[Congressional Record (Bound Edition), Volume 149 (2003), Part 19]
[Extensions of Remarks]
[Page 26776]
[From the U.S. Government Publishing Office, www.gpo.gov]




            THE DIETARY SUPPLEMENT ACCESS AND AWARENESS ACT

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                          HON. HENRY A. WAXMAN

                             of california

                    in the house of representatives

                       Thursday, October 30, 2003

  Mr. WAXMAN. Mr. Speaker, today, Representative Susan Davis, 
Representative Dingell, and I are introducing the Dietary Supplement 
Access and Awareness Act.
  Since the passage of the Dietary Supplement Health and Education Act 
ten years ago, it has become clear that the dietary supplement market 
includes not just vitamins, minerals, and nutrients that can safely 
promote health. The market also includes products that can cause harm. 
Ephedra, for example, is linked to a number of serious adverse events, 
including heart attack, stroke, and death. Aristolochic acid, which is 
in some traditional Chinese medicines, can cause kidney failure. Usnic 
acid, an ingredient in some weight loss supplements, may cause liver 
toxicity. These safety concerns are serious, and they deserve a serious 
response.
  In the last couple of years, Congress has begun to pay more attention 
to dietary supplement safety. Senator Durbin held hearings on ephedra 
and has introduced comprehensive legislation to ensure that supplements 
are safe. The House Commerce Committee has also held hearings, and 
today we are introducing legislation that would enhance FDA's authority 
to protect consumers from unsafe products. This is a common sense bill 
that contains many of the same elements as the Durbin bill and responds 
to concerns raised by consumers, medical groups, parents, and 
professional and collegiate athletic leagues. They have said it is time 
to mend the Dietary Supplement Health and Education Act in order to 
protect consumers from the few dietary supplements--like ephedra--that 
could pose a real risk to health and safety.
  The bill accomplishes this goal in four steps.
  First, the bill assures that the Food and Drug Administration has 
basic information about who makes dietary supplements. If a problem 
surfaces with a particular product, FDA will know who makes the product 
and can quickly inspect the plant or take other appropriate action.
  Second, the bill assures that FDA receives information about adverse 
effects associated with supplements. This information will allow the 
agency to spot signs of danger. The agency can then investigate 
further. This provision would prevent a repeat of the ephedra disaster, 
where one manufacturer denied the existence of thousands of adverse 
event reports for years.
  Third, the bill allows FDA to prohibit the sale to minors of 
supplement products that may cause significant harm. This is a very 
important power that FDA does not currently have. There are products 
being targeted to kids for which there is little or no evidence of 
safety but there is real evidence of risk. Many of these products are 
sold as performance enhancers and contain ephedra or steroid-like 
substances.
  Fourth, the bill gives FDA the tools to understand whether a 
potentially risky dietary supplement is dangerous or safe. Imagine a 
dietary supplement that is linked by physicians to serious illnesses 
and deaths. Under current law, this product is essentially assumed safe 
until demonstrated by FDA to be unsafe. This is a burden of proof that 
literally requires that more and more consumers be seriously injured or 
killed before the agency can take action. Under our bill, FDA can 
require that a manufacturer of a product provide evidence of safety if 
FDA has evidence that the product may pose serious risks to consumers. 
Most manufacturers say they already have substantiation of safety in 
their files. If this is true, this requirement should not pose an undue 
burden on manufacturers.
  Let me make one comment about what this bill does not do. This 
legislation will not in any way affect the regulation of vitamins and 
minerals. Vitamins and minerals are expressly exempted from this 
legislation.
  If passed, this legislation will address many of the concerns of 
medical groups, athletic organizations and leagues, and parents while 
preserving access to low-risk dietary supplements. It is a common sense 
approach that is urgently needed.
  Although this bill does not specifically address stimulants, like 
ephedra, in dietary supplements, I am very concerned about the risks 
associated with these products. These products can raise blood pressure 
and increase metabolism, which may lead to a number of serious 
problems, including increased susceptibility to heatstroke, as well as 
heart attack, stroke, and sudden death. I have written to FDA 
Commissioner McClellan asking him if there is any evidence that proves 
that these stimulant ingredients that are being marketed in ``ephedra-
free'' products are any safer than ephedra, and asking him if FDA 
shares the concern of many experts who believe that stimulants pose 
particular health risks.

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