[Federal Register Volume 63, Number 82 (Wednesday, April 29, 1998)]
[Rules and Regulations]
[Pages 23624-23632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11294]


      

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Part VI





Department of Health and Human Services





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Food and Drug Administration



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21 CFR Part 101



Regulations on Statements Made for Dietary Supplements Concerning the 
Effect of the Product on the Structure or Function of the Body; 
Proposed Rule and Dietary Supplements: Comments on Report of the 
Commission on Dietary Supplement Labels; Notice

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

[[Page 23624]]



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.

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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 
Sec. 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

    <bullet>  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:

[[Page 23625]]

    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 health-related 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).
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    \1\ The 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).
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    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 Sec. 101.93(f), dietary supplement labels and 
labeling may bear structure/function statements that are not disease 
claims within the meaning of proposed Sec. 101.93(g) and that otherwise 
comply with the notification and disclaimer provisions of Sec. 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 Sec. 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 health-related 
condition'' found in Sec. 101.14(a)(6) and used for purposes of the 
agency's regulation of health claims, the proposal would also amend 
Sec. 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);

[[Page 23626]]

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 Sec. 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 Sec. 101.14(a)(6) is intended to cover 
both diseases and ``health-related conditions.'' As amended, the 
proposed definition in Sec. 101.14(a)(6) would remain broader than the 
proposed definition of ``disease'' in proposed Sec. 101.93(g)(1) 
because proposed Sec. 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 Sec. 101.93(g)(1), 
Sec. 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 Sec. 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 Sec. 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 Sec. 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

[[Page 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 Sec. 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 Sec. 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 Sec. 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 
Sec. 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 disease-fighting 
capabilities. Under proposed Sec. 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 (disease-causing) 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'').

[[Page 23628]]

    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 
Sec. 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 Sec. 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 Sec. 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 Sec. 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

[[Page 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 Sec. 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 upper-bound 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 Category         12-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

[[Page 23630]]

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

[[Page 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 sub-
category) 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 upper-bound number of 
firms affected by this proposed rule is 215, for an upper-bound 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:


Sec. 101.14  Health claims: general requirements.

    (a) * * *
    (6) Disease or health-related condition means any deviation from, 
impairment

[[Page 23632]]

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 Sec. 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:

Sec. 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