Safety Issues Associated with Dietary
Supplement Use During Pregnancy; Public Meeting 3/30/00 FDA seeks comment on the following
issues:
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. 343r(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 aforementioned letters 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 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?
**There may be additional questions added prior to the
meeting.
FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OTCOM/DML
HTML by GYC |
