Independent Advisory Committee Review of E-Cigarette Applications Act

Bill: 116-hr-8343
Sponsor: full_name: Rep. Krishnamoorthi, Raja [D-IL-8]
Introduced: 2020-09-22
Policy area: Health
Subjects: Advisory bodies

Drug safety, medical device, and laboratory regulation

Drug, alcohol, tobacco use

Government information and archives

Product safety and quality
Latest action: action_date: 2020-09-22
text: Referred to the House Committee on Energy and Commerce.

Summaries:
action_date: 2020-09-22
action_desc: Introduced in House
text: <p><b>Independent Advisory Committee Review of E-Cigarette Applications Act</b></p> <p class="MsoNormal" style="line-height: normal;">This bill requires the Food and Drug Administration (FDA) to refer to the Tobacco Products Scientific Advisory Committee certain applications for premarket review of a new tobacco product, such as an e-cigarette. (Currently, the FDA may refer an application to the committee but is generally not required to do so.)</p> <p class="MsoNormal" style="line-height: normal;">The FDA shall notify the committee when receiving such an application. </p> <p class="MsoNormal" style="line-height: normal;">If the FDA intends to issue an order on an application, the FDA shall refer the application to the committee. With respect to a referred application, the committee shall make a public vote and issue recommendations about the application. </p> The committee must also make public a list of all applications for premarket review of new tobacco products.

tv_txt: I 116th CONGRESS 2d Session H. R. 8343 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. Short title This Act may be cited as the Independent Advisory Committee Review of E-Cigarette Applications Act . 2. Required referral to tobacco products scientific advisory committee (a) In general Section 910(b)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387j(b)(2) ) is amended to read as follows: (2) Referral to tobacco products scientific advisory committee Upon receipt of an application meeting the requirements set forth in paragraph (1), the Secretary shall— (A) provide a written notification of such application to the Tobacco Products Scientific Advisory Committee; and (B) in the case of an application with respect to which the Secretary intends to issue an order under subsection (c)(1)(A)(i), to enable the Advisory Committee to carry out paragraph (3), refer such application to the Advisory Committee for review prior to issuance of such an order. . (b) Tobacco products scientific advisory committee Section 910(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387j(b) ) is amended by adding at the end the following: (3) Tobacco products scientific advisory committee The Tobacco Products Scientific Advisory Committee shall— (A) within such period as the Secretary may establish, submit to the Secretary a report and recommendation with respect to an application referred to the Advisory Committee under paragraph (2), together with all underlying data and the reasons or basis for the recommendation (including the results of each vote taken under subparagraph (B)); (B) before issuing a report or recommendation with respect to an application under subparagraph (A), take a public vote on whether to recommend that the Secretary issue an order under subsection (c)(1)(A)(i) with respect to the application; and (C) make publicly available a list of all applications with respect to which the Advisory Committee has received a notification under paragraph (2)(A) that, with respect to each such application, identifies the applicant and each product that is the subject of the application. (4) Assistance The Secretary shall take all actions necessary to assist the Advisory Committee in carrying out its duties under this section. .