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119651645
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FDA 3: Steroids/Androstenedione [1]
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119651645
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document
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FDA 3: Steroids/Androstenedione [1]
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Records of the Domestic Policy Council (George W. Bush Administration)
Alan Gilbert's Files
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2014-0126-F
[
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Friday, July 24, 2015
FOIA Marker
This is not a textual record. This FOIA Marker indicates that material has been removed
during FOIA processing by George W. Bush Presidential Library staff.
Domestic Policy Council
Gilbert, Alan
Location or
NARA Number:
FRC ID:
OA Number:
Stack: Row: Sect.: Shelf: Pos.:
Hollinger ID:
W
8
17
11
3
6635
19570
8740
8813
Folder Title:
FDA 3: Steroids/Androstenedione [1] - (3)
Withdrawn/Redacted Material
The George W. Bush Library
DOCUMENT FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
NO.
001
Memorandum
Proposed FDA and DEA Actions on Steroids - To:
2
03/07/2004 P5;
POTUS - From: Alan Gilbert
002
Memorandum
Administration Action on the Improper Use of Steroids -
3
03/06/2004 P5;
To: POTUS - From: John P. Walters
003
Memorandum
Proposed FDA and DEA Actions on Steroids - To:
2
03/05/2004 P5;
POTUS - From: Alan Gilbert
004
Memorandum
Proposed FDA and DEA Actions on Steroids - To:
2
03/05/2004
P5;
POTUS - From: Alan Gilbert
005
Email
Memorandum: Proposed FDA and DEA Actions on
1
03/06/2004
P5;
Steroids - To: Taylor Hughes, et al. - From: Lauren
Vestewig
COLLECTION TITLE:
Domestic Policy Council
SERIES:
Gilbert, Alan - Subject Files
FOLDER TITLE:
FDA 3: Steroids/Androstenedione [1]
FRC ID:
6635
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
PI National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advise between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
2014-0126-F
Page 1 of 2
This document was prepared on Tuesday, August 11, 2015
Withdrawn/Redacted Material
The George W. Bush Library
DOCUMENT FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
NO.
006
Memorandum
Proposed FDA and DEA Actions on Steroids - To:
2
03/05/2004
P5;
POTUS - From: Alan Gilbert
007
Report
[HHS Proposed Actions]
1
03/01/2004
P5;
008
Agenda
Administration Action on Androstenedione [with
2
03/02/2004
P5;
attachment]
009
Memorandum
For Your Meeting at the White House Today - To: Amit
1
03/02/2004 P5;
Sachdev - From: Nancy Yanish
010
Memorandum
Proposed FDA and DEA Actions on Steroids - To:
2
03/05/2004
P5;
POTUS - From: Alan Gilbert
011
Email
Andro and FDA Action - To: Alan Gilbert - From: Philo
1
02/20/2004 P5;
Hall
COLLECTION TITLE:
Domestic Policy Council
SERIES:
Gilbert, Alan - Subject Files
FOLDER TITLE:
FDA 3: Steroids/Androstenedione [1]
FRC ID:
6635
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advise between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
2014-0126-F
Page 2 of 2
This document was prepared on Tuesday, August 11, 2015
FDA-
STEROID
FDA - STEROIDS/ANDRO
STAFF MEMO
Preservation Copy
Withdrawal Marker
The George W. Bush Library
FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
Memorandum
Proposed FDA and DEA Actions on Steroids - To: POTUS - From: Alan
2
03/07/2004
P5;
Gilbert
This marker identifies the original location of the withdrawn item listed above.
For a complete list of items withdrawn from this folder, see the
Withdrawal/Redaction Sheet at the front of the folder.
COLLECTION:
Domestic Policy Council
SERIES:
Gilbert, Alan - Subject Files
FOLDER TITLE:
FDA 3: Steroids/Androstenedione [1]
FRC ID:
FOIA IDs and Segments:
6635
2014-0126-F
OA Num.:
8813
NARA Num.:
8740
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
PI National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advise between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
This Document was withdrawn on 8/11/2015
by
erl
SS/ RM NO.
WHITE HOUSE STAFFING MEMORANDUM
Date: 3/6/04 1:15 PM
ACTION / CONCURRENCE / COMMENT DUE BY: 3/7/04 NOON
MEMO FOR THE PRESIDENT ON ADMINSTRATION ACTION ON THE IMPROPER
Subject: USE OF STEROIDS
ACTION FYI
ACTION FYI
VICE PRESIDENT
MANKIW
CARD
MARBURGER
BARTLETT
MCCLELLAN
BENNETT
MIERS
BOLTEN
MONTGOMERY
CONNAUGHTON
POWELL
FRIEDMAN
RICE
GAMBATESA
ROVE
GERSON
SPELLINGS
>
GONZALES
CLERK
GORDON
Walters
HAGIN
HOBBS
KAVANAUGH
REMARKS:
PLEASE FORWARD COMMENTS TO CHRIS MARSTON, EXTENSION 57286/FAX 56708, BY
NOON ON SUNDAY, MARCH 7, 2004, WITH A COPY TO THE STAFF SECRETARY. THANK
YOU.
RESPONSE:
ICS
Alan
Allison
Brett Kavanaugh
Assistant to the President
and Staff Secretary
Ext. 62702
FAX Ext. 62215
P
VVJ
Withdrawal Marker
The George W. Bush Library
FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
Memorandum
Administration Action on the Improper Use of Steroids - To: POTUS
-
3
03/06/2004
P5;
From: John P. Walters
This marker identifies the original location of the withdrawn item listed above.
For a complete list of items withdrawn from this folder, see the
Withdrawal/Redaction Sheet at the front of the folder.
COLLECTION:
Domestic Policy Council
SERIES:
Gilbert, Alan - Subject Files
FOLDER TITLE:
FDA 3: Steroids/Androstenedione [1]
FRC ID:
FOIA IDs and Segments:
6635
2014-0126-F
OA Num.:
8813
NARA Num.:
8740
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advise between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
This Document was withdrawn on 8/11/2015
by erl
Gilbert, Alan
From:
McClellan, Mark, M.D. [[email protected]]
Sent:
Saturday, March 06, 2004 4:27 PM
To:
Gilbert, Alan
Subject:
Re: Briefing Materials for White House--Sending Again
Rarely. Might be useful in certain adrenal cortex defects that lead to hormone
deficiencies. But there are generally better treatments.
Original Message
From: Gilbert, Alan <[email protected]>
To: Sachdev, Amit <[email protected]>; McClellan, Mark, M.D. <[email protected]>
Sent: Sat Mar 06 16:18:32 2004
Subject: RE: Briefing Materials for White House--Sending Again
Is there any redeeming quality of andro---under what circumstances would a doctor ever
prescribe andro?
Original Message
From: Sachdev, Amit [mailto:[email protected]]
Sent: Saturday, March 06, 2004 3:59 PM
To: Gilbert, Alan
Subject: Fw: Briefing Materials for White House--Sending Again
Argh, sorry, try this one it should have all the docs
Original Message
From: Yanish, Nancy <[email protected]>
To: Sachdev, Amit <[email protected]>; Anderson, Donna <[email protected]>
CC: Barrett, Kari <[email protected]>; Mital, Michele <[email protected]>
Sent: Tue Mar 02 11:57:12 2004
Subject: Briefing Materials for White House--Sending Again
Sorry, I will try this again.
Nancy Foster Yanish
Office of Legislation
(301) 827-5708 phone
(301) 827-1960 fax
1
SS/ RM NO.
WHITE HOUSE STAFFING MEMORANDUM
Date: 03-05-04 8:20 PM ACTION / CONCURRENCE / COMMENT DUE BY: 03-06-04 NOON
MEMORANDUM FOR THE PRESIDENT ON PROPOSED FDA AND DEA ACTIONS
Subject: ON STEROIDS
ACTION FYI
ACTION FYI
VICE PRESIDENT
MANKIW
CARD
MARBURGER
BARTLETT
MCCLELLAN
BENNETT
MIERS
BOLTEN
MONTGOMERY
CONNAUGHTON
POWELL
FRIEDMAN
RICE
GAMBATESA
ROVE
GERSON
SPELLINGS
GONZALES
CLERK
GORDON
HAGIN
HOBBS
KAVANAUGH
REMARKS:
PLEASE FORWARD COMMENTS TO ALAN GILBERT, EXTENSION 67105/FAX 65557, BY
NOON ON SATURDAY, MARCH 6, 2004 WITH A COPY TO THE STAFF SECRETARY. THANK
YOU.
RESPONSE:
KS
Auisn
-Alan
1
Brett Kavanaugh
Assistant to the President
and Staff Secretary
Ext. 62702
FAX Ext. 62215
VVJ
Withdrawal Marker
The George W. Bush Library
FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
Memorandum
Proposed FDA and DEA Actions on Steroids - To: POTUS - From: Alan
2
03/05/2004
P5;
Gilbert
This marker identifies the original location of the withdrawn item listed above.
For a complete list of items withdrawn from this folder, see the
Withdrawal/Redaction Sheet at the front of the folder.
COLLECTION:
Domestic Policy Council
SERIES:
Gilbert, Alan - Subject Files
FOLDER TITLE:
FDA 3: Steroids/Androstenedione [1]
FRC ID:
FOIA IDs and Segments:
6635
2014-0126-F
OA Num.:
8813
NARA Num.:
8740
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advise between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
This Document was withdrawn on 8/11/2015
by erl
Withdrawal Marker
The George W. Bush Library
FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
Memorandum
Proposed FDA and DEA Actions on Steroids - To: POTUS - From: Alan
2
03/05/2004
P5;
Gilbert
This marker identifies the original location of the withdrawn item listed above.
For a complete list of items withdrawn from this folder, see the
Withdrawal/Redaction Sheet at the front of the folder.
COLLECTION:
Domestic Policy Council
SERIES:
Gilbert, Alan - Subject Files
FOLDER TITLE:
FDA 3: Steroids/Androstenedione [1]
FRC ID:
FOIA IDs and Segments:
6635
2014-0126-F
OA Num.:
8813
NARA Num.:
8740
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(I) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advise between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
This Document was withdrawn on 8/11/2015
by
erl
Withdrawal Marker
The George W. Bush Library
FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
Email
Memorandum: Proposed FDA and DEA Actions on Steroids - To: Taylor
1
03/06/2004
P5;
Hughes, et al. - From: Lauren Vestewig
This marker identifies the original location of the withdrawn item listed above.
For a complete list of items withdrawn from this folder, see the
Withdrawal/Redaction Sheet at the front of the folder.
COLLECTION:
Domestic Policy Council
SERIES:
Gilbert, Alan - Subject Files
FOLDER TITLE:
FDA 3: Steroids/Androstenedione [1]
FRC ID:
FOIA IDs and Segments:
6635
2014-0126-F
OA Num.:
8813
NARA Num::
8740
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
, financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advise between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
This Document was withdrawn on 8/11/2015
by erl
Withdrawal Marker
The George W. Bush Library
FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
Memorandum
Proposed FDA and DEA Actions on Steroids - To: POTUS - From: Alan
2
03/05/2004
P5;
Gilbert
This marker identifies the original location of the withdrawn item listed above.
For a complete list of items withdrawn from this folder, see the
Withdrawal/Redaction Sheet at the front of the folder.
COLLECTION:
Domestic Policy Council
SERIES:
Gilbert, Alan - Subject Files
FOLDER TITLE:
FDA 3: Steroids/Androstenedione [1]
FRC ID:
FOIA IDs and Segments:
6635
2014-0126-F
OA Num.:
8813
NARA Num.:
8740
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advise between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
This Document was withdrawn on 8/11/2015
by erl
II
108TH CONGRESS
1ST SESSION
S. 1780
To amend the Controlled Substances Act to clarify the definition of anabolic
steroids and to provide for research and education activities relating
to steroids and steroid precursors.
IN THE SENATE OF THE UNITED STATES
OCTOBER 23, 2003
Mr. BIDEN (for himself, Mr. HATCH, Mr. GRASSLEY, and Mr. HARKIN) intro-
duced the following bill; which was read twice and referred to the Com-
mittee on the Judiciary
A BILL
To amend the Controlled Substances Act to clarify the defini-
tion of anabolic steroids and to provide for research
and education activities relating to steroids and steroid
precursors.
1
Be it enacted by the Senate and House of Representa-
2 tives of the United States of America in Congress assembled,
3 SECTION 1. SHORT TITLE.
4
This Act may be cited as the "Anabolic Steroid Con-
5 trol Act of 2003".
2
1 SEC. 2. AMENDMENTS TO THE CONTROLLED SUBSTANCES
2
ACT.
3
(a) DEFINITIONS.-Section 102 of the Controlled
4 Substances Act (21 U.S.C. 802) is amended-
5
(1) in paragraph (41)-
6
(A) by realigning the margin SO as to align
7
with paragraph (40);
8
(B) by striking subparagraph (A) and in-
9
serting the following:
10
"(A) The term 'anabolic steroid' means any drug or
11 hormonal substance, chemically and pharmacologically re-
12 lated to testosterone (other than estrogens, progestins,
13 corticosteroids, and dehydroepiandrosterone), and in-
14 cludes-
15
"(i) androstanediol-
16
"(I) 3B,17B-dihydroxy-5α-androstane and
17
"(II) 3q,17}-dihydroxy-5t-androstane;
18
"(ii) androstanedione (5α-androstan-3,17-
19
dione);
20
"(iii) androstenediol-
21
"(I) 1-androstenediol (3B,17ß-dihydroxy-
22
5α-androst-1-ene);
23
"(II) 1-androstenediol (3α,17ß-dihydroxy-
24
5α-androst-1-ene);
25
"(III) 4-androstenediol (3B,17ß-dihydroxy-
26
androst-4-ene); and
.S 1780 IS
3
1
"(IV) 5-androstenediol (3b,17ß-dihydroxy-
2
androst-5-ene);
3
"(iv) androstenedione-
4
"(I) 1-androstenedione ([50:]-androst-1-en-
5
3,17-dione);
6
"(II) 4-androstenedione (androst-4-en-
7
3,17-dione); and
8
"(III) 5-androstenedione (androst-5-en-
9
3,17-dione);
10
"(v) bolasterone (70,17α-dimethyl-17B-
11
hydroxyandrost-4-en-3-one);
12
"(vi) boldenone (17B-hydroxyandrost-1,4,-diene-
13
3-one);
14
"(vii) calusterone (7B,170x-dimethyl-17B-
15
hydroxyandrost-4-en-3-one);
16
"(viii) clostebol (4-chloro-17ß-hydroxyandrost-4-
17
en-3-one);
18
"(ix) dehydrochlormethyltestosterone (4-chloro-
19
17B-hydroxy-17-methyl-androst-1,4-dien-3-one).
20
"(x) 4-dihydrotestosterone (17B-hydroxy-
21
androstan-3-one);
22
"(xi) drostanolone (17B-hydroxy-2α-methyl-5-
23
androstan-3-one);
24
"(xii) ethylestrenol (17α-ethyl-17B-hydroxyestr-
25
4-ene);
.S 1780 IS
4
1
"(xiii) fluoxymesterone (9-fluoro-170-methyl-
2
11B,17β-dihydroxyandrost-4-en-3-one);
3
"(xiv) formebolone (2-formyl-170-methyl-
4
11o,17}-dihydroxyandrost-1,4-dien-3-one);
5
"(xv)
furazabol
(17α-methyl-17B-
6
hydroxyandrostano[2,3-c]-furazan);
7
"(xvi) 18α-homo-17B-hydroxyestr-4-en-3-one
8
(13β-ethyl-17ß-hydroxygon-4-en-3-one);
9
"(xvii) 4-hydroxytestosterone (4,17B-dihydroxy-
10
androst-4-en-3-one);
11
"(xviii) 4-hydroxy-19-nortestosterone (4,17ß-
12
dihydroxy-estr-4-en-3-one);
13
"(xix) mestanolone (17α-methyl-17ß-hydroxy-
14
5α-androstan-3-one);
15
"(xx) mesterolone (1α-methyl-17ß-hydroxy-
16
[5α]-androstan-3-one);
17
"(xxi) methandienone (17α-methyl-17B-
18
hydroxyandrost-1,4-dien-3-one);
19
"(xxii) methandriol (17α-methyl-3B,17B-
20
dihydroxyandrost-5-ene);
21
"(xxiii) methenolone (1-methyl-17ß-hydroxy-5α-
22
androst-1-en-3-one);
23
"(xxiv) methyltestosterone (17α-methyl-17B-
24
hydroxyandrost-4-en-3-one);
.S 1780 IS
5
1
"(xxv) mibolerone (70,17α-dimethyl-17B-
2
hydroxyestr-4-en-3-one);
3
"(xxvi) nandrolone (17}-hydroxyestr-4-en-3-
4
one);
5
"(xxvii) norandrostenediol--
6
"(I) 19-nor-4-androstenediol (3ß, 17B-
7
dihydroxyestr-4-ene);
8
"(II) 19-nor-4-androstenediol (3α, 17B-
9
dihydroxyestr-4-ene);
10
"(III) 19-nor-5-androstenediol (3ß, 17ß-
11
dihydroxyestr-5-ene); and
12
"(IV) 1'9-nor-5-androstenediol (3α, 17ß-
13
dihydroxyestr-5-ene);
14
"(xxviii) norandrostenedione-
15
"(I) 19-nor-4-androstenedione (estr-4-en-
16
3,17-dione); and
17
"(II) 19-nor-5-androstenedione (estr-5-en-
18
3,17-dione;
19
"(xxix)
norbolethone
(18α-homo-173-
20
hydroxypregna-4-en-3-one);
21
"(xxx) norclostebol (4-chloro-17ß-hydroxyestr-4-
22
en-3-one);
23
"(xxxi) norethandrolone (17α-ethyl-17B-
24
hydroxyestr-4-en-3-one);
.S 1780 IS
6
1
"(xxxii) oxandrolone (17α-methyl-17ß-hydroxy-
2
2-oxa-[5α]-androstan-3-one);
3
"(xxxiii) oxymesterone (17α-methyl-4,17B-
4
dihydroxyandrost-4-en-3-one);
5
"(xxxiv)
oxymetholone
(17α-methyl-2-
6
hydroxymethylene-17B-hydroxy-[5o|-androstan-3-
7
one);
8
"(xxxv) stanozolol (17α-methyl-17B-hydroxy-
9
[5α]-androst-2-eno[3,2-c]-pyrazole);
10
"(xxxvi) stenbolone (17ß-hydroxy-2-methyl-
11
[5α]-androst-1-en-3-one);
12
"(xxxvii) testolactone (13-hydroxy-3-oxo-13,17-
13
secoandrosta-1,4-dien-17-oic acid lactone);
14
"(xxxviii) 1-testosterone (17ß-hydroxy-50-
15
androst-1-en-3-one);
16
"(xxxix) testosterone (17}-hydroxyandrost-4-en-
17
3-one);
18
"(xl) tetrahydrogestrinone (13ß,17α-diethyl-
19
17B-hydroxygon-4,9,11-trien-3-one);
20
"(xli) trenbolone (17B-hydroxyestr-4,9,11-trien-
21
3-one); and
22
"(xlii) any salt, ester, or ether of a drug or sub-
23
stance described in this paragraph."; and
24
(C) by adding at the end the following:
.S 1780 IS
7
1
"(C) Notwithstanding subparagraph (A), the Attor-
2 ney General may not schedule Androstenedione as a con-
3 trolled substance in accordance with this Act until the At-1
4 torney General receives a finding from the Commissioner
5 of Food and Drugs relating to whether Androstenedione
6 is lawfully marketed under the Federal Food, Drug, and
7 Cosmetic Act (21 U.S.C. 321 et seq.)." and
8
(2) in paragraph (44), by inserting "anabolic
9
steroids," after "marihuana,"
10
(b) AUTHORITY AND CRITERIA FOR CLASSIFICA-
11 TION.-Section 201(g) of the Controlled Substances Act
12 (21 U.S.C. 811(g)) is amended-
13
(1) in paragraph (1), by striking "substance
14
from a schedule if such substance" and inserting
15
"drug which contains a controlled substance from
16
the application of titles II and III of the Comprehen-
17
sive Drug Abuse Prevention and Control Act (21
18
U.S.C. 802 et seq.) if such drug"; and
19
(2) in paragraph (3), by adding at the end the
20
following:
21
"(C) Upon the recommendation of the Sec-
22
retary of Health and Human Services, a compound,
23
mixture, or preparation which contains any anabolic
24
steroid, which is intended for administration to a
25
human being or an animal, and which, because of its
.S 1780 IS
8
1
concentration, preparation, formulation or delivery
2
system, does not present any significant potential for
3
abuse."
4
(c) ANABOLIC STEROIDS CONTROL ACT.-Section
5 1903 of the Anabolic Steroids Control Act of 1990 (Public
6 Law 101-647) is amended-
7
(1), by striking subsection (a); and
8
(2) by redesignating subsections (b) and (c) as
9
subsections (a) and (b), respectively.
10 SEC. 3. SENTENCING COMMISSION GUIDELINES.
11
The United States Sentencing Commission shall-
12
(1) review the Federal sentencing guidelines
13
with respect to offenses involving anabolic steroids;
14
(2) consider amending the Federal sentencing
15
guidelines to provide for increased penalties with re-
16
spect to offenses involving anabolic steroids in a
17
manner that reflects the seriousness of such offenses
18
and the need to deter anabolic steroid use; and
19
(3) take such other action that the Commission
20
considers necessary to carry out this section.
21 SEC. 4. PREVENTION AND EDUCATION PROGRAMS.
22
(a) IN GENERAL.-The Secretary of Health and
23 Human Services (referred to in this Act as the "Sec-
24 retary") shall award grants to public and nonprofit private
25 entities to enable such entities to carry out science-based
S 1780 IS
9
1 education programs in elementary and secondary schools
2 to highlight the harmful effects of anabolic steroids.
3
(b) ELIGIBILITY.-
4
(1) APPLICATION.-To be eligible for grants
5
under subsection (a), an entity shall prepare and
6
submit to the Secretary an application at such time,
7
in such manner, and containing such information as
8
the Secretary may require.
9
(2) PREFERENCE.-In awarding grants under
10
subsection (a), the Secretary shall give preference to
11
applicants that intend to use grant funds to carry
12
out programs based on-
13
(A) the Athletes Training and Learning to
14
Avoid Steroids program;
15
(B) the Athletes Targeting Healthy Exer-
16
cise and Nutrition Alternatives program; and
17
(C) other programs determined to be effec-
18
tive by the National Institute on Drug Abuse.
19
(c) USE OF FUNDS.-Amounts received under a
20 grant under subsection (a) shall be used primarily for edu-
21 cation programs that will directly communicate with
22 teachers, principals, coaches, as well as elementary and
23 secondary school children concerning the harmful effects
24 of anabolic steroids.
.S 1780 IS
10
1
(d) AUTHORIZATION OF APPROPRIATIONS.-There is
2 authorized to be appropriated to carry out this section,
3 $15,000,000 for each of fiscal years 2004 through 2009.
4 SEC. 5. NATIONAL SURVEY ON DRUG USE AND HEALTH.
5
(a) IN GENERAL.-The Secretary of Health and
6 Human Services shall ensure that the National Survey on
7 Drug Use and Health includes questions concerning the
8 use of anabolic steroids.
9
(b) AUTHORIZATION OF APPROPRIATIONS.-There is
10 authorized to be appropriated to carry out this section,
11 $1,000,000 for each of fiscal years 2004 through 2009.
.S 1780 IS
F:\MDB\2004\JUD\GB.001
H.L.C.
(Original Signature of Member)
108TH CONGRESS
2D SESSION
H. R. 3866
MARCH 1, 2004
IN THE HOUSE OF REPRESENTATIVES
Mr. SENSENBRENNER (for himself, Mr. CONYERS, Mr. SWEENEY, Mr.
OSBORNE, and Mr. BERMAN) introduced the following bill; which was re-
ferved to the Committee on
A BILL
To amend the Controlled Substances Act to provide increased
penalties for anabolic steroid offenses near sports facili-
ties, and for other purposes.
1
Be it enacted by the Senate and House of Representa-
2 tives of the United States of America in Congress assembled,
3 SECTION 1. SHORT TITLE.
4
This Act may be cited as the "Anabolic Steroid Con-
5 trol Act of 2004".
F:\V8\022404\022404.241
February 24, 2004 (5:22 PM)
F:\MDB\2004\JUD\GB.001
H.L.C.
2
1 SEC. 2. INCREASED PENALTIES FOR ANABOLIC STEROID
2
OFFENSES NEAR SPORTS FACILITIES.
3
(a) IN GENERAL.-Part D of the Controlled Sub-
4 stances Act is amended by adding at the end the following:
5
ANABOLIC STEROID OFFENSES NEAR SPORTS FACILITIES
6
"See. 424. (a) Whoever violates section 401(a)(1) or
7 section 416 by manufacturing, distributing, or possessing
8 with intent to distribute, an anabolic steroid near or at
9 a sports facility is subject to twice the maximum term of
10 imprisonment, maximum fine, and maximum term of su-
11 pervised release otherwise provided by section 401 for that
12 offense.
13
"(b) As used in this section-
14
"(1) the term 'sports facility' means real prop-
15
erty where athletic sports or athletic training takes
16
place, if such property is privately owned for com-
17
mercial purposes OF if such property is publicly
18
owned, but does not include any real property de-
19
scribed in section 419;
20
"(2) the term 'near or at' means in 01' on, OF
21
within 1000 feet of; and
22
"(3) the term 'possessing with intent to dis-
23
tribute' means possessing with the intent to dis-
24
tribute near or at a sports facility."
25
(b) TABLE OF CONTENTS AMENDMENT.-The table
26 of contents for Comprehensive Drug Abuse Prevention
F:\V8\022404\022404.241
February 24, 2004 (5:22 PM)
F:\MDB\2004\JUD\GB.001
H.L.C.
3
1 and Control Act of 1970 is amended by inserting after
2 the item relating to section 423 the following new item:
"424. Increased Penalties for Anabolie Steroid Offenses Near Sports Facili-
ties.".
3 SEC. 3. SENTENCING COMMISSION GUIDELINES.
4
The United States Sentencing Commission shall-
5
(1) review the Federal sentencing guidelines
6
with respect to offenses involving anabolic steroids;
7
(2) consider amending the Federal sentencing
8
guidelines to provide for increased penalties with re-
9
speet to offenses involving anabolic steroids in a
10
manner that reflects the seriousness of such offenses
11
and the need to deter anabolic steroid use; and
12
(3) take such other action that the Commission
13
considers necessary to carry out this section.
14 SEC. 4. AMENDMENTS TO THE CONTROLLED SUBSTANCES
15
ACT.
16
(a) DEFINITIONS-Section 102 of the Controlled
17 Substances Not (21 U.S.C. 802) is amended-
18
(1) in paragraph (41)
19
(A) by realigning the margin SO as to align
20
with paragraph (40); and
21
(B) by striking subparagraph (A) and in-
22
serting the following:
23
"(A) The term 'anabolic steroid' means any drug or
24 hormonal substance, chemically and pharmacologically re-
F:\V8\022404\022404.241
February 24, 2004 (5:22 PM)
F:\MDB\2004\JUD\GB.001
H.L.C.
4
1 lated to testosterone (other than estrogens, progestins,
2 corticosteroids, and dehydroepiandrosterone), and
3 includes-
4
"(i) androstanediol-
5
"(I) 3B,17B-dihydroxy-50-androstane; and
6
"(II) 3q,17B-dihydroxy-5ot-androstane
7
"(ii) androstanedione (50-androstan-3,17-
8
dione);
9
"(iii) androstenediol-
10
"(I) 1-androstenediol (3B,17B-dihydroxy-
11
50-androst-1-ene);
12
"(II) 1-androstenediol (30,17B-dihydroxy-
13
50-androst-1-ene);
14
"(III) 4-androstenediol (3B,17B-dihydroxy-
15
androst-4-ene); and
16
"(IV) 5-androstenediol (3b,17ß-dihydroxy-
17
androst-5-ene);
18
"(iv) androstenedione-
19
"(I) 1-androstenedione (|5α|-androst-1-en-
20
3,17-dione);
21
"(11) 4-androstenedione (androst-4-en-
22
3,17-dione); and
23
"(III) 5-androstenedione (androst-5-en-
24
3,17-dione);
F:\V8\022404\022404.241
February 24, 2004 (5:22 PM)
F:\MDB\2004\JUD\GB.001
H.L.C.
5
1
"(v)
bolasterone
(7α,17α-dimethyl-17B-
2
hydroxyandrost-4-en-3-one);
3
"(vi) boldenone (17B-hydroxyandrost-1,4,-diene-
4
3-one);
5
"(vii) calusterone (7B,17α-dimethyl-17B-
6
hydroxyandrost-4-en-3-one);
7
"(viii) clostebol (4-chloro-17B-hydroxyandrost-4-
8
en-3-one);
9
"(ix) dehydrochlormethyltestosterone (4-chloro-
10
17B-hydroxy-17α-methyl-androst-1,4-dien-3-one);
11
"(x) 4-dihydrotestosterone (17B-hydroxy-
12
androstan-3-one);
13
"(xi) drostanolone (17}-hydroxy-20-methyl-50-
14
androstan-3-one);
15
"(xii) ethylestrenol (17α-ethyl-17B-hydroxyestr-
16
4-ene);
17
"(xiii) fluoxymesterone (9-fluoro-170-methyl-
18
11B,17B-diliydroxyandrost-4-en-3-one);
19
"(xiv) formebolone (2-formyl-170-methyl-
20
110,17B-dilhydroxyandrost-1,4-dien-3-one);
21
"(xv)
furazabol
(17α-methyl-17B-
22
hydroxyandrostano|2.3-c|-furazan);
23
"(xvi) 180-homo-17B-hydroxyestr-4-en-3-one
24
(13B-ethyl-17B-hydroxygon-4-en-3-one):
F:\V8\022404\022404.241
February 24, 2004 (5:22 PM)
F:\MDB\2004\JUD\GB.001
H.L.C.
6
1
"(xvii) 4-hydroxytestosterone (4,17B-dihydroxy-
2
androst-4-en-3-one);
3
"(xviii) 4-hydroxy-19-nortestosterone (4,17B-
4
dihydroxy-estr-4-en-3-one);
5
"(xix) mestanolone (17&-methyl-17B-hydroxy-
6
50-androstan-3-one);
7
"(xx) mesterolone (1α-methyl-17B-hydroxy-
8
[5α|-androstan-3-one);
9
"(xxi) methandienone (17α-methyl-17B-
10
hydroxyandrost-1,4-dien-3-one);
11
"(xxii) methandriol (17α-methyl-3B,17B-
12
dihydroxyandrost-5-ene);
13
"(xxiii) methenolone (1-methyl-17B-hydroxy-5-
14
androst-1-en-3-one);
15
"(xxiv) methyltestosterone (17α-methyl-17B-
16
hydroxyandrost-4-en-3-one);
17
"(xxv) mibolerone (70,17α-dimethyl-17B-
18
hydroxyestr-4-en-3-one);
19
"(xxvi) nandrolone (17B-hydroxyestr-4-en-3-
20
one);
21
"(xxvii) norandrostenediol
22
"(I) 19-nor-4-androstenediol (3ß, 17B-
23
dihydroxyestr-4-ene);
24
"(II) 19-nor-4-androstenediol (3α. 17B-
25
dihydroxyestr-4-ene);
F:\V8\022404\022404.241
February 24, 2004 (5:22 PM)
F:\MDB\2004\JUD\GB.001
H.L.C.
7
1
"(III) 19-nor-5-androstenediol (3ß, 17ß-
2
dihydroxyestr-5-ene); and
3
"(IV) 19-nor-5-androstenediol (3α, 17B-
4
dihydroxyestr-5-ene);
5
"(xxviii) norandrostenedione-
6
"(I) 19-nor-4-androstenedione (estr-4-en-
7
3,17-dione); and
8
"(II) 19-nor-5-androstenedione (estr-5-en-
9
3,17-dione;
10
"(xxix)
norbolethone
(18α-homo-17B-
11
hydroxypregna-4-en-3-one);
12
"(xxx) norelostebol (4-chloro-17B-hydroxyestr-4-
13
en-3-one);
14
"(xxxi) norethandrolone (17α-ethyl-17B-
15
hydroxvestr-4-en-3-one);
16
"(xxxii) oxandrolone (17α-methyl-17B-hydroxy-
17
2-oxa-|5α|-androstan-3-one);
18
"(xxxiii) oxymesterone (17α-methyl-4,17B-
19
dihydroxyandrost-4-en-3-one);
20
"(xxxiv)
oxymetholone
(17α-methyl-2-
21
hydroxymethylene-17B-hvdroxy-|50|-androstan-3-
22
one);
23
"(xxxv) stanozolol (170-methyl-17B-hydroxy-
24
[5α|-androst-2-eno|3:2-c|-pyrazole);
F:\V8\022404\022404:241
February 24, 2004 (5:22 PM)
F:\MDB\2004\JUD\GB.001
II.L.C.
8
1
"(xxxvi) stenbolone (17ß-laydroxy-2-methyl-
2
[5α|-androst-1-en-3-one);
3
"(xxxvii) testolactone (13-hydroxy-3-oxo-13,17-
4
secoandrosta-1,4-dien-17-oic acid lactone);
5
"(xxxviii) 1-testosterone (17B-hydroxy-50-
6
androst-1-en-3-one);
7
"(xxxix) testosterone (17B-hydroxyandrost-4-en-
8
3-one);
9
"(xl) tetraliydrogestrinone (13B,17α-diethyl-
10
17B-hydroxygon-4,9,11-trien-3-one);
11
"(xli) trenbolone (17B-hydroxyestr-4,9,11-trien-
12
3-one); and
13
"(xlii) any salt, ester, OF ether of a drug or sub-
14
stance described in this paragraph."; and
15
(2) in paragraph (44), by inserting "anabolic
16
steroids," after "marihuana."
17
(b) AUTHORITY AND CRITERIA FOR CLASSIFICA-
18 TION.-Section 201(g) of the Controlled Substances Act
19 (21 U.S.C. 811(g)) is amended-
20
(1) in paragraph (1), by striking "substance
21
from a schedule if such substance" and inserting
22
"drug which contains a controlled substance from
23
the application of titles II and III of the Comprehen-
24
sive Drug Abuse. Prevention and Control Act (21
25
U.S.C. 802 et seq.) if such drug": and
F:\V8\022404\022404.241
February 24,2004 (5:22 PM)
F:\MDB\2004\JUD\GB.001
H.L.C.
9
1
(2) in paragraph (3), by adding at the end the
2
following:
3
"(C) Upon the recommendation of the See-
4
retary of Health and Human Services, a compound,
5
mixture, or preparation which contains any anabolic
6
steroid, which is intended for administration to a
7
human being or an animal, and which, because of its
8
concentration, preparation, formulation or delivery
9
system, does not present any significant potential for
10
abuse.
"
F:\V8\022404\022404.241
February 24, 2004 (5:22 PM)
Lonick, Saundra Jo
ubject:
Andro
ocation:
472
Start:
Tue 3/2/2004 4:00 PM
End:
Tue 3/2/2004 5:00 PM
Recurrence:
(none)
There will be a meeting re: the FDA proposed ban on Androstenedione (Andro) on Tuesday, March 2 at 4:00 pm in EEOB
Room 472. The purpose of this meeting is to hear from HHS about their proposed actions. Please respond to this e-mail
to confirm your attendance. Also, if you need to be cleared into the building, please include your clearance information
(DOB, SSN) with your response.
Participants include:
Paula Stannard, HHS
Ladd Wiley, HHS
Mark McClellan, FDA (Will be about 20 minutes late)
Amit Sachdev, FDA
TITOTALS
Chris Marston, Office of COS
Diana Schacht, DPC
Jonathan Burks, Office of COS
Eric Pelletier, LEG
Amy Jensen, LEG
Ginger Loper, LEG
Alan Gilbert, DPC
Philo Hall, DPC
m Capretta, OMB
arry Jackson, Office of Senior Advisor
Suzy DeFrancis, COMM
Ted Ullyot, Counsel's
Jennifer Newstead, Counsel's
Rex Cowdry (for Doug Badger), NEC
Kelly Spearman, Cab. Aff.
Abel Guerra, OPL
Chris Donesa, DEA
Paul Noe, OIRA
Fumie Yokota, OIRA
Not attending:
Kristin Silverberg, DPC
1
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Report
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FOLDER TITLE:
FDA 3: Steroids/Androstenedione [1]
FRC ID:
FOIA IDs and Segments:
6635
2014-0126-F
OA Num.:
8813
NARA Num.:
8740
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personal privacy [(a)(6) of the PRA]
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purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
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This Document was withdrawn on 8/11/2015
by erl
Message
Page 1 of 4
Gilbert, Alan
From: Besanceney, Brian R.
Sent:
Sunday, February 29, 2004 2:08 PM
To:
Gilbert, Alan; Marston, Christopher M.; Guerra, Abel
Subject: Steroids/Pro-Sports League meeting
Wondering if you guys have any insight into what we should be saying in response to the press inquiry below.
Original Message
From: Besanceney, Brian R.
Sent: Sunday, February 29, 2004 12:39 PM
To: Bartlett, Daniel J.; McClellan, Scott ; Silverberg, Kristen
Subject: non-Haiti press inquiry today
AP is looking for comment on this story - specifically the status of discussions toward a White House meeting on
steroids.
Any suggestions?
MLB Players' Union Balks At Steroids Summit (WPost)
Bush Administration's Proposed Meeting Would Include Representatives From All Four Major Sports
and USOC
By Steve Fainaru and Mike Allen
The Washington Post, February 29, 2004
A White House effort to organize a summit of the major sports leagues to examine the use of steroids by
athletes has run into resistance from the Major League Baseball Players Association, one of several
defensive positions the union has staked out recently on performance-enhancing drugs.
Commissioners from the NFL, NBA, NHL and Major League Baseball, along with representatives from
the United States Olympic Committee, have tentatively agreed to attend the meeting, officials from
those organizations said. Bush administration officials described the proposed summit as an attempt by
the president to hold direct discussions with the sports and their athletes and raise awareness of the
issue.
However, the administration's efforts to arrange the summit have been complicated by the Major League
Baseball Players Association (MLBPA), which has told the administration that baseball's steroids policy
is a matter of collective bargaining and not the responsibility of the federal government, according to
administration officials.
Bush's interest in the steroids issue arose, as aides tell it, from his personal interest in sports and his
continuing ties, as a former owner of the Texas Rangers, to coaches, players and owners. The topic was
quickly embraced by White House officials, who see steroids as another avenue for the president to
promote a discussion of values in an election year.
The resistance from the baseball players' union to a steroids event was apparently a byproduct of what a
senior administration official called the "acrimonious relationship between the players' union and
management" on performance-enhancing drugs. "That's why you're seeing this disagreement," said the
official, who refused to be identified by name because of the sensitivity of the negotiations. "There are
issues in baseball that you're not seeing in the other sports."
The baseball union's stance could dissuade other organizations from participating. The NFL Players
Association has signaled that it will not attend unless other sports, particularly Major League Baseball,
also agree. Gene Upshaw, the NFLPA's executive director, said: "None of us wants to be used in a
political way. What we want is to talk about what we've done in our sport and why we're proud of it.
3/2/2004
Message
Page 2 of 4
We're not going alone."
Gene Orza, who oversees drug matters for the MLBPA, suggested in an e-mail that the union is open to
discussions but left it unclear whether it would be willing to attend a summit. "I cannot imagine the
circumstances which would generate the rumor that we are telling a president of the United States that, if
he wants to talk to us, we are unwilling to do so," Orza said. "It is true we are steadfast in our
commitment to both the collective bargaining process generally, and the principle that people are
innocent until others who are duly charged with attempting to do SO prove them guilty."
The White House initially told the leagues that the summit would take place Feb. 23 or Feb. 24,
according to Joe Browne, the NFL's executive vice president. Browne and others in contact with the
White House said they had since been told that the White House is making preparations for late March.
The NFL and the NFLPA are particularly sensitive about being isolated on the issue. League and union
officials said they believe the NFL was unfairly singled out by President Bush's surprising reference to
steroids in his Jan. 20 State of the Union address. Cameras focused on New England Patriots
quarterback Tom Brady as the president said "the use of performance-enhancing drugs like steroids in
baseball, football and other sports is dangerous and sends the wrong message." He urged owners, union
representatives, coaches and players to "get rid of steroids now." Administration officials said Brady
was invited because of his mentoring efforts and were dismayed that the television cameras came to him
during Bush's steroids passage.
Steroids help athletes build muscle mass and speed recovery, and numerous studies have shown that
they may also contribute to a number of disorders.
On the afternoon of the speech, National Security Adviser Condoleezza Rice placed a heads-up call to
NFL Commissioner Paul Tagliabue, with whom she has a personal relationship, as well as Olympic and
NCAA officials. White House Chief of Staff Andrew H. Card Jr. notified NBA Commissioner David
Stern and MLB Commissioner Bud Selig. Representatives of the NHL also were informed, the league
said.
The NFL has the most aggressive drug policy of the four major professional sports leagues. League
officials said they believed the NFL sent Brady to be held up as a role model and were surprised when
he became linked to the steroid passage. Administration officials later said that the president was most
concerned about Major League Baseball, whose drug policy has been widely criticized. That policy,
which took effect last season, was significantly weakened during collective bargaining, and Orza has
said the final agreement was essentially designed by the players' union.
The absence of the MLBPA from a White House summit would undoubtedly affect preparations.
Baseball has come under intensifying scrutiny since a federal grand jury in San Francisco indicted four
men including the personal weight trainer for San Francisco Giants left fielder Barry Bonds -- on Feb.
12 for allegedly distributing steroids to elite athletes. The indictments were announced in Washington by
Attorney General John D. Ashcroft, a reflection of the administration's efforts to embrace the issue.
John P. Walters, director of the White House Office of National Drug Control Policy, said in an
interview that Major League Baseball needs more rigorous drug testing "to protect people from the
consequences of steroids and the sport as a whole from the consequences of being increasingly viewed
as corrupt."
The MLBPA has consistently said it views drug testing as a violation of players' privacy rights. "The
debate is not about the end, which is the elimination of steroids. Everyone is committed to that," Orza
wrote in his e-mail. "It is about what are appropriate means for achieving that end." The proposed
summit is the latest issue on which the baseball players' union has resisted taking action on
performance-enhancing drugs. Those positions have placed the union in conflict not only with the Bush
administration but also with members of Congress, the NFLPA and even, in some instances, its own
members.
The union, for example, has ignored appeals by the baseball commissioner's office to add the dietary
supplement ephedra to baseball's banned-substances list, according to sources familiar with the
discussions. Baseball's request followed the Food and Drug Administration's Dec. 30 announcement that
it intended to remove ephedra from the market.
3/2/2004
Message
Page 3 of 4
An ephedra-based supplement, Xenadrine RFA-1, played a "significant factor" in the death last spring of
Steve Bechler, a 23-year-old Baltimore Orioles pitcher, a coroner concluded.
The late pitcher's father, Ernie Bechler, said in an interview that he was baffled by the union's reluctance
to ban the drug. "My goodness, it took my son's life, just as plain as day," he said. "I just don't
understand it. I cannot understand it. Aren't their players valuable to them? Don't you think they would
want to protect their players? That's their bread and butter, man."
Orza wrote that baseball will ban ephedra when the government officially defines it a controlled
substance. The union, he said, has urged players not to use dietary supplements that contain it.
The union has also declined to support a Senate bill that would define steroid precursors as Schedule III
controlled substances, like steroids, meaning they would be illegal to use without a prescription. The bill
includes a prohibition on androstenedione, or andro, a dietary supplement that metabolizes into the
steroid testosterone once inside the body. Retired St. Louis Cardinals slugger Mark McGwire has
admitted that he used andro while chasing Roger Maris's single-season home run record in 1998.
The bill, which is sponsored by Sen. Orrin Hatch (R-Utah) and Sen. Joseph Biden (D-Del.), among
others, is endorsed by the NBA, NFL, Major League Baseball, the National High School Athletic
Coaches Association, the American Medical Association and the American Academy of Family
Physicians. Orza wrote that the union had "no objections" to the bill's passage. A Democratic aide
familiar with the legislation said the union has told sponsors that the players would neither oppose nor
support the bill.
"What's telling is that Major League Baseball itself, the NFL and the NBA are sort of falling all over
themselves to move the bill forward," said the staffer, who spoke on condition of anonymity because the
aide was not authorized to speak on policy matters. "And there's been a resounding silence from the
players association." Aides to Hatch and Biden met this week with representatives of the Justice
Department and the Drug Enforcement Administration to discuss the legislation with the expectation
that President Bush would soon endorse it.
The Bush administration has sought to push steroids onto the national agenda since the State of the
Union. Administration officials said the decision to place the steroid passage in the speech came from
president himself "straight from the Oval" as one aide put it.
White House communications director Dan Bartlett said Bush became focused on the issue after a
conversation at a White House Christmas party with a women's college track coach "who raised this
issue with him and said how much she was concerned about women taking steroids in college athletics,
and obviously in those who were performing professionally in track."
Walters said he and the president first discussed the issue about a week later, at a Dec. 19 meeting in the
Oval Office.
Speaking out on steroids is "a bully-pulpit issue -- using the power of the presidency to bring attention to
an issue that was not the most pressing in the consciousness of a lot of Americans," Bartlett said. "But a
lot of athletes and a lot of family members particularly those parents out there who have teens in high
school programs and junior high programs are struggling with this issue."
The steroids passage led to criticism that the White House was seeking to exploit a relatively frivolous
issue and to divert attention from weightier matters such as the economy and Iraq. A House Republican
leadership aide, who refused to be identified by name because he did not want to be seen as criticizing
the White House, said the steroids passage became known to some on Capitol Hill as "the crazy two
sentences."
A Republican adviser close to the White House said the administration also was looking for "a cluster of
issues" that resonate with conservatives but also appeal to broader constituencies that could tilt the
November election, such as suburban women.
"Steroids meets that test," said the adviser, who refused to be quoted by name because the White House
did not want the initiative to be viewed as political. "This is the kind of thing that gets folks in swing
states nodding their heads -- that New York and D.C. and California scoff at, but that middle America
understands and responds to
This is going to have more longevity than the rhetoric around the moon
and Mars."
3/2/2004
Message
Page 4 of 4
However, administration officials said the president has embraced an issue that touches upon the
integrity of American institutions and other agencies have taken their cues. A Justice Department
official described the decision to have Ashcroft announce the indictments in the steroid conspiracy case
as "a no-brainer. The president had mentioned it in the State of the Union, and this is something that
Americans deeply care about. It deserves a national stage, and it got it."
3/2/2004
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Agenda
Administration Action on Androstenedione [with attachment]
2
03/02/2004
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FOLDER TITLE:
FDA 3: Steroids/Androstenedione [1]
FRC ID:
FOIA IDs and Segments:
6635
2014-0126-F
OA Num.:
8813
NARA Num.:
8740
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advise between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
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security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
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This Document was withdrawn on 8/11/2015
by erl
Organizations Endorsing S. 1780, The Anabolic Steroid Control Act
American Academy of Family Physicians
American Academy of Pediatrics
American College of Obstetricians and Gynecologists
American College for Sports Medicine
American Council on Exercise
American Medical Association
Association of Tennis Professionals
Blue Cross Blue Shield Association
Boys and Girls Clubs
Community Anti-Drug Coalitions of America
Consumer Healthcare Products Association
Council for Responsible Nutrition
The Endocrine Society
The Hormone Foundation
Little League
Major League Baseball
National Athletic Trainers Association
National Basketball Association
The National Center on Addiction and Substance Abuse at
Columbia University
National Collegiate Athletic Association
National Federation of State High Schools Association
National Football League
National High School Athletic Coaches Association
National Junior College Athletic Association
National Nutritional Foods Association
Pharmacists Planning Services, Inc.
United States Anti-Doping Agency
U.S. Olympic Committee
U.S. Biathlon Association
U.S. Soccer Federation
USA Cycling
USA Luge
USA Swimming
USA Track and Field
Utah Natural Products Alliance
Women's National Basketball Association
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Memorandum
For Your Meeting at the White House Today - To: Amit Sachdev - From:
1
03/02/2004 P5;
Nancy Yanish
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COLLECTION:
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FOLDER TITLE:
FDA 3: Steroids/Androstenedione [1]
FRC ID:
FOIA IDs and Segments:
6635
2014-0126-F
OA Num.:
8813
NARA Num.:
8740
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advise between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
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of gift.
This Document was withdrawn on 8/11/2015
by erl
HUMAN
SERVICES
DEPARTMENT OF HEALTH a HUMAN SERVICES
Public Health Service
MEALTH
3
Food and Drug Administration
Rockville MD 20857
JUN 20 2002
The Honorable Orrin G. Hatch
United States Senate
Washington, D.C. 20510-4402
Dear Senator Hatch:
Thank you for your letters of October 11, 2001, and February 8, 2002, addressed to
Dr. Bernard Schwetz, then Acting Commissioner of Food and Drugs, regarding the marketing
of products as dietary supplements that contain the steroid hormone androstenedione. You
asked the Food and Drug Administration (FDA or the Agency) to inform you as to whether
androstenedione may be lawfully marketed as a dietary supplement. We regret the delay of
this response.
In your letters, you expressed concerns about the marketing of dietary supplements containing
androstenedione because of allegations that they may be potentially harmful to consumers.
You asked the Agency to provide you with an explanation of the legal status of such products
under the Federal Food, Drug, and Cosmetic (FD&C) Act, as amended by the Dietary
Supplement Health and Education Act of 1994 (DSHEA).
We appreciate your concerns about this matter and, moreover, regret that we have not been
able to respond to you within the time period you requested. However, in order to provide
you with an accurate and informed answer to your questions about the legal status of
androstenedione-containing products, a number of novel and complex legal and scientific
issues need to be considered. I want to assure you that, in response to your request, we are
diligently pursuing an evaluation of the legal and scientific issues that bear on
androstenedione's status under the Act and intend to provide answers to your questions as
soon as our evaluation is complete.
Thank you again for contacting us concerning this matter. A similar response has been sent
to Senator Harkin. Please contact us if you have further questions concerning this matter.
Sincerely
William K. Hubbard
Senior Associate Commissioner
for Policy, Planning, and Legislation
Page 2 - The Honorable Orrin G. Hatch
bcc: HFW-10
HFW-1
HFW-12
HFW-14
HF-22 (Hubbard)
HF-1
HF-40
HFA-224
HFC-1
HFC-200
HFD-1
HFD-300
HFS-1
HFS-22, Salsbury, CCO
HFS-800
HFS-811 (Moore)
GCF-1 (Troy, Nickerson)
Received by:HRubino:2/11/02 (CFSAN received simultaniously)
R/D:HFS-811:RMoore:6/5/02
reviewed:HFS-810:JForet:6/6/02
reviewed:HFS-800:VWilkening for CTaylor:6/7/02
Reviewed: P. Salsbury: HFS-22: 6/13/02
Reviewed/cleared: J. Levitt: HFS-1: 6/13/02
Revised: P.Salsbury: 6/14/02
Draft received by:NYanish:6/14/02
Edits:HRubino:6/17/02
Sent to type:6/17/02
Returned to LC:6/17/02
F/T:alb:6/17/02 G.\WP\Yanish\Dietary Supplements\02-776Hatch.doc
Control No. 02-776
FRC 1 Senator Orrin Hatch
FAX NO. :202 228 1178
--b. 08 2002 39PM P2
United States Senate
WASHINGTON, DC 20510
February 8, 2002
Dr. Bennard Schwetz
Acting Commissioner
of Food and Drugs
Rockville, Maryland 20852
Dear Dr. Schwetz:
We were very disappointed to be advised today by your legislative and legal staff that you
had not received our October 11, 2001, letter with respect to whether androstenedione may be
lawfully marketed as a dietary supplement under the Federal Food, Drug and Cosmetic Act. This
is somewhat disturbing. since the letter was not only telefaxed to your office. but mailed to you,
with scparate copies to Mr. Leavitt and Secretary Thompson. We had asked to have a reply by
Games. October 23, and wished to have your decision prior to commencement of the winter Olympic
As you may be aware, there have been numerous credible reports that young athletes are
taking this product with possible long-term, dotrimental health effects. Our interest in the well-
being of these athletes comes in the context of our growing concern that the agency is not
devoting adequate resources to enforcement of the Dietary Supplement Health and Education Act
(DSHEA) of 1994.
As this matter is of personal concern to us, we would appreciate your immediate reply as
to whether androstenedione may be marketed lawfully as a dietary supplement. We have
attached another copy of our letter.
Sincerely,
rom Hark Hatch
Tom Harkin
Orrin G. Hatch
United States Senator
United States Senator
72-776
ARUM Senator Orrin Hatch
FAX NO. :202 228 1178
reb. 08 2002 06:39PM P3
Hnited States Smate
WASHINGTON, DC 20510
October 11, 2001
Dr. Benuard P. Schwetz,
Acting Commissioner
of Food and Drugs
5600 Fishers Lane
Rockville, Maryland 20852
Dear Dr. Schwetz:
There have been numerous press accounts implicating the safety and alleging abuses of
the product androstenedione, marketed as a dietary supplement Almost invariably, these news
reports portray a range of adverse health consequences suffered by susceptible young athletes and
state that the Food and Drug Administration's "hands are tied" because dietary supplements are
"unregulated."
While we vigerously contest the false allegation that distary supplement products are
unregulated, we are extremely concerned about the potentially harmful effects of androstenedione
and its use, particularly by young people. As you know, if H product is unsafe, be it a dietary
supplement or other food, a drug or medical device, the FDA possesses a broad range of
authorities to take appropriate onforcement actions to safeguard the public health It is our strong
contention that, with respect to dietary supplements, this authority was enhanced - not
diminished- - by passage of the Dictary Supplement Health and Education Act (DSHEA), the
law we authored with then-Representative Bill Richardson and which passed the Congress
unanimously in 1994.
As a threshold matter, it is important to ascertain the regulatory status of androstenedione.
Therefore, we request that you provide a simple response to the following two questions:
1) La androstenedione a product that may be lawfully marketed as a dietary supplement
under the "grandfather" provisions of DSHEA (section 413(c) of the Federal Food Drug and
Cosmetic Act)?
FROM benator Urrin Hatch
FAX NO. :202 228 1178
Feb. 08 2002 06:40PM P4
2) If the answer to question number one is "no," has the agency received a new dietary
ingredient potition with respect to androstenedione and acted upon that submission under section
413(b) of the FDC Act?
We would appreciate receiving your response no later than October 23, 200L Thank you
very much for your prompt and personal attention to this matter.
Sincerely,
Tom Harti
Drive Hakl
Tom Harkin
Orrin G. Hatch
United States Senator
United States Senator
cc: Secretary Thompson
Joe Leavin
THE ANABOLIC STEROID CONTROL ACT OF 2003 -
SECTION-BY-SECTION ANALYSIS
Section 1 - Short Title
Establishes the short title of the bill as the Anabolic Steroid Control Act of 2003.
Section 2 - Amendments to the Controlled Substances Act
Under current law, the term "anabolic steroid" is defined at 21 U.S.C. 802 as "any
drug or hormonal substance, chemically and pharmacologically related to testosterone
(other than estrogens, progestins, and corticosteroids) that produces muscle growth." This
section amends that definition by removing the requirement that a substance be proven to
promote muscle growth. This would make it easier to add steroid precursors such as
androstenedione and other similar substances - many of which have been developed since
the Steroid Control Act of 1990 passed in order to evade the law - to be added to the list
of Schedule III anabolic steroids.
The provision also makes technical corrections to the current list of anabolic
steroids, adds a number of known steroid precursors to the anabolic steroid list and
exempts dehydroepiandrosterone (DHEA).
Finally, this section modifies the definition of "felony drug offense" in 21 U.S.C.
802 to apply to offenses involving anabolic steroids.
Section 3 - Sentencing Commission Guidelines
Directs the U.S. Sentencing Commission to review the Federal sentencing
guidelines for crimes involving anabolic steroids and consider increasing them. Currently,
the maximum sentence for offenses involving between 40,000 and 60,000 units of
anabolic steroids (a unit is defined as a 10 cc vial or 50 tablets) is a level 20 (which
translates to 33 - 41 months for first time offenders).
Section 4 - Prevention and Education Programs
Authorizes $15 million for the Secretary of Health and Human Services to award
grants to public and non-profit entities to carry out science-based education programs in
elementary and secondary schools to highlight the harmful effects of steroids and steroid
precursors. Preference will be given to programs based on the Athletes Training and
Learning to Avoid Steroids program (ATLAS), the Athletes Targeting Healthy Exercise
and Nutrition Alternatives (ATHENA) program, and other programs which the National
Institute on Drug Abuse has determined to be effective. ATLAS, which is aimed at male
student athletes, has been named as one of the Department of Education's Exemplary
Programs and is one of the Substance Abuse and Mental Health Services
Administration's Model Programs. ATHENA is ATLAS's companion program designed
for female athletes.
Section 5 - National Survey on Drug Use and Health
Directs the Secretary of Health and Human Services to include questions about the
use of steroids and steroid precursors in the National Survey on Drug Use and Health, an
annual survey to measure the extent of alcohol, drug and tobacco use in the United States.
The bill authorizes $1 million for this purpose.
Statement of
Senator Orrin G. Hatch
United States Senate
before the
Senate Committee on Commerce
"Regulation of Dietary Supplements"
October 28, 2003
Mr. Chairman and Members of the Committee:
I appreciate the opportunity to testify before you today and to discuss a topic very near and
dear to my heart: the regulation of dietary supplements.
There is no question that tens of millions of Americans rely daily on safe dietary
supplements to maintain and improve their healthy lifestyles. The popularity of these products and
the concern over their regulation are what led to enactment of the Dietary Supplement Health and
Education Act (DSHEA) in 1994, a bill that Senator Harkin and I were proud to author with now-
Governor of New Mexico Bill Richardson.
The message I wish to leave with you is simple: DSHEA is a strong law that properly
implemented will protect the interests of consumers. But, as with any law, it has to be implemented
for it to work.
Enactment of DSHEA followed literally decades of Food and Drug Administration
animosity toward dietary supplement products. This animosity and the lack of a clear regulatory
structure for supplements were clearly demonstrated prior to passage of DSHEA.
That is why two-thirds of the Senate cosponsored our bill.
That is why a majority of the House cosponsored the bill.
And that is why it passed so overwhelmingly.
The basic structure of DSHEA allowed all products marketed as dietary supplements when
the bill was enacted to stay on the market unless the FDA could show safety problems with a
particular product or line of products - this is the so-called "grandfather" provision; manufacturers
must notify the FDA before any new ingredients are marketed. At the same time, we provided the
FDA with the full range of enforcement mechanisms to act against unsafe or misbranded
supplements, including seizure, injunction, civil monetary penalties and even criminal penalties.
And, when Chairman Dingell and Chairman Waxman expressed lingering concerns that an
unsafe product might be marketed and FDA would not have adequate authority to act against it, we
Page 1
added a new tool - imminent hazard - so that the Secretary could take immediate action against a
product that he believed poses an imminent hazard to public health. I might add, the definition as to
what constitutes an "imminent hazard" is entirely up to the Department of Health and Human
Services, so this is a very broad authority.
Even so, there are some who believe that dietary supplements should not be marketed in the
United States without a preclearance similar to that for pharmaceuticals. We who drafted and
passed DSHEA along with millions of Americans were persuaded that was not necessary.
First, most supplements cannot be patented, so there is little incentive for manufacturers to
undergo the expensive and time-consuming FDA approval process.
Second, many, many supplements have been used safely for literally centuries, if not
millennia, so it is not necessary to subject them to the approval process. That was why even the
most liberal members felt comfortable with the grandfather structure.
Finally, we added a provision so that FDA would have the time to examine any ingredient
not previously marketed and the evidence of its safety before that product actually reached the
stores.
When we drafted DSHEA, ensuring the safety of products was at the forefront of our efforts.
The law gives the FDA abundant tools to remove products that are unsafe from the market. It
includes a safety standard that was carefully crafted with Senator Kennedy and Representatives
Dingell and Waxman, the chairs of FDA-related panels in 1994.
There is no excuse for a supplement manufacturer to market products that are unsafe or
inaccurately labeled or that make outlandish claims. Unfortunately, a small number of irresponsible
supplement companies are taking advantage of consumers.
I contend that the law is adequate to deal with them if FDA implements and enforces it.
Yet, in the nine-plus years since DSHEA was enacted, there has been too much talk that the
law handcuffs FDA and too little effort to apply the law.
It is impossible for this law to protect consumers if it is not enforced.
I have been pleased at the FTC's actions to challenge companies with inaccurate or
deceptive advertising.
The FDA's record has not been as strong.
I am not here to criticize the FDA or throw barbs. Frankly, the FDA under Commissioner
Mark McClellan has done more to enforce DSHEA than the previous administration had. I credit
Page 2
Commissioner McClellan for his commitment to implement the law fully. I truly believe he wants
to make this law work. Congress must support him.
That is why I have joined with Senator Harkin to introduce the DSHEA Full Implementation
and Enforcement Act of 2003 (S. 1538).
Yes, there is a small number of products that do raise serious concerns.
Ephedra is one. As I have done for many years, I urge the FDA to act definitively on this
issue based on the best available science, not politics. If the agency deems that ephedra poses a
significant or unreasonable risk of illness or injury when used as labeled, than the agency can - and
must - move to take the product off the market. This has gone on for too long.
Frankly, resources are a large issue here. The FDA simply does not have the staff or money
it needs to do the job.
While FDA is constrained by the President's budget in not seeking new funding for
DSHEA, I predict that members of the Committee who inquire of the FDA witness may receive
support for my contention that the agency is woefully underfunded, especially in this area.
That is the only reason I can see that the safety standard we enacted has never been invoked.
That has to be the reason that it has taken almost a decade to promulgate the good
manufacturing practice standards that can help guarantee the safety, the purity, and the accurate
labeling of products.
And that must be the reason that a product like androstenedione, which I believe is not even
a dietary supplement, continues to be marketed in this country.
I have been very concerned about the safety of steroid precursor products like andro -- and
especially when they fall into the hands of our youth.
That is why I have joined with Senator Biden, Senator Harkin and Senator Grassley to
cosponsor the Anabolic Steroid Control Act (S. 1780) that will add andro and other steroid
precursors, as well as THG, to the list of controlled substances. I intend for the Judiciary
Committee to make adoption of S. 1780 a priority and I hope my colleagues will join me in
supporting both S. 1780 and S. 1538.
Mr. Chairman, you have been very generous with your time, so I will close here. The
thought I wish to leave with my colleagues is that we have a solid law which can deal with the
problems witnesses will discuss today. But the FDA must use that law for it to be effective, and
Congress must support the agency in that effort.
Page 3
for S 1780 (108)
Page 1 of 1
GalleryWatch.com
HELP
CO-SPONSORS: S 1780 (108)
(W = Withdrawn)
ORIGINAL COSPONSORS (by date)
Total = 3 ( Dem = 1 Rep = 2)
10/23/2003
Sen. Chuck Grassley (R-IA)
Sen. Tom Harkin (D-IA)
Sen. Orrin G. Hatch (R-UT)
ADDITIONAL COSPONSORS
Total = 3 ( Dem = 1 Rep = 2)
10/30/2003
Sen. Ted Stevens (R-AK)
11/03/2003
Sen. John McCain (R-AZ)
02/26/2004
Sen. Bill Nelson (D-FL)
TOTAL COSPONSORS
Total = 6 ( Dem = 2 Rep = 4)
© Copyright GalleryWatch.com, Inc. (1999 - 2004), provided under license. NO CLAIM TO ORIGINAL U.S. OR
STATE GOVERNMENT WORKS
http://us.gallerywatch.com/section_loader.gw?optionid=350&bilsid-BILL:US:108S:01780
3/1/2004
Organizations Endorsing S. 1780, The Anabolic Steroid Control Act
American Academy of Family Physicians
American Academy of Pediatrics
American College of Obstetricians and Gynecologists
American College for Sports Medicine
American Council on Exercise
American Medical Association
Association of Tennis Professionals
Blue Cross Blue Shield Association
Boys and Girls Clubs
Community Anti-Drug Coalitions of America
Consumer Healthcare Products Association
Council for Responsible Nutrition
The Endocrine Society
The Hormone Foundation
Little League
Major League Baseball
National Athletic Trainers Association
National Basketball Association
The National Center on Addiction and Substance Abuse at
Columbia University
National Collegiate Athletic Association
National Federation of State High Schools Association
National Football League
National High School Athletic Coaches Association
National Junior College Athletic Association
National Nutritional Foods Association
Pharmacists Planning Services, Inc.
United States Anti-Doping Agency
U.S. Olympic Committee
U.S. Biathlon Association
U.S. Soccer Federation
USA Cycling
USA Luge
USA Swimming
USA Track and Field
Utah Natural Products Alliance
Women's National Basketball Association
Withdrawal Marker
The George W. Bush Library
FORM
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Memorandum
Proposed FDA and DEA Actions on Steroids - To: POTUS - From: Alan
2
03/05/2004
P5;
Gilbert
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COLLECTION:
Domestic Policy Council
SERIES:
Gilbert, Alan - Subject Files
FOLDER TITLE:
FDA 3: Steroids/Androstenedione [1]
FRC ID:
FOIA IDs and Segments:
6635
2014-0126-F
OA Num.:
8813
NARA Num.:
8740
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
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b(2) Release would disclose internal personnel rules and practices of
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b(4) Release would disclose trade secrets or confidential or financial
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personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
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PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
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Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
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security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
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the Freedom of Information Act.
of gift.
This Document was withdrawn on 8/11/2015
by erl
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The George W. Bush Library
FORM
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Email
Andro and FDA Action - To: Alan Gilbert - From: Philo Hall
1
02/20/2004
P5;
This marker identifies the original location of the withdrawn item listed above.
For a complete list of items withdrawn from this folder, see the
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COLLECTION:
Domestic Policy Council
SERIES:
Gilbert, Alan - Subject Files
FOLDER TITLE:
FDA 3: Steroids/Androstenedione [1]
FRC ID:
FOIA IDs and Segments:
6635
2014-0126-F
OA Num.:
8813
NARA Num.:
8740
RESTRICTION CODES
Presidential Records Act - [44] U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advise between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
P.RM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
This Document was withdrawn on 8/11/2015
by erl
DEA/DOJ Actions:
Baseball has come under intensifying scrutiny since a federal grand jury in San
Francisco indicted four men -- including the personal weight trainer for San
Francisco Giants left fielder Barry Bonds -- on Feb. 12 for allegedly distributing
steroids to elite athletes. The indictments were announced in Washington by
Attorney General John D. Ashcroft, a reflection of the administration's efforts to
embrace the issue.
03/06/2004 12:00 FAX
5
001
SS/ RM NO.
NOON
WHITE HOUSE STAFFING MEMORANDUM
Date: 03-05-04 8:20 PM ACTION / CONCURRENCE / COMMENT DUE BY: 03-06-04 NOON
MEMORANDUM FOR THE PRESIDENT ON PROPOSED FDA AND DEA ACTIONS
Subject: ON STEROIDS
ACTION FYI
ACTION FYI
VICE PRESIDENT
MANKIW
CARD
MARBURGER
BARTLETT
MCCLELLAN
BENNETT
MIERS
called
BOLTEN
MONTGOMERY
Tevr
CONNAUGHTON
POWELL
DOCE
FRIEDMAN
RICE
GAMBATESA
ROVE
GERSON
SPELLINGS
GONZALES
CLERK
GORDON
GINGER
HAGIN
HOBBS
called
KAVANAUGH
REMARKS:
PLEASE FORWARD COMMENTS TO ALAN GILBERT, EXTENSION 67105/FAX 65557, BY
NOON ON SATURDAY, MARCH 6, 2004 WITH A COPY TO THE STAFF SECRETARY. THANK
YOU.
ok
RESPONSE:
Brett Kavanaugh
Assistant to the President
and Staff Secretary
Ext. 62702
FAX Ext. 62215
Sent by: OSTP
21 PAA
2024566021;
03/06/04 10:48AM; #93;
Page 1/3
+ MARBURGER
001/003
SS/ RM NO.
WHITE HOUSE STAFFING MEMORANDUM
Date: 03-05-04 8:20 PM ACTION 1 CONCURRENCE / COMMENT DUE BY: 03-06-04 NOON
MEMORANDUM FOR THE PRESIDENT ON PROPOSED FDA AND DEA ACTIONS
Subject: ON STEROIDS
ACTION FYI
ACTION FYI
VICE PRESIDENT
MANKIW
CARD
MARBURGER
BARTLETT
MCCLELLAN
BENNETT
MIERS
S
BOLTEN
MONTGOMERY
CONNAUGHTON
POWELL
FRIEDMAN
RICE
GAMBATESA
ROVE
GERSON
SPELLINGS
GONZALES
CLERK
GORDON
HAGIN
HOBBS
>
KAVANAUGH
REMARKS:
PLEASE FORWARD COMMENTS TO ALAN GILBERT, EXTENSION 67105/FAX 65557, BY
NOON ON SATURDAY, MARCH 6, 2004 WITH A COPY TO THE STAFF SECRETARY. THANK
YOU.
RESPONSE:
See Comments
Brett Kavanaugh
Assistant to the President
and Staff Secretary
Ext. 62702
FAX Ext. 62215