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 Energy 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Independent Advisory 

5 Committee Review of E-Cigarette Applications Act’’. 


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1 SEC. 2. REQUIRED REFERRAL TO TOBACCO PRODUCTS SCI2 ENTIFIC ADVISORY COMMITTEE. 

3 (a) IN GENERAL.—Section 910(b)(2) of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 387j(b)(2)) is 

5 amended to read as follows: 

6 ‘‘(2) REFERRAL TO TOBACCO PRODUCTS SCI7 ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 

8 application meeting the requirements set forth in 

9 paragraph (1), the Secretary shall— 

10 ‘‘(A) provide a written notification of such 

11 application to the Tobacco Products Scientific 

12 Advisory Committee; and 

13 ‘‘(B) in the case of an application with re14 spect to which the Secretary intends to issue an 

15 order under subsection (c)(1)(A)(i), to enable 

16 the Advisory Committee to carry out paragraph 

17 (3), refer such application to the Advisory Com18 mittee for review prior to issuance of such an 

19 order.’’. 

20 (b) TOBACCO PRODUCTS SCIENTIFIC ADVISORY COM21 MITTEE.—Section 910(b) of the Federal Food, Drug, and 

22 Cosmetic Act (21 U.S.C. 387j(b)) is amended by adding 

23 at the end the following: 

24 ‘‘(3) TOBACCO PRODUCTS SCIENTIFIC ADVISORY

25 COMMITTEE.—The Tobacco Products Scientific Ad26 visory Committee shall— 


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•HR 8343 IH

1 ‘‘(A) within such period as the Secretary 

2 may establish, submit to the Secretary a report 

3 and recommendation with respect to an applica4 tion referred to the Advisory Committee under 

5 paragraph (2), together with all underlying data 

6 and the reasons or basis for the recommenda7 tion (including the results of each vote taken 

8 under subparagraph (B)); 

9 ‘‘(B) before issuing a report or rec10 ommendation with respect to an application 

11 under subparagraph (A), take a public vote on 

12 whether to recommend that the Secretary issue 

13 an order under subsection (c)(1)(A)(i) with re14 spect to the application; and 

15 ‘‘(C) make publicly available a list of all 

16 applications with respect to which the Advisory 

17 Committee has received a notification under 

18 paragraph (2)(A) that, with respect to each 

19 such application, identifies the applicant and 

20 each product that is the subject of the applica21 tion. 

22 ‘‘(4) ASSISTANCE.—The Secretary shall take all 

23 actions necessary to assist the Advisory Committee 

24 in carrying out its duties under this section.’’. 

Æ 


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