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Diet Supplements: Another Failure of the FDA and Congress

[Column 322, January 31, 2005] Archived Columns

By Todd A. Smith*

Just because a product is said to be “natural” does not mean it is safe. And just because it isn’t safe, don’t think the Food and Drug Administration (FDA) is going to do something about it.

Take, for example, ephedra.

In 2003, major league baseball pitcher Steve Bechler died in part because of his use of ephedra. However, it took 14 months after his death for the FDA to finally ban its sale. In fact, the FDA had been trying to ban ephedra since as far back as 1997.

Ephedra was sold as an aid for losing weight and for improving athletic performance. But despite at least 163 deaths and 16,000 adverse reactions to it, ephedra remained on the market thanks in large part to the $20 billion diet supplement industry and the power it wields in the U.S. Congress to keep regulators away.

What many people do not realize is the extent to which the FDA is hampered in its ability to check on the safety or even the usefulness of the thousands of pills, potions, and powders masquerading as diet supplements.

And, of course, there is recent evidence that the FDA was ineffective even in protecting the public from the potentially lethal side effects of Vioxx and perhaps other prescription drugs.

Consumers would likely be astounded to discover that the FDA isn’t already regulating supplements even to the same extent that it is supposed to regulate prescription and over-the-counter drugs. A 2002 Harris poll found that 69% of the American people believed supplements receive government approval before being sold, and 68% thought the government requires warning labels on potential side effects and dangers. Wrong and wrong.

This seems especially silly when one stops to realize that lipstick and dandruff shampoos are regulated by the FDA.

Another scary example is aristolochic acid. While thought to be useful in curing a number of ailments, it is also a powerful carcinogen, linked to kidney failure and several deaths. Consumer Reports ranks it #1 on their list of a dozen dangerous supplements. The FDA issued a warning about aristolochic acid three years ago, and, while it is banned in 10 other countries, it is still legally sold in the United States.

It is easy to fault the FDA for failing to regulate supplements and to compel manufacturers to report adverse reactions to them, but the fault does not end there. In fact, another culprit in this instance is the U.S. Congress.

Congress has starved the FDA of both staff and sufficient funding, and there is no requirement forcing supplement manufacturers to report what they know about illnesses and deaths related to their products. One ephedra manufacturer was able to keep secret from the public more than 14,000 adverse incidents over five years. Tragically, efforts to make such disclosures mandatory were stifled by Congress.

Until the Congress decides to take this matter seriously, American families will continue to be at risk because of the dangers of unregulated diet supplements.

For more health and safety information and tips, please visit AAJ's "Keep Our Families Safe" Web site at http://www.justice.org/private/kofs/index.aspx.

 

*Todd A. Smith president of the American Association for Justice, is a partner in the Chicago, IL, law firm of Power Rogers & Smith.

Balancing the Scales of Justice
American Association for Justice
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