Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body; Public Meeting

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