SARMs Control Act of 2019

II 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Selective Androgen Re- 4 ceptor Modulators Control Act of 2019’’ or the ‘‘SARMs 5 Control Act of 2019’’. 6 SEC. 2. AMENDMENTS TO THE CONTROLLED SUBSTANCES 7 ACT. 8 (a) DEFINITION.—Section 102 of the Controlled Sub- 9 stances Act (21 U.S.C. 802) is amended— 10 VerDate Sep 11 2014 01:59 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2895.IS S2895 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 2895 IS (1) by redesignating paragraph (58) as para- 1 graph (59); 2 (2) by redesignating the second paragraph des- 3 ignated as paragraph (57) as paragraph (58); 4 (3) by moving paragraphs (57), (58) (as so re- 5 designated), and (59) (as so redesignated) 2 ems to 6 the left; and 7 (4) by adding at the end the following: 8 ‘‘(60)(A) The term ‘SARM’— 9 ‘‘(i) means any drug or other substance that is 10 a selective androgen receptor agonist chemically un- 11 related to testosterone, estrogens, progestins, 12 corticosteroids, and dehydroepiandrosterone; and 13 ‘‘(ii) includes— 14 ‘‘(I) (S)-N-(4-cyano-3-(trifluorometh- 15 yl)phenyl)-3-(4-cyanophenoxy)-2-hydroxy-2- 16 methylpropanamide (commonly known as 17 ‘ostarine’ or ‘enobosarm’); 18 ‘‘(II) 4-((R)-2-((R)-2,2,2-trifluoro-1-hy- 19 droxyethyl)pyrrolidin-1-yl)-2-(trifluorometh- 20 yl)benzonitrile (commonly known as ‘LGD- 21 4033’ or ‘ligandrol’); 22 ‘‘(III) 9-chloro-2-ethyl-1-methyl-3-(2,2,2- 23 trifluoroethyl)-3,6-dihydro-7H-pyrrolo[3,2- 24 VerDate Sep 11 2014 01:59 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2895.IS S2895 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 2895 IS f]quinolin-7-one (commonly known as ‘LGD- 1 3303’); 2 ‘‘(IV) isopropyl (S)-(7-cyano-4-(pyridin-2- 3 ylmethyl)-1,2,3,4-tetrahydrocyclopenta[b]indol-2 4 -yl)carbamate (commonly known as 5 ‘LY2452473’ or ‘TT701’); 6 ‘‘(V) 2-chloro-4-(((1R,2S)-1-(5-(4-cyano- 7 phenyl)-1,3,4-oxadiazol-2-yl)-2-hydroxypro- 8 pyl)amino)-3-methylbenzonitrile (commonly 9 known as ‘RAD-140’); 10 ‘‘(VI) (S)-3-(4-acetamidophenoxy)-2-hy- 11 droxy-2-methyl-N-(4-nitro-3-(trifluorometh- 12 yl)phenyl)propanamide (commonly known as 13 ‘andarine’); 14 ‘‘(VII) 2-chloro-4-((7R,7aS)-7-hydroxy-1,3- 15 dioxotetrahydro-1H-pyrrolo[1,2-c]imidazol- 16 2(3H)-yl)-3-methylbenzonitrile (commonly 17 known as ‘BMS-564929’); 18 ‘‘(VIII) 6-ethyl-4-(trifluoromethyl)-6,7,8,9- 19 tetrahydropyrido[3,2-g]quinolin-2(1H)-one 20 (commonly known as ‘LG-121071’); 21 ‘‘(IX) (S)-3-(4-chloro-3-fluorophenoxy)-N- 22 (4-cyano-3-(trifluoromethyl)phenyl)-2-hydroxy- 23 2-methylpropanamide (commonly known as ‘S- 24 23’); and 25 VerDate Sep 11 2014 01:59 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2895.IS S2895 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 2895 IS ‘‘(X) any salt, ester, ether, or substituted 1 analogue of a drug or other substance described 2 in subclauses (I) through (IX). 3 ‘‘(B) A substance excluded under subparagraph 4 (A)(i) may at any time be scheduled by the Attorney Gen- 5 eral in accordance with the authority and requirements 6 under subsections (a) through (c) of section 201. 7 ‘‘(C)(i) A drug or other substance (other than estro- 8 gens, progestins, corticosteroids, and dehydroepiandroster- 9 one, unless scheduled under subparagraph (B)) that is not 10 listed in subparagraph (A)(ii) and is derived from, or has 11 a chemical structure substantially similar to, one or more 12 SARMs listed in subparagraph (A)(ii) shall be considered 13 to be a SARM for purposes of this title if the drug or 14 other substance— 15 ‘‘(I) has been created or manufactured with the 16 intent of producing a drug or other substance that— 17 ‘‘(aa) promotes muscle growth; or 18 ‘‘(bb) otherwise causes a pharmacological 19 effect similar to that of testosterone; or 20 ‘‘(II) has been, or is intended to be, marketed 21 or otherwise promoted in any manner suggesting 22 that consuming the drug or other substance will pro- 23 mote muscle growth or any other pharmacological 24 effect similar to that of testosterone. 25 VerDate Sep 11 2014 01:59 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2895.IS S2895 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 2895 IS ‘‘(ii) A drug or other substance shall not be consid- 1 ered to be a SARM for purposes of this subparagraph if 2 the drug or other substance— 3 ‘‘(I) is— 4 ‘‘(aa) an herb or other botanical; 5 ‘‘(bb) a concentrate, metabolite, or extract 6 of, or a constituent isolated directly from, an 7 herb or other botanical; or 8 ‘‘(cc) a combination of two or more sub- 9 stances described in item (aa) or (bb); 10 ‘‘(II) is a dietary ingredient for purposes of the 11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 12 301 et seq.); and 13 ‘‘(III) is not anabolic or androgenic. 14 ‘‘(iii) In accordance with section 515(a), any person 15 claiming the benefit of an exemption or exception under 16 clause (ii) shall bear the burden of going forward with the 17 evidence with respect to that exemption or exception.’’. 18 (b) AMENDMENT TO SCHEDULE III.—Schedule III in 19 section 202(c) of the Controlled Substances Act (21 20 U.S.C. 812(c)) is amended by adding at the end the fol- 21 lowing: 22 ‘‘(f) SARMs.’’. 23 (c) TEMPORARY AND PERMANENT SCHEDULING OF 24 RECENTLY EMERGED SARMS.—Section 201 of the Con- 25 VerDate Sep 11 2014 01:59 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2895.IS S2895 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 2895 IS trolled Substances Act (21 U.S.C. 811) is amended by 1 adding at the end the following: 2 ‘‘(k) TEMPORARY AND PERMANENT SCHEDULING OF 3 RECENTLY EMERGED SARMS.— 4 ‘‘(1) TEMPORARY ORDERS.— 5 ‘‘(A) IN GENERAL.—The Attorney General 6 may issue a temporary order adding a drug or 7 other substance to the definition of the term 8 ‘SARM’ under section 102(60) if the Attorney 9 General finds that— 10 ‘‘(i) the drug or other substance satis- 11 fies the criteria for being considered a 12 SARM but is not listed in that section or 13 by regulation of the Attorney General as 14 being a SARM; and 15 ‘‘(ii) adding the drug or other sub- 16 stance to the definition of the term SARM 17 will assist in preventing abuse or misuse of 18 the drug or other substance. 19 ‘‘(B) EFFECTIVE DATE; DURATION.—A 20 temporary order issued under subparagraph 21 (A)— 22 ‘‘(i) shall take effect not earlier than 23 30 days after the date of publication by 24 VerDate Sep 11 2014 01:59 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2895.IS S2895 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 2895 IS the Attorney General of a notice in the 1 Federal Register of— 2 ‘‘(I) the intention of the Attorney 3 General to issue the temporary order; 4 and 5 ‘‘(II) the grounds on which the 6 temporary order is to be issued; and 7 ‘‘(ii) shall expire not later than 2 8 years after the date on which the tem- 9 porary order becomes effective, except that 10 the Attorney General may, during the 11 pendency of proceedings under paragraph 12 (2), extend the temporary order for not 13 more than 6 months. 14 ‘‘(C) NOTICE TO SECRETARY.— 15 ‘‘(i) IN GENERAL.—The Attorney 16 General shall transmit notice of a tem- 17 porary order proposed to be issued under 18 subparagraph (A) to the Secretary. 19 ‘‘(ii) CONSIDERATION.—In issuing a 20 temporary order under subparagraph (A), 21 the Attorney General shall take into con- 22 sideration any comments submitted by the 23 Secretary in response to a notice trans- 24 mitted under this subparagraph. 25 VerDate Sep 11 2014 01:59 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2895.IS S2895 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 2895 IS ‘‘(D) EFFECT OF PERMANENT SCHED- 1 ULING.—A temporary order issued under sub- 2 paragraph (A) shall be vacated upon the 3 issuance of a permanent order under paragraph 4 (2). 5 ‘‘(E) JUDICIAL REVIEW.—A temporary 6 order issued under subparagraph (A) shall not 7 be subject to judicial review. 8 ‘‘(2) PERMANENT ORDERS.— 9 ‘‘(A) IN GENERAL.—The Attorney General 10 may by rule issue a permanent order adding a 11 drug or other substance to the definition of the 12 term ‘SARM’ under section 102(60) if the drug 13 or other substance satisfies the criteria for 14 being considered a SARM under that section. 15 ‘‘(B) TIMING.—The Attorney General may 16 commence a rulemaking under subparagraph 17 (A) simultaneously with the issuance of a tem- 18 porary order under paragraph (1).’’. 19 (d) LABELING REQUIREMENTS.— 20 (1) IN GENERAL.—Section 305 of the Con- 21 trolled Substances Act (21 U.S.C. 825) is amended 22 by adding at the end the following: 23 ‘‘(f) FALSE LABELING OF SARMS.— 24 VerDate Sep 11 2014 01:59 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2895.IS S2895 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 2895 IS ‘‘(1) PROHIBITION.—It shall be unlawful to im- 1 port, export, manufacture, distribute, dispense, or 2 possess with intent to manufacture, distribute, or 3 dispense, a SARM or product containing a SARM, 4 unless the SARM or product containing the SARM 5 bears a label clearly identifying the SARM or prod- 6 uct containing the SARM by the nomenclature used 7 by the International Union of Pure and Applied 8 Chemistry. 9 ‘‘(2) EXEMPTION.— 10 ‘‘(A) IN GENERAL.—A SARM or product 11 containing a SARM described in subparagraph 12 (B) shall be exempt from the International 13 Union of Pure and Applied Chemistry nomen- 14 clature requirement under paragraph (1) if the 15 SARM or product containing a SARM is la- 16 beled in the manner required under the Federal 17 Food, Drug, and Cosmetic Act (21 U.S.C. 301 18 et seq.). 19 ‘‘(B) EXEMPT PRODUCTS.—A SARM or 20 product containing a SARM is described in this 21 subparagraph if the SARM or product con- 22 taining a SARM— 23 ‘‘(i) is the subject of an approved ap- 24 plication as described in subsection (b) or 25 VerDate Sep 11 2014 01:59 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2895.IS S2895 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 2895 IS (j) of section 505 of the Federal Food, 1 Drug, and Cosmetic Act (21 U.S.C. 355); 2 or 3 ‘‘(ii) is exempt from the provisions of 4 section 505 of the Federal Food, Drug, 5 and Cosmetic Act (21 U.S.C. 355) relating 6 to new drugs because— 7 ‘‘(I) the SARM or product con- 8 taining a SARM is intended solely for 9 investigational use as described in 10 subsection (i) of that section; and 11 ‘‘(II) the SARM or product con- 12 taining a SARM is being used exclu- 13 sively for purposes of a clinical trial 14 that is the subject of an effective in- 15 vestigational new drug application.’’. 16 (2) CLARIFICATION REGARDING FELONY DRUG 17 OFFENSES.—Section 102(44) of the Controlled Sub- 18 stances Act (21 U.S.C. 802(44)) is amended by in- 19 serting ‘‘SARMs,’’ after ‘‘anabolic steroids,’’. 20 (3) CIVIL PENALTIES.—Section 402 of the Con- 21 trolled Substances Act (21 U.S.C. 842) is amend- 22 ed— 23 (A) in subsection (a)(16)— 24 VerDate Sep 11 2014 01:59 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S2895.IS S2895 pamtmann on DSKBC07HB2PROD with BILLS 11 •S 2895 IS (i) by inserting ‘‘or (f)’’ after ‘‘sub- 1 section (e)’’; and 2 (ii) by striking ‘‘825’’ and inserting 3 ‘‘305’’; and 4 (B) in subsection (c)(1)(D), by inserting 5 ‘‘or a SARM’’ after ‘‘an anabolic steroid’’. 6 SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 7 COSMETIC ACT. 8 Section 413(c) of the Federal Food, Drug, and Cos- 9 metic Act (21 U.S.C. 350b(c)) is amended— 10 (1) in paragraph (1), by striking ‘‘an anabolic 11 steroid or an analogue of an anabolic steroid’’ and 12 inserting ‘‘an anabolic steroid, a SARM, an analogue 13 of an anabolic steroid, or an analogue of a SARM’’; 14 and 15 (2) in paragraph (2)— 16 (A) in subparagraph (A), by striking 17 ‘‘and’’ at the end; 18 (B) in subparagraph (B), by striking the 19 period at the end and inserting a semicolon; 20 and 21 (C) by adding at the end the following: 22 ‘‘(C) the term ‘analogue of a SARM’ 23 means a substance that has a chemical struc- 24 VerDate Sep 11 2014 01:59 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S2895.IS S2895 pamtmann on DSKBC07HB2PROD with BILLS 12 •S 2895 IS ture that is substantially similar to the chemical 1 structure of a SARM; and 2 ‘‘(D) the term ‘SARM’ has the meaning 3 given the term in section 102(60) of the Con- 4 trolled Substances Act (21 U.S.C. 802(60)).’’. 5 Æ VerDate Sep 11 2014 01:59 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6301 E:\BILLS\S2895.IS S2895 pamtmann on DSKBC07HB2PROD with BILLS