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The rational behind CODEX. (Archive.)

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Misty L. Trepke
http://www.searching-alternatives.com

Death Sentence for Dietary Supplements
31 July 2003
by Wyn Snow, Managing Editor
http://www.supplementquality.com/editorials/Senate722.html

Senate 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.

The 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.

Just one serious event triggers investigation of safety

The 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.

Getting 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 safe-by existing laws and FDA regulation-and that most
supplements have a better safety record than FDA-approved drugs,
both prescription and over-the-counter.

The 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.

No scientific proof of causality needed

Senate 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
consequences-such 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).

Thus, any hospitalization or low-birth-weight baby becomes a serious
adverse experience if the patient was taking a supplement-regardless
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
mother smokes.

Bill would create massive piles of paperwork

Roughly fifty percent of Americans take dietary supplements of one
kind or another. Half of those needing hospitalization are likely to
take supplements-creating at least 17 million such "serious adverse
experiences" per year.

Senate 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 well-and this
mound of paperwork could easily outweigh Mt. Everest.

All this for a simple fishing expedition-as 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.

The real issue is ephedra

The 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.

Experts 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?

We say no. There are better uses of the $10 million that S.722 would
appropriate.

Scientific research preferable to mounds of paperwork

Ten million dollars could fund a lot of scientific research into
ephedra safety-which 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.

Let's focus on the real problem

In 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 to consumers.

A 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.

Call, write or fax your Senators today to oppose Senate bill 722.

[Editor's note: We will soon compile a summary and commentary on all
the features of Senate bill 722.]

Sources

Agency 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.

Senator Durbin. "Senate 722: Dietary Supplement Safety Act of 2003".
108th CONGRESS, 1st Session.

TeacherVision.com, Ask the Editor. "What percentage of live births
yearly in the United States are premature?" Website
TeacherVision.com. www.teachervision.com/askeds/8-2-00askeds.html.

Washington 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.

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