same or different category as the proposed
reduced risk product; and
‘‘(ii) if required by the Secretary, in-
cludes studies of the long-term health ef-
fects of the product.
If such studies are required, the manufacturer
may consult with the Secretary regarding proto-
cols for conducting the studies.
‘‘(B) BASIS FOR FINDING.—In making the
finding under subparagraph (A), the Secretary
shall take into account—
‘‘(i) the risks and benefits to the pop-
ulation as a whole, including both users of
tobacco products and non-users of tobacco
products;
‘‘(ii) the increased or decreased likeli-
hood that existing users of tobacco prod-
ucts will stop using such products includ-
ing reduced risk tobacco products;
‘‘(iii) the increased or decreased likeli-
hood that those who do not use tobacco
products will start to use such products,
including reduced risk tobacco products;
and
‘‘(iv) the risks and benefits to con-
sumers from the use of a reduced risk to-
bacco product as compared to the use of
products approved under chapter V to re-
duce exposure to tobacco.
‘‘(3) MARKETING REQUIREMENTS.—A tobacco
product may be marketed and labeled as a reduced
risk tobacco product if it—
‘‘(A) has been designated as a reduced risk
tobacco product by the Secretary under para-
graph (2);
‘‘(B) bears a label prescribed by the Sec-
retary concerning the product’s contribution to
reducing harm to health; and
‘‘(C) complies with requirements prescribed
by the Secretary relating to marketing and ad-
vertising of the product, and other provisions of
this chapter as prescribed by the Secretary, al-
though in no event shall such requirements pro-
hibit the communication that such product is a
reduced risk product. The communication that
such product is a reduced risk product may
comply with requirements prescribed by the
Secretary relating to such communication, and
the Secretary may require prior approval of the
communication.
‘‘(b) REVOCATION OF DESIGNATION.—At any time
after the date on which a tobacco product is designated
as a reduced risk tobacco product under this section the
Secretary may, after providing an opportunity for an in-
formal hearing, revoke such designation if the Secretary
determines, based on information not available at the time
of the designation, that—
‘‘(1) the finding made under subsection (a)(2)
is no longer valid; or
‘‘(2) the product is being marketed in violation
of subsection (a)(3).
‘‘(c) LIMITATION.—A tobacco product that is des-
ignated as a reduced risk tobacco product that is in com-
pliance with subsection (a) shall not be regulated as a
drug or device.
‘‘(d) DEVELOPMENT OF REDUCED RISK TOBACCO
PRODUCT TECHNOLOGY.—A tobacco product manufac-
turer shall provide written notice to the Secretary upon
the development or acquisition by the manufacturer of any
technology that would reduce the risk of a tobacco product
to the health of the user for which the manufacturer is
not seeking designation as a ‘reduced risk tobacco product’
under subsection (a).
‘‘(e) POSTMARKET SURVEILLANCE.—
‘‘(1) 
DISCRETIONARY
SURVEILLANCE.—The
Secretary may require a tobacco product manufac-
turer to conduct postmarket surveillance for reduced
risk a tobacco product of the manufacturer if the
Secretary determines that postmarket surveillance of
the tobacco product is necessary to protect the pub-
lic health or is necessary to provide information re-
garding the health risks and other safety issues in-
volving the tobacco product.
‘‘(2) SURVEILLANCE APPROVAL.—Each tobacco
product manufacturer required to conduct a surveil-
lance of a reduced risk tobacco product under para-
graph (1) shall, within 30 days after receiving notice
that the manufacturer is required to conduct such
surveillance, submit, for the approval of the Sec-
retary, a protocol for the required surveillance. The
Secretary, within 60 days of the receipt of such pro-
tocol, shall determine if the principal investigator
proposed to be used in the surveillance has sufficient
qualifications and experience to conduct such sur-
veillance and if such protocol will result in collection
of useful data or other information necessary to pro-
tect the public health. The Secretary may not ap-
prove such a protocol until it has been reviewed by
an appropriately qualified scientific and technical re-
view committee established by the Secretary.
‘‘SEC. 913. PRESERVATION OF STATE AND LOCAL AUTHOR-
ITY.
‘‘(a) ADDITIONAL REQUIREMENTS.—
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), nothing in this Act shall be construed as
prohibiting a State or political subdivision thereof
from adopting or enforcing a requirement applicable
to a tobacco product that is in addition to, or more
stringent than, requirements established under this
chapter.
‘‘(2) PREEMPTION
OF
CERTAIN
STATE
AND
LOCAL REQUIREMENTS.—
‘‘(A) Except as provided in subparagraph
(B), no State or political subdivision of a State
may establish or continue in effect with respect
to a tobacco product any requirement which is
different from, or in addition to, any require-
ment applicable under the provisions of this
chapter relating to performance standards, pre-
market approval, adulteration, misbranding,
registration, 
labeling, 
good 
manufacturing
standards, or reduced risk products.
‘‘(B) Subparagraph (A) does not apply to
requirements relating to the sale, use, or dis-
tribution of a tobacco product including require-
ments related to the access to, and the adver-
tising and promotion of, a tobacco product.
‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT
LIABILITY.—No provision of this chapter relating to a to-
bacco product shall be construed to modify or otherwise
affect any action or the liability of any person under the
product liability law of any State.
‘‘SEC. 914. EQUAL TREATMENT OF RETAIL OUTLETS.
‘‘The Secretary shall issue regulations to require that
retail establishments for which the predominant business
is the sale of tobacco products comply with any advertising
restrictions applicable to retail establishments accessible
to individuals under the age of 18.
‘‘SEC. 915. ACCESS AND MARKETING RESTRICTIONS.
‘‘(a) DEFINITIONS.—For purposes of this section, the
following definitions apply:
‘‘(1) ADULT.—The term ‘adult’ means any per-
son who is older than the minimum age at which it
is legal to purchase or possess (whichever minimum
age is older) tobacco products.
‘‘(2) ADULT-ONLY FACILITY.—The term ‘adult-
only facility’ means a facility or restricted area
(whether open-air or enclosed) where the operator
ensures or has a reasonable basis to believe (such as
by checking identification as required under state
law, or by checking the identification of any person
appearing to be under the age of 27) that only
adults are present. A facility or restricted area need
not be permanently restricted to adults in order to
constitute an adult-only facility, provided that the
operator ensures or has a reasonable basis to believe
that only adults are present during the event or time
period in question.
‘‘(3) BRAND NAME.—The term ‘brand name’
means a brand name (alone or in conjunction with
any other word), trademark, logo, symbol, motto,
selling message, recognizable pattern of colors, or
any other indicia of product identification identical
or similar to, or identifiable with, those used for any
domestic brand of tobacco products. The term
’brand name’ shall not include the corporate name
of any tobacco product manufacturer that does not
after the date of the enactment of this Act sell a
brand of tobacco products in the United States that
includes such corporate name.
‘‘(b) CIGARETTE AND SMOKELESS TOBACCO PROD-
UCT REQUIREMENTS.—
‘‘(1) MINIMUM SALES AGE.—No retailer may
sell a tobacco product to any person younger than
18 years of age.
‘‘(2) PROOF OF AGE.—
‘‘(A) Except as otherwise provided in sub-
paragraph (B), each retailer shall verify by
means of photographic identification containing
the bearer’s date of birth that no person pur-
chasing the product is younger than 18 years of
age.
‘‘(B) No such verification is required for
any person over the age of 26.
‘‘(3) ENFORCEMENT
BY
THE
STATES.—The
Secretary may enter into an agreement with any
State which has in effect a State law that is at least
as restrictive as this subsection, whereby such State
agrees to enforce such State law in a manner rea-
sonably designed to prevent its violation and the
Secretary provides a grant to such State for the pur-
pose of enforcing such State law. No action taken by
the Secretary pursuant to this paragraph shall be
construed to limit the authority of the Secretary
under this subsection.
‘‘(4) MAIL
ORDER
SALES.—After two years
from the date of enactment of this Act, the Sec-
retary shall transmit to Congress a report describing
the extent, if any, to which individuals younger than
18 years of age are obtaining tobacco products
through the mail.
‘‘(c) MINIMUM PACKAGE SIZE REQUIREMENTS.—
‘‘(1) No manufacturer, distributor, or retailer
may sell or cause to be sold, or distribute or cause
to be distributed, any cigarette package that con-
tains fewer than 20 cigarettes.
‘‘(2) No retailer may break or otherwise open
any tobacco product package to sell or distribute in-
dividual cigarettes or a number of unpackaged ciga-
rettes that is smaller than the quantity in the min-
imum cigarette package size provided in paragraph
(1), or any quantity of another tobacco product that
is smaller than the smallest package distributed by
the manufacturer for individual consumer use.
‘‘(d) BAN ON YOUTH ACCESS TO FREE SAMPLES.—
‘‘(1) No manufacturer, distributor, or retailer
may distribute or cause to be distributed any free
samples of tobacco products, except in an adult-only
facility.
‘‘(2) For purposes of this subsection, a ‘free
sample’ does not include a tobacco product that is
provided to an adult in connection with—
‘‘(A) the purchase, exchange or redemption
for proof of purchase of any tobacco products
(including, but not limited to, a free offer in
connection with the purchase of tobacco prod-
ucts, such as a ‘two-for-one’ offer), or
‘‘(B) the conducting of consumer testing or
evaluation of tobacco products with persons who
certify that they are adults.
‘‘(e) VENDING MACHINES, SELF-SERVICE DISPLAYS,
MAIL-ORDER SALES, AND OTHER ‘IMPERSONAL’ MODES
OF SALE.—
‘‘(1) Except as otherwise provided in paragraph
(2), a retailer may sell a tobacco product only in a
direct, face-to-face exchange between the retailer and
the consumer. Examples of methods of sale that are
not permitted include vending machines and self-
service displays.
‘‘(2) The following methods of sale are per-
mitted under this subsection:
‘‘(A) Mail-order sales, excluding mail-order
redemption of coupons and distribution of free
samples through the mail.
‘‘(B) Vending machines that are located in
an adult-only facility.
‘‘(3) For purposes of this section, a ‘self-serv-
ice’ display means any display where the customer
has access to the tobacco products without the aid
of a sales clerk.
‘‘(f) PROHIBITION
ON
YOUTH
TARGETING.—No
manufacturer, distributor, or retailer may take any action,
directly or indirectly, to target youth in the advertising,
promotion, or marketing of tobacco products, or take any
action the primary purpose of which is to initiate, main-
tain, or increase the incidence of youth smoking. For pur-
poses of this subsection, the term ‘youth’ means any per-
son or persons under 18 years of age.
‘‘(g) BAN ON USE OF CARTOONS.—
‘‘(1) No manufacturer, distributor, or retailer
may use or cause to be used any cartoon in the ad-
vertising, promoting, packaging, or labeling of to-
bacco products.
‘‘(2) For purposes of this subsection, the term
‘cartoon’ means any drawing or other depiction of
an object, person, animal, creature, or any similar
caricature that satisfies any of the following criteria:
‘‘(A) The use of comically exaggerated fea-
tures;
‘‘(B) The attribution of human character-
istics to animals, plants, or other objects, or the
similar use of anthropomorphic technique.
‘‘(C) The attribution of unnatural or
extrahuman abilities, such as imperviousness to
pain or injury, X-ray vision, tunneling at very
high speeds, or transformation.
‘‘(3) The term ‘cartoon’ includes ‘Joe Camel,’
but does not include any drawing or other depiction
that, on July 1, 1998, was in use in the United
States in any manufacturer’s corporate logo or in
any manufacturer’s tobacco product packaging.
‘‘(h) ELIMINATION OF OUTDOOR ADVERTISING.—
‘‘(1) No manufacturer, distributor, or retailer
may place or cause to be placed any outdoor adver-
tising advertising tobacco products.
‘‘(2) For purposes of this subsection, the term
‘outdoor advertising’ means—
‘‘(A) billboards;
‘‘(B) signs and placards in arenas, sta-
diums, shopping malls, and video game arcades
(whether any of the foregoing are open air or
enclosed); and
‘‘(C) any other advertisements placed—
‘‘(i) outdoors, or