Federal Register: April 29, 1998 (Volume 63, Number 82)
Rules and Regulations
Page 23623-23632
From the Federal Register Online via GPO Access wais.access.gpo.gov
DOCID:fr29ap98-24
Page 23623
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Part VI
Department of Health and Human Services
_______________________________________________________________________
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
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:
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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
Extension of Comment Period August 26, 1998