[Congressional Record (Bound Edition), Volume 149 (2003), Part 3]
[Extensions of Remarks]
[Pages 4098-4099]
[From the U.S. Government Publishing Office, www.gpo.gov]




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

                                 ______
                                 

                          HON. SUSAN A. DAVIS

                             of california

                    in the house of representatives

                      Wednesday, February 12, 2003

  Mrs. DAVIS of California. Mr. Speaker, today I am re-introducing two 
bills that address an important public health issue: the safety of 
dietary supplements. Walk into any neighborhood drug store or discount 
store and you will find yourself surrounded by a variety of dietary 
supplements. Their labels tout promises ranging from ``safe and easy'' 
weight loss to increased muscle gain to lower cholesterol. However, 
dietary supplements are not subject to rigorous safety or efficacy 
standards and face only limited regulatory oversight under federal law.
  My bills will protect consumers and increase the flow of information 
to the public. They will give the Food and Drug Administration (FDA) 
the authority it needs to make informative and scientific decisions 
about the safety of dietary supplements.
  The Dietary Supplement Information Act requires manufacturers, 
producers and distributors of dietary supplements to register with the 
FDA. They would 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.
  Many of these dietary supplements contain ephedra, also commonly 
listed as ma-huang or ephedrine alkaloids. Sadly, a number of 
consumers, including some of my own constituents, have experienced 
adverse reactions after using ephedra-based supplements. Lured in by 
product claims of more energy, quick weight loss or improved athletic 
performance, consumers experienced depression, agitation, heart 
attacks, and strokes. In some cases, people have died after taking 
ephedra supplements. These severe effects demand increased public 
awareness, especially since the average customer profile includes young 
people.
  The Ephedrine Alkaloid Consumer Protection Act gives 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, products will 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 risks associated with ephedra. 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 about possible side 
effects.
  Since I first introduced these bills two years ago, momentum has 
clearly grown for improving consumer safety regarding ephedra. I have 
seen a growing number of organizations that are addressing the issue on 
their own. The American Medical Association and its Canadian 
counterpart recommend banning ephedra. The National Football League 
recently joined the ranks of the International Olympic Committee, and 
the National Collegiate Athletic Association in prohibiting ephedra use 
among their athletes.
  Collaborating developments in the science community and courtrooms 
support these actions. A recent study conducted by the University of 
California at San Francisco reported that dietary supplements 
containing ephedra accounted for 64 percent of all adverse event 
reports related to dietary supplements. The emergence of ``ephedra-
free'' products indicates conflict within the industry, possibly a sign 
that the supplement industry is also slowly realizing the negative 
effects of ephedra. Allegations against ephedra supplement 
manufacturers include sloppy research practices, the omission or 
destruction of negative research data, study design violations, 
unreported adverse events, along with deception and fraud. In fact, 
last year a jury in Alabama awarded $4.1 million to four people who 
suffered strokes or heart attacks after taking ephedra diet pills.
  Despite the growing list of allies and evidence, there is still much 
work left to do within our own communities. Earlier this year, I 
received a compelling letter from a young woman in San Diego. She said,

       Being a 23-year-old woman, I am exposed to hundreds of diet 
     pills and the need to be thin. One of my dear friends had a 
     stroke from taking an over-the-counter diet pill. She went 
     from a coma, to a vegetable, graduated to a wheelchair and 
     now walks with a cane one year later. She is unable to go to 
     school or work and cannot function as a normal 23-year-old.
       These dietary supplements are dangerous and harmful. People 
     do not realize the consequences of these magical pills. They 
     are given the notion that they are going to become this 
     ``model-type image'' from taking supplements, but the adverse 
     effects of them outweigh any benefits.

  It is heartbreaking to think of how an innocent purchase irrevocably 
changed this young

[[Page 4099]]

woman's life. Ephedra has opened eyes about the need for regulation of 
the entire dietary supplement industry. Ephedra is a symptom, a deadly 
symptom, of a larger issue, which is the lack of regulatory control 
over a multibillion dollar industry.
  A change in the current law is critically needed. The FDA must be 
allowed to collect and distribute accurate information about dietary 
supplements. At present, its hands are tied. I want to make it very 
clear that my legislation will not ban dietary supplements. Rather, 
they offer a common-sense approach to giving the FDA the authority to 
regulate the industry while maintaining freemarket access. Consumers 
have a right to know what they are putting into their bodies. We cannot 
continue to stand on the sidelines and watch them suffer serious 
medical consequences from these products. Our young people and loved 
ones are at risk.
  I urge my colleagues in Congress to join me in swiftly passing these 
two bills into law.

                          ____________________