Senator Durbin's Response in Congress

 

The Truth About the Dietary Supplement Act - Fair Comment

The following piece was written by Sen. Dick Durbin (D-Ill.). He held the first hearing to examine problems surrounding ephedra and other dietary supplements. His e-mail address is dick.durbin@senate.gov.

On the penultimate day of his life, 16-year-old Sean Riggins wasn't thinking about product-safety testing or government regulation of dietary supplements. He was thinking about playing in his high-school football game that night. Less than 36 hours later, he would be dead of a massive heart attack caused by dietary supplements in particular a stimulant called ephedra. Ephedra's dangers are well-documented. The American Medical Association and American Heart Association have called for a ban on its use. Health Canada, the Canadian Food and Drug Administration (FDA), launched a nationwide ephedra recall. The National Football League, the National Collegiate Athletic Association and the International Olympic Committee don't allow ephedra use by their athletes. The U.S. Department of Defense prohibits its commissaries from selling ephedra. Illinois, New York state and California have banned sales of this drug. Even dietary-supplement manufacturers are marketing "ephedra-free" alternatives.

Riggins' death, and the ephedra-related deaths of other high-profile professional athletes, have helped spark a national debate on the safety of dietary supplements and the government's role in safeguarding public health. Legislation I introduced to protect consumers from dangerous dietary supplements such as ephedra and the new "ephedra-free" stimulants has been the main target in this controversy.

The hired guns of the dietary-supplement industry say my legislation, the Dietary Supplement Safety Act of 2003 (S. 722), will create hardships for millions of fitness buffs and everyday Americans who use vitamins or herbal remedies. Such claims are totally misleading and are part of a well-orchestrated campaign designed to scare consumers. So I'd like to set the record straight.

Currently, ephedra and other natural stimulants are exempt from most federal regulation. Companies aren't required to report serious adverse health events such as death, heart attack or seizure to the U.S. FDA, so there is no easy way to know if a particular supplement is dangerous.

My bill says that before a manufacturer can market a dietary supplement containing a stimulant, the manufacturer must prove the stimulant is safe. It also prevents manufacturers from using the term "dietary supplement" to mask dangerous drugs such as steroids. And it says makers of dietary supplements must report serious negative health consequences resulting from the use of their products.

The $18 billion-per-year, dietary-supplement industry says these requirements are costly and unreasonable. Take, for example, Project: FANS (Freedom of Access to Nutritional Supplements), an organization funded by the supplement industry that said my bill would "hold long-used nutritional supplements, from calcium to Flintstone vitamins, to a higher reporting standard than is currently set for many prescription drugs." Or a recent "investigative report" for Insight stating that my bill "would give the Food and

Drug Administration the authority to remove from the market any dietary supplement it chooses, including vitamins E and C" and would "require exotic proof of safety from any dietary-supplement maker if the agency has received so much as a single report of an adverse reaction" [see "Regulating Vitamins," Sept. 16-29].

Nonsense. This isn't a higher reporting standard than exists for prescription drugs or even over-the-counter medications such as ibuprofen and cough syrup. Our laws already require those drugs and medicines be proved safe and effective before they legally are sold. Health problems related to the use of such medications must be reported to the FDA.

My bill doesn't require safety testing for vitamins, minerals or the vast majority of dietary supplements; only stimulants must be proved safe before being sold. The bill also calls for reporting of only serious adverse events death, heart attack, stroke, hospitalization or serious complications in pregnancies. It doesn't require reports of stomach aches, rashes, muscle pains, headaches, etc. The vitamin industry is not threatened by my bill, but the ephedra-peddlers would be.

The idea that products could be pulled from the market because of one bad report also is inaccurate.

Under my bill, if a dietary supplement was alleged to have caused a stroke, the FDA would be required first to conduct a clinical evaluation to determine if the report was valid and credible. If the evaluation indicated the stroke was not caused by the supplement, that's the end of the matter. If the FDA's evaluation raised questions that the product might present a significant or unreasonable health risk, it could require the manufacturer to show the supplement is safe. Finally, after reviewing the manufacturer's safety data, the FDA could remove a product from the market only if it concluded that it was unsafe under ordinary conditions of use.

U.S. consumers should have the right to choose products they believe are best for their health. But the companies selling these products have an obligation to make certain their products are safe. If the dietary-supplement industry will not accept that responsibility, Congress should enact a law to require it.

Related

Dietary Supplement Health and Education Act of 1994
The Bottom Line about Diet Pills