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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5005 Introduced in House (IH)]

<DOC>

116th CONGRESS
  1st Session
                                H. R. 5005

 To amend the Federal Food, Drug, and Cosmetic Act to require a recall 
 of electronic nicotine delivery systems that have not been subject to 
               premarket review, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            November 8, 2019

Mr. DeSaulnier 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 a recall 
 of electronic nicotine delivery systems that have not been subject to 
               premarket review, 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 ``Preventing Vape Use Act''.

SEC. 2. INCLUSION OF ENDS IN DEFINITION OF TOBACCO PRODUCT.

    (a) Confirmation of Inclusion of ENDS in Definition of Tobacco 
Product.--Section 201(rr)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321(rr)(1)) is amended by adding at the end the 
following: ``Such term includes an electronic nicotine delivery 
system.''.
    (b) ENDS Defined.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the 
following:
    ``(ss) The term `electronic nicotine delivery system' means a 
tobacco product that is an electronic device that delivers nicotine, 
flavor, or another substance via an aerosolized solution to the user 
inhaling from the device (including e-cigarettes, e-hookah, e-cigars, 
vape pens, advanced refillable personal vaporizers, and electronic 
pipes) and any component, liquid, part, or accessory of such a device, 
whether or not sold separately.''.

SEC. 3. MANDATORY RECALL OF ENDS PENDING PREMARKET REVIEW.

    Section 908(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 387h(c)) is amended by adding at the end the following:
            ``(4) Mandatory recall of ends pending premarket review.--
                    ``(A) Issuance of order.--Notwithstanding 
                paragraphs (1) and (2), in the case of a tobacco 
                product that is an electronic nicotine delivery system 
                with respect to which, as of the date of the enactment 
                of this subparagraph, an order under section 
                910(c)(1)(A)(i) has not been issued, the Secretary 
                shall, not later than 60 days after such date of 
                enactment, issue an order requiring--
                            ``(i) the appropriate person (including the 
                        manufacturers, importers, distributors, or 
                        retailers of the tobacco product) to 
                        immediately cease distribution of such tobacco 
                        product; and
                            ``(ii) the recall of such tobacco product.
                    ``(B) Hearing.--The order under subparagraph (A) 
                shall provide the person subject to the order with an 
                opportunity for an informal hearing, to be held not 
                later than 10 days after the date of the issuance of 
                the order, on the actions required by the order and the 
                terms of the recall required by such order.
                    ``(C) Contents of order.--An order issued under 
                subparagraph (A) shall specify a timetable in which the 
                tobacco product recall will occur and shall require 
                periodic reports to the Secretary describing the 
                progress of the recall.
                    ``(D) Notice.--An order under subparagraph (A)--
                            ``(i) shall not include recall of a tobacco 
                        product from individuals; and
                            ``(ii) shall provide for notice to persons 
                        subject to the risks associated with the use of 
                        such tobacco product.
                    ``(E) Assistance allowed.--In providing the notice 
                required by subparagraph (D)(ii), the Secretary may use 
                the assistance of retailers and other persons who 
                distributed such tobacco product. If a significant 
                number of such persons cannot be identified, the 
                Secretary shall notify such persons under section 
                705(b).
                    ``(F) Withdrawal of order.--The Secretary may only 
                withdraw an order issued under subparagraph (A) with 
                respect to a tobacco product described in such 
                subparagraph upon the issuance of an order section 
                910(c)(1)(A)(i) with respect to that product.''.

SEC. 4. NO EXEMPTIONS ALLOWED FOR ENDS.

    Section 910(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 387j(a)) is amended--
            (1) in paragraph (2), by adding at the end the following:
                    ``(C) Application to ends.--Notwithstanding clauses 
                (i) and (ii) of subparagraphs (A) and (B), beginning on 
                the date that is 60 days after the date of the 
                enactment of this subparagraph--
                            ``(i) electronic nicotine delivery systems 
                        are deemed to be not substantially equivalent 
                        to any predicate tobacco product; and
                            ``(ii) the requirement for premarket review 
                        under subparagraph (A) shall apply to a tobacco 
                        product that is an electronic nicotine delivery 
                        system.''; and
            (2) in paragraph (3)(C)--
                    (A) by striking ``equivalent to a predicate'' and 
                inserting the following: ``equivalent--
                    ``(A) to a predicate'';
                    (B) by striking ``adulterated.'' and inserting 
                ``adulterated; or''; and
                    (C) by adding at the end the following:
                    ``(B) beginning on the date that is 60 days after 
                the date of the enactment of this subparagraph, if the 
                tobacco product is an electronic nicotine delivery 
                system.''.
                                 <all>
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