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II
113th CONGRESS
2d Session
S. 2012
IN THE SENATE OF THE UNITED STATES
February 11, 2014
Mr. Whitehouse (for himself and Mr. Hatch) introduced the following bill; which was read twice and referred to the Committee on the Judiciary
A BILL
To amend the Controlled Substances Act to more effectively regulate anabolic steroids.
1.
Short
title
This Act may be cited as
the Designer Anabolic Steroid Control Act of 2014.
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 (lxxvii); and
(C)
by inserting
after clause (xlix) the following:
(l)
5α-Androstan-3,6,17-trione;
(li)
Androst-4-ene-3,6,17-trione;
(lii)
Androsta-1,4,6-triene-3,17-dione;
(liii)
6-bromo-androstan-3,17-dione;
(liv)
6-bromo-androsta-1,4-diene-3,17-dione;
(lv)
4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;
(lvi)
4-chloro-17α-methyl-androst-4-ene-3β,17β-diol;
(lvii)
4-chloro-17α-methyl-17β-hydroxy-androst-4-en-3-one;
(lviii)
4-chloro-17α-methyl-17β-hydroxy-androst-4-ene-3,11-dione;
(lix)
4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;
(lx)
2α,17α-dimethyl-17β-hydroxy-5α-androstan-3-one;
(lxi)
2α,17α-dimethyl-17β-hydroxy-5β-androstan-3-one;
(lxii)
2α,3α-epithio-17α-methyl-5α-androstan-17β-ol;
(lxiii)
[3,2-c]-furazan-5α-androstan-17β-ol;
(lxiv)
3β-hydroxy-estra-4,9,11-trien-17-one;
(lxv)
17α-methyl-androst-2-ene-3,17β-diol;
(lxvi)
17α-methyl-androsta-1,4-diene-3,17β-diol;
(lxvii)
Estra-4,9,11-triene-3,17-dione;
(lxviii)
18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one;
(lxix)
6α-Methyl-androst-4-ene-3,17-dione;
(lxx)
17α-Methyl-androstan-3-hydroxyimine-17β-ol;
(lxxi)
17α-Methyl-5α-androstan-17β-ol;
(lxxii)
17β-Hydroxy-androstano[2,3-d]isoxazole;
(lxxiii)
17β-Hydroxy-androstano[3,2-c]isoxazole;
(lxxiv)
4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole-5α-androstan-17β-ol;
(lxxv)
[3,2-c]pyrazole-androst-4-en-17β-ol;
(lxxvi)
[3,2-c]pyrazole-5α-androstan-17β-ol;
and
;
and
(2)
by adding at the
end the following:
(C)
(i)
Subject to clause (ii)
and the limitations under section 201(i)(6), 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); and
(II)
is a dietary ingredient for purposes of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(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
list 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 list of anabolic steroids will assist in
preventing
the unlawful importation, manufacture, distribution, or dispensing
of such 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 (5), extend the temporary scheduling
order for up
to 6 months.
(3)
A temporary
scheduling order issued under paragraph (1) shall be vacated upon
the issuance
of a permanent scheduling order under paragraph (5).
(4)
An order issued
under paragraph (1) is not subject to judicial review.
(5)
The Attorney
General may, by rule, issue a permanent order adding a drug or
other substance
to the list 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).
(6)
If a drug or
other substance has not been temporarily or permanently added to
the list of
anabolic steroids pursuant to this subsection, the drug or other
substance
shall be considered an anabolic steroid if in any criminal, civil,
or
administrative proceeding arising under this Act it has been
determined in such
proceeding, based on evidence presented in the proceeding, that the
substance
satisfies the criteria for being considered an anabolic steroid
under paragraph
(41)(A), (41)(C)(i), or (41)(C)(ii) of section
102.
.
(c)
Labeling
requirements
(1)
In general
The Controlled Substances Act is amended by
inserting after section 305 (21 U.S.C. 825) the following:
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,
unless it
bears 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 product that is
the subject of an approved application as described in section
505(b), (i) or
(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b),
(i), or (j))
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 by the Federal Food, Drug, and Cosmetic Act.
(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.
.
3.
Sentencing
commission guidelines
The
United States Sentencing Commission shall—
(1)
review and amend
the Federal sentencing guidelines with respect to offenses involving
anabolic
steroids, including the offenses under section 305A of
the
Controlled Substance Act, as added by section 2;
(2)
amend the Federal
sentencing guidelines, including notes to the drug quantity tables, to
provide
clearly that in a case involving an anabolic steroid not in a tablet,
capsule,
liquid, or other form where dosage can be readily ascertained (such as a
powder, topical cream, gel, or aerosol), the sentence shall be determined
based
on the entire weight of the mixture or substance;
(3)
amend the
applicable guidelines by designating quantities of mixture or substance
that
correspond to a unit so that offenses involving such forms of anabolic
steroids
are penalized at least as severely as offenses involving forms whose
dosage can
be readily ascertained; and
(4)
take such other
action as the Commission considers necessary to carry out this Act and
this
section.
4.
Congressional
oversight
The Administrator of
the Drug Enforcement Administration shall report to Congress every 2
years—
(1)
what anabolic
steroids have been scheduled on a temporary basis under the provisions of
this
Act; and
(2)
the findings and
conclusions that led to such scheduling.