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Failed Ephedrine Safety Measures
On June 2, 1997, the FDA proposed ephedrine safety meausures
by limiting the amount of ephedrine alkaloids in products
and by requiring labeling and marketing measures that
give adequate warning and ephedrine side effects information
to consumers. Ephedrine has a chemical structure that
is similar to amphetamines, differing only in that ephedrine
is less potent. An October 11, 2001, Public Citizen
made a statement before the National Academy of Sciences
on the Framework for Evaluating the Safety of Dietary
Supplements. The group pointed out the similarity of
the ephedrine structure to now banned PPA and amphetamine
structure. Public Citizen's Dr. Sidney Wolfe exhibited:
The following chart shows the closely related chemical
structures of phenylpropanolamine (PPA), amphetamine
and ephedrine. PPA is identical to ephedrine except
for the absence of a methyl (CH3) group. In fact, the
body metabolizes a small portion of ephedrine to PPA
(now banned), which is also called norephedrine ("nor"
meaning no methyl group).
It was noted that PPA is also known as norephedrine,
which is ephedrine without the methyl.
Interestingly, Metabolife President and co-founder
Michael Ellis, a former police officer, had been convicted
in a 1990 drug related charge. This charge involved
the illegal manufacture and sale of methamphetamine,
which can be produced using ephedra, and Ellis pleaded
guilty to a felony charge. The Public Citizen consumer
group noted the Metabolife co-founder's previous criminal
record when urging Secretary Thompson to direct the
FDA to open a criminal investigation of Metabolife.
The 1997 FDA proposal was intended not to ban dietary
supplements containing ephedrine, but to make consumers
aware that "natural" or herbal sources does
not qualify a product to be safe. The FDA proposal wished
to prohibit marketing of dietary supplements containing
8 mg or more of ephedrine per serving after the FDA
noted in 1994 that increased marketing and use of the
ephedrine products had resulted in an increasing number
of adverse
ephedrine side effects reports. Since 1994, the
FDA had received and investigated over 800 reports of
adverse events associated with the use of ephedrine
products, which resulted in the FDA's proposal to require
label statements to include the statement that "taking
more than the recommended serving may result in heart
attack, stroke, seizure or death" and to instruct
consumers to use the ephedrine product for less than
7 days.
The FDA's efforts to limit the use of ephedrine in
dietary supplements had been blocked by the industry's
high-powered lobbying efforts and by Congress according
to the FDA's deputy commissioner Dr. Ester Crawford.
Even Public Citizen's petition to the FDA requesting
the ban of dietary supplements containing ephedrine
in September 2001 did not result in any changes made
to ephedrine containing products like Metabolife. On
June 14, 2002, the Public Citizen responded to the Department
of Health and Human Service's failure to ban ephedra
or issue adequate warnings by saying their lack of response
towards to the dangerous herb should "result in
the firing of all officials in the HHS and the FDA who
are responsible for this dangerous cowardice."
On August 15, 2002, the FDA Deputy Commissioner Crawford
made a statement that they had asked the Department
of Justice to pursue a criminal investigation of Metabolife,
regarding if the company had made false statements to
FDA regarding the existence of adverse event reports.
The FDA noted that Congress had placed the burden on
the Secretary of Health and Human Services to prove
that these products are unsafe and so the Secretary
had called for an extensive scientific review of ephedra
in June in order to establish a scientific base for
addressing health concerns around the side effects of
ephedrine. Metabolife finally allowed the release of
its records of more than 13,000 health complaints Metabolife
had received since 1997, a move the FDA called "disingenuous"
due to Metabolife's long history of being uncooperative.
A criminal
investigation is now underway concerning the safety
of the nation's best selling ephedrine
product Metabolife.
For
more information on ephedrine safety contact us and
learn more about your legal rights.
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