[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
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 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