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.
Retailers of vapor products must register with the FDA.
[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1136 Introduced in House (IH)]
<DOC>
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).''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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