H. Rept. 113-587 - DESIGNER ANABOLIC STEROID CONTROL ACT OF 2014113th Congress (2013-2014)
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113th Congress Rept. 113-587
HOUSE OF REPRESENTATIVES
2d Session Part 1
======================================================================
DESIGNER ANABOLIC STEROID CONTROL ACT OF 2014
_______
September 15, 2014.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Upton, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 4771]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 4771) to amend the Controlled Substances Act to
more effectively regulate anabolic steroids, having considered
the same, report favorably thereon with an amendment and
recommend that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 4
Background and Need for Legislation.............................. 4
Hearings......................................................... 4
Committee Consideration.......................................... 5
Committee Votes.................................................. 5
Committee Oversight Findings..................................... 5
Statement of General Performance Goals and Objectives............ 5
New Budget Authority, Entitlement Authority, and Tax Expenditures 5
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 5
Committee Cost Estimate.......................................... 5
Congressional Budget Office Estimate............................. 5
Federal Mandates Statement....................................... 7
Duplication of Federal Programs.................................. 7
Disclosure of Directed Rule Makings.............................. 7
Advisory Committee Statement..................................... 7
Applicability to Legislative Branch.............................. 8
Section-by-Section Analysis of the Legislation................... 8
Changes in Existing Law Made by the Bill, as Reported............ 8
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Designer Anabolic Steroid Control Act
of 2014''.
SEC. 2. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT.
(a) Definitions.--Section 102(41) of the Controlled Substances Act
(21 U.S.C. 802(41)) is amended--
(1) in subparagraph (A)--
(A) in clause (xlix), by striking ``and'' at the end;
(B) by redesignating clause (xlx) as clause (lxxv);
and
(C) by inserting after clause (xlix) the following:
``(l) 5a-Androstan-3,6,17-trione;
``(li) 6-bromo-androstan-3,17-dione;
``(lii) 6-bromo-androsta-1,4-diene-3,17-dione;
``(liii) 4-chloro-17a-methyl-androsta-1,4-diene-3,17+-diol;
``(liv) 4-chloro-17a-methyl-androst-4-ene-3+,17+-diol;
``(lv) 4-chloro-17a-methyl-17+-hydroxy-androst-4-en-3-one;
``(lvi) 4-chloro-17a-methyl-17+-hydroxy-androst-4-ene-3,11-
dione;
``(lvii) 4-chloro-17a-methyl-androsta-1,4-diene-3,17+-diol;
``(lviii) 2a,17a-dimethyl-17+-hydroxy-5a-androstan-3-one;
``(lix) 2a,17a-dimethyl-17+-hydroxy-5+-androstan-3-one;
``(lx) 2a,3a-epithio-17a-methyl-5a-androstan-17+-ol;
``(lxi) [3,2-c]-furazan-5a-androstan-17+-ol;
``(lxii) 3+-hydroxy-estra-4,9,11-trien-17-one;
``(lxiii) 17a-methyl-androst-2-ene-3,17+-diol;
``(lxiv) 17a-methyl-androsta-1,4-diene-3,17+-diol;
``(lxv) Estra-4,9,11-triene-3,17-dione;
``(lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one;
``(lxvii) 6a-Methyl-androst-4-ene-3,17-dione;
``(lxviii) 17a-Methyl-androstan-3-hydroxyimine-17+-ol;
``(lxix) 17a-Methyl-5a-androstan-17+-ol;
``(lxx) 17+-Hydroxy-androstano[2,3-d]isoxazole;
``(lxxi) 17+-Hydroxy-androstano[3,2-c]isoxazole;
``(lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole-
5a-androstan-17+-ol;
``(lxxiii) [3,2-c]pyrazole-androst-4-en-17+-ol;
``(lxxiv) [3,2-c]pyrazole-5a-androstan-17+-ol; and''; and
(2) by adding at the end the following:
``(C)(i) Subject to clause (ii), a drug or hormonal substance
(other than estrogens, progestins, corticosteroids, and
dehydroepiandrosterone) that is not listed in subparagraph (A)
and is derived from, or has a chemical structure substantially
similar to, 1 or more anabolic steroids listed in subparagraph
(A) shall be considered to be an anabolic steroid for purposes
of this Act if--
``(I) the drug or substance has been created or
manufactured with the intent of producing a drug or
other substance that either--
``(aa) promotes muscle growth; or
``(bb) otherwise causes a pharmacological
effect similar to that of testosterone; or
``(II) the drug or substance has been, or is intended
to be, marketed or otherwise promoted in any manner
suggesting that consuming it will promote muscle growth
or any other pharmacological effect similar to that of
testosterone.
``(ii) A substance shall not be considered to be a drug or
hormonal substance for purposes of this subparagraph if it--
``(I) is--
``(aa) an herb or other botanical;
``(bb) a concentrate, metabolite, or extract
of, or a constituent isolated directly from, an
herb or other botanical; or
``(cc) a combination of 2 or more substances
described in item (aa) or (bb);
``(II) is a dietary ingredient for purposes of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.); and
``(III) is not anabolic or androgenic.
``(iii) In accordance with section 515(a), any person
claiming the benefit of an exemption or exception under clause
(ii) shall bear the burden of going forward with the evidence
with respect to such exemption or exception.''.
(b) Classification Authority.--Section 201 of the Controlled
Substances Act (21 U.S.C. 811) is amended by adding at the end the
following:
``(i) Temporary and Permanent Scheduling of Recently Emerged Anabolic
Steroids.--
``(1) The Attorney General may issue a temporary order adding
a drug or other substance to the definition of anabolic
steroids if the Attorney General finds that--
``(A) the drug or other substance satisfies the
criteria for being considered an anabolic steroid under
section 102(41) but is not listed in that section or by
regulation of the Attorney General as being an anabolic
steroid; and
``(B) adding such drug or other substance to the
definition of anabolic steroids will assist in
preventing abuse or misuse of the drug or other
substance.
``(2) An order issued under paragraph (1) shall not take
effect until 30 days after the date of the publication by the
Attorney General of a notice in the Federal Register of the
intention to issue such order and the grounds upon which such
order is to be issued. The order shall expire not later than 24
months after the date it becomes effective, except that the
Attorney General may, during the pendency of proceedings under
paragraph (6), extend the temporary scheduling order for up to
6 months.
``(3) The Attorney General shall transmit notice of an order
proposed to be issued under paragraph (1) to the Secretary of
Health and Human Services. In issuing an order under paragraph
(1), the Attorney General shall take into consideration any
comments submitted by the Secretary in response to a notice
transmitted pursuant to this paragraph.
``(4) A temporary scheduling order issued under paragraph (1)
shall be vacated upon the issuance of a permanent scheduling
order under paragraph (6).
``(5) An order issued under paragraph (1) is not subject to
judicial review.
``(6) The Attorney General may, by rule, issue a permanent
order adding a drug or other substance to the definition of
anabolic steroids if such drug or other substance satisfies the
criteria for being considered an anabolic steroid under section
102(41). Such rulemaking may be commenced simultaneously with
the issuance of the temporary order issued under paragraph
(1).''.
(c) Labeling Requirements.--
(1) In general.--The Controlled Substances Act is amended by
inserting after section 305 (21 U.S.C. 825) the following:
``SEC. 305A. OFFENSES INVOLVING FALSE LABELING OF ANABOLIC STEROIDS.
``(a) Unlawful Acts.--
``(1) It shall be unlawful--
``(A) to import into the United States or to export
from the United States;
``(B) to manufacture, distribute, dispense, sell, or
offer to sell; or
``(C) to possess with intent to manufacture,
distribute, dispense, sell, or offer to sell;
any anabolic steroid, or any product containing an anabolic
steroid, that does not bear a label clearly identifying any
anabolic steroid contained in such steroid or product by the
nomenclature used by the International Union of Pure and
Applied Chemistry (IUPAC).
``(2)(A) A product described in subparagraph (B) is exempt
from the International Union of Pure and Applied Chemistry
nomenclature requirement of this subsection if such product is
labeled in the manner required under the Federal Food, Drug,
and Cosmetic Act.
``(B) A product is described in this subparagraph if the
product--
``(i) is the subject of an approved application as
described in section 505(b) or (j) of the Federal Food,
Drug, and Cosmetic Act; or
``(ii) is exempt from the provisions of section 505
of such Act relating to new drugs because--
``(I) it is intended solely for
investigational use as described in section
505(i) of such Act; and
``(II) such product is being used exclusively
for purposes of a clinical trial that is the
subject of an effective investigational new
drug application.
``(b) Criminal Penalties.--Any person who violates subsection (a)
knowing, intending, or having reasonable cause to believe, that the
substance or product is an anabolic steroid, or contains an anabolic
steroid, shall be sentenced to a term of imprisonment of not more than
10 years, a fine not to exceed the greater of that authorized in
accordance with the provisions of title 18, United States Code, or
$500,000 if the defendant is an individual or $2,500,000 if the
defendant is other than an individual, or both.
``(c) Civil Penalties.--
``(1) Any person who violates subsection (a) shall be subject
to a civil penalty as follows:
``(A) In the case of an importer, exporter,
manufacturer, or distributor (other than as provided in
subparagraph (B)), up to $500,000 per violation. For
purposes of this subparagraph, a violation is defined
as each instance of importation, exportation,
manufacturing, or distribution, and each anabolic
steroid or product imported, exported, manufactured, or
distributed.
``(B) In the case of a sale or offer to sell at
retail, up to $25,000 per violation. For purposes of
this subparagraph, each sale and each product offered
for sale shall be considered a separate violation.
Continued offers to sell by a person 10 or more days
after written notice (including through electronic
message) to the person by the Attorney General or the
Secretary shall be considered additional violations.
``(2) In this subsection, the term `product' means a discrete
article, either in bulk or in finished form prepared for sale.
A number of articles, if similarly packaged and bearing
identical labels, shall be considered as one product, but each
package size, form, or differently labeled article shall be
considered a separate product.
``(d) Identification and Publication of List of Products Containing
Anabolic Steroids.--
``(1) The Attorney General may, in his discretion, collect
data and analyze products to determine whether they contain
anabolic steroids and are properly labeled in accordance with
this section. The Attorney General may publish in the Federal
Register or on the website of the Drug Enforcement
Administration a list of products that he has determined, based
on substantial evidence, contain an anabolic steroid and are
not labeled in accordance with this section.
``(2) The absence of a product from the list referred to in
paragraph (1) shall not constitute evidence that the product
does not contain an anabolic steroid.''.
(2) Table of contents.--The table of contents for the
Comprehensive Drug Abuse Prevention and Control Act of 1970 is
amended by inserting after the item relating to section 305 the
following:
``Sec. 305A. Offenses involving false labeling of anabolic steroids.''.
Purpose and Summary
The bill would amend the Controlled Substances Act (CSA) to
expand the definition of ``anabolic steroids,'' authorize the
Attorney General to issue a temporary order adding a drug or
substance to the definition of anabolic steroids and to collect
data and analyze products to determine whether they contain
anabolic steroids and are properly labeled, and impose
additional criminal and civil penalties for possessing or
trafficking any anabolic steroid that does not bear a label
clearly identified the anabolic steroid by the nomenclature
used by the International Union of Pure and Applied Chemistry
or is not labeled in a manner that is not labeled in the manner
required under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
Background and Need for Legislation
Misbranded products that contain designer anabolic steroids
present serious health risks to consumers. Consumers oftentimes
unknowingly purchase products labeled as dietary supplements
that contain such ingredients. Anabolic steroids are synthetic
forms of testosterone that can be extremely dangerous and are
Class III controlled substances under the Controlled Substances
Act. To skirt the law, however, certain entities alter the
chemical structure of such substances and promote these
designer products for their anabolic effects. H.R. 4771
provides the Drug Enforcement Administration (DEA) with the
tools and authority to protect consumers from these dangerous
products.
Hearings
The Committee on Energy and Commerce has not held hearings
on H.R. 4771.
Committee Consideration
On June 19, 2014, the Subcommittee on Health met in open
markup session and approved H.R. 4771 for full Committee
consideration by a voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
H.R. 4771 reported. A motion by Mr. Upton to order H.R. 4771
reported to the House, with amendment, was agreed to by voice
vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has not held hearings
on this legislation.
Statement of General Performance Goals and Objectives
The objective of this legislation is to ensure that the DEA
has adequate authority to protect consumers from designer
anabolic steroids.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
4771 would result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
In compliance with clause 9(e), 9(f), and 9(g) of rule XXI
of the Rules of the House of Representatives, the Committee
finds that H.R. 4771 contains no earmarks, limited tax
benefits, or limited tariff benefits.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, July 25, 2014.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 4771, the Designer
Anabolic Steroid Control Act of 2014.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Mark
Grabowicz.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
H.R. 4771--Designer Anabolic Steroid Control Act of 2014
CBO estimates that implementing H.R. 4771 would have no
significant costs to the federal government. Enacting the bill
could affect direct spending and revenues; therefore, pay-as-
you-go procedures apply. However, CBO estimates that any
effects would be insignificant for each year.
H.R. 4771 would expand the list of anabolic steroids
regulated by the Drug Enforcement Administration (DEA) to
include about two dozen new substances and would establish new
crimes relating to false labeling of steroids. As a result, the
government might be able to pursue cases involving drug use
that it otherwise would not be able to prosecute. CBO expects
that H.R. 4771 would apply to a relatively small number of
additional offenders, however, so any increase in costs for law
enforcement, court proceedings, or prison operations would not
be significant. Any such costs would be subject to the
availability of appropriated funds.
Because those prosecuted and convicted under H.R. 4771
could be subject to civil and criminal fines, the federal
government might collect additional fines if the legislation is
enacted. Civil fines are recorded as revenues. Criminal fines
are recorded as revenues, deposited in the Crime Victims Fund,
and later spent. CBO expects that any additional revenues and
direct spending would not be significant because of the small
number of additional cases likely to be affected.
H.R. 4771 contains no intergovernmental mandates as defined
in the Unfunded Mandates Reform Act (UMRA) and would impose no
costs on state, local, or tribal governments.
H.R. 4771 would impose private-sector mandates, as defined
in UMRA, on manufacturers, sellers, importers, exporters,
distributors, and consumers of products that contain certain
chemical compounds that would be defined as anabolic steroids.
CBO estimates that the cost of complying with those mandates
would probably exceed the annual threshold established in UMRA
for private-sector mandates ($152 million in 2014, adjusted
annually for inflation).
The bill would impose private-sector mandates by adding 25
new compounds, and any compounds found to be structurally
similar, to the list of anabolic steroids regulated under the
Controlled Substances Act. Consumers would need a prescription
from a licensed practitioner in order to purchase products
containing the newly listed compounds. Sellers, manufacturers,
and importers of such products would be required to obtain an
authorization from state and federal authorities in order to
make or possess the compounds. However, based on information
from the Food and Drug Administration (FDA), the DEA, and
industry professionals, CBO expects that the majority of the
affected entities would either replace the regulated compounds
with new ones or discontinue the distribution of the affected
products. Therefore, the cost of the mandate would be the
forgone income from lost sales.
Because of the nature of the market being regulated, the
scope of sales affected is difficult to determine. As products
are found to contain compounds that are structurally similar to
the compounds listed, industry sales could decline
significantly. Some industry experts estimate that the revenues
generated by the sale of products containing such compounds
amount to between $2 billion and $5 billion annually. (Those
figures include sales of some products that already are not in
compliance or not being sold in compliance with FDA or DEA
regulations.) Although identifying which items would be
affected by the legislation would be difficult, given the
estimated magnitude of industry profits, even a 10 percent
decrease in income as a result of the bill would exceed the
annual threshold for private-sector mandates.
The bill also would impose a mandate on importers,
exporters, manufacturers, and distributors by requiring that
any anabolic steroid or product containing an anabolic steroid
be labeled as such, using the nomenclature of the International
Union of Pure and Applied Chemistry. The cost of the mandate
would probably be small.
The CBO staff contacts for this estimate are Mark Grabowicz
(for federal costs) and Marin Burnett (for the private-sector
impact). The estimate was approved by Theresa Gullo, Deputy
Assistant Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Duplication of Federal Programs
No provision of H.R. 4771 establishes or reauthorizes a
program of the Federal Government known to be duplicative of
another Federal program, a program that was included in any
report from the Government Accountability Office to Congress
pursuant to section 21 of Public Law 111-139, or a program
related to a program identified in the most recent Catalog of
Federal Domestic Assistance.
Disclosure of Directed Rule Makings
The Committee estimates that enacting H.R. 4771
specifically directs to be completed zero specific rule makings
within the meaning of 5 U.S.C. 551.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1: Short title
Section 1 provides the short title of the ``Designer
Anabolic Steroid Control Act of 2014.''
Section 2: Amendments to the Controlled Substances Act
Subsection (a) amends section 102(41) of the CSA by adding
25 substances to the definition of ``anabolic steroid.''
In addition, it provides that a drug or hormonal substance
that is not listed under section 102(41), but is derived from,
or has a chemical structure substantially similar to, one or
more of the listed anabolic steroids, such drug or hormonal
substance shall be considered an anabolic steroid for purposes
of the CSA if it has been created or manufactured with the
intent of producing a drug or other substance that either
promotes muscle growth or causes a pharmacological effect
similar to that of testosterone, or has been, or is intended to
be, marketed or otherwise promoted as such.
Further, it clarifies that a substance shall not be
considered a drug or hormonal substance for such purposes if
any person claiming such exemption provides evidence that it
(A) is an herb or other botanical, or a concentrate,
metabolite, or extract thereof; (B) is a dietary supplement
under the FFDCA; and (C) is not anabolic or androgenic.
Subsection (b) authorizes the Attorney General to issue a
temporary order adding a drug or substance to section 102(41)
if it meets the criteria under such section and doing so will
assist in preventing abuse or misuse of the drug or other
substance. In doing so, the Attorney General must transmit
notice of such order to the Secretary of Health and Human
Services and take into consideration any comments submitted by
the Secretary in response. The Attorney General may commence a
rulemaking to issue a permanent order adding such drug or
substance to section 102(41) simultaneously with the issuance
of such temporary order.
Finally, section 2 imposes enhanced criminal and civil
penalties for possessing or trafficking in any anabolic steroid
or product containing an anabolic steroid that does not bear a
label clearly identifying the anabolic steroid by the
nomenclature used by the International Union of Pure and
Applied Chemistry or is not labeled in a manner that is not
labeled in the manner required under the FFDCA.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT OF 1970
TABLE OF CONTENTS
TITLE II--CONTROL AND ENFORCEMENT
* * * * * * *
Part C--Registration of Manufacturers, Distributors, and Dispensers of
Controlled Substances; Piperidine Reporting
* * * * * * *
Sec. 305A. Offenses involving false labeling of anabolic steroids.
* * * * * * *
TITLE II--CONTROL AND ENFORCEMENT
Part A--Short Title; Findings and Declaration; Definitions
short title
Sec. 100. This title may be cited as the ``Controlled
Substances Act''.
* * * * * * *
definitions
Sec. 102. As used in this title:
(1) * * *
* * * * * * *
(41)
(A) The term ``anabolic steroid'' means any drug or hormonal
substance, chemically and pharmacologically related to
testosterone (other than estrogens, progestins,
corticosteroids, and dehydroepiandrosterone), and includes--
(i) * * *
* * * * * * *
(xlix) trenbolone (17b-hydroxyestr-4,9,11-trien-3-
one); [and]
(l) 5a-Androstan-3,6,17-trione;
(li) 6-bromo-androstan-3,17-dione;
(lii) 6-bromo-androsta-1,4-diene-3,17-dione;
(liii) 4-chloro-17a-methyl-androsta-1,4-diene-3,17b-
diol;
(liv) 4-chloro-17a-methyl-androst-4-ene-3b,17b-diol;
(lv) 4-chloro-17a-methyl-17b-hydroxy-androst-4-en-3-
one;
(lvi) 4-chloro-17a-methyl-17b-hydroxy-androst-4-ene-
3,11-dione;
(lvii) 4-chloro-17a-methyl-androsta-1,4-diene-3,17b-
diol;
(lviii) 2a,17a-dimethyl-17b-hydroxy-5a-androstan-3-
one;
(lix) 2a,17a-dimethyl-17b-hydroxy-5b-androstan-3-one;
(lx) 2a,3a-epithio-17a-methyl-5a-androstan-17b-ol;
(lxi) [3,2-c]-furazan-5a-androstan-17b-ol;
(lxii) 3b-hydroxy-estra-4,9,11-trien-17-one;
(lxiii) 17a-methyl-androst-2-ene-3,17b-diol;
(lxiv) 17a-methyl-androsta-1,4-diene-3,17b-diol;
(lxv) Estra-4,9,11-triene-3,17-dione;
(lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one;
(lxvii) 6a-Methyl-androst-4-ene-3,17-dione;
(lxviii) 17a-Methyl-androstan-3-hydroxyimine-17b-ol;
(lxix) 17a-Methyl-5a-androstan-17b-ol;
(lxx) 17b-Hydroxy-androstano[2,3-d]isoxazole;
(lxxi) 17b-Hydroxy-androstano[3,2-c]isoxazole;
(lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-
c]pyrazole-5a-androstan-17b-ol;
(lxxiii) [3,2-c]pyrazole-androst-4-en-17b-ol;
(lxxiv) [3,2-c]pyrazole-5a-androstan-17b-ol; and
[(xlx)] (lxxv) any salt, ester, or ether of a drug or
substance described in this paragraph.
The substances excluded under this subparagraph may at any time
be scheduled by the Attorney General in accordance with the
authority and requirements of subsections (a) through (c) of
section 201.
* * * * * * *
(C)(i) Subject to clause (ii), a drug or hormonal
substance (other than estrogens, progestins,
corticosteroids, and dehydroepiandrosterone) that is
not listed in subparagraph (A) and is derived from, or
has a chemical structure substantially similar to, 1 or
more anabolic steroids listed in subparagraph (A) shall
be considered to be an anabolic steroid for purposes of
this Act if--
(I) the drug or substance has been created or
manufactured with the intent of producing a
drug or other substance that either--
(aa) promotes muscle growth; or
(bb) otherwise causes a
pharmacological effect similar to that
of testosterone; or
(II) the drug or substance has been, or is
intended to be, marketed or otherwise promoted
in any manner suggesting that consuming it will
promote muscle growth or any other
pharmacological effect similar to that of
testosterone.
(ii) A substance shall not be considered to be a drug
or hormonal substance for purposes of this subparagraph
if it--
(I) is--
(aa) an herb or other botanical;
(bb) a concentrate, metabolite, or
extract of, or a constituent isolated
directly from, an herb or other
botanical; or
(cc) a combination of 2 or more
substances described in item (aa) or
(bb);
(II) is a dietary ingredient for purposes of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.); and
(III) is not anabolic or androgenic.
(iii) In accordance with section 515(a), any person
claiming the benefit of an exemption or exception under
clause (ii) shall bear the burden of going forward with
the evidence with respect to such exemption or
exception.
* * * * * * *
Part B--Authority To Control; Standards and Schedules
authority and criteria for classification of substances
Sec. 201. (a) * * *
* * * * * * *
(i) Temporary and Permanent Scheduling of Recently Emerged
Anabolic Steroids.--
(1) The Attorney General may issue a temporary order
adding a drug or other substance to the definition of
anabolic steroids if the Attorney General finds that--
(A) the drug or other substance satisfies the
criteria for being considered an anabolic
steroid under section 102(41) but is not listed
in that section or by regulation of the
Attorney General as being an anabolic steroid;
and
(B) adding such drug or other substance to
the definition of anabolic steroids will assist
in preventing abuse or misuse of the drug or
other substance.
(2) An order issued under paragraph (1) shall not
take effect until 30 days after the date of the
publication by the Attorney General of a notice in the
Federal Register of the intention to issue such order
and the grounds upon which such order is to be issued.
The order shall expire not later than 24 months after
the date it becomes effective, except that the Attorney
General may, during the pendency of proceedings under
paragraph (6), extend the temporary scheduling order
for up to 6 months.
(3) The Attorney General shall transmit notice of an
order proposed to be issued under paragraph (1) to the
Secretary of Health and Human Services. In issuing an
order under paragraph (1), the Attorney General shall
take into consideration any comments submitted by the
Secretary in response to a notice transmitted pursuant
to this paragraph.
(4) A temporary scheduling order issued under
paragraph (1) shall be vacated upon the issuance of a
permanent scheduling order under paragraph (6).
(5) An order issued under paragraph (1) is not
subject to judicial review.
(6) The Attorney General may, by rule, issue a
permanent order adding a drug or other substance to the
definition of anabolic steroids if such drug or other
substance satisfies the criteria for being considered
an anabolic steroid under section 102(41). Such
rulemaking may be commenced simultaneously with the
issuance of the temporary order issued under paragraph
(1).
* * * * * * *
Part C--Registration of Manufacturers, Distributors, and Dispensers of
Controlled Substances; Piperidine Reporting
* * * * * * *
SEC. 305A. OFFENSES INVOLVING FALSE LABELING OF ANABOLIC STEROIDS.
(a) Unlawful Acts.--
(1) It shall be unlawful--
(A) to import into the United States or to
export from the United States;
(B) to manufacture, distribute, dispense,
sell, or offer to sell; or
(C) to possess with intent to manufacture,
distribute, dispense, sell, or offer to sell;
any anabolic steroid, or any product containing an
anabolic steroid, that does not bear a label clearly
identifying any anabolic steroid contained in such
steroid or product by the nomenclature used by the
International Union of Pure and Applied Chemistry
(IUPAC).
(2)(A) A product described in subparagraph (B) is
exempt from the International Union of Pure and Applied
Chemistry nomenclature requirement of this subsection
if such product is labeled in the manner required under
the Federal Food, Drug, and Cosmetic Act.
(B) A product is described in this subparagraph if
the product--
(i) is the subject of an approved application
as described in section 505(b) or (j) of the
Federal Food, Drug, and Cosmetic Act; or
(ii) is exempt from the provisions of section
505 of such Act relating to new drugs because--
(I) it is intended solely for
investigational use as described in
section 505(i) of such Act; and
(II) such product is being used
exclusively for purposes of a clinical
trial that is the subject of an
effective investigational new drug
application.
(b) Criminal Penalties.--Any person who violates subsection
(a) knowing, intending, or having reasonable cause to believe,
that the substance or product is an anabolic steroid, or
contains an anabolic steroid, shall be sentenced to a term of
imprisonment of not more than 10 years, a fine not to exceed
the greater of that authorized in accordance with the
provisions of title 18, United States Code, or $500,000 if the
defendant is an individual or $2,500,000 if the defendant is
other than an individual, or both.
(c) Civil Penalties.--
(1) Any person who violates subsection (a) shall be
subject to a civil penalty as follows:
(A) In the case of an importer, exporter,
manufacturer, or distributor (other than as
provided in subparagraph (B)), up to $500,000
per violation. For purposes of this
subparagraph, a violation is defined as each
instance of importation, exportation,
manufacturing, or distribution, and each
anabolic steroid or product imported, exported,
manufactured, or distributed.
(B) In the case of a sale or offer to sell at
retail, up to $25,000 per violation. For
purposes of this subparagraph, each sale and
each product offered for sale shall be
considered a separate violation. Continued
offers to sell by a person 10 or more days
after written notice (including through
electronic message) to the person by the
Attorney General or the Secretary shall be
considered additional violations.
(2) In this subsection, the term ``product'' means a
discrete article, either in bulk or in finished form
prepared for sale. A number of articles, if similarly
packaged and bearing identical labels, shall be
considered as one product, but each package size, form,
or differently labeled article shall be considered a
separate product.
(d) Identification and Publication of List of Products
Containing Anabolic Steroids.--
(1) The Attorney General may, in his discretion,
collect data and analyze products to determine whether
they contain anabolic steroids and are properly labeled
in accordance with this section. The Attorney General
may publish in the Federal Register or on the website
of the Drug Enforcement Administration a list of
products that he has determined, based on substantial
evidence, contain an anabolic steroid and are not
labeled in accordance with this section.
(2) The absence of a product from the list referred
to in paragraph (1) shall not constitute evidence that
the product does not contain an anabolic steroid.
* * * * * * *