March 17, 2000

Jane A. Henney, M.D.
Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD  20857

Dear Commissioner Henney:

It has been brought to our attention that the Food and Drug
Administration (FDA) intends to take actions that will have
a direct impact on an ongoing FDA rulemaking that we believe
could be detrimental to small business interests.  FDA's
planned actions may violate the Freedom of Information Act
(FOIA), and may also undermine an important public trust
that is placed in FDA to act in a fair and scientific manner
to advance the interests of public health.  We respectfully
request that FDA reconsider its planned course of action,
discussed below, and that FDA adopt an alternative plan of
action that will preserve the interests of the law and of
public health.

Background

As you may recall, the Office of Advocacy filed extensive
comments on FDA's June 4, 1997 proposed rule regarding
dietary supplements containing ephedrine alkaloids.  Our
comments focused on small business concerns and FDA's lack
of compliance with the Regulatory Flexibility Act (RFA) and
other applicable laws protecting small business interests.
In particular, Advocacy expressed concerns over the apparent
lack of valid scientific evidence to support the proposed
restrictions on these dietary supplements.  This point was
of extreme importance given that theat proposed
restrictions, if they had been put into effect, would have
banned the major market for these products-use as an aid to
weight loss-with profound effect on the livelihoods of
hundreds of thousands of independent distributors and on
consumers who rely on these products to stay healthy.

Subsequent to our comments, the General Accounting Office
(GAO) conducted an audit of FDA's proposed rule and
confirmed what experts outside the agency had found in their
analysis-that there was an inadequate basis for FDA's
duration limits for these products (on which FDA's proposed
ban on marketing for weight-loss was based), and that FDA
had based its proposed serving limits on just thirteen
adverse event reports (AERs).  FDA, in response to the
findings in the GAO report, stated that they did not base
dose limits on only thirteen reports-even though FDA stated
explicitly in the preamble of the proposed rule that those
thirteen reports were the basis for the limits.

The Industry's FOIA Request

FDA's proposal was based on AERs that had been submitted to
FDA through June of 1997.  After it became clear to industry
that the rulemaking might take a considerable amount of
time, industry representatives apparently attempted to gain
access to the new AERs on ephedra products that were
submitted to FDA after June 1997.  Several important
purposes were to be achieved through compilation and
evaluation of these AERs.

First, industry needed the AERs to confirm what their own
records were showing-that the national standard theat
industry had established was causing a substantial decrease
in AERs despite soaring sales of these products.  Industry
established voluntary trade standards (e.g., the American
Herbal Products Ephedra Trade Recommendation), and had these
standards incorporated into state laws.  In 1997, industry
standards were adopted as law in Ohio and Washington and
most recently, in Hawaii and Michigan.  The major industry
trade associations claims that their members, representing
the vast majority of all the major supplement companies, now
comply with the national standard for these products, which
includes per serving and daily intake limits of 25 mg and
100 mg, a comprehensive warning statement including a
recommendation against use by minors, and a prohibition on
marketing for herbal "highs."

Second, industry needed to monitor the reports to respond to
press reports of serious adverse events that were alleged to
be connected to the consumption of Ephedra products.
Finally, individual companies needed to obtain the reports
for their own analysis to further evaluate their products to
assure safety, to monitor product and ingredient quality,
and to assure independent distributors that press reports
were not accurate.

FDA is required by law to respond to FOIA requests within 20
days.  The industry claims that it has been two or more
years since repeated FOIA requests for new Ephedra AERs have
been filed.,  hHowever, FDA has only said that it lacks the
resources to respond to the FOIA requests.

Most recently, FDA has said that they it plans to withdraw
the proposed dose and duration limits for these products and
to release the AERs to the public in the near future.  In
itself, this is good news.  However, the industry has been
told that FDA simultaneously plans to publish in the Federal
Register a detailed scientific analysis of the reports, as
well as a new analysis of the scientific literature that
relates to these products.

The industry has expressed concern that the agency on the
one hand lacks the resources to conduct a simple purging of
the reports to remove confidential patient information,
while on the other had, FDA has the resources to conduct a
thorough medical and scientific evaluation of the same AERs.
The industry is also concerned that FDA is purposefully
manipulating the system and withholding information from the
public and the industry in order to redeem the agency's
reputation.  Advocacy does not believe this to be the case;
however, FDA is losing a great deal of good will within the
industry because of its actions.

The release of the reports with a negative FDA analysis
could eliminate the market for these products without FDA
ever needing to continue its rulemaking.  Further, small
business is concerned that if FDA releases the AERs with an
analysis, the agency will not put the AERs in proper
context; that is, FDA will not inform the public what the
real risk of any particular event is, will not inform the
public of the enormous numbers of individuals consuming
these products, and will not inform the public that the
number of events has dropped significantly in the past years
despite soaring sales.  FDA did not attempt to frame the
AERs that were released with its June 1997 proposal in the
proper context, hence the concern as to whether FDA intends
to do so now.

The industry would like FDA to provide an opportunity to
evaluate the reports before FDA characterizes them to the
press and the public.  Although Advocacy has no statutory
authority to force FDA to comply with the industry's FOIA
requests, in the spirit of fairness and cooperation, we
would ask that FDA make a serious effort to comply.
Moreover, the perceived mistrust the agency has apparently
generated over the past couple of years could possibly be
alleviated if the agency would release the AERs, as should
have been done long ago, and provide industry with ample
time to review these reports before FDA holds a public forum
on these products.  An FDA analysis that is released after
all of the available information is carefully considered,
including the views and analysis of interested members of
the public, including small business, will be much more
credible than any agency analysis that is released prior to
public review and comment. were to at least formally
withdraw the proposal and work with the industry to find
some acceptable solutions.

Advocacy would be happy to meet with you if you wish to
discuss this matter further.  In the meantime, do not
hesitate to call if you have any questions.

Sincerely,

Jere W. Glover                Shawne Carter McGibbon
Chief Counsel for Advocacy              Assistant Chief
Counsel for Advocacy

Shawne Carter McGibbon
Assistant Chief Counsel for Advocacy