BY HAND
DELIVERY
Jane A.
Henney, M.D.
Commissioner
Food
and Drug Administration
5600
Fishers Lane
Rockville,
MD
Dear Commissioner
Henney:
The
undersigned trade associations represent the vast majority of
the manufacturers of dietary supplements, including supplements
that contain naturally occurring ephedrine alkaloids. We were
pleased with the Food and Drug Administration�s (FDA�s) February
25, 2000 letter to Members of Congress announcing that the Agency
will withdraw the proposed serving and duration limits on dietary
supplements containing ephedra. We commend this action. We believe
that consumers and industry will benefit from an open dialogue
with FDA in the decision-making process that will assess the
scientific data and will help establish appropriate standards
for these products.
We appreciate
the need for FDA to go back to the ephedra issue and to review
all of the available data using a new process. In light of the
criticisms by the General Accounting Office (GAO) of the previous
process, FDA should develop a new position through a completely
open and transparent public process. An initial and crucial
requirement for developing a new position is the collection
of all available data, including the adverse event reports (AERs)
that have accumulated since the proposed rule was published
in 1997, independent reviews of the new AERs, as well as information
on the impact of industry and state standards on safety.
GAO�s July
1999 report on FDA�s ephedra proposal recognized that studying
the effect of current standards is an essential starting point
before deciding whether to invest additional resources to regulate
ephedra at the federal level. Industry has adopted serving and
daily intake limits and an extensive warning label to address
adverse events. These standards are now required by law in several
states. A transparent and public process will provide more information
to further confirm the safety of these products, including information
on the increase in sales of ephedra products and a concurrent
decrease in the number of AERs.
It is also
essential for FDA to propose and make public in advance criteria
for evaluation methods that will define the process that is
appropriate for reviewing ephedra products in light of the new
AERs and in the context of other necessary data, including consumption
data. We believe that this approach will enhance the likelihood
of a policy decision that can withstand scrutiny.
Thus, to
build a transparent basis for a new position on ephedra, we
urgently recommend that FDA:
- Immediately
release all new AERs (after redaction to protect privacy)
without any analysis of the AERs;
- Announce
a public forum as a process to gather all available information,
to permit independent evaluation of the new AERs, and to assess
the evaluation method that should be used to develop a policy
position; and
- Withhold
final interpretation of the new AERs until the public process
is complete.
The undersigned
trade associations commit to work with FDA to provide all of
the information that industry has assembled over the last three
years and to identify a valid and widely supportable evaluation
method for ephedra products that will incorporate all of the
available information.
We thank
you again for your help with this issue, and we look forward
to working with you on this and other dietary supplement issues.
