Sentence for Dietary Supplements
by Wyn Snow, Managing Editor
bill 722 is like using a nuclear bomb to catch Sadaam Hussein: It
might work, but the cost is too high because many innocents would
be killed as well.
consequences of this proposed legislation (S.722) are unacceptably
severe. It would introduce massive inefficiencies in both government
and industry, and would not be an effective use of taxpayer money.
It is also likely to remove important supplements that consumers
rely on from the marketplace, not just the riskiest ones, and drive
up the cost of those that remain.
one serious event triggers investigation of safety
report of a single "serious adverse dietary supplement experience"
would enable the FDA to require the manufacturer to submit safety
data on that product. Senate 722 then gives the FDA the authority
to decide whether that safety data is adequate. If not, the supplement
would be removed from the marketplace.
safety data sounds like a good thing. Who wouldn't want a dietary
supplement to be safe? Especially when reports of athletes' deaths
associated with ephedra hit the headlines every year. But this bill
ignores the fact that all supplements are
already required to be safeby existing laws and
FDA regulationand that most supplements have a better safety
record than FDA-approved drugs, both prescription and over-the-counter.
underlying purpose of S.722 is to move the burden of proof from
the FDA (to show a supplement is not safe and must be removed from
the marketplace) to the manufacturer (to show a supplement is safe
and can continue to be available to consumers). However, its methodology
hands the FDA a blank check for removing any supplement it chooses
from the marketplace. Given the FDA's continuing hostile stance
on supplements (as shown in its 400-page preface to newly proposed
good-manufacturing-practice regulations), it is safe to predict
that safety criteria would be set excessively high, and ephedra
would be only the first of many supplements to be banned.
scientific proof of causality needed
722 defines an "adverse dietary supplement experience" as a negative
health experience that is associated with, but not necessarily
caused by, a dietary supplement. A "serious" adverse dietary
supplement experience is one resulting in severe consequencessuch
as death, hospitalization, and anything involving pregnancy, including
premature labor and low birth weight (which affect 11% and 8% of
the USA's 4 million annual births, respectively).
any hospitalization or low-birth-weight baby becomes a serious adverse
experience if the patient was taking a supplementregardless
of whether that supplement had anything to do with the reason for
hospitalization or the baby's condition. Perhaps an elderly woman
falls and fractures a hip. Perhaps a youngster develops bone cancer.
Perhaps an alcoholic's liver succumbs to cirrhosis. Perhaps the
would create massive piles of paperwork
fifty percent of Americans take dietary supplements of one kind
or another. Half of those needing hospitalization are likely to
take supplementscreating at least 17 million such "serious
adverse experiences" per year.
722 would require each of these serious experiences to be reported
to the FDA and would require both the manufacturer and FDA to investigate
the event. This in itself would create a mountain of paperwork
making Mt. Rushmore look like a molehill, but S.722 doesn't stop
there. The bill would also require manufacturers to report all the
non-serious adverse experiences as welland this mound of paperwork
could easily outweigh Mt. Everest.
this for a simple fishing expeditionas Perry Mason might have
described it. The FDA cannot possibly want all this paper clogging
the in-boxes and file cabinets of its personnel. What it really
wants is a "smoking gun"which S.722 provides by defining a
single serious adverse experience as the threshold for requiring
safety data. Senate 722 also makes it easy to get a single serious
adverse experience for any dietary supplement
on the market today.
real issue is ephedra
real issue behind Senate 722 is made clear by the testimony surrounding
it: The FDA wants to remove ephedra from the marketplace, and so
far has been unable to do so. Scientific studies, all relatively
small, have not found significant differences in rates of adverse
events between groups of people who take ephedra and those who don't.
agree that supplement safety ranges from the exceptional (such as
vitamin C) to the questionable (such as ephedra, anabolic steroid
precursors and others). But is creating a new mound of paperwork
the best way of addressing the challenges posed by ephedra?
say no. There are better uses of the $10 million that S.722 would
research preferable to mounds of paperwork
million dollars could fund a lot of scientific research into ephedra
safetywhich would apply the money directly to the problem.
Large-scale research projects could establish whether ephedra is
safe when used as directed by healthy people, or causes serious
health problems for some otherwise apparently healthy people. Given
the quantities of people who are clamoring to continue using ephedra,
it would be easy to find many volunteer study subjects! A similar
process could be applied to other supplements that are determined
to be "high risk" through some scientifically-based process.
focus on the real problem
conclusion, the current system works well for 98 percent of the
supplements in the marketplace. Senate bill 722 would create a mountain
of paperwork, place excessive burdens on supplement manufacturers,
and allow the FDA to use unduly high and arbitrary criteria for
deciding that a supplement was unsafe and cannot be made available
better use of limited funds and resources is enforcing existing
laws and regulations (taking action against shoddy manufacturers
and sleazy marketeers)and finding scientific answers to questions
raised when a specific supplement is associated with an unusually
high incidence of serious adverse events.
write or fax your Senators today to oppose Senate bill 722.
We will soon compile a summary and commentary on all the features
of Senate bill 722.]
for Health Care Policy and Research. "Table 1. Statistics for 1996
HCUP Nationwide Inpatient Sample, by multi-level CCS diagnosis (principal
diagnosis only), Hospital Inpatient Statistics, 1996." Healthcare
Cost and Utilization Project (HCUP). www.ahcpr.gov/data/hcup/his96/table1a.htm.
Durbin. "Senate 722: Dietary Supplement Safety Act of 2003". 108th
CONGRESS, 1st Session.
Ask the Editor. "What percentage of live births yearly in the United
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State Department of Health. "Compared to U.S., Washington has fewer
low-birth weight babies, higher death rates due to suicide and Alzheimer's."15
November 1999. www.doh.wa.gov/publicat/99_news/99-97.htm.