[Congressional Record (Bound Edition), Volume 147 (2001), Part 13]
[Extensions of Remarks]
[Pages 19083-19084]
[From the U.S. Government Publishing Office, www.gpo.gov]



    THE DIETARY SUPPLEMENT INFORMATION ACT & THE EPHEDRINE ALKALOID 
                        CONSUMER PROTECTION ACT

                                 ______
                                 

                            HON. SUSAN DAVIS

                             of california

                    in the house of representatives

                        Tuesday, October 9, 2001

  Mrs. DAVIS of California. Mr. Speaker, today I am introducing two 
bills that address

[[Page 19084]]

an important public health issue: the safety of dietary supplements. 
Over the past few years, we have heard about many tragedies linked to 
dietary supplements. This summer, America witnessed the deaths of some 
fine athletes.
  One supplement in particular, Ephedrine, has received a lot of 
scrutiny. The Food and Drug Administration (FDA) has collected more 
than 800 reports of Ephedrine users suffering adverse reactions, 
ranging from dizziness and dementia to stroke, heart attack, and sudden 
death. While these reports indicate that Ephedrine may be dangerous, 
the FDA does not have enough information to prove or disprove it is 
unsafe.
  Current law is preventing the FDA from collecting additional adverse 
event reports. It also prevents the agency from asking supplement 
companies for copies of their safety studies. Without this information, 
the FDA cannot adequately research the risks and benefits of dietary 
supplements. This is simply unacceptable.
  Congress has the authority and the obligation to protect American 
consumers. It is time for Congress to stop standing on the sidelines. 
We must take action.
  We need to stand up for Tammy Cole, a 35-year-old San Diego resident 
who suffered panic attacks, chest pain, and insomnia after taking an 
ephedra supplement for one month.
  We need to stand up for Sarah Ingham, a 24-year-old Manassas resident 
who suffered a stroke in the spring of 2000. She had been taking an 
ephedra supplement to lose weight for her wedding.
  We need to stand up for Rosanna Porras, a 15-year-old Californian who 
died on a high school soccer field from a massive heart attack. Her 
parents believe that ephedrine pills triggered an underlying heart 
condition, causing her death.
  We need to stand up for the 11 high school, college and professional 
football players, including Rashidi Wheeler, whose supplement use may 
have contributed to or caused their deaths in the last year.
  The problems we face today are in large part due to Congressional 
action in the early 1990s. In 1994, Congress passed the Dietary 
Supplement Health and Education Act into law (DSHEA). This bill 
virtually deregulated the supplement industry.
  Prior to 1994, all food, drug and supplement manufacturers had to 
prove that their products were safe before they could be sold in the 
U.S. DSHEA created a substantial loophole for dietary supplements by 
shifting the burden of proof to the FDA. Now the FDA must prove that a 
dietary supplement is unsafe before it can be banned for sale.
  Since 1994, supplement production and sales have exploded. Industry 
trade groups report that supplement sales reached $16.8 billion in 
2000. Americans are spending billions on products that have not been 
proven to be safe or effective. The American public deserves better 
than this. They deserve clear information about the benefits and risks 
of supplements. My legislation, the Ephedrine Alkaloid Consumer 
Protection Act and the Dietary Supplement Information Act, will give 
consumers the information they deserve.
  The Ephedrine Alkaloid Consumer Protection Act will give consumers 
information about the potentially lethal side effects and drug 
interactions of ephedrine alkaloid products. First, it will require a 
standardized warning to be printed on the label. The bill will also 
make sure that consumers know how to report any concerns or adverse 
reactions by requiring the FDA's MedWatch phone number and website to 
be printed on the product label. Finally, the bill will protect our 
kids by prohibiting the sale of ephedrine to minors. No person under 
the age of 18 years old will be able to buy ephedrine products.
  To ensure that this provision is enforced, we will require the 
products to be kept ``behind the counter'' so that sales personnel are 
more aware of the age restriction. Putting the product behind the 
counter will also make adults more aware of the dangers of Ephedrine 
products. If they have to ask for assistance to get the product, they 
will be more likely to read the warning label and talk to the 
pharmacist or seller about Ephedrine.
  My second bill, the Dietary Supplement Information Act, addresses 
many of the public health and safety concerns about the lack of 
information and regulation of products defined as dietary supplements. 
First, manufacturers, producers and distributors of dietary supplements 
will be required to register with the Food and Drug Administration. 
Manufacturers will also be required to register their specific products 
with the FDA. The supplement industry will be required to submit all 
serious adverse event reports to the FDA within 15 days. Supplement 
manufacturers and the FDA will work as partners to investigate and 
analyze these reports. To make sure that consumers know how to report 
an incident to the FDA directly, my legislation will require the FDA's 
MedWatch phone number and website to be printed on all dietary 
supplement product labels. 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.
  I want to make it very clear that my legislation will not ban dietary 
supplements. However, consumers have a right to know the benefits and 
risks of the supplements they are taking. We cannot continue to stand 
on the sidelines and watch consumers suffer serious medical 
consequences from these products. I urge my colleagues in Congress to 
join me into passing these two bills swiftly into law.

                          ____________________