[Congressional Record (Bound Edition), Volume 149 (2003), Part 19]
[Extensions of Remarks]
[Pages 26135-26136]
[From the U.S. Government Publishing Office, www.gpo.gov]




           DIETARY SUPPLEMENT ACCESS AND AWARENESS ACT (DSAA)

                                 ______
                                 

                          HON. SUSAN A. DAVIS

                             of california

                    in the house of representatives

                       Tuesday, 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).

[[Page 26136]]

  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.

                          ____________________