[Federal Register Volume 64, Number 130 (Thursday, July 8, 1999)]
[Proposed Rules]
[Pages 36824-36826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17424]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 64, No. 130 / Thursday, July 8, 1999 /
Proposed Rules
[[Page 36824]]
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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;
Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; reopening of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to solicit additional comments on three particularly
controversial issues raised by FDA's proposed rule on statements made
for dietary supplements concerning the effect of the product on the
structure or function of the body (``structure/function claims''). This
meeting is intended to provide the public an additional opportunity to
provide focused comment on these issues in a manner that will assist
FDA in evaluating appropriate policies and approaches. FDA is also
reopening, until August 4, 1999, the comment period for the proposed
rule, to allow interested persons to comment on the issues raised in
this document.
DATES: The meeting will be held on August 4, 1999, from 8 a.m. to 6
p.m. Submit written comments on or before August 4, 1999.
ADDRESSES: The meeting will be held at the Jefferson Auditorium, U.S.
Department of Agriculture, 1400 Independence Ave. SW., Washington, DC.
Submit written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852, or via e-mail to ``FDAD[email protected]''. Comments are to
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Lisa Barclay, Office of Policy,
Planning, and Legislation (HF-22), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-3360.
SUPPLEMENTARY INFORMATION:
I. Introduction
In the Federal Register of April 29, 1998 (63 FR 23624), FDA
published a proposed rule on the types of claims that could be made for
dietary supplements without prior authorization by FDA. Under Federal
Food, Drug, and Cosmetic Act (the act), as amended by the Dietary
Supplement Health and Education Act of 1994 (DSHEA), a dietary
supplement may carry 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 [the supplement] acts to maintain such structure or
function.'' These types of claims are referred to as structure/function
claims. However, a permitted structure/function statement ``may not
claim to diagnose, mitigate, treat, cure, or prevent a specific disease
or class of diseases.'' These types of claims are referred to as
``disease claims.''
In the April 29, 1998, proposal, FDA stated its belief that the
line between structure/function claims and disease claims was not
always clear and that clarifying criteria were needed. The proposed
rule was intended to help identify disease claims; claims that did not
qualify as disease claims would be considered acceptable structure/
function claims. The proposal contained a definition of ``disease,''
based upon current definitions of the term in medical and legal
dictionaries. This definition differed from a definition of ``disease
or health-related condition'' already found in FDA's regulations
implementing the health claims provisions of the Nutrition Labeling and
Education Act (NLEA). FDA proposed to conform the definition of
``disease or health-related condition'' in the health claims regulation
to the proposed new definition of ``disease.'' The proposal also
contained 10 criteria for identifying disease claims.
FDA received over 100,000 comments on the proposed rule. Most of
the comments objected to the proposed definition of disease or to some
or all of the criteria for identifying disease claims. Although the
comments raised many issues, three issues received particular
attention: (1) Whether FDA should retain the definition of ``disease or
health-related condition'' issued for NLEA health claims, rather than
issue a new definition of ``disease''; (2) whether certain common
conditions associated with natural states, such as hot flashes
associated with menopause, or premenstrual syndrome associated with the
menstrual cycle, should be considered ``diseases''; and (3) whether
dietary supplements may carry implied disease claims. Because of the
degree of controversy surrounding these issues, FDA believes that
further public discussion focused on the three issues would be useful.
FDA is therefore holding a public meeting to obtain further input on
how to develop appropriate rules or policies that are consistent with
the intent of DSHEA and with protection of the public health.
II. Scope of Discussion
The scope of the meeting will be limited to the three issues
discussed in this notice. A brief discussion of each of the issues with
specific questions on which FDA would like input follows.
A. Definition of Disease
In 1993, FDA issued regulations implementing the health claims
provisions of NLEA. NLEA requires food manufacturers, including dietary
supplement manufacturers, to obtain prior FDA authorization for any
labeling statement that characterizes the relationship between a
nutrient in the food to a ``disease or a health-related condition''
(section 403(r)(1)(B) of the act (21 U.S.C. 343(r)(1)(B)). The phrase
``disease or health-related condition'' was defined in those
regulations 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);
except that diseases resulting from essential nutrient deficiencies
(e.g., scurvy, pellagra) are not included in this definition * * *
Sec. 101.14(a)(6) (21 CFR 101.14(a)(6)).
In the proposed rule on structure/function claims, FDA proposed a
new definition of ``disease'':
[[Page 36825]]
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.
FDA's proposed definition of disease was based on current medical
and legal definitions of the term. FDA stated in the preamble to the
proposed rule that the agency did not want to make use of the older
health claims definition of ``disease or health-related condition''
because its use of the term ``damage'' could be interpreted to limit
the definition to serious or long-term diseases, and might exclude
conditions that are medically understood to be diseases, such as
depression or migraine headaches.
A very large percentage of the comments received on the proposal
objected to the new definition of disease. Among the principal
objections were that: (1) The new definition is too broad, sweeping in
many minor deviations or abnormalities that are not diseases; and (2)
Congress should be presumed to have been aware of the 1993 definition
of ``disease or health-related condition'' and to have intended FDA to
use that definition. Almost all of the comments from the dietary
supplement industry and from individuals recommended that FDA return to
the 1993 definition. Comments from health professional groups tended to
support the new definition of disease as more consistent than the NLEA
definition with a medical understanding of disease.
FDA seeks further input on the appropriate definition of disease.
To help focus comments on this issue for the public meeting, the agency
seeks input on the following questions: (1) What are the consequences,
with respect to the range of permissible structure/function claims, of
adopting: (a) The 1993 definition in Sec. 101.14(a)(6), or (b) the
definition in the proposed rule? (2) If FDA were to retain the 1993
definition, does the reference to ``damage'' exclude any conditions
that are medically understood to be diseases? Please provide examples.
(3) If it does not exclude any such conditions, is the 1993 definition
otherwise consistent with current medical definitions of disease? (4)
If it does exclude conditions that are medically understood to be
diseases, could it be revised in a way that would include such
conditions?
B. Common Conditions Associated With Natural States
The proposed rule stated that natural states such as aging,
menopause, pregnancy, and the menstrual cycle, were not themselves
diseases, but could be associated with abnormal conditions that were
diseases. FDA proposed to treat as a disease claim a statement that a
product had an effect on a condition associated with a natural state if
the condition presented ``a characteristic set of signs or symptoms
recognizable to health care professionals or consumers'' as an
``abnormality'' (see proposed Sec. 101.93(g)(2)(iii)). FDA provided as
examples of such abnormal conditions the following: Toxemia of
pregnancy, premenstrual syndrome, hot flashes, and presbyopia,
decreased sexual function; and Alzheimer's disease associated with
aging.
Many comments strongly objected to classifying common conditions
associated with natural states as diseases. While no one argued that
toxemia of pregnancy or Alzheimer's disease are not diseases, a very
large number of comments contended that premenstrual syndrome, hot
flashes, and decreased sexual function associated with aging are so
common that they should be considered neither abnormal nor diseases.
To help focus comments on this issue for the public meeting, FDA
seeks input on the following questions: (1) If FDA were to treat some
conditions associated with natural states as diseases (e.g., toxemia of
pregnancy and Alzheimer's disease) but not others (e.g., hot flashes,
common symptoms associated with the menstrual cycle, and decreased
sexual function associated with aging), what would be an appropriate
principle for distinguishing the two groups? (2) For example, would it
be appropriate to consider the severity of the health consequences if
the condition were to go without effective treatment? (3) If so, how
should ``severity'' be defined?
C. Implied Disease Claims
FDA proposed to treat both express and implied disease claims as
disease claims that could not be made for dietary supplements without
prior FDA review (either as health claims or as drug claims). Many
comments objected, arguing that Congress intended to include implied
disease claims within the category of structure/function claims that do
not require prior FDA review.
Most of the comments contended that Congress intended to prohibit
only express disease claims, which, according to the comments, are
limited to claims that explicitly refer to a specific disease. For
example, ``for the treatment of lung cancer'' would be an express
disease claim because it uses the term ``cancer.'' According to the
comments, implied disease claims are those that do not explicitly
mention a specific disease. Implied disease claims may, however, refer
to identifiable characteristics of a disease from which the disease
itself may be inferred. There are many possible ways to imply treatment
or prevention of disease, from listing the characteristic signs and
symptoms of the disease to providing images of people suffering from
the disease. As defined by the comments, the last 9 of the 10 criteria
proposed by FDA for identifying disease claims could be considered
methods of implying disease treatment or prevention.
Many comments argued with particular energy that dietary
supplements should be allowed to claim to alleviate the characteristic
signs or symptoms of a disease. Few comments offered examples of the
types of implied disease claims they believed should be permitted.
Applying the principle that dietary supplement labeling should be
allowed to list the signs and symptoms of a disease, ``shrinks tumors
of the lung'' or ``prevents development of malignant tumors'' would be
permitted claims because they refer to the remedial effect of a product
on a defining symptom of cancer, but do not mention the name of the
disease itself. Similarly, while ``treatment of epilepsy'' would be
prohibited as an express disease claim, ``prevention of seizures''
would be acceptable as an implied disease claim. ``Treatment of hay
fever'' would be prohibited as an express disease claim, while ``relief
of sneezing, runny nose, and itchy watery eyes caused by exposure to
pollen or other allergens'' would be permitted as an implied disease
claim.
The comments argued that Congress' intent to permit implied
disease claims can be seen in at least three provisions of DSHEA.
First, the Findings section of DHSEA refers to the relationship between
dietary supplements and disease prevention. Second, section 403(r)(6)
of the act states that structure/function statements may not ``claim''
to treat or prevent disease, and this term should be read to refer only
to express claims. Third, DSHEA requires structure/function claims to
be accompanied by a disclaimer that ``this product is not intended to
diagnose, treat, cure, or prevent any disease.'' According to the
comments, Congress understood that specific disease treatment or
prevention effects can also be described as effects on the structure
[[Page 36826]]
or function of the body, and resolved the tension by requiring the
disclaimer. Many comments also argued generally that DSHEA was intended
to promote the free-flow of truthful information about dietary
supplements, and that prohibiting implied disease claims is contrary to
this legislative goal.
FDA had proposed to treat both express and implied claims as
disease claims on two grounds. First, the agency has always exercised
authority over both express and implied claims under section
201(g)(1)(B) of the act (21 U.S.C. 321(g)(1)(B)) , and believed that
Congress would have explicitly authorized implied claims if it intended
to change the agency's longstanding interpretation of the statute. The
sections of DSHEA cited by the comments do not contain such an express
authorization. Second, FDA believed that most disease treatment or
prevention claims, including claims about serious and life-threatening
diseases, can be described in a manner that will be easily understood
by consumers without express reference to the name of the disease
(e.g., ``shrinks tumors of the lung''). If dietary supplements were
permitted to make implied disease claims, the burden would be on
consumers to evaluate the validity of claims about dietary supplements
marketed for serious and life-threatening diseases. In addition,
dietary supplements could be given an unfair advantage over
prescription and over-the-counter drugs in the marketplace that are
required to establish their safety and effectiveness for disease
treatment and prevention.
In the proposed rule, FDA asked for comment on a specific type of
implied disease claim: A claim that a dietary supplement prevents or
treats abnormal or unhealthy conditions or clinical measurements that
are not themselves diseases but are markers of, or risk factors for,
diseases, e.g., ``lowers cholesterol.'' FDA proposed to treat such
claims as disease claims, but to permit claims that a product maintains
healthy function, e.g., ``helps maintain a healthy cholesterol level.''
Most of the comments argued that consumers do not perceive a
distinction between claims that a product treats or prevents abnormal
function, and claims that the product maintains healthy function.
Comments from dietary supplement manufacturers and some consumer groups
argued that both types of claims should be permitted, while comments
from health professional groups, groups devoted to specific diseases,
and other consumer groups tended to argue that neither type of claim
should be permitted.
FDA seeks further input on whether dietary supplements should be
permitted to carry implied disease claims without prior review, either
as health claims or as drug claims. To help focus comments on this
issue for the public meeting, the agency seeks input on the following
questions: (1) If such claims should be permitted, how should FDA
correctly draw the line between what constitutes a prohibited express
claim and what constitutes a permitted implied claim? (2) If such
claims should be permitted, what are representative examples of the
types of implied disease claims that should be permitted without prior
review? (3) Are the examples mentioned in this notice appropriate
structure/function claims? (4) Is a claim that a product ``maintains
healthy function'' an implied disease claim in all cases? If not, under
what circumstances is such a claim not an implied disease claim?
III. Registration and Requests to Make Oral Presentations
If you would like to attend the meeting, you must register with
the contact person (address above) by July 16, 1999, by providing your
name, title, business affiliation, address, telephone, and fax number.
To expedite processing, registration information may also be faxed to
301-594-6777. If you need special accommodations due to disability,
please inform the contact person when you register.
FDA intends to invite representatives from industry, health
professional groups, and consumer groups to participate in panel
discussions on the three issues discussed previously during the first
portion of the meeting. Presentations by members of the public will be
permitted during the second portion of the meeting, as time permits.
If, in addition to attending, you wish to make an oral presentation
during the meeting, when you register to attend you must so inform the
contact person and submit: (1) A brief written statement of the general
nature of the arguments you wish to present, (2) the names and
addresses of the persons who will give the presentation, and (3) an
indication of the approximate time that you request to make your
presentation. Depending upon the number of people who register to make
presentations, we may have to limit the time allotted for each
presentation. We anticipate that, if time permits, those attending the
meeting will have the opportunity to ask questions during the meeting.
IV. Comments
Interested persons may, on or before August 4, 1999, submit
written comments to the Dockets Management Branch (address above). You
may also send comments to the Dockets Management Branch via e-mail to
``FDAD[email protected]''. You should annotate and organize your
comments to identify the specific issues to which they refer. You must
submit two copies of comments, identified with the docket number found
in brackets in the heading of this document, except that you may submit
one copy if you are an individual. You may review received comments in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
V. Transcripts
You may request transcripts of the meeting in writing from the
Freedom of Information Office (HFI-35), Food and Drug Administration,
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15
working days after the meeting at a cost of 10 cents per page. You may
also
examine the transcript of the meeting at the Dockets Management Branch
(address above) between 9 a.m. and 4 p.m., Monday through Friday, as
well as on the FDA Website ``http://www.fda.gov''.
Dated: July 2, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-17424 Filed 7-6-99; 12:26 pm]
BILLING CODE 4160-01-F