# Opening Statement

Chairman Dan Burton

Subcommittee on Human Rights & Wellness

Government Reform Committee

"10 Years After the Implementation of DSHEA:

# **The Status of Dietary Supplements in the United States"**

March 24, 2004

**Good Afternoon, a Quorum being present, the Subcommittee on Human
Rights and Wellness will come to order. I ask unanimous consent that all
Members' and witnesses' written and opening statements be included in
the record. Without objection, so ordered.**

I ask unanimous consent that all articles, exhibits, and extraneous or
tabular material referred to be included in the record. Without
objection, so ordered.

Today, the Subcommittee has the honor of being joined on the dais by my
colleagues Congressman Frank Pallone, Representative from New Jersey;
and Congresswoman Susan Davis, Representative from California.

In the event of other Members of Congress joining us at today's hearing,
I ask unanimous consent that they be permitted to serve as a member of
the Subcommittee for the day. Without objection, so ordered.

The Subcommittee is convening today to discuss the Federal government's
implementation and status of the Dietary Supplement Health Education Act
of 1994, commonly referred to as DSHEA. To aid us in this dialogue, the
Subcommittee will be hearing from the U.S. Food and Drug Administration,
dietary supplement industry leaders, medical professionals, and policy
researchers regarding the impact of this law in the United States.

I, along with millions of Americans, firmly believe that dietary
supplements have been shown through research and historical use to be of
immeasurable benefit to human health.

That is why I proudly serve as Co-Chairman of the Complementary and
Alternative Medicine Caucus in Congress, along with my colleague
Representative Dennis Kucinich of Ohio here in the House, and Senators
Orrin Hatch of Utah and Tom Harkin of Iowa who have been true champions
on these issues in the other body.

Given this role, as well as my duties here as the Chairman of the
Subcommittee on Human Rights and Wellness, I am particularly concerned
with the status and implementation of the Dietary Supplement Health
Education Act of 1994. This legislation has provided the framework for
how the Federal government ensures the safety and efficacy of dietary
supplements sold in the United States.

Prior to DSHEA, dietary supplements were treated and regulated as food
products. Seeing a need for the Federal government to address the
American consumer's growing interest in dietary products and public
safety, Congress overwhelmingly passed the Dietary Supplement Health and
Education Act to make certain that all dietary health products sold in
the United States are held to the highest and safest quality standards.

This legislation ensures the safety of dietary supplements by requiring
manufacturers to follow standards called "Good Manufacturing Practices,"
or GMPs. Essentially, all ingredients in supplements sold in the United
States must be previously approved by the FDA and listed on the bottle
label, and distributors must follow strict guidelines on any claims that
are made in regard to a particular product -- to provide consumers with
the most accurate information on supplements. Additionally, if at any
time the FDA decides that a particular product or dietary ingredient is
detrimental to human health, it reserves the right to have those items
removed from the marketplace.

Now that we have reached the 10^th^ Anniversary of the enactment of this
legislation, I found it necessary to conduct an oversight hearing to
ensure that our Federal health agencies and the dietary supplement
industry have maintained the integrity of this Act so that Congress
might consider ways in which the Act could be improved, and educate
American consumers to the latest developments in dietary supplement
policy and nutritional labeling practices.

To explain in greater detail the status of DSHEA's implementation on the
Federal government level, the Subcommittee has the pleasure of hearing
testimony from the Honorable Robert Brackett, M.D., and Director of the
Center for Food Safety and Applied Nutrition (CFSAN) with the U.S. Food
and Drug Administration. As Director of CFSAN, Dr. Brackett is directly
responsible for overseeing the day-to-day implementation of DSHEA in the
U.S.

To provide insight into how DSHEA has affected the dietary supplement
industry, the Subcommittee will be hearing from a good friend of mine,
Mr. David Seckman, Chairman & CEO of the National Nutritional Foods
Association (NNFA), on these matters. Founded in 1936, the NNFA is the
Nation's oldest and largest trade association in the natural products
industry, and they represent over 5,000 retailers, manufacturers,
suppliers, and distributors of health-related products.

The Subcommittee will also be hearing testimony on the impact of DSHEA
from Ms. Annette Dickinson, President of the Council for Responsible
Nutrition, which represents many suppliers, manufacturers, and marketers
of dietary supplements in the United States.

In today's rapidly changing health care delivery system, many medical
practitioners have combined traditional medical treatments with
complementary and alternative medicine to create the discipline of
"integrative medicine" in an effort to give more complete healthcare to
their patients.

Dr. Marc Micozzi (Mick-koh-zee), Director of the Policy Institute for
Integrative Medicine (PIIM) at Thomas Jefferson Hospital in
Philadelphia, Pennsylvania, will testify before the Subcommittee on the
current research of the PIIM, and how DSHEA has played a successful role
in the integrative care of many American patients. The Subcommittee will
also hear from Mr. Alan Dumoff (Doom-off) of the American Association
for Health Freedom on these most important issues.

As I stated before, dietary supplements have been shown through credible
scientific research to provide substantial health benefits for their
users. Mr. Doug Rose, a good friend and private businessman from my home
State of Indiana, is here to discuss his experiences about the potential
health benefits of folic acid, and how this supplement may decrease the
likelihood of birth defects in children, such as Spina Bifida (Spine-uh,
Bih-fid-uh).

From my own personal experience and observations over the last decade,
the FDA's implementation and execution of DSHEA has generally provided
the dietary supplement industry with the increased opportunity for
competition, as well as easier access to safe health products for the
millions of American consumers like me who use these supplements to
maintain and improve their health.

While no government program is perfect, I would like to congratulate all
of the men and women at the U.S. Department of Health and Human Services
for their hard work over the years to put into place and strengthen the
principles originally outlined in DSHEA ten years ago.

It is my sincere hope that this hearing will help point out the positive
effects of the Dietary Supplement Health and Education Act, while at the
same time providing suggestions from our witnesses that could further
improve this program to better accommodate U.S. health policy makers and
supplement consumers many more years to come. Once again, I look forward
to hearing from today's witnesses.