[Senate Hearing 111-570]
[From the U.S. Government Publishing Office]
S. Hrg. 111-570
``BODY BUILDING PRODUCTS AND HIDDEN STEROIDS: ENFORCEMENT BARRIERS''
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HEARING
before the
SUBCOMMITTEE ON CRIME AND DRUGS
of the
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
SEPTEMBER 29, 2009
__________
Serial No. J-111-51
__________
Printed for the use of the Committee on the Judiciary
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57-768 PDF WASHINGTON : 2010
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20402-0001
PATRICK J. LEAHY, Vermont, Chairman
HERB KOHL, Wisconsin JEFF SESSIONS, Alabama
DIANNE FEINSTEIN, California ORRIN G. HATCH, Utah
RUSSELL D. FEINGOLD, Wisconsin CHARLES E. GRASSLEY, Iowa
CHARLES E. SCHUMER, New York JON KYL, Arizona
RICHARD J. DURBIN, Illinois LINDSEY GRAHAM, South Carolina
BENJAMIN L. CARDIN, Maryland JOHN CORNYN, Texas
SHELDON WHITEHOUSE, Rhode Island TOM COBURN, Oklahoma
AMY KLOBUCHAR, Minnesota
EDWARD E. KAUFMAN, Delaware
ARLEN SPECTER, Pennsylvania
AL FRANKEN, Minnesota
Bruce A. Cohen, Chief Counsel and Staff Director
Matt Miner, Republican Chief Counsel
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Subcommittee on Crime and Drugs
ARLEN SPECTER, Pennsylvania, Chairman
HERB KOHL, Wisconsin LINDSEY GRAHAM, South Carolina
DIANNE FEINSTEIN, California ORRIN G. HATCH, Utah
RUSSELL D. FEINGOLD, Wisconsin CHARLES E. GRASSLEY, Iowa
CHARLES E. SCHUMER, New York JEFF SESSIONS, Alabama
RICHARD J. DURBIN, Illinois TOM COBURN, Oklahoma
BENJAMIN L. CARDIN, Maryland
AMY KLOBUCHAR, Minnesota
EDWARD E. KAUFMAN, Delaware
Hanibal Kemerer, Democratic Chief Counsel
Walt Kuhn, Republican Chief Counsel
C O N T E N T S
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STATEMENTS OF COMMITTEE MEMBERS
Page
Grassley, Hon. Chuck, a U.S. Senator from the State of Iowa,
prepared statement............................................. 144
Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah...... 2
Specter, Hon. Arlen, a U.S. Senator from the State of
Pennsylvania................................................... 1
WITNESSES
Fabricant, Daniel, Ph.D., Interim executive Director and CEO Vice
President, Scientific & Regulatory Affairs, National Products
Association, Washington, DC.................................... 13
Kinghman, Richard F., Partner, Covington, & Burling LLP,
Washington, DC................................................. 15
Levy, Michael, Division Director, Office of Compliance, Center
for Drug Evaluation and Research, Food and Drug Administration,
Washington, DC................................................. 7
Rannazzisi, Joseph T., Deputy Assistant Administrator, Office of
Division Control, Drug Enforcement Administration, Department
of Justice, Washington, DC..................................... 9
Tygart, Travis, chief Executive Officer, United States Anti
Doping Agency, Colorado Springs, Colorado...................... 11
QUESTIONS AND ANSWERS
Responses of Daniel Fabricant to questions submitted by Senators
Hatch and Specter.............................................. 29
Responses of Richard Kingham to questions submitted by Senators
Specter and Hatch.............................................. 40
Responses of Michael Levy to questions submitted by Senators
Hatch and Specter.............................................. 57
Responses of Joseph T. Rannazzisi to questions submitted by
Senators Hatch and Specter..................................... 126
Responses of Travis Tygart to questions submitted by Senator
Hatch.......................................................... 139
SUBMISSIONS FOR THE RECORD
Fabricant, Daniel, Ph.D., Interim executive Director and CEO Vice
President, Scientific & Regulatory Affairs, National Products
Association, Washington, DC, statement......................... 141
Kinghman, Richard F., Partner, Covington, & Burling LLP,
Washington, DC, statement...................................... 146
Levy, Michael, Division Director, Office of Compliance, Center
for Drug Evaluation and Research, Food and Drug Administration,
Washington, DC, statement...................................... 149
Mister, Steve, President and CEO, Council for Responsible
Nutrition, Washington, DC, statement........................... 164
Rannazzisi, Joseph T., Deputy Assistant Administrator, Office of
Division Control, Drug Enforcement Administration, Department
of Justice, Washington, DC, statement.......................... 171
Tygart, Travis, Chief Executive Officer, United States Anti
Doping Agency, Colorado Springs, Colorado, statement........... 177
``BODY BUILDING PRODUCTS AND HIDDEN STEROIDS: ENFORCEMENT BARRIERS''
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TUESDAY, SEPTEMBER 29, 2009
U.S. Senate,
Subcommittee on Crime and Drugs,
Committee on the Judiciary,
Washington, DC
The Subcommittee met, pursuant to notice, at 2:30 p.m., in
room SD-226, Dirksen Senate Office Building, Hon. Arlen
Specter, Chairman of the Subcommittee, presiding.
Present: Senator Hatch.
OPENING STATEMENT OF HON. ARLEN SPECTER, A U.S. SENATOR FROM
THE STATE OF PENNSYLVANIA
Chairman Specter. Good afternoon, ladies and gentlemen. The
hour of 2:30 having arrived, the Subcommittee on the Committee
of the Judiciary on Crime and Drugs will now proceed with this
hearing on bodybuilding supplements and the possibility of
their containing steroids or steroid-like substances.
The Federal laws which govern this subject are complex. If
the substance is a drug within the meaning of the Food and Drug
Act, it is subject to preclearance by the FDA. Failure to
comply with Federal law may result in criminal penalties. If
the item comes within the Controlled Substances Act as one of
the titled defining steroids, there again may be a criminal
violation.
The legislation provides that substances produced before
1994, which are body-building, are not subject to the rules of
the Food and Drug Administration. But experience has shown that
there are many of these body-building supplements which are
sold over the counter which may contain steroids or steroid-
like substances which may cause very severe damage to the liver
or the kidneys.
We find that our society, which is very much addicted to
supports and very much addicted to excelling in sports, that
athletes are very anxious to buildup their bodies to be able to
excel or at least to do better. And this is an attitude which
goes from professionals like Mark McGuire who received
disciplinary action as a result of having steroids in his body
to J. C. Romero of the Philadelphia Phillies who was suspended
this year to the detriment, candidly, of my home town team for
50 games because he had steroid-like substances in his body. Or
at least that was the allegation and the judgment of some.
So the question arises as to whether there needs to be a
change in Federal law. The consequences can be very serious for
using steroids as identified by the Food and Drug
Administration in serious terms as follows:
Anabolic steroids may cause serious long-term adverse
health consequences in men and women. These include shrinkage
of the testes and male infertility, masculinazation of women,
breast enlargement in males, short stature in children, adverse
effects on blood lipid levels, and increased risk of heart
attack and stroke. The consequences of liver failure and kidney
disorder have already been identified.
On one of the morning television shows a young man appeared
to say, in anticipation of this hearing there was television
coverage, that he had used a steroid-like substance and became
very ill, went to a doctor and was told that if he hadn't
secured medical aid by 2 days he might well have been dead at
that point.
There is a collateral issue which the Subcommittee will
take a look at and that is a Federal court decision which
prohibited the national football league from taking
disciplinary action against athletes under the anti-doping
provisions. There the Eight Circuit Court of Appeals upheld a
District Court decision saying that it was a matter of
Minnesota law and that the individuals cited could defend
themselves under a Minnesota statute. Well, it is an item which
most likely can be handled by Federal supremacy. If the
Congress decides to act to eliminate any ambiguity that Federal
law will control notwithstanding Minnesota law which Federal
statute could supercede the decision of the Court of Appeals
for the Eighth Circuit.
These are very important items. We are dealing with a
multi-billion dollar industry, estimated to bring in on dietary
supplements like $24 billion a year and body-building
supplements projected to yield in the range of $2.5 billion a
year. So there are substantial property rights involved. But
there are also very substantial health risks involved.
In existing legislation as noted, under the Food and Drug
Administration, under controlled substances there are tough
penalties. We may need to take a look at what we are going to
do here with the exemption which allows these body-building
steroids to be sold without preclearance under 1994
legislation.
Now I am pleased to yield to my distinguished colleague,
Senior Senator from Utah. This hearing panel is small, but
loaded with ex-chairmen of this Judiciary Committee. Senator
Hatch.
STATEMENT OF HON. ORRIN HATCH, A U.S. SENATOR FROM THE STATE OF
UTAH
Senator Hatch. Thank you, Mr. Chairman. It is nice to be
with you as always. We are very close friends and I appreciate
being here at this hearing.
There should be a high priority to enforce the laws
currently on the books so that no one, a high school football
player, a middle-aged dieter, or a major league baseball player
may walk into a health food store and purchase a product off
the shelf that contains steroids. Today such purchases are
illegal, plain and simple. Any company that sells such products
is in violation of law and those types of products should be
taken off the market immediately, no infrastructure, ands, or
buts about it.
So this is an important issue and is equally important that
this hearing clear up the abundant confusion and misinformation
about what the laws are, how they are being enforced, and which
agency is responsible for overseeing and enforcing laws that
make anabolic steroids illegal.
It is my hope that we can use this hearing as an
opportunity both to educate American consumers, especially
teens and athletes about the dangers of steroids and to ensure
them that laws do exist to protect them from these dangerous
products.
As members of the Subcommittee know, we have worked hard to
ensure that the government has adequate authority to take
products containing anabolic steroids off the market.
Many of us have been concerned as we begin to see the use
of anabolic steroids increase in professional and amateur
athletics. That was the primary reason for the enactment of the
1990 Anabolic Steroids Control Act which banned anabolic
steroid use in the United States.
Senator Biden and I were the prime sponsors of that bill.
While the 1990 law was successful in deterring potential
steroid abuse, new products were being developed to circumvent
the reach of Federal law enforcers. And while not technically
anabolic steroids, these steroid precursors react in a
virtually identical dangerous manner once inside the human
body. So we worked closely with the Drug Enforcement
Administration and then Senator Biden to update the law and
pass the Anabolic Steroid Control Act of 2004.
Mr. Chairman, I recall your being very supportive of this
legislation as well and I personally appreciated it. This was
not controversial legislation. It passed the Senate unanimously
and the House of Representatives passed it by a vote of 408 to
3.
The Anabolic Steroid Control Act of 2004 addressed the
abuse of steroids by athletes and also youngsters and teenagers
by listing new steroid precursors as controlled substances. The
law also gave the DEA the authority to schedule new precursors
more easily without the sometimes difficult process of proving
the product builds muscle mass.
Importantly the law designated the substance
androstenedione as a controlled substance, thus clearing up any
ambiguity that this dangerous product could mask as a dietary
supplement regulated by the Food and Drug Administration.
Senator Harkin of Iowa and I had spent considerable time
urging the government to ban andro, as it is called, and I was
very supportive of its listing which thus placed significant
controls on its distribution and use including substantial
criminal penalties.
Let me take this opportunity to raise one issue that will
probably be considered within the context of this hearing. When
the 2004 law was considered on the floor, Senators Biden,
Kennedy, Durbin and I had a detailed colloquy including
discussion of how DHEA, a hormone precursor, which is sometimes
marketed as a dietary supplement would be treated under the
Anabolic Steroid Control Act. As we recognized, it was not the
intent of Congress to stop the use of substances that are
legitimately marketed as dietary supplements, or to limit
access to substances that are not abused as steroids by
athletes or children.
The 2004 law deliberately did not schedule DHEA and as a
result legitimate users of DHEA continue to have access to it
if it is lawfully marketed. However, the 2004 law does allow
the DEA, the Drug Enforcement Administration, if it should find
that the product is being abused by athletes, by youngsters, or
by teenagers to schedule it as a controlled substance by
applying the standards in Section 201 of the Controlled
Substances Act including the eight factor analysis listed in
Section 201.C of that Act.
But I add that in fact the DEA need not find that DHEA
meets each of the eight factors before it can be scheduled. For
example, if the DEA considers that DHEA has no or minimal
psychic or physiological dependence liability, the DEA may
schedule DHEA if the agency concludes, after consideration of
the facts and relative importance of other factors, such as the
actual or relative potential for abuse, the history and current
pattern of abuse, or the scope, duration, and significance of
abuse, that it should be scheduled.
So that we would be clear, I asked that the Administration
provide its written understanding of that provision. And
Administrator Karen Tandy wrote a letter to me stating that the
presence of each of the eight factors is not a mandatory
prerequisite to scheduling.
Now, Mr. Chairman, I ask unanimous consent that that letter
be submitted for the record.
Chairman Specter. Without objection, it will be made a part
of the record.
[The letter of Administrator Tandy appears as a submission
for the record.]
Senator Hatch. Thank you, sir.
If I could take a few more minutes because this is a
subject that is very important to me and my home state of Utah,
world leader in the manufacture of dietary supplements.
I would like to take a few minutes to discuss briefly the
Dietary Supplement Health and Education Act of 1994 known as
DSHEA. While the Health Committee has jurisdiction over this
bipartisan law, that Senator Harkin and I wrote, it is an
important piece of supplement regulatory structure. DSHEA
clarified the Food and Drug Administration's regulatory
authority over supplements while ensuring that consumers will
continue to have access to safe supplements and information
about their use. It passed the Senate not once but twice by
unanimous consent. The law established a statutory framework
for FDA so that these vitamins, minerals, herbal products,
amino acids, enzymes and other dietary supplements are
generally recognized as foods.
The law ``grandfathered'' supplements on the market in the
United States at the time of enactment. The presumption being
that these products had an abundant history of long and safe
use. At the same time we wrote a strong safety standard into
the law the products that might be harmful could be removed
from the market.
As a double safeguard we also gave the FDA an ``imminent
hazard'' authority so the agency can immediately remove from
the market a product it suspects to be unsafe, no questions
asked. We also included a provision to require manufacturers to
submit to the FDA, 75 days prior to marketing, safety
information about any new ingredients not previously marketed.
A key principle of the law is that supplements were not
subject to premarket approval since the cost and time alone
required to see a product through the FDA approval process
would sound the death nail for this industry. Most supplement
products cannot be patented and there is no incentive for a
manufacturer to put its products through this costly and
onerous process when any other manufacturer could benefit
equally from the research and investment.
Another key provision in the law authorized issuance of
good manufacturing practice standards for supplements so that
FDA inspectors could make certain the products are being
manufactured in compliance with all the safeguards of the law.
Finally, we required that all ingredients be listed on the
label and that any claims must be made truthful and not
misleading.
The reason I outline these provisions is to illustrate that
we took great pains to design a regulatory framework that will
assure supplements are manufactured and marketed with consumer
safety as the top priority. We provided the FDA with an arsenal
of new tools to enforcement the law. Some they have used,
others not. And since that time the industry has grown. By some
estimates it is a $20 billion industry today. While critics of
the industry have viewed this growth as a negative development,
repeatedly stating that the industry is unregulated, is simply
the wrong statement. All of these requirements are set out in
the law in order to be administered by the regulatory agency,
the FDA.
While the great majority of supplement products are used
safely, there have been problems with some products. Some of
the problems relate to manufacturing, some relate to labeling.
I do not see this as a failure in the law. Supplements are
regulated under the law. But let me be clear. We all recognize
there are bad actors in the supplement industry. These
individuals should be subject to swift punishment by the FDA
and the Federal Trade Commission. Their products should be
removed from the marketplace immediately and the full weight of
the law should be brought down on these bad actors.
Unfortunately it is no secrete that the FDA is a woefully
underfunded agency. The agency will be the first to admit that
its oversight of the dietary supplement industry is hampered by
a lack of resources.
For several years I have worked with Senator Harkin to
rectify that shortcoming by requesting that the Appropriations
Committees in the House and the Senate provide the FDA with
more resources so that it can do a better job regulating the
industry. Senator Kohl, Senator Bennett, and Senator Cochrane
have been very helpful as well in this regard.
One other regulatory authority should be mentioned before I
conclude. The situation with the herb ephedra certainly pointed
out that the FDA could benefit from earlier warnings about
serious problems with supplement and over-the-counter drug
products. Senator Durbin was instrumental in pushing this issue
forward. We worked together with Senators Harkin, Enzi, and
Chairman Kennedy to pass the Dietary Supplement and
Nonprescription Drug Consumer Protection Act in 2006 which
mandated a system of adverse event reports to the FDA regarding
all serious events which are associated with the use of these
products.
Finally, I also want to mention that the Government
Accountability Office issued a report on the regulation of
dietary supplements at the end of January. The GAO report, in
my opinion, made some helpful recommends regarding FDA
oversight of these products.
We, in Congress, will continue to evaluate GAO's
recommendations on how to improve the regulation of this
industry. But one of the important points the report raises is
the lack of FDA resources to enforce the laws already on the
books. I will continue to work with my colleagues in Congress
and the FDA to provide more resources to the FDA for dietary
supplement oversight.
Before I conclude I want to stress and extremely important
point. Since enactment of DSHEA almost every FDA Commissioner,
Henney, McClellan, Crawford, and von Eschenbach on record
stating that the agency has enough enforcement authority to
regulate dietary supplements. And the current Commissioner, Dr.
Margaret Hamburg, in a recent speech to the Food and Drug Law
Institute on effective enforcement and benefits to public
health mentioned that, ``reports have noted that there has been
a steep decline in the FDA's enforcement activities.'' And,
``in some cases serious violations have gone unaddressed for
far too long. These include violations involving product
quality, adulteration, and misbranding. False, misleading, or
otherwise unlawful labeling, and misleading advertising.''
Furthermore, in providing an example of the FDA stepping up
its enforcement activities, Dr. Hamburg cited enforcement
actions against companies selling over-the-counter, body-
building products that contain anabolic steroid under the guise
of dietary supplements. Dr. Hamburg stated in referring to
these steroid products, ``these are unproven and unapproved
drugs not dietary supplements.''
In other words, these products are considered
``adulterated'' and ``misbranded'' under the Food, Drug and
Cosmetic Act. Simply put, under current law, these products are
not allowed to be marketed.
I appreciate the Chairman's willingness to listen to my
long statement. But as you know, this subject is near and dear
to my heart.
I want to welcome our witnesses and thank them for taking
the time out of their busy schedules today to join us. I look
forward to discussing this important issue with them and of
course with my Chairman and, of course, other members of this
subcommittee.
Chairman Specter. Will the witnesses please raise your
right hands?
[Whereupon, the witnesses were sworn en masse.]
Chairman Specter. You may be seated. We will proceed now to
our first witness who is Mr. Michael Levy, Director of the New
Drugs and Labeling Compliance in the Office of Compliance for
the Center for Drug Evaluation and Research at the Food and
Drug Administration.
Since 2000 he was associate Chief Counsel at one of the
branches of FDA. And before that he was an assistant district
attorney in the Philadelphia DEA's office. Outstanding academic
record, Duke, cum laude, Bachelors Degree; Amherst, Duke, cum
laude, law degree, and Amherst College, magna cum laude.
I note your service with the Philadelphia District
Attorney's Office.
Mr. Levy. That's correct, yes.
Chairman Specter. So you have obviously had excellent
training.
[Laughter.]
Mr. Levy. Thank you.
Chairman Specter. You have the same name as a former
Assistant District Attorney.
Mr. Levy. I do, yes.
Chairman Specter. Is he your father?
Mr. Levy. He is not. No, we are not related.
Chairman Specter. You are not related?
Mr. Levy. Not related.
Chairman Specter. Well, I hired him as an assistant DA in
1971. He could qualify. He is now the distinguished United
States Attorney for the Eastern District of Pennsylvania.
Thank you for joining us, Mr. Levy. We look forward to your
testimony. There is a 5-minute limitation.
Mr. Levy. OK.
Chairman Specter. Which is the standard rule in the
subcommittees on the Judiciary.
STATEMENT OF MICHAEL LEVY, DIVISION DIRECTOR OFFICE OF
COMPLIANCE, CENTER FOR DRUG EVALUATION AND RESEARCH U.S. FOOD
AND DRUG ADMINISTRATION WASHINGTON, DC
Mr. Levy. OK. Mr. Chairman, and members of the Committee I
am Michael Levy, as you mentioned, Director of the Division of
New Drugs and Labeling Compliance in the Office of Compliance
of FDA's Center for Drug Evaluation and Research.
Chairman Specter. As Senator Thurmond used to say, pull the
machine a little closer.
Mr. Levy. OK. With me today is Doctor Vascilios H. Francos,
Ph.D., Director of the Division of Dietary Supplement Programs
in FDA's Center for Food Safety and Applied Nutrition.
Dr. Francos will assist me in responding to questions
pertaining to products marketed as dietary supplements and
their regulation under the Federal Food, Drug and Cosmetic Act.
At this point I want to take the opportunity to thank
Senator Hatch for his long-standing leadership on dietary
supplement issues and specifically the 2004 Anabolic Steroid
Control Act and adverse event reporting for dietary
supplements.
Senator Hatch. Well, thank you so much.
Mr. Levy. And thank you to the Subcommittee for the
opportunity to discuss FDA's perspective on the issue of
steroids and products marketed as dietary supplements.
FDA is very concerned with products containing synthetic
steroid ingredients that are marketed as dietary supplements.
Body-building products marketed as dietary supplements are
commonly found to contain these types of steroids. There is no
requirement for the manufacturer of a dietary supplement to
provide FDA with evidence of the product effectiveness or
safety prior to marketing unless the product contains a
substance that was marketed as a dietary ingredient before 1994
and that has not been a part of the food supply which the law
defines as a ``new dietary ingredient.''
In addition to the agency's concerns that many of these
products have not been clinically studied or demonstrated to be
safe, the products are often sold with misleading labeling and
they are frequently manufactured without quality controls.
By labeling steroid products as dietary supplements
unscrupulous firms can introduce into the marketplace products
that contain ingredients that may pose risks to health.
FDA has recently taken action to protect the public from
illegal steroids and dietary supplements. In July 2009, for
example, FDA issued a public health advisory warning consumers
to stop using any body-building products that are represented
to contain steroids or steroid-like substances. The public
health advisory was issued in response to a cluster of serious
adverse event reports submitted to FDA associated with several
products containing synthetic steroids and marketed as dietary
supplements. Adverse events included serious liver injury,
stroke, kidney failure, and pulmonary embolism.
Although the body-building products containing these
synthetic steroids were marketed as dietary supplements they
were not dietary supplements. Rather, they were unapproved and
misbranded drugs that had not been reviewed by FDA for safety
and effectiveness.
FDA executed a criminal search warrant and issued a warning
letter to American Cellular Labs regarding the illegal
manufacture of these products. FDA also, last week, executed a
criminal search warrant at the premises of Body-building.com.
This search warrants involves an active criminal investigation
into the distribution of body-building products marketed as
dietary supplements that have been found to contain steroids.
In the past 5 years FDA has sent 28 warning letters to
firms that were illegally marketing products marketed as
dietary supplements and containing steroids. Currently FDA's
civil and criminal enforcement offices are gathering and
reviewing additional data about other products that are
marketed for body building and that claim to contain steroids
or steroid-like substances.
Despite these actions FDA enforcement in this area is
challenging. Because FDA generally does not receive information
on these products prior to marketing, FDA generally cannot
identify violative products before they enter the marketplace.
After products enter the market, FDA must undertake a
painstaking investigative and analytical process of the
products, ingredients, and labeling that often involves
laboratory testing to show that they are violative.
Currently the agency struggles to provide effective civil
and criminal deterrents to prevent unscrupulous firms from
fraudulently marketing these products. We are also unable to
effectively prevent the importation of many violative products
because of the sheer volume of imports and the agency's
inability to do a comprehensive examination of all packages
entering the United States.
These challenges make it very difficult to stop the sale of
these dangerous products. FDA, however, will continue its
efforts to identify and remove illegal steroid products from
the marketplace. FDA is committed to doing everything we can to
protect the American public, not only through regulation and
enforcement, but also through education, outreach and
collaboration with entities outside FDA.
FDA looks forward to working with Congress on this
important public health issue and I would be happy to answer
any questions.
Chairman Specter. Thank you, Mr. Levy.
Our next witness is Mr. Joseph Rannazzisi, Deputy Assistant
Administrator for the Drug Enforcement Agency, coordinates
major drug investigations and serves as liaison to the
pharmaceutical industry.
He has his Bachelors degree in Pharmacy from Butler
University, a law degree from Detroit College at Michigan
State, registered pharmacist and a member of the Michigan Bar.
Thank you for coming in today and the floor is yours for 5
minutes.
STATEMENT OF JOSEPH T. RANNAZZISI, DEPUTY ASSISTANT
ADMINISTRATOR, OFFICE OF DIVERSION CONTROL, DRUG ENFORCEMENT
ADMINISTRATION, DEPARTMENT OF JUSTICE, WASHINGTON, DC
Mr. Rannazzisi. Thank you, sir.
Chairman Specter, Senator Hatch, distinguished members of
the panel, on behalf of Acting Administrator Michelle Lynhart
and the more than 9,400 men and women of the Drug Enforcement
Administration I want to thank you for the opportunity to
appear today and provide testimony concerning body-building
products, hidden steroids and enforcement barriers.
To understand the use of steroid products for body-building
and performance enhancement, we must start by discussing
testosterone. Testosterone is a hormone that is produced in the
body and primarily responsible for the development and
maintenance of male sexual characteristics and the promotion of
muscle growth. It is a Schedule III controlled substance that
has legitimate medical use as a therapeutic agent. It is also
used non-medically by body builders, weight lifters, and
amateur and professional athletes to perfect body appearance,
increase physical performance and gain muscle size and mass.
Over time scientists developed and synthesized compounds or
derivatives that were structurally similar to testosterone and
prohormones such as androstenedione, andro, a steroid that when
ingested is metabolized into testosterone. Androstenedione was
sold over the Internet and in health food and nutrition stores
as a dietary supplement until 2004. Many, if not all the
designer steroids, steroid prohormones and testosterone
boosters on the market today are sold as dietary supplements.
In 1990 Congress passed the Anabolic Steroid Control Act
which placed 27 anabolic steroids into schedule III of the
Controlled Substances Act. Pursuant to the 2004 Act the
Congress placed an additional 36 steroids and over-the-counter
prohormone dietary supplements into schedule III of the CSA
including androstenedione and its derivatives.
Dietary supplements are regulated under amendments to the
Federal Food, Drug and Cosmetic Act; added by the Dietary
Supplement Health and Education Act of 1994. The Drug
Enforcement Administration has no statutory authority to
enforce provisions of DSHEA. But does have statutory authority
to investigate the manufacture and distribution of anabolic
steroids in the dietary supplement market. With the passage of
the Anabolic Steroid Control Act of 2004, Congress refined the
definition of the original 1990 law to allow DEA to
administratively classify a substance as an anabolic steroid if
the substance is both chemically and pharmacologically related
to testosterone, not an estrogen, progestin, or codoco steroid
and not dyhydroepiandrosterone or DHEA. Using this provision
DEA identified substances marketed as anabolic products in the
dietary supplement market and then conducts a scientific
review, an analysis of the substance to determine if it is
related to testosterone and if the substance meets the criteria
to be classified as a schedule III anabolic steroid.
The scheduling process requires an interagency review, the
publication of a notice of proposed rulemaking and the review
of public comments and the publication of a final rule in the
Federal Register that provides notice to the public and
industry of the scheduling action. This is a lengthy process
and there is no method under the current statute to expedite
this scheduling process.
DEA is currently in the final stages of the scheduling
process for boldione, desoxymethyltestosterone, 19-nor4-
4,9(10)-androstadi- enedione, three substances that are sold
and marketed as anabolic steroids in the dietary supplement and
found to be chemically and pharmacologically similar to
testosterone. DEA is aware of 58 supplements that purportedly
contain one or more of these steroids.
The initial notice of proposed rulemaking concerning the
scheduling of these substances was published in April of 2008.
We anticipate publishing the final rule in the next several
months. When finalized, these products would be the first
substances scheduled under the 2004 Act. As you can see, the
overall time period to perform an anabolic steroid scheduling
action may take as long as 2 years to complete. In the time
that it takes DEA to administratively schedule an anabolic
steroid, several new products can enter the dietary supplement
market to take the place of products that have been scheduled.
Chemists continue to create new derivative products by
substituting and altering the structure of testosterone and
then market them as dietary supplements. Often these new
formulations have never been clinically tested and the
potential adverse reactions in humans are simply unknown.
DEA has also identified products in the dietary supplement
market that contain small amounts of schedule III anabolic
steroids. The presence of these anabolic steroids is not listed
on the label of these products. The companies manufacturing,
bottling, and marketing them do not hold controlled substance
registrations and the manufacture and distribution of these
products violate various provisions of the Controlled
Substances Act.
In conclusion, DEA will continue to identify products that
are structurally and pharmacologically similar to testosterone
that are masquerading as dietary supplements and classify them
as controlled substances. We will continue to investigate
companies that market and sell dietary supplement products that
are adulterated with controlled substances and pursue the
appropriate criminal, civil and administrative remedies to
prevent the continued sale of these products.
Again, I thank the Subcommittee for the opportunity to
discuss this issue and welcome any questions you may have.
Chairman Specter. Thank you very much.
Our next witness now is Mr. Travis T. Tygart, CEO of the
U.S. Anti Doping Agency.
Prior to joining the agency Mr. Tygart was an associate in
sports law at Holme, Roberts and Owen. A distinguished academic
background, Bachelors degree from North Carolina, law degree
from Southern Methodist, Order of the Coif.
We appreciate you being here, Mr. Tygart and look forward
to your testimony. Five minutes.
STATEMENT OF MR. TRAVIS TYGART, CHIEF EXECUTIVE OFFICER, UNITED
STATES ANTI-DOPING AGENCY, COLORADO SPRINGS, COLORADO
Mr. Tygart. Thank you, Mr. Chairman, members of the
Committee, Good afternoon.
My name is Travis Tygart and I am the Chief Executive
Officer of the United States Anti-Doping Agency, or USADA. On
behalf of the millions of participants who demand fair, clean,
and safe sport that we represent, I appreciate the opportunity
to be here today to discuss these important issues.
USADA has been recognized by Congress as the independent,
national anti-doping agency for Olympic sport in the United
States. We are greatly concerned about the ease with which
products containing steroids can be purchased in America's
supplement storefronts. We are equally concerned that some
athletes have tested positive for banned drugs because the
product they were using were either contaminated or
intentionally spiked by manufacturers.
Designer steroids made their leap into America's
consciousness in 2003 when the BALCO Doping Conspiracy was
revealed. One of the designer steroids found in BALCO was
Madol. The story of Madol conforms the alarming migration of
designer steroids from underground, clandestine laboratories to
mainstream marketing.
Since its discovery, Madol quickly rose from an unknown
substance to the signature ingredient in nutritional products
readily available in retail supplement stores and over the
Internet.
Unfortunately Madol is just one example of a designer
steroid that is marketed as an otherwise legitimate supplement
to an unsuspecting public. It is estimated that 10 percent or
$2.8 billion is spent annually on performance-enhancing
products. Best estimates suggest that there are hundreds to
thousands of products currently available that contain one or
more of these 20 designer steroids.
It is all too easy for the junior high or college athlete
to walk into a local health food store or log onto the Internet
and see the glossy labels and the bright bold claims of legal
and all natural. He thinks, as we all believe, that because
these supplements are readily available that they must be safe
and effective. What he does not know is that all it takes for a
supplement maker to cash in on the storefront steroid craze is
a credit card to import raw materials from China, the ability
to pour powder into a bottle, and a printer to create a label.
What he does not know is that the maker can create a new
steroid product, have it on the shelves within a matter of
weeks, make unsubstantiated claims, and sell millions of
dollars of product before the FDA has the ability to take
action.
Unfortunately we don't just have to imagine such an athlete
because one is here with us today. His name is Jareem Gunter. I
have not known Jareem long, but it doesn't take long to realize
that Jareem and others like him are sobering examples of how
unscrupulous profiteers are trading the health of our children
for the pursuit of quick cash.
Jareem was fortunate to have some God-given athletic
ability and to work hard to earn financial assistance to play
baseball at a small college. Jareem decided to look for a legal
nutritional product to help his workouts. He did his due
diligence, even checking the school's prohibited drug list. And
he found a product not on that list called ``Super Draw.''
According to court papers, and its advertising materials at the
time, Super Draw even invoked the name of Congress to suggest
that because Congress had not added it to the Controlled
Substance Act that it was 100 percent legal.
Shortly after using Super Draw Jareem started feeling ill
and the pain eventually drove him to the emergency room. If he
had waited another day, according to the doctor, he might not
be alive today, because he suffered acute liver failure.
Jareem's pursuit of the American dream was compromised by what
he reasonably believed to be a safe and legal product.
I want to thank Jareem for being here today and letting me
share his story. Today his health is better, but he is forced
to be constantly vigilant looking for the return of the
symptoms caused by Super Draw.
He now works with children at a mentoring center, city of
Dreams, in the Bay Area, trying to help other kids stay away
from drugs and stay off the streets.
Jareem's only mistake was believing that products sold
over-the-counter and readily available on the Internet can be
assumed to be safe and legal in the United States. Jareem had
no way of knowing that a regulatory scheme designed over 15
years ago, for a few companies, selling a limited number of
simple vitamins and minerals has been hijacked by unscrupulous
manufacturers. He had no way of knowing these companies are
exploiting the lack of premarket regulation to sell magic pills
while using the reputation of the legitimate food and vitamin
industry to cloak themselves with the appearance of safety and
propriety.
Mr. Chairman, we applaud this Committee for holding this
hearing today because now is the time to fix this problem.
While the recent FDA raids that were earlier referenced are an
important step to protect consumers, the current law severely
restricts the FDA and its ability to stop, much less slow down
the designer steroid gold rush.
Both pre-market and post-market changes are required to
give all consumers a truly healthy choice.
The legitimate dietary supplement companies truly concerned
about the health and safety of our consumers have nothing to
fear by the proposals that hopefully will be discussed and are
presented in my written testimony. You saw it as committed to
being part of the solution. And in the weeks to come we will be
announcing an effort supported by the National Football League,
Major League Baseball, National Basketball Association, and the
United States Olympic Committee and many other entities equally
concerned about this topic and committed to solving the
problem.
We look forward to working with all groups that have a
sincere interest in preventing these dangerous products from so
easily getting into the hands of our young children.
I would like to finally thank this Committee for its time
and its interest in this important public health issue and for
inviting me to share USADA's experience about the reality of
the market.
Thank you.
Chairman Specter. Thank you very much, Mr. Tygart.
We now turn to Mr. Daniel Fabricant, Interim Executive
Director and CEO of the Natural Products Association, which is
a trade association representing the natural product industry.
Mr. Fabricant has his Bachelors degree in Chemistry from
the University of North Carolina; Ph.D. in Pharmacology from
the University of Illinois at Chicago.
Thank you for coming in, Mr. Fabricant. Your testimony is
next.
STATEMENT OF DANIEL FABRICANT, Ph.D., INTERIM EXECUTIVE
DIRECTOR AND CEO, VICE PRESIDENT SCIENTIFIC AND REGULATORY
AFFAIRS NATURAL PRODUCTS ASSOCIATION, WASHINGTON, DC
Mr. Fabricant. Thank you, Mr. Chairman, Senator Hatch. On
behalf of the NPA, thank you for the opportunity to be here
today. We represent the interests of more than 10,000
retailers, manufacturers, suppliers, and distributors of
healthcare products, dietary supplements, and natural personal
care as well as our source for the millions of Americans who
use supplements each year. I am also a former college athlete
and sports nutrition expert, so I have a deep personal
understanding of this issue.
First let me say that we welcome this hearing because we
share your concerns about illegal steroids. Selling products
containing illegal substance is already a crime. Whenever a
product containing illegal substance is identified, be they
steroids or something else, we are the first to call for
throwing the book at the offending party. Anyone caught selling
steroids should be prosecuted to the full extent of the law and
the natural products industry has worked for years to pass
those laws.
We believe that tougher enforcement and prosecution, again,
to the fullest extent of the law, are the best ways to stop the
criminals. The barriers to enforcement are simple: money,
manpower and will.
We fully support strong rules to ensure what is on the
label is what is in the bottle. The criminals who illegally
sell steroids do not. We fought for additional DEA enforcement
ability, especially concerning the passage of the Anabolic
Steroid Control Act of 2004. This law gave DEA additional
authority and made it easier for them to schedule anabolic
chemicals. We have also worked hard for good manufacturing
practice regulations, serious adverse event reporting and the
pre-market, new dietary ingredient notification system as well
as other important provisions of the Federal Food, Drug, and
Cosmetic Act which are used to regulate the space. We also
strongly support the FTC's activities against false and
deceptive advertising.
Criminal activity is always a problem. We are not surprise
that criminals defy these laws. That's what criminals do. We
are not surprised that criminals ignore current legal
requirements to notify the government of their intent to sell
illegal substances.
So, again, we urge the panel to get tough on criminals.
That is why our industry has fought repeatedly for Congress and
the Administration to provide the Drug Enforcement Agency, the
FDA, the FTC, and other agencies the resources they need to
enforce the law. For many years, quite frankly, their budgets
were slashed and these resources were lacking.
Over the past 12 months, notably at FDA, Congress has
provided a significant infusion of funding which has led to a
noticeable increase in activity like the enforcement activity
last week that made the new cycle. We welcome this increased
government enforcement and support efforts to boost resources
further. The criminals who illegally sell steroids do not.
There are additional enforcement measures that under
current law could be used. For instance, the FDA sent 28
warning letters to firms that were illegally marketing products
containing steroids in the past 5 years. While warning letters
are certainly a good start, how many of those letters were
followed up with court action which is well within the
authority of the FDA to pursue.
Likewise, to our knowledge, DEA has only proposed listing
of three additional compounds under the Anabolic Steroid
Control Act of 2004 in the past 5 years. These limited
enforcement activities are not an effective deterrent and make
it far too easy for criminals to stay one step ahead of the
law.
One place the agencies might concentrate an increasing
effort is on those products marketing themselves with street
drug names for steroids. I would also say this to any athlete
out there, beware of any product that sounds like an illegal
steroid. Because if it is posing as steroid or some steroid-
like knock off, chances are, it very well might be. And anyone
seeking to buy these illegal products is doing such at a great
risk to themselves.
Finally, it is in our best interest to continue to earn the
public's trust and anything we can do to separate the legal,
safe, healthy supplement industry from the seedy, fly-by-night,
and unsafe world of illegal steroids is worthwhile.
Indeed, when any athlete blames an off-the-shelf dietary
supplement as the cause for a banned substance being found in
their bodies, our industry is always the first one to ask them
to name the supplement, name of the manufacturer, and name the
store where they bought it. We asked the same question of
Donald Fehr who essentially blamed the entire steroids scandal
in major league baseball on the legal dietary supplement
industry.
Clearly, when it comes to drug testing in athletes we all
have more questions than we do good answers.
So, Mr. Chairman, again, we are glad you are holding this
hearing. We support efforts to stop the sale of illegal
steroids. We strongly support resources for government agencies
to enforcement the law. We stand ready to work with the
committee, the government, non-government agencies, and
supporting agencies to help identify and remove criminal
activity which is the root cause of this tragedy.
Thank you. And, again, I look forward to your questions.
Chairman Specter. Thank you, Mr. Fabricant.
Our final witness is Mr. Richard Kingham, partner at
Covington and Burling, concentrating on food and drug law,
product liability and product safety. Represented many major
pharmaceutical manufacturers and biotech companies as well as
trade associations. Graduate of George Washington University,
law degree from the University of Virginia.
Thank you very much for coming in Mr. Kingham and the floor
is yours.
STATEMENT OF RICHARD KINGHAM, COVINGTON & BURLING, LLP,
WASHINGTON, DC
Mr. Kingham. Thank you, Mr. Chairman and Senator Hatch.
Manufacturers of legitimate dietary supplements share the
concerns that you have with the distribution of body-building
products that contain anabolic steroids. The adverse effects of
those products are well-known and those substances should not
be available for general use.
It is important to recognize, however, that the vast
majority of dietary supplements are in no way implicated by the
matters being discussed in this hearing. More than 150 million
Americans regularly use legitimate dietary supplements and
those products offer significant health benefits to the people
who use them.
There is, moreover, and this is the main focus of my
presentation, no need to amend existing legislation to deal
with anabolic steroids. The Food and Drug Administration and
the Drug Enforcement Administration both have ample authority
to deal with the problem by making use of existing statutory
powers.
Congress has twice amended the Controlled Substances Act to
give DEA special power to regulate anabolic steroids. The most
recent amendments enacted in 2004 greatly expanded the list of
substances subject to regulation under the statute to include
metabolic precursors, salts, esters and ethers of listed
substances. Congress also authorized DEA to add new substances
to the relevant schedule without proof of anabolic effect, thus
simplifying the burden for administrative scheduling actions.
Persons who traffic illegally and scheduled anabolic steroids
are liable to severe criminal penalties.
FDA also has broad powers to prevent distribution of
products containing anabolic steroids under existing provisions
of the Federal Food, Drug, and Cosmetic Act. Although many of
the products that are currently promoted in stores and in the
Internet are labeled as dietary supplements. They seldom, if
ever, are in compliance with dietary supplement provisions of
the law.
FDA has multiple enforcement tools which, in fact, are set
out in Mr. Levy's written testimony to this hearing, to deal
with products of that type. These include provisions of the
Federal Food, Drug, and Cosmetic Act that relate both to drugs
and to dietary supplements. Many product, for example, are
advertised with claims that fall within the new drug provisions
of the Food and Drug Act and are, for this reason, both
misbranded and in violation of statutory provisions that
require pre-market approval of new drugs. Others contain new
dietary ingredients for which required pre-market notifications
have not been made to FDA under the dietary supplement
provisions of the statute. Those products are legally deemed
adulterated and are liable to the full range of enforcement
measures under the statute including seizures, injunctions, and
criminal prosecution of responsible persons.
The provisions of the Food and Drug Act governing pre-
market submissions for new drugs and new dietary ingredients do
not require FDA to prove that a product is unsafe, but only
that the required pre-market procedures have not been followed.
Thus, the burden of proof on the government is minimal and
experience suggests the courts are willing to interpret the
provisions of the act liberally to protect the public against
unlawful products.
For this reason a warning from FDA backed up with a
credible threat to take formal enforcement action is usually
sufficient to achieve compliance.
FDA has, as Mr. Levy has stated, issued a number of warning
letters to companies that distribute products containing
anabolic steroids and it has the capacity to issue more letters
and to take formal enforcement actions as appropriate.
The Food and Drug Act also effectively addresses the
problem of so-called ``designer drugs'' that are formulated to
circumvent the scheduling provisions of the Controlled
Substances Act. Anabolic steroids that are not listed in the
relevant schedule will typically be new within the meaning of
the provisions of the Food and Drug Act that require prior
approval of new drug applications or submission of new dietary
ingredient notifications.
Now, as has also been mentioned, and recent reports
suggest, that there are some products on the market whose
labeling does not declare the presence of anabolic steroids
that are detected in laboratory assays. Those ingredients might
be surreptitiously added to what would otherwise be lawful
products. But those practices are clearly illegal under
multiple provisions of existing law.
The Food and Drug Act, for example, prohibits the addition
of the deleterious substances to legitimate products. It
imposes special requirements for good manufacturing practice
for dietary supplements that include controls on contaminants
and the ingredients that are added to products and it requires
label disclosure of ingredients.
As Dr. Fabricant said, what's in the bottle must be on the
label of a dietary supplement.
As with the provisions of the law relating to new drugs and
new dietary ingredients, these provisions can be enforced with
the full range of sanctions under the law.
For these reasons I do not believe that amendments to the
law, especially a pre-market approval requirement would be
appropriate. Existing law, if properly enforced, is sufficient
to assure protection of the public.
A pre-market approval requirement for these products,
which, by the way, they were not subject to prior to 1994,
would only add to the expense of bringing them to the market
and increase administrative responsibilities at FDA.
Body-building products constitute less than 10 percent of
the market for dietary supplements in the United States. And
the products that are the subject of this hearing are a tiny
fraction of that market segment. It would be a mistake to alter
the carefully crafted regulatory framework for all dietary
supplements simply to deal with a small number of outlier
products that can be effectively controlled under existing
statutory provisions.
Thank you.
Chairman Specter. Thank you, Mr. Kingham.
We will now proceed with a 10-minute round of questioning.
Mr. Tygart, in your judgment are the existing laws adequate
to protect the public from dietary supplements--represented as
dietary supplements which have steroids or steroid substances?
Mr. Tygart. I think clearly no, from our perspective.
Chairman Specter. You have Mr. Jareem Gunter, would you
have him step forward and let us hear what happened to him.
Mr. Gunter, would you mind stepping forward?
Mr. Tygart has described your experience. Would you tell us
what happened to you in your own words?
Mr. Gunter. Yes. So I went to college in Missouri, Lincoln
University, to be exact. And while I was in school I ended up
getting sick. I went home for the summer and I found a
supplement on line that I thought would be healthy for me or
would be something that wouldn't hurt me.
In the beginning of the year our coach comes in with the
health instructor that comes in and gives us a list of all the
substances that we cannot take. So the list was pretty in
depth. I looked at the list and I went to GNC and compared and
contrasted things that I could not--that I wasn't able to take.
And most things that were at GNC I could not take because it
had some--either the supplement was on there or something that
was in the supplement was banned from NCAA or conference.
So I went back to the computer and was trying to figure out
things I could take. I researched for about three to 4 weeks
different products that I could take that would be legal that
wouldn't be harmful to me. When I found the product that I
took, it was called Super Draw. When I found it I thought I had
found a diamond in the rough, something that I felt that
wouldn't harm me at all. And also it would be helpful to me.
Chairman Specter. Did you take it?
Mr. Gunter. Yes.
Chairman Specter. And did it harm you?
Mr. Gunter. Yes.
Chairman Specter. And in what way did it harm you?
Mr. Gunter. It actually gave me liver failure. So I was in
the hospital for a while.
Chairman Specter. Gave you what?
Mr. Gunter. Liver failure.
Chairman Specter. Liver failure?
Mr. Gunter. Yes. So I was in the hospital.
Chairman Specter. How long were you in the hospital?
Mr. Gunter. It was about 4 years ago, so I--to be exact, it
was anywhere between four to 6 weeks I was in the hospital. And
it constantly wasn't four to 6 weeks in and out, I was in there
for good and couldn't leave.
Chairman Specter. And were you advised as to what potential
consequences there could have been from taking that supplement
of your liver failure?
Mr. Gunter. So the doctor let me know that throughout my
life it could come back at any time. As of right now I am OK.
But the doctor told me to be aware of whatever I do just to
make sure because it could come back at any time.
Chairman Specter. Mr. Levy, you testified that there are
problems with misleading labeling, there are no quality
controls, you issue warnings and public health advisories, some
28 warnings, you specified. You listed a long line of problems,
pulmonary embolism, stroke, kidney failure, liver problems. In
the absence of preclearance is there any effective way for the
FDA to deal with these problems?
Mr. Levy. I would answer that by saying that this is a very
challenging area in which to regulate because it's difficult to
find violative products and it can be difficult to act on those
products.
Chairman Specter. Did Mr. Tygart accurately describe all
that it takes to put one of these dietary supplements on that
market?
Mr. Levy. I don't recall exactly what Mr. Tygart said.
Generally ?
Chairman Specter. He said you could get a substance--he
testified just a few minutes ago; were you listening?
Mr. Levy. Yes. Yes.
Chairman Specter. Well, he testified that you could take a
substance, you could put it in a bottle, you could put some
liquid in it, then you could get a printer and put a label on
it and sell it.
Mr. Levy. That is . . .
Chairman Specter. Did he actually describe the process?
Mr. Levy. Yes, I think that's quite possible. That probably
would not be legal, but, yes, it's possible.
Chairman Specter. Well, we know it's not legal and Mr.
Kingham and Mr. Fabricant had decried these illegal practices
to Senator Hatch. But the question is, how do you safeguard the
public against that?
Mr. Rannazzisi, you described what you have to go through
in a very elongated process. Does DEA have any effective way of
dealing with this problem considering the description you made
as to the lengthy kind of an investigation, the kinds of notice
you have to put out, the kinds of public hearings there has to
be, and the opportunity for people to substitute materials
while you're in that process so you have to start all over
again?
Mr. Rannazzisi. Sir, the process is extremely frustrating
because by the time we get something to the point where it will
be administratively scheduled, there are two to three
substances out there to replace it.
Chairman Specter. Never mind whether it's frustrating, is
it possible for it to be effective?
Mr. Rannazzisi. At the present time I don't believe we are
being effective as far as controlling these drugs; no.
Senator Specter. Mr. Fabricant, you accurately depict the
situation as having or Senator Hatch said, you don't use the
same words, ``bad actor'', but how is it realistically possible
given what the Food and Drug Administration has by way of
resources to deal with this problem without preclearance?
Mr. Fabricant. Well, I think you touched on it as a matter
of resources. I think all of us at the table and those
distinguished members of the Committee were all happy with the
recent activity last week. I think that calls directly for the
need for more enforcement. That is the critical issue here.
Chairman Specter. Well, how about it, Mr. Levy, is it
realistic for you to follow these people after the fact? How
many of these so-called ``bad actors'' do you think there are
out there?
Mr. Levy. I think there are quite a few bad actors out
there. Is it realistic to follow after every one? No, I don't
believe so. So, you know, what we have chosen to do is to try
to be strategic in the way we approach enforcement actions and
to try to get the biggest bang for our buck, if you will.
Chairman Specter. Well, the biggest bang for the fewest
bucks may not be a very big bang as big bangs go.
Mr. Tygart, come back to the witness stand. What is the
impact on these dietary supplements which have steroids with
respect to the younger generation like Mr. Jareem Gunter?
Mr. Tygart. Well, I think it's huge. And while my fellow
panelists said it's only 10 percent of the $28 billion industry
or 10 percent of the 150 million consumers, 10 percent is 15
million if my math is right. That's huge. And a lot of those
are our kids. Just like Jareem, they are going to stores to buy
these to be the best that they can be and pursue their American
dream.
Chairman Specter. How effective is the professional
leagues' anti-doping policy?
Mr. Tygart. The leagues are part of this effort. They
haven't yet adopted the world anti-doping code, which we think
is the gold standard for anti-doping programs and is what our
Olympic athletes----
Chairman Specter. They have not?
Mr. Tygart. They have not.
Chairman Specter. And why not?
I'm not sure. We wish they would. We frankly think they
should if they want the most effective policies in place. But
they've decided not to.
Chairman Specter. And what problems are caused by the
decision by the Court of Appeals for the Eighth Circuit
stopping the enforcement by the NFL of the disciplinary action
taken against the two athletes?
Mr. Tygart. I think it's potentially big and that it could
gut the effectiveness of the programs. If every state's law----
Chairman Specter. What were the facts of those cases, if
you know?
Mr. Tygart. As I understand them from the Minnesota case,
and there was a parallel case down in Louisiana, but there were
three Minnesota Vikings that were using an over-the-counter
product advertised as a dietary supplement for weight loss.
Chairman Specter. Did they have adequate notice that they
were doing something which could get them into that kind of
trouble?
Mr. Tygart. From what I understand of the facts, they were
told, as all of our league-level athletes are told, these
products are dangerous.
Chairman Specter. And how about with J. Ramero, was he
adequately on notice?
Mr. Tygart. I think he was adequately warned.
Chairman Specter. Why do you say that?
Mr. Tygart. Well, I know the policies are at that level as
well as in our world to notify athletes of the potential risk
of positive tests in taking any of these supplements.
Chairman Specter. Well, who notifies the athletes--the
league?
Mr. Tygart. I would think the league and hopefully the
union, if they are there to protect their players, they
probably have that same obligation.
Chairman Specter. And what were the facts of the Mark
McGuire case?
Mr. Tygart. I think it came out publicly that he used
andro. I don't know that he received any sanction for his use
of androstenedione. And that was obviously before
androstenedione was controlled as a schedule III controlled
substance which it is now.
Chairman Specter. Whether he had a sanction, he declined to
testify before a Congressional Committee on the privilege
against self incrimination; right?
Mr. Tygart. That's right. That's exactly right.
Chairman Specter. Do you think there is any doubt that
Congress has the authority to legislate to overrule the Court
of Appeals opinion in the Eighth Circuit and enforce those
laws?
Mr. Tygart. I think so.
Chairman Specter. My red light just went on, so I am going
to yield now to Senator Hatch. I am going to observe that time
limit. Senator Hatch.
Senator Hatch. This is an interesting hearing. Like
everything else, law enforcement can only do so much. But the
laws are certainly clear that these type of products are
illegal. And we wrote them very carefully so they would be.
What it really basically comes down to, are we going to put the
funds in to be able to do the work that has to be done?
I think FDA, Mr. Levy, is overburdened as it is, without
question. And we treat it like a wicked step-sister around here
even though, you know, I passed the FDA Revitalization Act in
the early 1990's and yet we are still not finished with that
class out there. It didn't even start until around 2000 and I
blame Congress for a lot of these things and we don't give you
enough support.
But let me go to you, Mr. Rannazzisi. I want to thank you
for your testimony here today. In your prepared statement you
reference the Anabolic Steroid Control Act of 2004. As you
know, I was the prime sponsor----
Mr. Rannazzisi. Yes, sir.
Senator Hatch [continuing]. Of that legislation with former
Senator Biden, now Vice President Biden. In that bill we
followed the recommendations of the DEA to refine the
definition of what a steroid is and we followed your advice.
The purpose of the amendment, the amended definition was to
allow the DEA to administratively classify additional compounds
as schedule II anabolic steroids. In preparation for this
hearing, I was reviewing your previous testimony before the
House Committee on the Judiciary from March of 2004. In that
testimony you expressed the support of the DEA for the Anabolic
Steroid Control Act of 2004. In speaking for DEA you appealed
to Congress to provide a legislative remedy of refining the
definition of a steroid.
In your testimony you said, this would, ``give us new tools
to more quickly and effectively classify new steroids as
controlled substances.'' And as I stated, Congress did that
just 5 years ago. We gave the DEA what you basically asked for.
However, I noted in your prepared statement that the DEA is in
the final stages of classifying three substances scheduled
under the Anabolic Steroid Control Act of 2004. You also stated
the DEA is in the process of reviewing three other substances.
Now, can you tell me why 5 years after Congress expanded
DEA's authority only three substances have been scheduled? And
I'm puzzled as to why three substances, which by your own
testimony, have not been finalized yet, will be the first three
scheduled under the Anabolic Steroid Control Act of 2004? Is
this also a lack of resources?
Mr. Rannazzisi. No, sir. If we go back to the 1990 Act, if
you remember, the 1990 Act required us to show promotion of
muscle growth which was virtually impossible for us. We looked
at andro for almost 5 years by independent labs and we still,
up until the time the act was passed in 2004, could not show
that andro promoted muscle growth. That's why we asked for the
removal of the promotion of muscle growth.
While it made our job a lot easier, it, by all means, was
still a very difficult process. The problem is, when we
schedule a drug it's got to be based on scientific evidence. It
takes at least six to 8 months just to do the cellular studies
required to schedule a drug. We have to show that that drug is
not a cortical steroid, it is not a progesterone, and it's not
estrogen. That requires several binding studies--cellular
binding affinity studies. These are done by outside labs. It
takes a while to get all of this evidence necessary to go
through the formal process of scheduling. Plus we have public
comment. Plus we have to go through the initial notice of
proposed rulemaking. And we have to vet it through all the
different agencies. This is not a process that can be done
overnight.
My colleagues on the panel make it sound like it's an easy
process. It is far from easy. I think doing those first three
will help us streamline the process, but I can't tell you it is
going to be much quicker than it is right now.
Senator Hatch. Does DEA have a memo of understanding with
the FDA but to assure that the two agencies are effectively
coordinating their activities relative to steroids? Do you work
together?
Mr. Rannazzisi. We do work together. In fact, on several
investigations DEA and FDA are working together. We just met
with the OIG from FDA that were looking at other products in
the pharmaceutical chain. We work together. It is not a
question of us not working together. It is a question of the
process, the scheduling process. I think we are working
together fine.
Senator Hatch. Why haven't you come to Congress then and
let us know that you need changes in the law? I mean, frankly
I'm not sure you do. We are always going to have bad actors. We
are always going to have people who are criminals. It seems to
me there's enough legal authority there to get these bad
substances off the marketplace. But I understand that there are
some pretty wicked, evil people out there that are constantly
coming up with these.
Does FDA tell you when they deny a new ingredient
notification that could involve an anabolic steroid?
Mr. Rannazzisi. If I may, sir, could I just talk to one of
my scientists?
Senator Hatch. Sure.
[Pause.]
Mr. Rannazzisi. No, we don't receive a warning scientist to
scientist, no.
Senator Hatch. Do you outsource some of this analysis or do
you do it with your own chemists?
Mr. Rannazzisi. No. Well, the chemical analysis we do. But
the studies, the cellular studies, animal studies, that all has
to be outsourced. We can't do that. Yes, sir.
Senator Hatch. Do you check with FDA to see if they have
received a new dietary ingredient notice for a compound you're
looking at possibly listing under the Controlled Substances
Act?
Mr. Rannazzisi. Not in regard to anabolic steroids, sir.
Senator Hatch. Let me ask you, Mr. Levy, on page 11 of your
testimony in the first full paragraph, all three examples that
you present would be illegal under the 1994 DSHEA law. In every
example under DSHEA they would be illegal. Now, FDA has the
authority to take those products off the market and tell me why
that isn't happening or is it happening? If it isn't, then I
want to know what we can do to help you.
I mean, I made it pretty clear, I think, that you don't
have the resources to be able to do everything you need to do
in these areas. And I blame us for that because we've tried to
get you the resources and we just haven't been able to be as
successful as I would like us to be.
Mr. Levy. I would say that I think that we are doing what
we can. You know, we have had an agency-wide reemphasis
recently on drug safety as a part of this. I think that we have
taken our recent actions--I'm struggling to find what three
ingredients you are specifically referring to. But I would say
that I think that the ingredients that we mentioned in my
testimony, we have at some point taken some enforcement action
with respect to all of those.
Senator Hatch. Let me ask just a couple of questions to Mr.
Fabricant and Mr. Kingham.
Has the Federal Government, specifically the FDA and the
DEA reached out to the industry to work in a collaborative
manner to address issues associated with products containing
synthetic steroid ingredients that are marketed as dietary
supplements?
Mr. Fabricant. Not in any formal manner. There is no
memorandum of understanding or agreement in that capacity.
Senator Hatch. Do you work together at all?
Mr. Fabricant. We do from time to time, but it is on an
informal basis and we have notified them of ingredients that
are of concern to us that they should be monitoring for.
Senator Hatch. Mr. Kingham, what is your response to the
concerns raised by both the FDA and DEA about the difficulties
encountered when they try to pull products containing steroids
off the market?
Mr. Kingham. Well, Senator Hatch, first of all, let me
point out, and I think from reading Mr. Levy's testimony, that
we agree on this, the products that this hearing is about
require some form of submission to FDA before they enter the
market, either a new drug appointment or a new dietary
ingredient notification. And, moreover, for multiple other
reasons are almost always in violation of other provisions of
the Federal Food, Drug, and Cosmetic Act.
If people violate existing requirements for new drug
application submissions and new dietary ingredient
notifications, why would we believe that they would comply with
some new pre-market approval requirement that you would put in
the law?
The answer is, I think, that the FDA, in particular, has to
use the authority it already has to bring severe, serious,
informal enforcement actions against violators.
Senator Hatch. Does it have enough authority?
Mr. Kingham. I think they do, Senator. I believe they do.
And I think looking at Mr. Levy's testimony that he and I agree
that the products that we're discussing today are almost
invariably clearly in violation of law. The question is whether
the law will be enforced.
Warning letters are good, seizure actions are a good thing
as well. But eventually if people float the law, I believe that
criminal prosecutions may be appropriate.
Senator Hatch. Thank you, sir.
My time is up, Mr. Chairman.
Chairman Specter. Thank you, Senator Hatch.
I will now proceed with 5-minute rounds.
Mr. Kingham, your testimony is, documented in the written
part submitted, more than 150 million Americans regularly use
legitimate dietary supplements. And you say that body-building
products constitute less than 10 percent. So by your statistics
you have something in the range of 15 million people, somewhat
less than 15 million people use body-building dietary
supplements. Now, given the facts of life as to what is
happening in this field, don't you think it's important that
Congress should modify the law to have some preclearance
requirements on these body-building supplements?
Mr. Kingham. Well, Senator, first of all, what I meant to
say and I am sorry if I wasn't clear is that the whole body-
building segment of the dietary supplement market is about 10
percent. But, of course, that includes vitamins and minerals
and other products that are specifically marketed to body-
builders. It is a tiny fraction of the business that comprises
the products we are talking about.
Chairman Specter. Now, wait a minute. Wait a minute. You
have a 150 million people who take supplements?
Mr. Kingham. Yes.
Chairman Specter. So you have 10 percent, you say, on body-
building supplements, that's 15 million people; am I correct?
Mr. Kingham. You are absolutely right.
Chairman Specter. That's a lot of people at risk.
Mr. Kingham. You are correct. But that includes a market
segment to which legitimate dietary supplements that are
perfectly safe and perfectly appropriate are promoted.
Chairman Specter. Well, no doubt about the fact that many
are legitimate that are not causing damage.
Mr. Kingham. Yes.
Chairman Specter. But you still have millions of people
being exposed to the problem. Now, I agree with you that more
has to be done on the regulators.
Now, let me turn to you Mr. Rannazzisi. You have Super Draw
which was on the market which Mr. Jareem Gunter used. In the
affidavit issued by your agency says that Super Draw is a
synthetic anabolic steroid. But yet Super Draw is not listed on
schedule III as a prohibited anabolic steroid; why not?
Mr. Rannazzisi. It is one of the substances that we are
looking at.
Chairman Specter. What?
Mr. Rannazzisi. It is one of the substances that we are
looking at. It is out on the market. It is not----
Chairman Specter. Wait a minute, what are you looking at?
You've got the affidavit which your agency filed, what more is
there to look at?
Mr. Rannazzisi. It still has to go through the scheduling
process, sir. It still has to go through the scheduling
process.
Chairman Specter. Wait a minute. You took an affidavit that
it was an anabolic steroid.
Mr. Rannazzisi. Yeah.
Chairman Specter. When you say something that is false in
an affidavit filing we may find a criminal case here, but in
the wrong direction.
But when you have identified Super Draw as an anabolic
steroid and you have a case of a young man who has been hurt,
is there any conceivable excuse for your agency not having
listed it on schedule III?
Mr. Rannazzisi. Sir, I can't just list something on
schedule III. It still has to go through the scheduling
process. It must go through the scheduling process. I don't
have the authority just to say, I want this drug scheduled.
There's a process through the Administrative Procedures Act----
Chairman Specter. You can take an affidavit that it's an
anabolic steroid but not put it on schedule III?
Would you like us to change the law to simply the
scheduling process?
Mr. Tygart. We would, Senator.
[Laughter.]
Chairman Specter. We understand that.
Mr. Tygart. And worse than that----
Chairman Specter. We are going to give Mr. Tygart's
testimony right under your name if you don't speak up.
[Laughter.]
Mr. Rannazzisi. I apologize sir.
Chairman Specter. Let me turn to you, Mr. Levy. My time is
about up and I want to observe the time.
Ethodura was sold as a dietary supplement banned by the FDA
in 2004, but the ban occurred 10 years after FDA issued its
first advisory and only after FDA had received thousands of
reports of adverse effects, including deaths. What possible
explanation is there for that kind of a delay?
Mr. Levy. I am going to turn to Dr. Francos on this.
Chairman Specter. Do you want to consult your lawyer?
[Laughter.]
Mr. Levy. My dietary supplement expert.
Chairman Specter. Well, let's come back to you Mr. Tygart,
since nobody else seems ready to----
Mr. Tygart. Worse than the fact that it's not in the
process of being scheduled, the very same product that was
identified by affidavit in that search warrant, certain
products in that search warrant were seized. You can still buy
that designer steroid over the Internet. We purchased this
through Amazon.com and it has the same designer steroid that
should be controlled being sold today by other companies.
Chairman Specter. Mr. Rannazzisi, we are about to close
this hearing, and Mr. Levy, too, you can supplement your
answers to the Committee in writing.
Senator Hatch.
Senator Hatch. When you were talking about 10 percent, you
didn't mean 15 million people, you meant there might be that
many who are taking some sort of dietary supplements and some
may even be taking some body-building supplements as well.
Mr. Kingham. That's correct.
Senator Hatch. That doesn't mean all 15 million were taking
these----
Mr. Kingham. No, I don't think so.
Senator Hatch [continuing]. Banned substances or the
substances that should be banned?
Mr. Kingham. That's right. And the other thing I really
want to underscore, it's terribly important, I believe, and I
don't think the FDA disagrees, that virtually all the products
we are talking about require, already, under current law, some
kind of submission to FDA before they enter the market. These
people are just breaking the law. They need to be punished.
They need to be caught, and the law needs to be enforced. But
the law is not the problem. The problem is enforcement.
Senator Hatch. Well, that is my contention. I think we
wrote the laws well.
Now, let me ask you--let me see if I can find my notes
here--Mr. Tygart, on too many occasions athletes have appeared
before the cameras and apologized for testing positive for a
banned substance. In some cases the athlete may not have
intended to ingest a substance banned by his or her collective
bargaining agreement or rules of competition. However athletes
sometimes fail to assume personal responsibility when they make
a mistake, especially in cases that if they had consulted with
their league office or Olympic Committee the issue could have
been avoided from the onset.
Now, that does not excuse bad actors in the sports
nutrition industry. However, athletes skirting the truth need
to be held accountable for their own actions, and I think you
certainly have indicated you believe that.
In your prepared statement you stated that the USADA's
mission is to, ``preserve and protect the health of athletes.''
Can you explain to me the support USADA provides to athletes
when they are considering taking a supplement? For example, is
there a dedicated telephone number or a hotline that athletes
may call to seek advice on supplements?
I ask this because in a recent case a high-profile athlete
failed to call his league's hotline and the result was he
tested positive for a banned substance. Now, the league
representatives have stated time and time again that had the
athlete called the hotline he would have been told not to
ingest that product.
Do you have the same system for your----
Mr. Tygart. We do. We are very clear in our educational
materials to the millions of athletes that technically fall
into our jurisdiction. That given the poor regulation in the
dietary supplement market, any product you take from a
multivitamin to an anabolic-type product, you run a risk of
testing positive.
And, of course, I don't believe every athlete that stands
up and says they got it from a supplement. I don't think that's
the case. We have had at least two cases, one the Jessica Hardy
case, one the Kicker Vinsel case where Kicker Vinsel was taking
a multivitamin. And a panel after a full litigated case
determined that the multivitamin that he took was what caused
his positive test for a steroid. The same in the Jessica Hardy
case.
Mr. Fabricant. May I make a point on the Kicker Vinsel
case? I believe it was overturned later on appeal and then
settled out of court.
Senator Hatch. OK. Well, Mr. Fabricant, you are also a
pharmacist?
Mr. Fabricant. Pharmacologist. Designing drugs; yes.
Senator Hatch. As I understand it, the report said there
were upwards of 100,000 people who may in part lose their lives
because of pharmaceuticals in this country. Is that way off the
beam?
Mr. Fabricant. Adverse event reports?
Senator Hatch. No, I'm talking about actually are harmed by
ingesting pharmaceuticals that really they shouldn't have
taken.
Mr. Fabricant. I would say that, you know, we worked hard
to put the adverse event reporting system in place and we
haven't seen any numbers anywhere near that with respect to
that.
Senator Hatch. OK. Well, then in dietary supplements do you
see any real--and I'm talking about dietary supplements that
are legal--do you see any real adverse events?
Mr. Fabricant. With the legal dietary supplement world we
see the system as working. We have had issues, we've had
signals, we've had notices, and they've all been acted upon
very quickly by industry. We have had recalls--voluntary
recalls where the industry acted very responsibly based on only
14 products--14 adverse event reports. You compare that with
other industries, other consumer product industries it exceeds
60,000 for them to even take action against a pharmaceutical on
the market.
So, you know, for the assertions that the industry isn't
tightly regulated, I would advise them to look at just how
quickly the supplement world has responded in a short time.
Senator Hatch. Our system is working?
Mr. Fabricant. Yeah, very well.
Senator Hatch. All right. Now, let me ask you this, Mr.--I
am having trouble----
Mr. Rannazzisi. Rannazzisi.
Senator Hatch [continuing]. Of the 58 dietary supplements
mentioned in your testimony that purportedly contain one or
more of the three steroids in the final stages of the
scheduling process, how many of them are currently on the
market? And isn't it true that the FDA has the authority to
remove any of those products under the laws that we've passed
here?
Mr. Rannazzisi. Yes, sir. I think our scientists have
talked about those substances. Some are, some aren't. We don't
know because this is over a period of time.
I have the list of the drugs and the names of the drugs
that are on the market or were on the market when we did our
checks. And I believe that list was shared to FDA.
I have the brand names. If you would like I could submit it
for the record.
Senator Hatch. I think it would be good if you submitted
that.
Chairman Specter. Well, thank you very much, gentlemen. I
am constrained to conclude the hearing by four. Senator Hatch,
would you like to make a closing comment?
Senator Hatch. Thank you, Mr. Chairman. As usual you are
always courteous and a dear friend.
But let me just say this to you. We have done our very God-
level best to try and make sure these laws have the strength in
them to be able to be implemented. I still believe that they
are well put together. If we had premarket approval the whole
industry would be gone and we would all be bereft of what
really are very, very good vitamins and minerals, amino acids,
and herbal products.
Because to go through the safety and efficacy process of
the FDA can cost up to a billion dollars or more and even as
many as 15 years. So there is no way anybody in the dietary
supplement industry could go through that.
But I think by and large the industry is a highly
competent, highly good industry. But it is inexcusable that we
permit any of these anabolic steroids to be on the market.
Mr. Tygart, I appreciate what you are trying to do. It is a
tough, tough thing because all of us hate to see a star athlete
get chewed up, especially in the Olympics. But I hate to see it
in professional sports too. And, you know, sometimes it really
isn't their fault, many times it is. But I just hope that we
all will work together. And if you can give us better ways of
amending these laws or making them even better than they are, I
would be happy to consider that. But I think there's enough
language in the laws, in these various laws that we've passed
that I've personally been a proud sponsor of for FDA to do the
job, for DEA to do the job, and of course hopefully helpful to
you on USADA group as well.
There is no desire on any of our part to have anybody
illegally use anything. And we certainly don't want our folks
in this country or any other country to be subject to
deleterious substances, which, under the DSHEA law, FDA has an
absolute right to take off the marketplace automatically.
So it isn't like the laws aren't there. The question is, I
would suggest to all of you--and this is my last sentence--that
you really push the Congress to give FDA the resources it needs
to do this job. The law is there. All we have to do is have the
resources.
Thank you, Mr. Chairman.
Chairman Specter. Thank you, Senator Hatch.
The efforts to give FDA more resources on many, many lines
has not been successful. I think there are some things that
need to be done here, some real questions. And I think the Drug
Enforcement Administration needs to answer the question which
hasn't been answered here today about why Super Draw was not
placed on the schedule III list after it was identified and an
affidavit had filed as being an anabolic steroid. And if you
need some revision on your listing, let us know. Don't wait for
us to come to you.
And the business about ephedra being identified in 2004
with a ban 10 years after the FDA first issued its first
advisory and only after the FDA received thousands of reports
of adverse effects, including deaths, that's not satisfactory.
When Senator Hatch talks about the legitimate part of the
industry, I think it's true, vastly legitimate. But still, if
you have 15 million people who were taking supplement with
steroids and although some of that is legitimate, we're
exposing millions of people to problems. So that from my view,
I think we need to look at some preclearance issues here unless
we find some way to solve it otherwise.
And the leagues have a question to answer which the
Subcommittee is going to put to the leagues. Why haven't you
adopted the anti-doping policy? So perhaps the hearing was
useful for all the questions which have emerged.
We thank you all and we especially thank Mr. Jareem Gunter
and wish him well and wish you all well.
That concludes our hearing.
[Whereupon, at 4 p.m., the hearing was concluded.]
[Questions and answers and submissions for the record
follow.]
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