Unregulated supplements are a tragedy in waiting

The latest supplement toxic alert thankfully involves only two young soldiers who died suddenly, both reported to have the unregulated amphetamine-like dimethylamylamine, DMAA, aka “Jack3d” and “OxyelitePro,” as the suspected death-dealing toxicant.

Who knows how many other unexplained deaths and near-deaths can be attributed to the vast experiment foisted upon an unwary American populace by such drugs — I mean, “supplements”?

Thanks to 1994′s Hatch Act, the Dietary Supplement Health and Education Act (DSHEA), pushed through Congress and released upon a then-unprotesting public by Utah’s Sen. Orrin Hatch (R-UT), substances which may be benign, toxic, and everything in between, as long as they are sold as “dietary nutritional supplements,” get a virtual free pass.

The supplement manufacturer can make “structure-function” claims, such as “supports sexual health,” but not health claims. Such assertions must clarify that the substance is not FDA approved “to diagnose, treat, cure or prevent any disease.”

Part of the law mandates that ingredients brought to market after 1994, so-called “novel” ingredients — and only those — be shown to have passed safety tests.

Older ingredients got “grandfathered” in without the need to be proven either safe or effective.

How is that working out? There have been approximately 51,000 new ingredients brought to market since DSHEA passed, of which about 0.3% — that’s not a misprint, 170 out of 51,000 — have documented safety tests.

Who cares? “Why worry?,” perhaps under the delusion that some substance termed “natural” must be safe, seems to be the governing mantra of the American consumer on this subject, since about 100 million of us spend, at last tally, over $28 billion per year on these products — vitamins, minerals, potions, herbals, biologicals, who-knows-what.

If a shopper has a question about the efficacy or danger of a supplement, they may simply ask the health-food store employee.

Obviously, trusting a sales clerk to be expert is pure foolishness.

We Americans, so concerned about minute amounts of this or that chemical in our food and water, and ready to challenge our board-certified internist on treatment decisions, gobble down supplements with alarming obliviousness to their potential dangers and denial of the overwhelming absence of evidence of benefit.

A “Perspective” article in a recent New England Journal of Medicine by Dr. Pieter Cohen called for a tightening — no, not even that, merely actually enforcing the law as written — by having the FDA demand that, instead of pleading with, the supplement manufacturers supply the agency with at least the legal minimum of data on their products’ safety.

Some have responded with protests over “Big Government” intervention.

One of these days some supplement, contaminated or virginal, will kill a bunch of naive customers, and cries will ring out over their lax regulation.

Responsible public health authorities should effect long overdue legal and regulatory control over this millions-strong, uncontrolled experiment before such a tragedy forces their hands.

George Lundberg is a MedPage Today Editor-at-Large and former editor of the Journal of the American Medical Association. Gilbert Ross is the Executive Director and Medical Director of the American Council on Science and Health.

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