[Federal Register Volume 65, Number 37 (Thursday, February 24, 2000)]
[Proposed Rules]
[Pages 9230-9232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4276]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 00N-0506]


Safety Issues Associated With Dietary Supplement Use During 
Pregnancy; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Announcement of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting on safety issues associated with dietary supplement use during 
pregnancy. The purpose of this meeting is to obtain public comment on 
safety concerns that have been raised regarding structure/function 
claims for dietary supplements used during pregnancy. On January 6, 
2000, FDA published a final rule on statements that may be made for 
dietary supplements concerning the effect of the product on the 
structure or function of the body. FDA has since received comments from 
public health professionals and others concerned about the safety of 
using dietary supplements during pregnancy. The public meeting is 
intended to give the public an opportunity to comment on these issues.

DATES: The meeting will be held on April 24, 2000, from 9 a.m. to 5 
p.m. Submit written comments by April 24, 2000.

ADDRESSES: The public meeting will be held in the Crystal Ballroom at 
the Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, MD 20877. 
Submit written comments to the Dockets Management Branch (DMB) (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. 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.

FOR FURTHER INFORMATION CONTACT: Rose Cunningham, Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane (HFD-6), Rockville, MD 20857, 301-594-5468, FAX 301-594-5493, e-
mail: [email protected].
    See SUPPLEMENTARY INFORMATION for electronic access addresses.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this announcement for a public meeting on safety issues 
associated with dietary supplement use during pregnancy apply to me?

    This announcement is directed to the general public. It may, 
however, be of particular interest to individuals or organizations 
concerned with public health, pregnancy, or dietary supplements. 
Specific groups that may want to attend include: Consumers; public 
health professionals, including obstetricians, gynecologists, 
neonatologists, pediatricians, and pediatric and obstetric nurses; 
dietary supplement producers, processors, distributors, and retailers; 
academia; and State, Tribal, and local public health agencies. Other 
entities or individuals may also be interested in attending.

B. Where will this meeting be held?

    This meeting will be held in the Crystal Ballroom at the 
Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, MD 20877.

C. When will this meeting be held?

    This meeting will be held on March 30, 2000, from 9 a.m. to 5 p.m.

D. How can I participate?

    1. In person. Anyone interested in dietary supplement use during 
pregnancy is encouraged to attend the public meeting. Persons who wish 
to speak during the public meeting must file an electronic, written, or 
facsimile notice of participation with Rose Cunningham by March 17, 
2000. To ensure timely handling, the outer envelope or facsimile cover 
sheet should be clearly marked with Docket No. 00N-0506. Groups should 
submit two copies. The notice of participation should contain the 
speaker's name, address, telephone number, FAX

[[Page 9231]]

number, title, business affiliation, if any, a brief summary of the 
presentation, and approximate amount of time requested for the 
presentation. The notice of participation form is available on the 
Internet and can be e-mailed to [email protected] or printed and 
faxed to 301-594-5493.
    Individuals and organizations with common interests are encouraged 
to consolidate or coordinate their presentations and to request time 
for a joint presentation. FDA may require joint presentations by 
persons with common interests. Participants may request a specific 
amount of time for their presentation. After registration has closed, 
FDA will inform participants of the amount of time available for their 
presentation.
    Persons requiring a sign language interpreter or other special 
accommodations should notify Rose Cunningham at 301-594-5468 by March 
21, 2000.
    2. In writing. FDA has established a public docket for comments. 
Comments should be submitted by April 24, 2000. It is important that 
comments submitted to the docket are identified with Docket No. 00N-
0506. Submit written comments to DMB (address above).

E. Is there a registration fee for this meeting?

    There is no registration fee for this meeting.

F. How can I get additional information, including copies of this 
document or other related documents?

    1. Electronically. You may obtain electronic copies of this 
document and other related documents on the Internet at http://www.fda.gov/ohrms/dockets/default.htm. The notice of participation 
form, information about the meeting, and other related documents are 
available at http://www.fda.gov/cder/calendar/meeting/pregsup2000/default.htm. Additional information regarding dietary supplements is 
available at http://vm.cfsan.fda.gov/dms/supplmnt.html.
    2. By phone. If you have any questions about the public meeting, 
please consult the person listed under FOR FURTHER INFORMATION CONTACT.

G. Can I get a transcript of this meeting?

    A transcript of the public meeting will be available from DMB 
(address above), approximately 15 business days after the meeting at a 
cost of 10 cents per page. The transcript of the public meeting will 
also be available for public examination at the office above between 
the hours of 9 a.m. and 4 p.m., Monday through Friday.

II. Background Information

A. Why is FDA holding this meeting?

    FDA is holding this meeting in response to comments it received 
after publishing a final rule regarding claims that may be made for 
dietary supplements concerning the effect of the product on the 
structure or function of the body (65 FR 1000, January 6, 2000).
    In that final rule, FDA announced that it would not treat as 
diseases common conditions associated with natural states or processes 
that do not cause significant or permanent harm and that claims about 
beneficial effects on such conditions would not be treated as disease 
claims. In the preamble to the final rule, FDA noted that pregnancy is 
associated with common and mild conditions such as morning sickness and 
leg edema that cause no permanent harm if left untreated, as well as 
with such serious conditions as hyperemesis gravidarum, toxemia of 
pregnancy, and acute psychosis of pregnancy, which can be life-
threatening if not effectively treated. FDA stated that claims about 
common, mild conditions related to pregnancy such as morning sickness 
and leg edema would be considered structure/function claims. FDA also 
noted that claims to treat some conditions related to pregnancy would 
remain disease claims that could not be made without prior review, for 
example, toxemia of pregnancy, hyperemesis gravidarum, and acute 
psychosis of pregnancy.
    After FDA published the final rule, it received additional comments 
raising safety concerns about dietary supplement use during pregnancy. 
As a result, on February 9, 2000, FDA issued a statement concerning the 
structure/function rule and pregnancy claims. That statement said:

    To ensure that careful consideration is given to concerns 
recently raised regarding how the structure/function rule relates to 
pregnancy, FDA today is advising dietary supplement manufacturers 
not to make any claims related to pregnancy on their products based 
on the agency's recently issued structure/function rule. FDA will 
issue a Federal Register Notice shortly describing these concerns in 
more detail, stating the agency's intention to fully review these 
concerns, hold a public meeting related to potential pregnancy 
related safety concerns, and then issue further guidance. FDA urges 
all pregnant women to consult their health care provider before 
taking any dietary supplements or medications.

    FDA is issuing this Federal Register notice in accordance with that 
statement.

B. What concerns have been raised to FDA in recent letters?

    FDA has received three letters from medical doctors, one letter 
from a law professor, and one letter from a citizen's group. Several 
newspapers have also run articles regarding the marketing of dietary 
supplements to pregnant women. All the incoming letters indicate 
opposition to classifying ``ordinary morning sickness'' and ``leg edema 
associated with pregnancy'' as non-diseases and express concern that 
use of dietary supplements during pregnancy may adversely affect the 
fetus. They strongly urge revising the rule so it does not allow these 
claims to be made in the absence of evidence of fetal safety. Several 
letters argue that FDA should treat as disease claims all conditions 
associated with pregnancy. In addition, similar safety concerns were 
raised about the safety of dietary supplement use in other vulnerable 
populations such as infants, who may be exposed thru nursing and 
children.

C. On what issues does FDA seek comment?

    The Dietary Supplement Health and Education Act (DSHEA) allows 
manufacturers of dietary supplements to claim effects on the 
``structure or function'' of the body, but not to make claims to 
mitigate, treat, prevent, cure, or diagnose disease (21 U.S.C. 
343(r)(6)). The structure/function rule focuses on the distinction 
between disease claims, which require evidence of safety and efficacy 
to be presented to the agency before marketing, and structure/function 
claims. In contrast, the comments received by the agency focus 
primarily on the safety issues that may result from the use of dietary 
supplements during pregnancy. The purpose of this meeting is to obtain 
public comment on safety concerns that have been raised regarding 
structure/function claims for dietary supplements used during 
pregnancy. Although FDA welcomes comments on all of the issues 
discussed in the letters mentioned previously and on all aspects of 
dietary supplement use during pregnancy, FDA specifically seeks comment 
on the following points.
    1. What are the potential hazards that may be associated with use 
of dietary supplements for conditions associated with pregnancy, both 
to the pregnant woman and the fetus? Should these hazards be considered 
to be different than hazards to other potential users of dietary 
supplements? If so, why and on what basis under DSHEA?
    2. Are there certain conditions associated with pregnancy (in 
addition to those already identified in the final

[[Page 9232]]

rule) for which structure/function claims should not be permitted? If 
so, why and on what basis?
    3. What is the potential for harm that may be associated with the 
use of dietary supplements during pregnancy for conditions unrelated to 
pregnancy?
    4. Are there means to address safety concerns associated with 
dietary supplement use during pregnancy, for example, a requirement to 
conduct animal studies or collect human safety information?
    5. Should dietary supplements with a specific recommended use 
during pregnancy be required to bear specific warnings about use during 
pregnancy? Should all dietary supplements be required to bear such 
warnings?
    FDA will post any additional questions to be addressed on the 
Internet at http://www.fda.gov/cder/calendar/meeting/pregsup2000/default.htm.

    Dated: February 16, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-4276 Filed 2-18-00; 10:05 am]
BILLING CODE 4160-01-F