Public Policy Center
The History Of FDA's Opposition To Ephedra
Adverse event reports
The FDA's proposed rule was based primarily on the more than
800 adverse event reports that the agency received between 1993
and 1997, despite billions of servings consumed. The FDA failed
to perform even the most simple quality review of these reports.
As a result, the record for the proposed rule included reports such
as the following:
- A report of a woman whose blood alcohol was twice the legal limit
and died of a fractured skull after driving her truck into a tree
at 90 mph.
- A report of a man who shot himself.
- A report of a suicide from a gunshot wound.
- A report of a man who died of environmental hyperthermia.
- A report stating "Shot and killed store clerk."
- A report of a woman who "got pregnant though using Norplant."
- Reports of excessive hairiness.
- A report of a 75-year old woman menstruating.
- A report of a possible diagnosis of multiple sclerosis.
- A report of impotence.
- A report of constant erection.
Careful analysis of the FDA record shows that approximately 85 percent
of the reports included in the FDA's decision regarding Ephedra
had none of the information needed to make a credible scientific
assessment of their relationship to the consumption of Ephedra.
Furthermore, the FDA relied on just 13 of the reports as a basis
for the proposed dosage limits even though the agency never reviewed
these few reports to determine if they were causally related to
the consumption of Ephedra.
These immediate problems with FDA's proposed rule led to a
more thorough review of the rule by Congress. Congress found the
following problems with the AERs:
- Some reports had nothing to do with Ephedra but were included
anyway;
- Approximately eighty-five percent of the reports were considered
"informationally worthless" because they lacked information
essential for a scientific assessment;
- Proposed dose limit rules were based on just 13 AERs that were
not reviewed to establish whether consumption of Ephedra caused
the problem.
This congressional review led to a critical GAO
report. You can access the report by clicking on this link.
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