA has not objected to the claim.

Any product that is marketed for the

first time after publication of the final

rule, and any new claims made for an

existing product for the first time after

publication of the final rule, will be

expected to be in compliance beginning

30 days after publication of the final

rule.

During the pendency of this

rulemaking, manufacturers will

continue to be under an obligation to

comply with section 403(r)(6) and other

applicable provisions of the act and

applicable regulations. FDA will

continue to respond to notifications

submitted under section 403(r)(6) of the

act, and the agency will continue to

enforce that provision and all other

applicable legal requirements.

V. Environmental Impact

The agency has determined under 21

CFR 25.30(h), (k) and 25.34(f) that this

action is of a type that does not

individually or cumulatively have a

significant effect on the human

environment. Therefore, neither an

environmental assessment nor an

environmental impact statement is

required.

VI. Analysis of Economic Impacts

A. Benefit—Cost Analysis

FDA has examined the economic

implications of this proposed rule as

required by Executive Order 12866.

Executive Order 12866 directs agencies

to assess all costs and benefits of

available regulatory alternatives and,

when regulation is necessary, to select

the regulatory approach which

maximizes net benefits (including

potential economic, environmental,

public health and safety effects;

distributive impacts; and equity).

According to Executive Order 12866, a

rule is significant if it meets any one of

a number of specified conditions,

including having an annual effect on the

economy of $100 million or adversely

affecting in a material way a sector of

the economy, competition, or jobs, or if

it raises novel legal or policy issues.

Because it raises novel policy issues,

FDA finds that this proposed rule is a

significant regulatory action as defined

by Executive Order 12866.

In addition, FDA has determined that

this rule does not constitute a

significant rule under the Unfunded

Mandates Reform Act of 1995 requiring

cost-benefit and other analyses. A

significant rule is defined in Section

1531(a) as ‘‘a Federal mandate that may

result in the expenditure by State, local,

and tribal governments in the aggregate,

or by the private sector, of $100,000,000

(adjusted annually for inflation) in any

1 year * * *’’.

Finally, in accordance with the Small

Business Regulatory Enforcement

Fairness Act, the administrator of the

Office of Information and Regulatory

Affairs of the Office of Management and

Budget has determined that this

proposed rule is not a major rule for the

purpose of Congressional review.

There are several different types of

products that may be considered to be

dietary supplements. These products

include but are not limited to vitamin

and mineral supplements, herbal

products, and products that contain

other similar nutritional substances.

Estimates of the number of dietary

supplements are approximate because

no one source collects information on

all types of dietary supplements. In fact,

until the DSHEA, there was no agreed

upon definition of a dietary supplement.

Some sources include only dietary

supplements of vitamins and minerals,

others include herbals or botanicals, and

still others include other types of

products that may or may not be dietary

supplements, such as sports nutrition

products and ‘‘functional foods,’’ a term

for which there is no regulatory

definition. FDA’s preliminary estimate

of the number of such products is

approximately 29,000. FDA’s estimate of

the number of stockkeeping units (skus),

a more accurate count of the number of

labels, is approximately 75,000.

In its analysis of the rule establishing

nutrition labeling requirements for

dietary supplements (62 FR 49826 at

49843), FDA provided an estimate of the

number of dietary supplement firms.

According to Dun’s Market Identifiers

(Ref. 5), there are approximately 250

manufacturers of vitamin and mineral

products. According to Nutrition

Business Journal (Ref. 6), the dietary

supplement industry includes 850

supplement manufacturing companies.

The Journal reports 1995 industry

revenues at $4.5 billion. The Journal’s

estimate of 850 firms is an overestimate

of the dietary supplement industry as

defined by FDA because it includes

homeopathic products, which are drugs

by statutory definition, and ‘‘functional
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations 23629

foods’’ and sports nutrition products,

which may be either conventional foods

or dietary supplements depending on

how they are marketed and used.

Although the Journal does not break

down the number of firms by the type

of dietary supplement produced, it does

specify that 250 firms produce herbal or

botanical products.

For purposes of determining the costs

of regulation, FDA has used 850 as an

upper bound estimate of the number of

firms. As a lower bound estimate, FDA

has used 500 (250 vitamin/mineral firms

plus 250 herbal/botanical firms). Since

publication of the nutrition labeling

final rule in September 1997 (62 FR

49826), FDA has not been challenged on

these estimates. Therefore, the same

range of estimates is used in this

analysis.

In this proposed rule, FDA is

clarifying the distinction between

disease claims and structure/function

claims in dietary supplement labeling. If

the proposed rule becomes final, any

firm currently making a claim that was

not previously classified as a disease

claim but is classified as a disease claim

by the rule will be required to change

the claim to an acceptable structure/

function claim, remove the claim from

labeling, petition and be granted

permission to carry a health claim, or

bear the consequences of being

classified as an unapproved drug. FDA

has received approximately 2,300

notifications of structure/function

claims and has sent objection letters for

approximately 150 of the notifications.

FDA believes that those firms have

made the necessary changes to make

their claims come into compliance. FDA

has estimated the number of additional

notifications to which it would have

objected under the criteria in this

proposed rule. Using conservative,

worst-case estimates, FDA estimated

that it would have objected to

approximately 60 additional

notifications. The firms making these 60

products will have to change their

claims if the proposal becomes final;

these firms would bear the costs of this

proposed rule.

FDA is aware that, despite the

notification requirements in section

403(r)(6) of the act and § 101.93(a), some

firms that have not sent notifications are

in fact marketing products whose

labeling contains structure-function

claims. If the labels contain claims that

are unacceptable under the criteria FDA

is proposing to adopt, and if the firms

change those labels in response to this

proposed rule, then the costs of those

labeling changes can be attributed to the

rule.

1. Costs

Only those firms who must change

their labeling will bear the costs of this

rule. Categories of costs for relabeling

include administrative, analytical,

printing, and inventory disposal. FDA

will first estimate compliance costs for

the 60 products for which the agency

has received notifications of claims that

would be classified as disease claims

under the criteria in the proposed rule.

These costs will be the lower-bound

costs of the proposed rule. FDA will

then estimate the compliance costs for

the products for which FDA has not

received notification, but whose

labeling contains claims that would be

classified as disease claims under the

criteria in the proposed rule. The sum

of the compliance costs for the two

categories of products will be the upperbound costs of the proposed rule.

a. Lower-bound Estimate

The administrative costs associated

with a labeling regulation result from

the incremental administrative labor

expended in order to comply with a

regulation. FDA estimates

administrative costs at approximately

$425 per firm for a 1-year compliance

period and approximately $320 for an

18-month compliance period. Longer

compliance periods decrease

administrative effort because firm

executives often delegate downward

decisions that are less immediate. FDA

will assume that the number of firms

affected by the proposed rule is

proportional to the number of labels

affected. FDA therefore estimates the

number of firms affected by multiplying

the upper-bound estimate of total firms

in the industry by the fraction of the

labels in violation, or 850 x (60/2,300)

= 22. Total administrative costs are

estimated to be $7,040 (22 x $320) with

an 18-month compliance period and

$9,350 (22 x $425) with a 1-year

compliance period.

Based on an average of the estimates

provided in comments to earlier rules,

FDA estimates that the average redesign

cost for a 1-year compliance period is

$1,700 per dietary supplement label.

Redesign costs associated with an 18 -

month compliance period are typically

3/4 of those for a 1 year compliance

period, or $1,300 per dietary

supplement label. Therefore, FDA

estimates total redesign costs to be

$102,000 (60 x $1,700) for a 12-month

compliance period and $78,000 (60 x

$1,300) for an 18-month compliance

period.

FDA received information from an

earlier rule affecting the entire dietary

supplement industry indicating that

inventory disposal costs would be $8

million for an 18-month compliance

period and $15 million for a 12-month

compliance period. FDA has some

experience suggesting that some firms

will experience minimal inventory

disposal costs due to the rapid

frequency with which they change

labels or move product. Because FDA is

assuming that 0.08 percent (60/75,000)

of the industry will incur costs as a

result of this rule, total inventory

disposal costs are estimated to be $6,400

(0.0008 x $8 million) for an 18-month

compliance period and $12,000 (0.0008

x $15 million) for a 12-month

compliance period.

FDA has estimated the impact of the

proposed regulation and has determined

that, for a 1-year compliance period,

lower-bound total costs would be

approximately $123,400. Alternatively,

if FDA were to provide 18 months for

compliance, lower-bound total costs

would be approximately $91,400. The

components of lower-bound total costs

are shown in the following table.

Cost Category12-month

compliance

18-month

compliance

Administrative $9,400 $7,000

Redesign $102,000 $78,000

Inventory $12,000 $6,400

Total $123,400 $91,400

b. Upper-bound Estimate

Some manufacturers of dietary

supplements may not have notified FDA

that their product labels contain

structure-function claims. Because these

manufacturers have not complied with

the existing legal requirement to notify

FDA of the claims they are making for

their products, FDA believes that it is

unlikely that they would change their

labels to comply with new regulations

defining acceptable structure/function

claims. However, to ensure that all

possible costs are considered in this

impact analysis, the agency is including

costs that might be incurred by such

manufacturers as an upper bound on its

estimate of the costs of this proposed

rule. Based on visual observation of

dietary supplements sold in retail

establishments (grocery, drug, and

health food stores), FDA estimates that

up to 30 percent of all labels contain

structure-function claims. FDA therefore

estimates that up to 22,500 (0.3 x

75,000) dietary supplement labels may

contain structure-function claims.

Although it is uncertain how many of

these labels contain claims that would

be disease claims under the proposed

rule, if the proportion of all labels

containing such claims is the same as

the proportion of notifications

containing such claims, then there may
23630 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations

be up to 585 [(60/2,300) x 22,500] labels

that would need to be changed if the

proposed rule becomes final.

Subtracting the 60 unacceptable labels

for which FDA has received

notifications leaves about 525 additional

labels that may be affected by the rule.

Based on its model of food labeling

compliance costs, FDA assumes that

compliance costs per label double with

each halving of the compliance period

(Ref. RTI Final Report, ‘‘Compliance

Costs of Food Labeling Regulations’’).

The cost per label for a 12-month

compliance period is approximately

$2,000 ($123,400/60). The compliance

period for claims for which no

notification has been received is 30

days. Based on the model, FDA expects

that compliance costs will double as the

compliance period falls from 12 to 6

months, and double again as the

compliance period falls to 3 months.

Although the model does not predict

compliance costs for periods shorter

than 3 months, FDA assumes that as the

compliance period falls from 3 months

to 30 days, compliance costs are likely

to double again. Estimated costs per

label should therefore be approximately

8 times (2 x 2 x 2) higher for a

compliance period of 30 days than for

a compliance period of 12 months. FDA

therefore estimates compliance costs per

label for current structure-function

claims for which no notification has

been received to be $16,000 (8 x $2,000).

The total costs for 525 label changes

would be $8.4 million (525 x $16,000).

Although FDA believes that it is very

unlikely that all of these label changes

would be made, the upper-bound total

cost of this proposed rule is the sum of

the costs for the 60 unacceptable claims

for which notifications have been

received and the costs of the additional

unacceptable claims. The total cost will

thus range between approximately $0.1

million and $8.5 million.

2. Benefits

Most of the benefits from this rule

will come from the reduced uncertainty

associated with structure/function

claims in dietary supplement labeling.

Some manufacturers of dietary

supplements, as shown by the

submission of a significant number of

notifications for purported structure/

function statements that are clearly

disease claims, are uncertain about what

constitutes an acceptable structure/

function claim. This proposed rule

establishes clarifying criteria that will

reduce and perhaps eliminate this

uncertainty.

FDA cannot quantify the benefits from

this proposed rule. Because of the

uncertainty about what constitutes an

acceptable structure/function claim,

some manufacturers of dietary

supplements may have hesitated to

attempt to make structure/function

claims. These clarifying criteria will

enable those firms to go forward with

those claims. To the extent that the lack

of these claims has caused consumers to

seek out the information from other

sources, this rule will benefit consumers

by reducing the cost of searching for

information and ensuring that the

information provided to consumers is

appropriate.

Manufacturers who were considering

making claims that would be considered

unacceptable will be provided with

clear criteria showing that the claims are

unacceptable. As evidenced by

notifications of structure/function

claims already received by FDA, several

firms have had to bear the cost of

redesigning labeling to incorporate the

changes recommended by the agency.

By providing criteria to firms before

they submit notifications to FDA, this

rule will reduce costs to firms by

reducing the probability of having to

redo labels. Government costs will also

be lessened by reducing the number of

letters informing firms of inappropriate

label statements.

3. Regulatory Alternatives

FDA considered, but did not adopt,

other regulatory options. First, the

agency considered treating a statement

about a dietary supplement as a disease

claim only if the statement included an

express reference to a specific disease.

This option would have resulted in a

significantly larger number of permitted

claims for dietary supplements, and

reduced costs for dietary supplement

manufacturers. FDA did not adopt this

option for several reasons. First, it

would be inconsistent with FDA’s

longstanding policy of considering both

express and implied claims when

determining whether a product falls

within various definitions under the act.

Second, it would be inconsistent with

the interpretation of ‘‘disease claims’’

that FDA has used in administering

section 403(r)(6) of the act prior to

issuing this proposed rule. Finally,

because many implied claims, e.g.,

claims that list the symptoms of a

disease without naming the disease, are

well-understood by consumers as

disease treatment or prevention claims,

this option would be inconsistent with

the intent of section 403(r)(6).

Second, FDA considered treating any

mention of an abnormality of the

structure or function of the body as a

disease claim, even if the abnormality

was not characterized by a set of signs

or symptoms recognized as a disease.

This option would have resulted in a

significantly smaller number of

permitted claims for dietary

supplements, and greater costs for

dietary supplement manufacturers. FDA

did not adopt this option because

section 403(r)(6) of the act prohibits

only claims of an effect on a disease.

Because not all abnormalities are

recognized by health professionals or

consumers as diseases, this option

would have been overbroad, and would

have prevented manufacturers from

making claims permitted by the statute.

Finally, FDA considered taking no

new regulatory action. This option

would have resulted in no immediate

change in the number of permitted

claims, and no costs for dietary

supplement manufacturers. FDA

rejected this option because there is

substantial confusion among dietary

supplement manufacturers and

consumers about what types of claims

are permitted for dietary supplements,

and the agency has been called upon to

provide clarification of permitted and

prohibited claims. In the absence of

direction from the agency, an increasing

number of products in the marketplace

carry express and implied disease

claims, misleading consumers and

creating unfairness to those

manufacturers who have attempted to

comply with advice from FDA.

B. Small Entity Analysis

According to the Regulatory

Flexibility Act, the definition of a small

entity is a business independently

owned and operated and not dominant

in its field. The Small Business

Administration (SBA) has set size

standards for most business categories

through use of four-digit Standard

Industrial Classification (SIC) codes.

Dietary supplements of vitamins and

minerals are included in the industry

group Pharmaceutical Preparations (SIC

2834); a business in that classification is

considered small if it has fewer than 750

employees. According to Dun’s Market

Identifiers, there are approximately 250

producers of vitamin and mineral

supplements, of which 200 have fewer

than 750 employees. The remaining

dietary supplement products—mainly

herbs, other botanicals, and amino

acids—do not fit in any classification,

but come closest to the industry groups

Food Preparations Not Elsewhere

Classified (SIC 2099) and Medicinal

Chemicals and Botanical Products (SIC

2833). The SBA size standards are 500

or fewer employees for food

preparations and 750 or fewer

employees for medicinal and botanical

products.

According to Nutrition Business

Journal (Ref. 6), 11 of the 850 dietary

supplement manufacturing firms have
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations 23631

total revenues over $100 million,

accounting for 53 percent of total sales;

30 firms have sales revenues between

$20 and $100 million, accounting for 28

percent of industry sales; and 809 firms

have sales under $20 million,

accounting for 19 percent of industry

sales. The 809 firms in the under $20

million category have an average sales

revenue of $800,000 and will be

considered small by FDA.

No employment data are available for

some of these firms. Many of the firms

are in the SIC codes 2833 and 2834,

however. According to Dun’s Market

Identifiers, no firms for which both

employment and sales data are available

in SIC code 2833 have less than $20

million in annual sales and more than

500 employees. Indeed, 96% of the

firms in that sales category have fewer

than 100 employees. By contrast, over

90% of the firms in SIC codes 2833 and

2834 (vitamin and minerals subcategory) with annual sales greater than

$100 million have more than 750

employees. If the relationship between

sales and employment for SIC codes

2833 and 2834 holds for other sectors of

the dietary supplement industry, then

the proportion of firms with sales under

$20 million should be approximately

the same as the proportion of firms with

fewer than 500 employees, an

employment category that is classified

as small for any SIC code involving the

manufacture of foods, chemicals and

kindred or allied products. FDA

concludes therefore that as many as 809

firms in the dietary supplement

industry, or 95 percent of firms, could

be considered small (sales under $20

million). As stated previously in this

analysis, 809 small firms may be an

overestimate because it counts firms

that produce homeopathic products,

which are drugs, and sports nutrition

products and ‘‘functional foods,’’ which

may be either foods or dietary

supplements. If there are as few as 500

dietary supplement firms, there may be

475 small dietary supplement firms.

Because virtually all firms affected by

this rule will be classified as small

under SBA standards, FDA assumes that

small entities will bear 100 percent of

the costs. Because per firm labeling

costs are probably burdensome for small

firms and because the costs of this rule

are borne entirely by small firms, FDA

tentatively concludes that this rule will

result in a significant economic impact

on a substantial number of small

entities. In section VI. A. of this

document, entitled Benefit—Cost

Analysis, FDA estimated that, as a

lower-bound, 22 firms would be affected

by this proposed rule and that the

lower-bound costs with a compliance

period of 12 months would be

approximately $123,400, or about

$5,600 per small firm. FDA estimated

upper-bound costs, $8.5 million, by

adding the costs of changing 525

additional labels (with a 30-day

compliance period) to the lower-bound

costs. If the number of additional firms

affected is proportional to the number of

additional labels changed, the upperbound number of firms affected by this

proposed rule is 215, for an upperbound average cost of about $40,000 per

small firm.

The Regulatory Flexibility Act

requires agencies to examine regulatory

alternatives that would minimize the

impact on small entities. FDA

considered exempting small entities

from this rule, which would eliminate

the costs borne by small entities. FDA

rejected this option for several reasons.

First, the agency has no authority to

exempt small entities from their

statutory obligations, and this proposed

rule merely clarifies a statutory

requirement. Second, as described

above, virtually all manufacturers

covered by this proposal are small

entities. Exempting small entities would

thus eliminate the benefits of the

proposed rule. Finally, some of the

benefits of the rule, such as reducing the

uncertainty associated with structure/

function claims and reducing the

probability of having to re-do labels,

will accrue to small entities.

FDA has examined the impact of

different compliance periods and has

determined that extending the

compliance period from 12 to 18

months for firms that have notified the

agency of a claim and have not received

an objection reduces the burden on

small entities in this category.

Extending the compliance period from

12 to 18 months reduces lower-bound

estimated costs borne by small firms by

$32,000, and average costs per firm

would fall from $5,600 to about $4,200.

Extending the compliance period

beyond 18 months could provide

additional relief to these small entities.

Based on FDA’s experience with the

dietary supplement industry, however,

the agency believes that labels are

changed more often than every 18

months; therefore, FDA believes that

this additional relief would be small.

FDA has tentatively concluded that the

compliance period for those firms

whose products contain structure/

function claims but who have not

complied with the legal requirement to

notify FDA of those claims should not

be extended.

VII. Paperwork Reduction Act of 1995

FDA tentatively concludes that this

proposed rule contains no collections of

information. Therefore, clearance by the

Office of Management and Budget under

the Paperwork Reduction Act of 1995 is

not required.

VIII. Comment Request

Interested persons may, on or before

August 27, 1998, 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 Dockets

Management Branch 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. Dorland’s Illustrated Medical Dictionary,

28th Edition, W.B. Saunders Co.,

Philadelphia, p. 478, 1994.

2. Stedman’s Medical Dictionary, 26th

Edition, Williams & Wilkins, Baltimore, p.

492, 1995.

3. The Encyclopedia Americana,

International Edition, Grolier Inc., Danbury,

p. 168, 1985.

4. Black’s Law Dictionary, 6th Edition,

West Publishing Co., St. Paul, p. 467, 1990.

5. Dun’s Market Identifiers, Knight-Ridder

Information, Inc., Mountain View, CA, 1998.

6. Nutrition Business Journal, 1(1):15, 16,

1996.

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: 15 U.S.C. 1453, 1454, 1455; 21

U.S.C. 321, 331, 342, 343, 348, 371.

2. Section 101.14, as currently in

effect, is amended by revising paragraph

(a)(6) to read as follows:

§ 101.14 Health claims: general

requirements.

(a) * * *

(6) Disease or health-related condition

means any deviation from, impairment
23632 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations

of, or interruption of the normal

structure or function of any part, organ,

or system (or combination thereof) of

the body that is manifested by a

characteristic set of one or more signs or

symptoms (including laboratory or

clinical measurements that are

characteristic of a disease), or a state of

health leading to such deviation,

impairment, or interruption; except that

diseases resulting from essential

nutrient deficiencies (e.g., scurvy,

pellagra) are not included in this

definition (claims pertaining to such

diseases are thereby not subject to this

section or § 101.70).

* * * * *

3. Section 101.93, as currently in

effect, is amended by revising the

section heading and by adding

paragraphs (f) and (g) to read as follows:

§ 101.93 Certain types of statements for

dietary supplements.

* * * * *

(f) Permitted structure/function

statements. (1) Dietary supplement

labels or labeling may, subject to the

requirements of this section, bear

statements that describe the role of a

nutrient or dietary ingredient intended

to affect the structure or function in

humans or that characterize the

documented mechanism by which a

nutrient or dietary ingredient acts to

maintain such structure or function, but

may not bear statements that are disease

claims under paragraph (g) of this

section.

(g) Disease claims. (1) Definition of

disease. For purposes of 21 U.S.C.

343(r)(6), a ‘‘disease’’ is any deviation

from, impairment of, or interruption of

the normal structure or function of any

part, organ, or system (or combination

thereof) of the body that is manifested

by a characteristic set of one or more

signs or symptoms, including laboratory

or clinical measurements that are

characteristic of a disease.

(2) Disease claims. FDA will find that

a statement about a product claims to

diagnose, mitigate, treat, cure, or

prevent disease (other than a classical

nutrient deficiency disease) under

section 403(r)(6) of the act if it meets

one or more of the criteria listed in this

paragraph (g)(2). In determining

whether a statement is a disease claim

under these criteria, FDA will consider

the context in which the claim is

presented. A statement claims to

diagnose, mitigate, treat, cure, or

prevent disease if it claims, explicitly or

implicitly, that the product:

(i) Has an effect on a specific disease

or class of diseases;

(ii) Has an effect, using scientific or

lay terminology, on one or more signs or

symptoms that are recognizable to

health care professionals or consumers

as being characteristic of a specific

disease or of a number of different

specific diseases;

(iii) Has an effect on a consequence of

a natural state that presents a

characteristic set of signs or symptoms

recognizable to health care professionals

or consumers as constituting an

abnormality of the body;

(iv) Has an effect on disease through

one or more of the following factors:

(A) The name of the product;

(B) A statement about the formulation

of the product, including a claim that

the product contains an ingredient that

has been regulated by FDA as a drug

and is well known to consumers for its

use in preventing or treating a disease;

(C) Citation of the title of a

publication or reference, if the title

refers to a disease use;

(D) Use of the term ‘‘disease’’ or

‘‘diseased’’; or

(E) Use of pictures, vignettes,

symbols, or other means;

(v) Belongs to a class of products that

is intended to diagnose, mitigate, treat,

cure, or prevent a disease;

(vi) Is a substitute for a product that

is a therapy for a disease;

(vii) Augments a particular therapy or

drug action;

(viii) Has a role in the body’s response

to a disease or to a vector of disease;

(ix) Treats, prevents, or mitigates

adverse events associated with a therapy

for a disease and manifested by a

characteristic set of signs or symptoms;

or

(x) Otherwise suggests an effect on a

disease or diseases.

Dated: April 22, 1998.

Michael A. Friedman,

Lead Deputy Commissioner for the Food and

Drug Administration.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 98–11294 Filed 4–24–98; 4:27 pm]

BILLING CODE 4160–01–F