[Congressional Record Volume 151, Number 91 (Friday, July 1, 2005)]
[Extensions of Remarks]
[Page E1441]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




           DIETARY SUPPLEMENT ACCESS AND AWARENESS ACT (DSAA)

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                          HON. SUSAN A. DAVIS

                             of california

                    in the house of representatives

                        Thursday, June 30, 2005

  Mrs. DAVIS of California. Mr. Speaker, with the support of my 
colleagues, Rep. Henry Waxman and Rep. John Dingell, I rise today to 
introduce the Dietary Supplement Access and Awareness Act of 2005.
  This legislation presents a balanced and reasonable approach to 
improving the safety of dietary supplements while making sure that 
consumers continue to have access to them.
  According to a report by the National Center for Health Statistics 
released last year, approximately 62% of adults use some form of 
alternative therapy, including herbal remedies and dietary supplements. 
Dietary supplement sales in the U.S. alone are $19.8 billion. This 
popularity, however, alarms consumer health advocates. Current law does 
not require dietary supplements to prove their efficacy or safety, 
leaving consumers vulnerable to unexpected side-effects and other 
health risks.
  The dilemma we face today is due to Congressional action in the early 
1990s. In 1994, Congress passed the Dietary Supplement Health and 
Education Act (DSHEA). Cited as the greatest removal of FDA 
jurisdiction in the history of the agency, this legislation deregulated 
the supplement industry. Instead of requiring manufacturers to prove 
that their products are safe, DSHEA required that FDA prove that the 
products are unsafe before it can take action against a potentially 
deadly product. Furthermore, under this law, manufacturers are not 
required to inform the FDA of any reported health problems associated 
with supplement use.
  This means consumers and regulators may not have access to 
information regarding the side effects of these products. Former FDA 
director David Kessler wrote about DSHEA in the New England Journal of 
Medicine, explaining ``Congress has put the FDA in the position of 
being able to act only after the fact and after substantial harm has 
already occurred.''
  The story of ephedra, a product that was pulled from the market only 
after thousands of reports of serious injuries including heart attack, 
stroke, and death, demonstrates that FDA does not have adequate 
authority to protect the public from unsafe supplements. In 2004, only 
after eight long years, and a Herculean effort to amass a mountain of 
evidence, the FDA banned the sale of ephedra products.
  This past April, a ruling by a federal judge in Utah called into 
question the ban on ephedra citing insufficient evidence and the lack 
of authority to ban it without such proof. This ruling, made almost 
exactly one year after the FDA ban on ephedra, underscores the present 
difficulty with regulating dietary supplements.
  Today with Rep. Henry Waxman and Rep. 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 post-market 
surveillance study to ensure that the product is safe.
  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 fair decision for American consumers. It also clarifies the 
standard the FDA must meet in determining whether a dietary supplement 
poses an unreasonable risk to consumers. This bill allows the FDA to 
use data from clinical trials, adverse event reports and other relevant 
scientific information to reach an informed decision.
  Our legislation gives the FDA the authority to prohibit sales of 
dietary supplements that may pose significant risk to minors. Many 
young athletes emulate the practices of their professional sport 
heroes, yet their developing bodies are much more susceptible to the 
effects of stimulants and steroid-like products such as ``andro.''
  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, there are dietary supplements that offer benefits. Folic 
acid intake by women, for example, has been shown to reduce birth 
defects in unborn children and 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. This provision should alleviate worries about the 
Codex Alimentarius and its guidelines for vitamin and minerals.
  The FDA has its hands tied behind its back. Limited funding and 
manpower has left the FDA overextended and diluted its efforts to 
protect the public. 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 
do about the safety of the products on the market. We cannot continue 
to stand on the sidelines and let this serious 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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