Independent Advisory Committee Review of E-Cigarette Applications Act

I 116TH CONGRESS 2D SESSION H. R. 8343 To amend the Federal Food, Drug, and Cosmetic Act to require the Secretary to refer each application for review of certain tobacco products to the Tobacco Products Scientific Advisory Committee, and for other purposes. IN THE HOUSE OF REPRESENTATIVES SEPTEMBER 22, 2020 Mr. KRISHNAMOORTHI (for himself, Mr. KING of New York, Mr. COHEN, Ms. NORTON, Ms. JOHNSON of Texas, Mr. DESAULNIER, and Mr. RASKIN) introduced the following bill; which was referred to the Committee on En- ergy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to require the Secretary to refer each application for review of certain tobacco products to the Tobacco Products Scientific Advisory Committee, 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 ‘‘Independent Advisory 4 Committee Review of E-Cigarette Applications Act’’. 5 VerDate Sep 11 2014 00:14 Oct 04, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H8343.IH H8343 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 8343 IH SEC. 2. REQUIRED REFERRAL TO TOBACCO PRODUCTS SCI- 1 ENTIFIC ADVISORY COMMITTEE. 2 (a) IN GENERAL.—Section 910(b)(2) of the Federal 3 Food, Drug, and Cosmetic Act (21 U.S.C. 387j(b)(2)) is 4 amended to read as follows: 5 ‘‘(2) REFERRAL TO TOBACCO PRODUCTS SCI- 6 ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 7 application meeting the requirements set forth in 8 paragraph (1), the Secretary shall— 9 ‘‘(A) provide a written notification of such 10 application to the Tobacco Products Scientific 11 Advisory Committee; and 12 ‘‘(B) in the case of an application with re- 13 spect to which the Secretary intends to issue an 14 order under subsection (c)(1)(A)(i), to enable 15 the Advisory Committee to carry out paragraph 16 (3), refer such application to the Advisory Com- 17 mittee for review prior to issuance of such an 18 order.’’. 19 (b) TOBACCO PRODUCTS SCIENTIFIC ADVISORY COM- 20 MITTEE.—Section 910(b) of the Federal Food, Drug, and 21 Cosmetic Act (21 U.S.C. 387j(b)) is amended by adding 22 at the end the following: 23 ‘‘(3) TOBACCO PRODUCTS SCIENTIFIC ADVISORY 24 COMMITTEE.—The Tobacco Products Scientific Ad- 25 visory Committee shall— 26 VerDate Sep 11 2014 00:14 Oct 04, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8343.IH H8343 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 8343 IH ‘‘(A) within such period as the Secretary 1 may establish, submit to the Secretary a report 2 and recommendation with respect to an applica- 3 tion referred to the Advisory Committee under 4 paragraph (2), together with all underlying data 5 and the reasons or basis for the recommenda- 6 tion (including the results of each vote taken 7 under subparagraph (B)); 8 ‘‘(B) before issuing a report or rec- 9 ommendation with respect to an application 10 under subparagraph (A), take a public vote on 11 whether to recommend that the Secretary issue 12 an order under subsection (c)(1)(A)(i) with re- 13 spect to the application; and 14 ‘‘(C) make publicly available a list of all 15 applications with respect to which the Advisory 16 Committee has received a notification under 17 paragraph (2)(A) that, with respect to each 18 such application, identifies the applicant and 19 each product that is the subject of the applica- 20 tion. 21 ‘‘(4) ASSISTANCE.—The Secretary shall take all 22 actions necessary to assist the Advisory Committee 23 in carrying out its duties under this section.’’. 24 Æ VerDate Sep 11 2014 00:14 Oct 04, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\H8343.IH H8343 kjohnson on DSK79L0C42PROD with BILLS