Title: FDA Deeming Authority Clarification Act of 2017
Policy area: Health

Summary:
FDA Deeming Authority Clarification Act of 2017
This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to: (1) revise premarket review and reporting requirements for products newly deemed by the Food and Drug Administration (FDA) to be tobacco products; and (2) grant the FDA the authority to regulate vapor products, which include products that produce vapor with nicotine (e.g., e-cigarettes) and nicotine intended to be used with such a product (e.g., nicotine cartridges).
A product is not subject to premarket review by the FDA if it is marketed before it is deemed a tobacco product.
The bill delays deadlines for reports to the FDA on products similar to a marketed product that are introduced to market less than 21 months after that type of product is deemed a tobacco product.
The bill grants the FDA regulatory authority over vapor products that is in addition to the FDA's existing authority to regulate vapor products as tobacco products.
Provisions of the FFDCA applicable to tobacco product components also apply to vapor product batteries. The FDA must establish standards for vapor product batteries. Vapor products first marketed not later than 24 months after enactment of this bill are not subject to premarket review or reporting requirements based on changes to the product's battery to conform to standards.
Vapor products may not be advertised in publications, except publications with adult readership.
Vapor products may be sold only face-to-face, through vending machines in facilities where only adults are permitted, or by mail order.
Vapor products must be labeled with their nicotine content and specified phrases.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1136 Introduced in House (IH)]

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115th CONGRESS
  1st Session
                                H. R. 1136

  To amend the Federal Food, Drug, and Cosmetic Act to provide for a 
  certain effective date with respect to deemed tobacco products, to 
 provide for the establishment of product standards for vapor product 
 batteries, to provide for regulation of vapor products, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 16, 2017

    Mr. Cole (for himself and Mr. Bishop of Georgia) 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 provide for a 
  certain effective date with respect to deemed tobacco products, to 
 provide for the establishment of product standards for vapor product 
 batteries, to provide for regulation of vapor products, 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 ``FDA Deeming Authority Clarification 
Act of 2017''.

SEC. 2. DATE FOR APPLICATION OF FEDERAL FOOD, DRUG, AND COSMETIC ACT TO 
              DEEMED TOBACCO PRODUCTS.

    Section 901(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 387a(b)) is amended--
            (1) by striking ``This chapter shall apply'' and inserting 
        the following:
            ``(1) In general.--This chapter shall apply''; and
            (2) by adding at the end the following new paragraph:
            ``(2) Deemed tobacco products.--For each tobacco product 
        deemed subject to the requirements of this chapter pursuant to 
        paragraph (1), each reference in sections 905(j) and 910(a)--
                    ``(A) to `February 15, 2007', shall be considered 
                to be a reference to `the effective date of the 
                regulation under which a tobacco product is deemed 
                subject to the requirements of this chapter pursuant to 
                section 901(b)'; and
                    ``(B) to `21 months after the date of enactment of 
                the Family Smoking Prevention and Tobacco Control Act', 
                shall be considered to be a reference to the later of--
                            ``(i) `21 months after the date of 
                        enactment of the FDA Deeming Authority 
                        Clarification Act of 2017'; and
                            ``(ii) `21 months after the effective date 
                        of such deeming regulation'.''.

SEC. 3. PRODUCT STANDARDS FOR VAPOR PRODUCT BATTERIES.

    (a) Applicability of Standards.--Section 907 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 387g) and any related provisions of 
such Act shall apply with respect to a vapor product battery to the 
same extent and in the same manner as such section 907 and related 
provisions apply with respect to a component of a tobacco product.
    (b) Promulgation of Standards.--
            (1) Proposed standards.--Not later than 12 months after the 
        date of enactment of this Act, the Secretary of Health and 
        Human Services shall issue a notice of proposed rulemaking to 
        establish product standards for vapor product batteries 
        pursuant to section 907 of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 387g).
            (2) Final standards.--Not later than 24 months after the 
        date of enactment of this Act, the Secretary shall promulgate 
        the vapor product battery standards required by this section.
    (c) Compliance With Final Standards.--For any vapor product 
(including those products in test markets) that has a battery and is 
commercially marketed in the United States as of the date by which 
final standards are required to be promulgated under subsection (b)(2), 
the Secretary of Health and Human Services, based on any change to the 
battery for the purpose of conforming to such final standards, shall 
not--
            (1) require the submission of a report under section 905(j) 
        of such Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        387e(j)); or
            (2) treat such vapor product as a new tobacco product for 
        which an order is required under section 910(c)(1)(A)(i) of 
        such Act (21 U.S.C. 387j(c)(1)(A)(i)).
    (d) Definition.--In this section, the term ``vapor product'' has 
the meaning given to such term in section 921(f) of the Federal Food, 
Drug, and Cosmetic Act, as added by section 4 of this Act.

SEC. 4. REGULATION OF VAPOR PRODUCTS.

    (a) In General.--Chapter IX of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 920 of such Act (21 U.S.C. 
387t) the following:

``SEC. 921. VAPOR PRODUCTS.

    ``(a) Relation to Other Provisions.--The authorities vested in the 
Secretary by this section to regulate vapor products are in addition 
to, not in lieu of, the authorities vested in the Secretary by other 
sections of this Act to regulate vapor products as tobacco products.
    ``(b) Advertising in Print Publications.--
            ``(1) In general.--The manufacturer, distributor, or 
        retailer of a vapor product shall not disseminate or cause to 
        be disseminated advertising or labeling of the vapor product in 
        a newspaper, magazine, periodical or other publication (whether 
        periodic or limited distribution), other than an adult 
        publication.
            ``(2) Definition.--In this subsection, the term `adult 
        publication' means a newspaper, magazine, periodical, or other 
        publication--
                    ``(A) whose readers younger than 18 years of age 
                constitute 15 percent or less of the total readership 
                as measured by competent and reliable survey evidence; 
                and
                    ``(B) that is read by fewer than 2 million persons 
                younger than 18 years of age as measured by competent 
                and reliable survey evidence.
    ``(c) Prohibit Self-Service Displays of Vapor Products.--
            ``(1) In general.--A retailer may sell vapor products only 
        in a direct face-to-face exchange.
            ``(2) Exception.--Paragraph (1) does not apply--
                    ``(A) to mail order sales; or
                    ``(B) to sales by means of a vending machine or 
                self-service display that is located in a facility 
                where the retailer ensures that no person under 18 
                years of age is present or permitted to enter at any 
                time.
            ``(3) Civil penalty.--A violation of this subsection shall 
        be subject to a civil penalty under section 303(f)(9) to the 
        same extent and in the same manner as a violation of any 
        requirement of this Act which relates to a tobacco product.
    ``(d) Labeling.--
            ``(1) In general.--Not later than 12 months after the date 
        of enactment of the FDA Deeming Authority Clarification Act of 
        2017, the Secretary shall promulgate final regulations to 
        require packages of vapor products to bear a label containing--
                    ``(A) the phrase `Keep Out of Reach of Children';
                    ``(B) the phrase `Underage Sale Prohibited'; and
                    ``(C) if the vapor product includes nicotine in a 
                solution or other form at the time of sale, an accurate 
                statement of the nicotine content.
            ``(2) Misbranding.--A vapor product whose label is in 
        violation of paragraph (1) is deemed to be a misbranded tobacco 
        product under section 903.
    ``(e) Annual Registration Requirements for Vapor Product 
Retailers.--
            ``(1) Registration by retailers.--Every person who owns or 
        operates an establishment in any State engaged in the retail 
        sale of a vapor product shall register that establishment with 
        the Secretary by the later of--
                    ``(A) 60 days after the date of the enactment of 
                the FDA Deeming Authority Clarification Act of 2017; 
                and
                    ``(B) 30 days after first engaging in such retail 
                sale.
            ``(2) Exclusion.--The requirements of this subsection do 
        not apply with respect to any establishment subject to an 
        active registration or retail license under--
                    ``(A) any State law relating to tobacco products; 
                or
                    ``(B) section 905.
            ``(3) Public access to registration information.--The 
        Secretary shall make available for inspection, to any person so 
        requesting, any registration filed under this subsection.
    ``(f) Vapor Product Defined.--In this section:
            ``(1) In general.--The term `vapor product'--
                    ``(A) means any noncombustible product that employs 
                a heating element, power source, electronic circuit, or 
                other electronic, chemical, or mechanical means, 
                regardless of shape or size, to produce vapor from 
                nicotine in a solution or other form; and
                    ``(B) includes--
                            ``(i) any electronic cigarette, electronic 
                        cigar, electronic cigarillo, electronic pipe, 
                        or similar product or device that is intended 
                        to produce vapor from nicotine in a solution of 
                        other form; and
                            ``(ii) nicotine in a solution or other 
                        form, whether in a cartridge or container or 
                        otherwise dispensed, that is intended to be 
                        used with or in a product described in clause 
                        (i).
            ``(2) Exclusion.--The term `vapor product' does not include 
        any product regulated as a drug or device under chapter V.''.
    (b) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(eee) The disseminating or causing to be disseminated, by a 
manufacturer, distributor, or retailer of a vapor product, advertising 
or labeling of the vapor product in violation of section 921(b).
    ``(fff) The failure of a person who owns or operates an 
establishment in any State engaged in the retail sale of a vapor 
product to register as required by section 921(e).''.
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