Section 1 Short title
This Act may be cited as the “Independent Advisory Committee Review of E-Cigarette Applications Act”.
Independent Advisory Committee Review of E-Cigarette Applications Act
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.
Sec. 2 Required referral to tobacco products scientific advisory committee
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.”
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.”