Dietary Supplement Access and Awareness Act by Susan Davis

Dietary Supplement Access and Awareness Act by Susan Davis


HON. SUSAN DAVIS

OF CALIFORNIA
IN THE HOUSE OF REPRESENTATIVES

October 28, 2003


Ms. DAVIS of California. Mr. Speaker, with the support of my colleagues, Representative Henry Waxman and Representative John Dingell, I rise today to introduce the Dietary Supplement Access and Awareness Act of 2003.

This legislation presents a balanced, reasonable approach to improving the safety of dietary supplements while maintaining market access for responsible supplement manufacturers.

Hallie Bechler looks almost exactly like her father. She was born in late April, almost two months after her father, Baltimore Orioles pitcher Steve Bechler, collapsed from a heatstroke during spring training. A county medical examiner linked his death to the use of a dietary supplement containing ephedra. Steve Bechler was 23 years old.

Like any person interested in losing weight, Steve Bechler may have been lured by the dietary supplement's claims of ``rapid and extremely dramatic results. In fact, for an athlete like Steve Bechler, playing baseball in the Florida heat, ephedra did not cause rapid and extremely dramatic weight loss, but rather contributed to a rapid and extreme heatstroke, which killed him.

Dietary supplement use is not limited to adults. Teenagers are certainly vulnerable to pressures regarding weight and athletic expectations. Teenage athletes are especially vulnerable to these pressures. Last year, Illinois high school student Sean Riggins took an ephedra product to improve his football performance. He had a heart attack and passed away at age 16.

The ephedra crisis has raised public awareness about dietary supplements and the absence of accurate information concerning risks and benefits. Much of the confusion surrounding dietary supplements can be attributed to the changes made in 1994 by the Dietary Supplement Health and Education Act (DSHEA).

Cited as the greatest removal of FDA jurisdiction in the history of the agency, DSHEA has greatly curtailed its authority. Simply put, this legislation deregulated the supplement industry. Consequently, there has been an explosion of herbal remedies. Moreover, natural, yet risky, stimulants have also entered the market. The FDA, however, is prohibited from screening out any of these potentially dangerous dietary supplements. What if ephedra is only the tip of the dietary supplement iceberg?

Former FDA director David Kessler wrote in the New England Journal of Medicine, ``Congress has put the FDA in the position of being able to act only after the fact and after substantial harm has already occurred. This is because DSHEA shifted the burden of proof from dietary supplement manufacturers to the FDA. Consumers have no way of learning about reported side effects and the FDA does not possess the authority to require such reports. As a result, American consumers have been unwitting victims of a multibillion-dollar industry!


Today with my colleagues, Representative Henry Waxman and Representative John Dingell, I am proud to introduce the Dietary Supplement Access and Awareness Act. This bill will address the gaps created by DSHEA through greater information exchange and accountability.

Our legislation contains commonsense provisions requiring dietary supplement manufacturers to provide the FDA with a list of their products and reports of all serious adverse events. These actions will alert the FDA to problematic dietary supplements and will give the FDA access to information it needs to take action more swiftly. If the FDA determines that a specific supplement may have serious health consequences, it can require the manufacturer to do a postmarket surveillance study to ensure that the product is safe.

The ephedra tragedies have shown us that proving a dietary supplement to be unsafe requires a Herculean effort and mountain of evidence. Sadly, the evidence is often a growing body count. Our legislation engages manufacturers in determining the safety of dietary supplements. By providing their studies and other related data, manufacturers and the FDA would come together to make a comprehensive and accurate decision for American consumers.

Our legislation gives the FDA the authority to prohibit sales to minors of dietary supplements that may pose significant risk. Many young athletes emulate the practices of their professional sport heroes. Their developing bodies are especially susceptible to the effect of stimulants and steroid-like products such as ``andro.

Numerous supplement products have emerged in the market in the last ten years. They range from vitamins and minerals to herbals and hormones. This boom has created an uncertain situation as to the quality and safety of dietary supplements. According to Bruce Silverglade from the Center for Science in the Public Interest, ``the challenge for most consumers is to determine which supplements are beneficial and which are nothing more than 21st-century snake oil--or even dangerous. That is why this legislation includes authorization of funds for physician and consumer education programs regarding adverse reactions.

Certainly, some dietary supplements offer benefits. Folic acid intake by women, for example, has been shown to reduce birth defects in unborn children. We are all familiar with the benefits of taking vitamin C and monitoring adequate calcium intake. Despite claims to the contrary, the Dietary Supplement Access and Awareness Act will not take away vitamins and minerals from consumers. In fact, my colleagues and I included language to specifically exempt them from this legislation.

The FDA has its hands tied behind its back. Limited funding and manpower has made the FDA's efforts to protect the public scattershot. The measures and education programs in this legislation will enable the FDA to gather solid data about the dangers some dietary supplements pose. With this information in hand, the FDA can make sensible, informed decisions and policies about dietary supplements. Consumers can have greater assurance than they currently have about the safety of the products on the market. We cannot continue to stand on the sidelines and let this insidious public health threat go unchecked. The health and well being of our young people and loved ones are at risk.

I urge my colleagues to join me in supporting the Dietary Supplement Access and Awareness Act.

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This work is in the public domain in the United States because it is a work of the United States federal government (see 17 U.S.C. 105).