[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2895 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                S. 2895

  To amend the Controlled Substances Act to more effectively regulate 
    selective androgen receptor modulators, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           November 19, 2019

Mr. Grassley (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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Selective Androgen Receptor 
Modulators Control Act of 2019'' or the ``SARMs Control Act of 2019''.

SEC. 2. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT.

    (a) Definition.--Section 102 of the Controlled Substances Act (21 
U.S.C. 802) is amended--
            (1) by redesignating paragraph (58) as paragraph (59);
            (2) by redesignating the second paragraph designated as 
        paragraph (57) as paragraph (58);
            (3) by moving paragraphs (57), (58) (as so redesignated), 
        and (59) (as so redesignated) 2 ems to the left; and
            (4) by adding at the end the following:
    ``(60)(A) The term `SARM'--
            ``(i) means any drug or other substance that is a selective 
        androgen receptor agonist chemically unrelated to testosterone, 
        estrogens, progestins, corticosteroids, and 
        dehydroepiandrosterone; and
            ``(ii) includes--
                    ``(I) (S)-N-(4-cyano-3-(trifluoromethyl)phenyl)-3-
                (4-cyanophenoxy)-2-hydroxy-2-methylpropanamide 
                (commonly known as `ostarine' or `enobosarm');
                    ``(II) 4-((R)-2-((R)-2,2,2-trifluoro-1-
                hydroxyethyl)pyrrolidin-1-yl)-2-
                (trifluoromethyl)benzonitrile (commonly known as `LGD-
                4033' or `ligandrol');
                    ``(III) 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');
                    ``(IV) isopropyl (S)-(7-cyano-4-(pyridin-2-
                ylmethyl)-1,2,3,4-tetrahydrocyclopenta[b]indol-2 -
                yl)carbamate (commonly known as `LY2452473' or 
                `TT701');
                    ``(V) 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');
                    ``(VI) (S)-3-(4-acetamidophenoxy)-2-hydroxy-2-
                methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)propanamide 
                (commonly known as `andarine');
                    ``(VII) 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');
                    ``(VIII) 6-ethyl-4-(trifluoromethyl)-6,7,8,9-
                tetrahydropyrido[3,2-g]quinolin-2(1H)-one (commonly 
                known as `LG-121071');
                    ``(IX) (S)-3-(4-chloro-3-fluorophenoxy)-N-(4-cyano-
                3-(trifluoromethyl)phenyl)-2-hydroxy- 2-
                methylpropanamide (commonly known as `S-23'); and
                    ``(X) any salt, ester, ether, or substituted 
                analogue of a drug or other substance described in 
                subclauses (I) through (IX).
    ``(B) 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.
    ``(C)(i) 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, one 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--
            ``(I) has been created or manufactured with the intent of 
        producing a drug or other substance that--
                    ``(aa) promotes muscle growth; or
                    ``(bb) otherwise causes a pharmacological effect 
                similar to that of testosterone; or
            ``(II) 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.
    ``(ii) A drug or other substance shall not be considered to be a 
SARM for purposes of this subparagraph if the drug or other substance--
            ``(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 two 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 that 
exemption or exception.''.
    (b) 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:
    ``(f) SARMs.''.
    (c) 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:
    ``(k) Temporary and Permanent Scheduling of Recently Emerged 
SARMs.--
            ``(1) Temporary orders.--
                    ``(A) 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(60) if 
                the Attorney General finds that--
                            ``(i) 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
                            ``(ii) 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.
                    ``(B) Effective date; duration.--A temporary order 
                issued under subparagraph (A)--
                            ``(i) 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--
                                    ``(I) the intention of the Attorney 
                                General to issue the temporary order; 
                                and
                                    ``(II) the grounds on which the 
                                temporary order is to be issued; and
                            ``(ii) 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.
                    ``(C) Notice to secretary.--
                            ``(i) In general.--The Attorney General 
                        shall transmit notice of a temporary order 
                        proposed to be issued under subparagraph (A) to 
                        the Secretary.
                            ``(ii) Consideration.--In issuing a 
                        temporary order under subparagraph (A), the 
                        Attorney General shall take into consideration 
                        any comments submitted by the Secretary in 
                        response to a notice transmitted under this 
                        subparagraph.
                    ``(D) Effect of permanent scheduling.--A temporary 
                order issued under subparagraph (A) shall be vacated 
                upon the issuance of a permanent order under paragraph 
                (2).
                    ``(E) Judicial review.--A temporary order issued 
                under subparagraph (A) shall not be subject to judicial 
                review.
            ``(2) Permanent orders.--
                    ``(A) 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(60) if the drug or other substance 
                satisfies the criteria for being considered a SARM 
                under that section.
                    ``(B) Timing.--The Attorney General may commence a 
                rulemaking under subparagraph (A) simultaneously with 
                the issuance of a temporary order under paragraph 
                (1).''.
    (d) Labeling Requirements.--
            (1) In general.--Section 305 of the Controlled Substances 
        Act (21 U.S.C. 825) is amended by adding at the end the 
        following:
    ``(f) False Labeling of SARMs.--
            ``(1) 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.
            ``(2) Exemption.--
                    ``(A) 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.).
                    ``(B) Exempt products.--A SARM or product 
                containing a SARM is described in this subparagraph if 
                the SARM or product containing a SARM--
                            ``(i) 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
                            ``(ii) 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--
                                    ``(I) the SARM or product 
                                containing a SARM is intended solely 
                                for investigational use as described in 
                                subsection (i) of that section; and
                                    ``(II) 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.''.
            (2) 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,''.
            (3) Civil penalties.--Section 402 of the Controlled 
        Substances Act (21 U.S.C. 842) is amended--
                    (A) in subsection (a)(16)--
                            (i) by inserting ``or (f)'' after 
                        ``subsection (e)''; and
                            (ii) by striking ``825'' and inserting 
                        ``305''; and
                    (B) in subsection (c)(1)(D), by inserting ``or a 
                SARM'' after ``an anabolic steroid''.

SEC. 3. 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--
            (1) 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
            (2) in paragraph (2)--
                    (A) in subparagraph (A), by striking ``and'' at the 
                end;
                    (B) in subparagraph (B), by striking the period at 
                the end and inserting a semicolon; and
                    (C) by adding at the end the following:
                    ``(C) 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
                    ``(D) the term `SARM' has the meaning given the 
                term in section 102(60) of the Controlled Substances 
                Act (21 U.S.C. 802(60)).''.
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