Title: Independent Advisory Committee Review of E-Cigarette Applications Act
Policy area: Health

Summary:
Independent Advisory Committee Review of E-Cigarette Applications Act
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.)
The FDA shall notify the committee when receiving such an application.
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.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8343 Introduced in House (IH)]

<DOC>






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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Independent Advisory Committee 
Review of E-Cigarette Applications Act''.

SEC. 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.''.
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