H. Rept. 113-587 - DESIGNER ANABOLIC STEROID CONTROL ACT OF 2014 (Parts 1 - 2)113th Congress (2013-2014)
Committee Report
Reports for H.R.4771
H. Rept. 113-587, Part 2 - 113th Congress (2013-2014)
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House Report 113-587 - DESIGNER ANABOLIC STEROID CONTROL ACT OF 2014
[House Report 113-587]
[From the U.S. Government Publishing Office]
113th Congress } { Rept. 113-587
HOUSE OF REPRESENTATIVES
2d Session } { Part 2
======================================================================
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. Goodlatte, from the Committee on the Judiciary, 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 the Judiciary, 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, reports favorably thereon with an amendment and
recommends that the bill as amended do pass.
CONTENTS
Page
The Amendment.................................................... 1
Purpose and Summary.............................................. 4
Background and Need for the Legislation.......................... 4
Hearings......................................................... 5
Committee Consideration.......................................... 5
Committee Votes.................................................. 6
Committee Oversight Findings..................................... 6
New Budget Authority and Tax Expenditures........................ 6
Congressional Budget Office Cost Estimate........................ 6
Duplication of Federal Programs.................................. 8
Disclosure of Directed Rule Makings.............................. 8
Performance Goals and Objectives................................. 8
Advisory on Earmarks............................................. 8
Section-by-Section Analysis...................................... 8
Changes in Existing Law Made by the Bill, as Reported............ 10
The Amendment
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).''.
SEC. 3. LABELING REQUIREMENTS.
(a) In General.--Section 305 of the Controlled Substances Act (21
U.S.C. 825) is amended by adding at the end the following:
``(e) False Labeling of Anabolic Steroids.--
``(1) It shall be unlawful to import, export, manufacture,
distribute, dispense, or possess with intent to manufacture,
distribute, or dispense, an anabolic steroid or product
containing an anabolic steroid, unless the steroid or product
bears a label clearly identifying an anabolic steroid or
product containing an anabolic steroid 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) Clarification to Import and Export Statute.--Section 1010 of the
Controlled Substances Import and Export Act (21 U.S.C. 960) is amended,
in subsection (a)(1), by inserting ``305,'' before ``1002''.
(c) Civil Penalties.--Section 402 of the Controlled Substances Act
(21 U.S.C. 842) is amended--
(1) in subsection (a)--
(A) in paragraph (14), by striking ``or'' at the end;
(B) in paragraph (15), by striking the period at the
end and inserting ``; or''; and
(C) by inserting, after paragraph (15), the
following:
``(16) to violate subsection (e) of section 305 of the
Controlled Substances Act.''; and
(2) in subsection (c)(1)--
(A) by inserting, in subparagraph (A), after
``subparagraph (B)'' the following: ``, (C), or (D)'';
and
(B) by inserting after subparagraph (B) the
following:
``(C) In the case of a violation of paragraph (16) of subsection (a)
of this section by an importer, exporter, manufacturer, or distributor
(other than as provided in subparagraph (D)), up to $500,000 per
violation. For purposes of this subparagraph, a violation is defined as
each instance of importation, exportation, manufacturing, distribution,
or possession with intent to manufacture or distribute, in violation of
paragraph (16) of subsection (a).
``(D) In the case of a distribution, dispensing, or possession with
intent to distribute or dispense in violation of paragraph (16) of
subsection (a) of this section at the retail level, up to $1000 per
violation. For purposes of this paragraph, the term `at the retail
level' refers to products sold, or held for sale, directly to the
consumer for personal use. Each package, container or other separate
unit containing an anabolic steroid that is distributed, dispensed, or
possessed with intent to distribute or dispense at the retail level in
violation of paragraph (16) of subsection (a) shall be considered a
separate violation.''.
SEC. 4. IDENTIFICATION AND PUBLICATION OF LIST OF PRODUCTS CONTAINING
ANABOLIC STEROIDS.
(a) 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.
(b) The absence of a product from the list referred to in subsection
(a) shall not constitute evidence that the product does not contain an
anabolic steroid.
Purpose and Summary
H.R. 4771 is intended to more effectively regulate anabolic
steroids. It does this by adding 25 new ``designer'' chemicals,
all of which have been marketed as anabolic steroids, to the
list of substances that meet the Controlled Substances Act
(``CSA'') definition of anabolic steroid.
H.R. 4771 amends the CSA's scheduling authority to allow
the Attorney General to issue a temporary order adding a drug
or other substance to the list of anabolic steroids if he
determines: (1) that the drug or other substance is an anabolic
steroid, and (2) adding the drug or other substance to the list
of anabolic steroids will assist in preventing the unlawful
importation, manufacture, distribution or dispensing of the
drug or other substance.
H.R. 4771 also establishes a new subsection (e) in section
305 of the CSA (21 U.S.C. Sec. 825) criminalizing the false
labeling of anabolic steroids or substances containing anabolic
steroids, and establishes new civil penalties for violations.
Finally, the legislation gives the Attorney General the
authority to publish, in the Federal Register, a list of
products that contain anabolic steroids and are improperly
labeled.
Background and Need for the Legislation
Anabolic steroids are synthetically-produced variants of
the naturally occurring male hormone testosterone (``anabolic''
means that the substance affects the body in a similar fashion
as testosterone). They are currently listed as controlled
substances under Schedule III of the CSA (21 U.S.C.
Sec. 802(41)). Only a small number of anabolic steroids are
approved for either human or veterinary use. They may be
prescribed by a physician for the treatment of a variety of
therapeutic uses, including testosterone deficiency, delayed
puberty, low red blood cell count, breast cancer, and tissue
wasting resulting from AIDS. However, anabolic steroids are
also used illicitly as performance-enhancing drugs. Long-term
or high-dosage use of these substances can have severe adverse
health effects, including dramatic mood swings, increased
feelings of hostility, increased levels of aggression, and
stunted level of growth in children, as well as heart and liver
damage.
Unlike most other controlled substances, anabolic steroids
are often disguised as legal products such as dietary
supplements. This poses a substantial risk to consumers.
Although anabolic steroids are listed as controlled substances
in Schedule III of the CSA, chemists are able to create
``designer'' anabolic steroids that are chemically distinct
from the listed steroids but have the same pharmacological
effect. The Drug Enforcement Administration (DEA), which
enforces the CSA on behalf of the Attorney General, cannot take
enforcement action against those who manufacture, market, or
distribute unscheduled anabolic steroids. This poses a
significant risk to consumers, especially if the ``designer''
anabolic steroids are being falsely marketed as dietary
supplements.
During full Committee consideration of H.R. 4771, the
Judiciary Committee adopted by voice vote an amendment in the
nature of a substitute. The amendment preserves several
provisions in the bill as reported by the Committee on Energy
and Commerce, including the addition of 25 new chemicals to the
definition of anabolic steroids in the CSA; the amendment to
DEA's temporary and permanent scheduling authority; and the
provision giving the Attorney General the authority to publish
a list of improperly labeled substances.
The substitute amendment substantially revises the criminal
and civil penalties contained in the bill as reported by the
Committee on Energy and Commerce, which created a new section
of the CSA criminalizing the false labeling of anabolic
steroids and assigning criminal and civil penalties. The
Committee on the Judiciary concluded that creation of a new
section of the CSA to prohibit the false labeling of anabolic
steroids is redundant and unnecessary. Rather, the substitute
amendment achieves this prohibition by amending existing
section 305 of the CSA (21 U.S.C. Sec. 825) (relating to
labeling and packaging). In doing so, the amendment builds upon
the existing statutory framework for imposing civil penalties
for this type of conduct. See 21 U.S.C. Sec. 842. The CSA
currently prohibits the unlawful importation, exportation,
manufacture, distribution, or dispensation of a schedule III
controlled substance. See 21 U.S.C. Sec. 841(b)(1)(E)).
Therefore, the Committee concluded that it was unnecessary to
create a new criminal offense for the false labeling of
anabolic steroids where the elements of such offense are
largely consistent with existing law.
Hearings
The Committee on the Judiciary held no hearings on H.R.
4771.
Committee Consideration
On September 10, 2014, the Committee met in open session
and ordered the bill H.R. 4771 reported, with an amendment, by
voice vote, a quorum being present.
Committee Votes
In compliance with clause 3(b) of rule XIII of the Rules of
the House of Representatives, the Committee advises that there
were no recorded votes during the Committee's consideration of
H.R. 4771.
Committee Oversight Findings
In compliance with clause 3(c)(1) of rule XIII of the Rules
of the House of Representatives, the Committee advises that the
findings and recommendations of the Committee, based on
oversight activities under clause 2(b)(1) of rule X of the
Rules of the House of Representatives, are incorporated in the
descriptive portions of this report.
New Budget Authority and Tax Expenditures
Clause 3(c)(2) of rule XIII of the Rules of the House of
Representatives is inapplicable because this legislation does
not provide new budgetary authority or increased tax
expenditures.
Congressional Budget Office Cost Estimate
In compliance with clause 3(c)(3) of rule XIII of the Rules
of the House of Representatives, the Committee sets forth, with
respect to the bill, H.R.4771, the following estimate and
comparison prepared by the Director of the Congressional Budget
Office under section 402 of the Congressional Budget Act of
1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, September 15, 2014.
Hon. Bob Goodlatte, Chairman,
Committee on the Judiciary,
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, who can be reached at 226-2860.
Sincerely,
Douglas W. Elmendorf,
Director.
Enclosure
cc:
Honorable John Conyers, Jr.
Ranking Member
H.R. 4771--Designer Anabolic Steroid Control Act of 2014.
As ordered reported by the House Committee on the Judiciary
on September 15, 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.
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 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), 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 ($152 million in
2014, adjusted annually for inflation).
The bill also would impose a private-sector 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.
On July 25, 2014, CBO transmitted a cost estimate for H.R.
4771 as ordered reported by the House Committee on Energy and
Commerce on July 15, 2014. The estimate of Federal costs is the
same for the two versions of the bill.
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.
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 No. 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 H.R. 4771 specifically directs
to be completed no specific rule makings within the meaning of
5 U.S.C. Sec. 551.
Performance Goals and Objectives
The Committee states that pursuant to clause 3(c)(4) of
rule XIII of the Rules of the House of Representatives, H.R.
4771 is intended to more effectively regulate anabolic
steroids.
Advisory on Earmarks
In accordance with clause 9 of rule XXI of the Rules of the
House of Representatives, H.R. 4771 does not contain any
congressional earmarks, limited tax benefits, or limited tariff
benefits as defined in clause 9(e), 9(f), or 9(g) of Rule XXI.
Section-by-Section Analysis
The following discussion describes the bill as reported by
the Committee.
Sec. 1. Short Title. This section cites the short title of
the bill as the ``Designer Anabolic Steroid Control Act of
2014.''
Sec. 2. Amendments to the Controlled Substances Act. This
section adds 25 new substances to the list of what constitutes
an anabolic steroid under section 402 of the CSA (21 U.S.C.
Sec. 802). This section also amends the definition of anabolic
steroid to include substances that promote muscle growth,
otherwise cause a pharmacological effect similar to
testosterone, or are marketed in a manner suggesting that the
substances do either of those things. The definition excludes
from the definition of anabolic steroid herbs or other
botanicals, concentrates, metabolites, or extracts of, or
constituents isolated directly from, an herb or other
botanical, or any combination of the two; dietary ingredients
for purposes of the Federal Food, Drug, or Cosmetic Act; or
substances that are not anabolic or androgenic.
Section 2 also authorizes the Attorney General to issue a
temporary order adding a drug or other substance to the
definition of anabolic steroids if the Attorney General finds
(1) that the drug or other substance satisfies the criteria for
being considered an anabolic steroid but is not listed in the
CSA or the relevant regulations as being an anabolic steroid;
and (2) adding the drug or other substance to the definition of
anabolic steroids will assist in preventing abuse or misuse of
the drug or other substance. This section imposes a timeline
upon the Attorney General for issuing such an order, and allows
the Attorney General to extend the order once for up to six (6)
months. This section also requires the Attorney General to
transmit notice of a proposed order to the Secretary of Health
and Human Services; provides that a temporary scheduling order
shall be vacated upon the issuance of a permanent scheduling
order; provides that a temporary scheduling order is not
subject to judicial review; and provides that the Attorney
General may initiate a rulemaking to control a drug or other
substance simultaneously with the temporary scheduling order.
Sec. 3. Labeling Requirements. This section adds a new
subsection (e) to section 305 of the CSA (21 U.S.C. Sec. 825)
prohibiting the importation, exportation, manufacture,
distribution, or dispensation--or possession with intent to
manufacture, distribute, or dispense--an anabolic steroid
unless the anabolic steroid is clearly labeled using the
nomenclature of the International Union of Pure and Applied
Chemistry (IUPAC). IUPAC has long been recognized as the world
authority on chemical nomenclature. This section exempts drugs
or other substances from the IUPAC nomenclature requirement if
the product(s) are labeled in the manner required under the
Federal Food, Drug, and Cosmetic Act. Violations of the new
subsection (e) are subject to civil penalties contained in
section 402 of the CSA (21 U.S.C. Sec. 842) as described below.
This section adds a new paragraph (16) to section 402(a) of
the CSA (21 U.S.C. Sec. 842(a)), which provides that violations
of section 825(e) are subject to civil penalties under the CSA.
Section 3 creates new civil penalties in subsection (c) of
section 402 for violations of paragraph (16). False labeling
violations by importers, exporters, manufacturers, or
distributors, but not retailers, are punishable by a fine of up
to $500,000 per violation. ``Violation'' is defined as ``each
instance'' of importation, exportation, manufacturing,
distribution, or possession with intent to manufacture or
distribute, in violation of paragraph (16). In the case, for
example, of a shipping container that is wrapped and
transported as one cohesive item but holds within it thousands
of boxes containing tens of thousands of individual bottles or
packages, this section would treat that shipping container as
one ``instance'' (and hence one violation) punishable by a
civil fine of up to $500,000.
With regard to distribution, dispensing, or possession with
intent to distribute or dispense at the retail level, Section 3
imposes a civil penalty of up to $1,000 per violation. ``At the
retail level'' is defined as products sold, or held for sale,
directly to the consumer for personal use. This would include
not only products held for sale on the shelves of a retail
establishment, but also the products held in stock. Each
package, container or other separate unit containing an
anabolic steroid that is distributed, dispensed, or possessed
with intent to distribute or dispense at the retail level is
considered to be a separate violation.
Section 3 also amends the Controlled Substances Import and
Export Act (21 U.S.C. Sec. 960 et seq.) to clarify that
violations of subsection (e) involving the importation or
exportation of falsely-labeled anabolic steroids may be
punished in accordance with the provisions of the Import and
Export Act.
Sec. 4. Identification and Publication of List of Products
Containing Anabolic Steroids. This section gives the Attorney
General the authority to collect data and analyze products to
determine whether they contain anabolic steroids and are
properly labeled in accordance with this section, and to
publish in the Federal Register, or on the DEA website, a list
of products that he has determined contain an anabolic steroid
and are not appropriately labeled.
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 italics, existing law in which no change
is proposed is shown in roman):
CONTROLLED SUBSTANCES ACT
* * * * * * *
TITLE II--CONTROL AND ENFORCEMENT
* * * * * * *
Part A--Short Title; Findings and Declaration; Definitions
* * * * * * *
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;
(lxx) 17b-Hydroxy-androstano[2,3-d]isoxazole;
(lxix) 17a-Methyl-5a-androstan-17b-ol;
(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.
* * * * * * *
(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
* * * * * * *
labeling and packaging requirements
Sec. 305. (a) * * *
* * * * * * *
(e) False Labeling of Anabolic Steroids.--
(1) It shall be unlawful to import, export,
manufacture, distribute, dispense, or possess with
intent to manufacture, distribute, or dispense, an
anabolic steroid or product containing an anabolic
steroid, unless the steroid or product bears a label
clearly identifying an anabolic steroid or product
containing an anabolic steroid 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.
* * * * * * *
Part D--Offenses and Penalties
* * * * * * *
prohibited acts b--penalties
Sec. 402. (a) It shall be unlawful for any person--
(1) * * *
* * * * * * *
(14) who is a regulated seller or an employee or
agent of such seller to disclose, in violation of
regulations under subparagraph (C) of section
310(e)(1), information in logbooks under subparagraph
(A)(iii) of such section, or to refuse to provide such
a logbook to Federal, State, or local law enforcement
authorities; [or]
(15) to distribute a scheduled listed chemical
product to a regulated seller, or to a regulated person
referred to in section 310(b)(3)(B), unless such
regulated seller or regulated person is, at the time of
such distribution, currently registered with the Drug
Enforcement Administration, or on the list of persons
referred to under section 310(e)(1)(B)(v)[.]; or
(16) to violate subsection (e) of section 305 of
the Controlled Substances Act.
As used in paragraph (11), the term ``laboratory supply'' means
a listed chemical or any chemical, substance, or item on a
special surveillance list published by the Attorney General,
which contains chemicals, products, materials, or equipment
used in the manufacture of controlled substances and listed
chemicals. For purposes of paragraph (11), there is a
rebuttable presumption of reckless disregard at trial if the
Attorney General notifies a firm in writing that a laboratory
supply sold by the firm, or any other person or firm, has been
used by a customer of the notified firm, or distributed further
by that customer, for the unlawful production of controlled
substances or listed chemicals a firm distributes and 2 weeks
or more after the notification the notified firm distributes a
laboratory supply to the customer. For purposes of paragraph
(15), if the distributor is temporarily unable to access the
list of persons referred to under section 310(e)(1)(B)(v), the
distributor may rely on a written, faxed, or electronic copy of
a certificate of self-certification submitted by the regulated
seller or regulated person, provided the distributor confirms
within 7 business days of the distribution that such regulated
seller or regulated person is on the list referred to under
section 310(e)(1)(B)(v).
* * * * * * *
(c)(1)(A) Except as provided in subparagraph (B), (C), or
(D) of this paragraph and paragraph (2), any person who
violates this section shall, with respect to any such
violation, be subject to a civil penalty of not more than
$25,000. The district courts of the United States (or, where
there is no such court in the case of any territory or
possession of the United States, then the court in such
territory or possession having the jurisdiction of a district
court of the United States in cases arising under the
Constitution and laws of the United States) shall have
jurisdiction in accordance with section 1355 of title 28 of the
United States Code to enforce this paragraph.
* * * * * * *
(C) In the case of a violation of paragraph (16) of
subsection (a) of this section by an importer, exporter,
manufacturer, or distributor (other than as provided in
subparagraph (D)), up to $500,000 per violation. For purposes
of this subparagraph, a violation is defined as each instance
of importation, exportation, manufacturing, distribution, or
possession with intent to manufacture or distribute, in
violation of paragraph (16) of subsection (a).
(D) In the case of a distribution, dispensing, or
possession with intent to distribute or dispense in violation
of paragraph (16) of subsection (a) of this section at the
retail level, up to $1000 per violation. For purposes of this
paragraph, the term ``at the retail level'' refers to products
sold, or held for sale, directly to the consumer for personal
use. Each package, container or other separate unit containing
an anabolic steroid that is distributed, dispensed, or
possessed with intent to distribute or dispense at the retail
level in violation of paragraph (16) of subsection (a) shall be
considered a separate violation.
* * * * * * *
----------
CONTROLLED SUBSTANCES IMPORT AND EXPORT ACT
* * * * * * *
TITLE III--IMPORTATION AND EXPORTATION; AMENDMENTS AND REPEALS OF
REVENUE LAWS
* * * * * * *
Part A--Importation and Exportation
* * * * * * *
prohibited acts a--penalties
Sec. 1010. (a) Any person who--
(1) contrary to section 305, 1002, 1003, or 1007,
knowingly or intentionally imports or exports a
controlled substance,
* * * * * * *
shall be punished as provided in subsection (b).
* * * * * * *
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