Death Sentence for Dietary Supplements
31 July 2003
by Wyn Snow, Managing Editor

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.