"John Galt" <
[email protected]> wrote in message
news:
[email protected]...
> Epedra Ban -
>
> Why? If 100 people died from ephedra abuse, and edphedra is being
> banned, why is tobacco not banned? How many have died from tobacco
> abuse? Certainly more than 100!
A reasonable question. It is simply different legislation. They explain
it all here ---
http://www.fda.gov/oc/initiatives/ephedra/december2003/qa.html
One section which shows how limited FDA powers really are under DSHEA ----
Why didn't FDA reach this conclusion sooner?
The law that governs how FDA can regulate dietary supplements, the Dietary
Supplement Health and Education Act (DSHEA), requires FDA to do a lot of
hard work with limited tools in order to determine that a dietary supplement
is too unsafe to be marketed. In contrast to drugs, which must be proven
safe and effective to be marketed, DSHEA requires FDA to develop evidence
post marketing that a dietary supplement presents an "unreasonable risk of
illness or injury." But FDA has no authority to require any studies of
safety or effectiveness, or even to obtain reports of adverse events from
manufacturers. FDA first proposed regulating ephedra in 1997, but commenters
including the U.S. General Accounting Office generally believed that FDA had
not developed sufficient evidence for action. There is now considerably more
evidence available on ephedra's risks and benefits than when the proposed
rule was published. Earlier this year, the Agency published a Federal
Register (FR) notice reopening the comment period on its 1997 proposed rule
on dietary supplements containing ephedrine alkaloids to seek comment on new
scientific evidence about the risks of these products and on a proposed
warning statement for the labels of these products. The FR announcement also
sought comments on whether, in light of current information, FDA should
determine that dietary supplements containing ephedrine alkaloids present a
significant or unreasonable risk of illness or injury under the conditions
of use recommended or suggested in labeling, or under ordinary conditions of
use if the labeling is silent. In FDA's view, "unreasonable risk" implies a
risk-benefit calculus. In order to make such a calculus, the FDA had to
examine the best available scientific evidence and take it into account in
assessing whether the product's known or suspected risks outweigh its known
or suspected benefits. We sought comment from health professionals, the
supplement industry, and the general public on any additional data on
ephedra's safety, so that FDA could acquire the most complete picture
possible of the product's potential risks, as a basis for appropriate
further regulatory action.
Peter Moran
