Title: E-Cigarette Device Standards Act of 2019
Policy area: Health

Summary:
E-Cigarette Device Standards Act of 2019
This bill requires the Food and Drug Administration to establish design standards that prevent consumers from modifying electronic nicotine delivery systems (e.g., e-cigarettes and vape pens) or their components.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2536 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                S. 2536

 To establish standards for the design of electronic nicotine delivery 
                                systems.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 24, 2019

 Mr. Merkley (for himself, Ms. Murkowski, Mr. Durbin, Mr. Blumenthal, 
 and Mrs. Shaheen) introduced the following bill; which was read twice 
and referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To establish standards for the design of electronic nicotine delivery 
                                systems.

    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 ``E-Cigarette Device Standards Act of 
2019''.

SEC. 2. STANDARDS RELATING TO ELECTRONIC NICOTINE DELIVERY SYSTEMS.

    (a) Establishment of Standards.--
            (1) In general.--Section 907(a) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 387g(a)) is amended by adding at 
        the end the following:
            ``(7) Standards relating to electronic nicotine delivery 
        systems.--The Secretary shall establish standards regarding the 
        design of electronic nicotine delivery systems that, at a 
        minimum, prevent consumers from modifying or adding any 
        substances to electronic nicotine delivery systems (including 
        their components or parts) in a way that is not intended by the 
        manufacturer.''.
            (2) Timing.--The Secretary of Health and Human Services 
        shall--
                    (A) not later than 180 days after the date of 
                enactment of this Act, issue proposed regulations to 
                carry out the amendment made by paragraph (1); and
                    (B) not later than 1 year after the date of 
                enactment of this Act, issue final regulations to carry 
                out such amendment.
    (b) Definition.--Section 900 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 387) is amended--
            (1) by redesignating paragraphs (8) through (22) as 
        paragraphs (9) through (23), respectively; and
            (2) by inserting after paragraph (7) the following:
            ``(8) Electronic nicotine delivery system.--
                    ``(A) In general.--The term `electronic nicotine 
                delivery system' means any 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, 
                vapes, 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, and includes components and parts 
                of the electronic nicotine delivery system.
                    ``(B) Component or part.--With respect to an 
                electronic nicotine delivery system, the terms 
                `component' and `part'--
                            ``(i) mean any software or assembly of 
                        materials intended or reasonably expected--
                                    ``(I) to alter or affect the 
                                tobacco product's performance, 
                                composition, constituents or 
                                characteristics; or
                                    ``(II) to be used with or for the 
                                human consumption of a tobacco product;
                            ``(ii) exclude anything that is an 
                        accessory of a tobacco product; and
                            ``(iii) include e-liquids; atomizers; 
                        batteries (with or without variable voltage); 
                        cartomizers (atomizer plus replaceable fluid-
                        filled cartridge); digital display or lights to 
                        adjust settings; clearomisers, tank systems, 
                        flavors, vials that contain e-liquids, and 
                        programmable software, flavor enhancers and the 
                        vials in which such flavor enhancers are 
                        contained; hose cooling attachments; water 
                        filtration base additives (including flavored 
                        additives); flavored waterpipe tobacco 
                        charcoals and the wrappers or boxes that 
                        contain the charcoals; and bowls, valves, 
                        hoses, and heads.''.
    (c) Conforming Amendment.--Section 9(1) of the Comprehensive 
Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4408(1)) is 
amended by striking ``section 900(18)'' and inserting ``section 
900(19)''.
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