II
115th CONGRESS
2d Session
S. 2742
IN THE SENATE OF THE UNITED STATES
April 24, 2018
Mr. Hatch (for himself and Mr. Whitehouse) 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 selective androgen receptor modulators, and for other purposes.
Short title
This Act may be cited as the
Selective Androgen Receptor Modulators Control Act of
2018
or the SARMs Control Act of
2018
.
Amendments to the Controlled Substances Act
Definition
Section 102 of the Controlled Substances Act (21 U.S.C. 802) is amended by adding at the end the following:
The term SARM—
means any drug or other substance that is a selective androgen receptor agonist chemically unrelated to testosterone, estrogens, progestins, corticosteroids, and dehydroepiandrosterone; and
includes—
(S)-N-(4-cyano-3-(trifluoromethyl)phenyl)-3-(4-cyanophenoxy)-2-hydroxy-2-methylpropanamide
(commonly known as ostarine
or
enobosarm
);
4-((R)-2-((R)-2,2,2-trifluoro-1-hydroxyethyl)pyrrolidin-1-yl)-2-(trifluoromethyl)benzonitrile
(commonly known as LGD-4033
or
ligandrol
);
9-chloro-2-ethyl-1-methyl-3-(2,2,2-trifluoroethyl)-3,6-dihydro-7H-pyrrolo[3,2-f]quinolin-7-one
(commonly known as LGD-3303
);
isopropyl
(S)-(7-cyano-4-(pyridin-2-ylmethyl)-1,2,3,4-tetrahydrocyclopenta[b]indol-2
-yl)carbamate
(commonly known as LY2452473
or
TT701
);
2-chloro-4-(((1R,2S)-1-(5-(4-cyanophenyl)-1,3,4-oxadiazol-2-yl)-2-
hydroxypropyl)amino)-3-methylbenzonitrile (commonly
known as RAD-140
);
(S)-3-(4-acetamidophenoxy)-2-hydroxy-2-methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)propanamide
(commonly known as andarine
);
2-chloro-4-((7R,7aS)-7-hydroxy-1,3-dioxotetrahydro-1H-pyrrolo[1,2-c]imidazol-
2(3H)-yl)-3-methylbenzonitrile (commonly
known as
BMS-564929
);
6-ethyl-4-(trifluoromethyl)-6,7,8,9-tetrahydropyrido[3,2-g]quinolin-2(1H)-one
(commonly known as LG-121071
);
(S)-3-(4-chloro-3-fluorophenoxy)-N-(4-cyano-3-(trifluoromethyl)phenyl)-2-hydroxy-
2-methylpropanamide (commonly known as S-23
); and
any salt, ester, ether, or substituted analogue of a drug or other substance described in subclauses (I) through (IX).
A substance excluded under subparagraph (A)(i) may at any time be scheduled by the Attorney General in accordance with the authority and requirements under subsections (a) through (c) of section 201 (21 U.S.C. 811).
A drug or other substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone, unless scheduled under subparagraph (B)) that is not listed in subparagraph (A)(ii) and is derived from, or has a chemical structure substantially similar to, 1 or more SARMs listed in subparagraph (A)(ii) shall be considered to be a SARM for purposes of this title if the drug or other substance—
has been created or manufactured with the intent of producing a drug or other substance that—
promotes muscle growth; or
otherwise causes a pharmacological effect similar to that of testosterone; or
has been, or is intended to be, marketed or otherwise promoted in any manner suggesting that consuming the drug or other substance will promote muscle growth or any other pharmacological effect similar to that of testosterone.
A drug or other substance shall not be considered to be a SARM for purposes of this subparagraph if the drug or other substance—
is—
an herb or other botanical;
a concentrate, metabolite, or extract of, or a constituent isolated directly from, an herb or other botanical; or
a combination of 2 or more substances described in item (aa) or (bb);
is a dietary ingredient for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and
is not anabolic or androgenic.
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 that exemption or exception.
.
Amendment to schedule III
Schedule III in section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) is amended by adding at the end the following:
SARMs.
.
Temporary and permanent scheduling of recently emerged SARMs
Section 201 of the Controlled Substances Act (21 U.S.C. 811) is amended by adding at the end the following:
Temporary and permanent scheduling of recently emerged SARMs
Temporary orders
In general
The Attorney General may issue a temporary order adding a drug
or other substance to the
definition of the term
SARM
under section 102(57) if the Attorney
General finds that—
the drug or other substance satisfies the criteria for being considered a SARM but is not listed in that section or by regulation of the Attorney General as being a SARM; and
adding the drug or other substance to the definition of the term SARM will assist in preventing abuse or misuse of the drug or other substance.
Effective date; duration
A temporary order issued under subparagraph (A)—
shall take effect not earlier than 30 days after the date of publication by the Attorney General of a notice in the Federal Register of—
the intention of the Attorney General to issue the temporary order; and
the grounds on which the temporary order is to be issued; and
shall expire not later than 2 years after the date on which the temporary order becomes effective, except that the Attorney General may, during the pendency of proceedings under paragraph (2), extend the temporary order for not more than 6 months.
Notice to Secretary of Health and Human Services
In general
The Attorney General shall transmit notice of a temporary order proposed to be issued under subparagraph (A) to the Secretary of Health and Human Services.
Consideration
In issuing a temporary order under subparagraph (A), the Attorney General shall take into consideration any comments submitted by the Secretary of Health and Human Services in response to a notice transmitted under this subparagraph.
Effect of permanent scheduling
A temporary order issued under subparagraph (A) shall be vacated upon the issuance of a permanent order issued under paragraph (2).
Judicial review
A temporary order issued under subparagraph (A) shall not be subject to judicial review.
Permanent orders
In general
The Attorney General may by rule issue a permanent order
adding a drug or other
substance to the definition of the term
SARM
under section 102(57) if the drug or
other substance satisfies
the criteria for being considered a
SARM under that section.
Timing
The Attorney General may commence a rulemaking under subparagraph (A) simultaneously with the issuance of a temporary order under paragraph (1).
.
Labeling requirements
In general
Section 305 of the Controlled Substances Act (21 U.S.C. 825) is amended by adding at the end the following:
False labeling of SARMs
Prohibition
It shall be unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense, a SARM or product containing a SARM, unless the SARM or product containing the SARM bears a label clearly identifying the SARM or product containing the SARM by the nomenclature used by the International Union of Pure and Applied Chemistry.
Exemption
In general
A SARM or product containing a SARM described in subparagraph (B) shall be exempt from the International Union of Pure and Applied Chemistry nomenclature requirement under paragraph (1) if the SARM or product containing a SARM is labeled in the manner required under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
Exempt products
A SARM or product containing a SARM is described in this subparagraph if the SARM or product containing a SARM—
is the subject of an approved application as described in subsection (b) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); or
is exempt from the provisions of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) relating to new drugs because—
the SARM or product containing a SARM is intended solely for investigational use as described in subsection (i) of that section; and
the SARM or product containing a SARM is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application.
.
Clarification regarding felony drug offenses
Section 102(44) of the Controlled Substances Act (21 U.S.C. 802(44)) is
amended by inserting SARMs,
after anabolic
steroids,
.
Civil penalties
Section 402 of the Controlled Substances Act (21 U.S.C. 842) is amended—
in subsection (a)(16)—
by inserting or (f)
after subsection
(e)
; and
by striking 825
and inserting 305
;
and
in subsection (c)(1)(D), by inserting or a SARM
after
an anabolic steroid
.
Amendments to the Federal Food, Drug, and Cosmetic Act
Section 413(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b(c)) is amended—
in paragraph (1), by striking an
anabolic steroid or an analogue of an anabolic
steroid
and inserting
an anabolic steroid, a SARM, an analogue of an anabolic steroid, or
an analogue of a SARM
; and
in paragraph (2)—
in subparagraph (A), by striking and
at the end;
in subparagraph (B), by striking the period at the end and inserting a semicolon; and
by adding at the end the following:
the term analogue of a SARM means a substance that has a chemical structure that is substantially similar to the chemical structure of a SARM; and
the term SARM has the meaning given the term in section 102(57) of the Controlled Substances Act (21 U.S.C. 802(57)).
.
