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is no longer valid; or 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 chapter 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 chapter, 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—
100
‘‘(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.
101
‘‘(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;
102
‘‘(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
103
‘‘(ii) on the inside surface of a window 
facing outward. 
‘‘(D) The term ‘outdoor advertising’ does 
not mean—
‘‘(i) an advertisement on the outside 
of a tobacco product manufacturing facil-
ity; 
‘‘(ii) an individual advertisement that 
does not occupy an area larger than 14 
square feet (and that neither is placed in 
such proximity to any other such advertise-
ment so as to create a single ‘mosaic’-type 
advertisement larger than 14 square feet, 
nor functions solely as a segment of a larg-
er advertising unit or series), and that is 
placed on the outside of any retail estab-
lishment that sells tobacco products (other 
than solely through a vending machine), on 
the outside (but on the property of) any 
such establishment, or on the inside sur-
face of a window facing outward in any 
such establishment; or 
‘‘(iii) an advertisement inside a retail 
establishment that sells tobacco products 
(other than solely through a vending ma-
104
chine) that is not placed on the inside sur-
face of a window facing outward. 
‘‘(3) For purposes of this subsection, the term 
‘video game arcade’ means an entertainment estab-
lishment primarily consisting of video games (other 
than video games intended primarily for use by per-
sons 18 years of age or older) and/or pinball ma-
chines. 
‘‘(i) ELIMINATION OF TRANSIT ADVERTISEMENTS.—
‘‘(1) No manufacturer, distributor, or retailer 
may place or cause to be placed any transit adver-
tisements advertising tobacco products. 
‘‘(2) For purposes of this subsection, the term 
‘transit advertisements’ means advertising on or 
within private or public vehicles and all advertise-
ments placed at, on or within any bus stop, taxi 
stand, transportation waiting area, train station, air-
port, or any similar location. 
‘‘(3) The term ‘transit advertisements’ does not 
include any advertisement placed in, on, or outside 
the premises of any retail establishment that sells 
tobacco products (other than solely through a vend-
ing machine), except if such individual advertise-
ment—
105
‘‘(A) occupies an area larger than 14 
square feet; 
‘‘(B) is placed in such proximity to any 
other such advertisement so as to create a sin-
gle ‘mosaic’-type advertisement larger than 14 
square feet; or 
‘‘(C) functions solely as a segment of a 
larger advertising unit or series). 
‘‘(j) BAR
ON ADVERTISING
IN ANY YOUTH-ORI-
ENTED PUBLICATION.—
‘‘(1) No manufacturer, distributor, or retailer 
shall advertise a tobacco product in any youth-ori-
ented publication (whether periodic or limited dis-
tribution). 
‘‘(2) For purposes of this subsection, a ‘youth 
oriented publication’ is a newspaper, magazine, peri-
odical, or other publication—
‘‘(A) whose readers younger than 18 years 
of age constitute more than 15 percent of the 
total readership as measured by competent and 
reliable survey evidence; or 
‘‘(B) that is read by 2,000,000 or more 
persons younger than 18 years of age as meas-
ured by competent and reliable survey evidence.
106
‘‘(k) BAN
ON TOBACCO PRODUCT BRAND NAME 
SPONSORSHIPS.—
‘‘(1) No manufacturer, distributor, or retailer 
may sponsor or cause to be sponsored any athletic, 
musical, artistic, or other social or cultural event, or 
any entry or team in any event, in the brand name 
(alone or in conjunction with any other word), logo, 
symbol, motto, selling message, recognizable color or 
pattern of colors, or any other indicia of product 
identification identical or similar to, or identifiable 
with, those used for any brand of cigarettes or 
smokeless tobacco. 
‘‘(2) Nothing in this subsection shall be con-
strued to prevent a manufacturer, distributor, or re-
tailer from sponsoring or causing to be sponsored 
any athletic, musical, artistic, or other social or cul-
tural event, or team or entry, in the name of the 
corporation which manufactures the tobacco product, 
provided that both the corporate name and the cor-
poration were registered and in use in the United 
States prior to January 1, 2001, and that the cor-
porate name does not include any brand name (alone 
or in conjunction with any other word), logo, symbol, 
motto, selling message, recognizable color or pattern 
of colors, or any other indicia of product identifica-
107
tion identical or similar to, or identifiable with, those 
used for any brand of cigarettes or smokeless to-
bacco. 
‘‘(3) This subsection shall not apply to any 
event sponsored in an adult-only facility. 
‘‘(l) BAN ON TOBACCO BRAND NAME MERCHAN-
DISE.—
‘‘(1) No manufacturer may market, distribute, 
offer, sell, license or cause to be marketed, distrib-
uted, offered, sold, or licensed (including, without 
limitation, by catalogue or direct mail), any apparel 
or other merchandise (other than tobacco products, 
items the sole function of which is to advertise to-
bacco products, or written or electronic publications) 
which bears a brand name. 
‘‘(2) Nothing in this subsection shall—
‘‘(A) prohibit the distribution to any man-
ufacturer’s employee who is an adult of any 
item described above that is intended for the 
personal use of such an employee; 
‘‘(B) require any manufacturer to retrieve, 
collect or otherwise recover any item that prior 
to the enactment of this chapter was marketed, 
distributed, offered, sold, licensed, or caused to
108
be marketed, distributed, offered, sold, or li-
censed by such manufacturer; 
‘‘(C) apply to coupons or other items used 
by adults solely in connection with the purchase 
of tobacco products; or 
‘‘(D) apply to apparel or other merchan-
dise used within an adult-only facility that is 
not distributed (by sale or otherwise) to any 
member of the general public. 
‘‘(m) BAN ON GIFTS TO UNDERAGE PERSONS BASED 
ON PROOFS OF PURCHASE.—
‘‘(1) No manufacturer, distributor, or retailer 
may provide or cause to be provided to any person, 
without sufficient proof that such person is an adult, 
any item in exchange for the purchase of tobacco 
products, or the furnishing of credits, proofs-of-pur-
chase, or coupons with respect to such a purchase. 
‘‘(2)(A) For purposes of paragraph (1), a driv-
er’s license or other government-issued identification 
(or legible photocopy thereof), the validity of which 
is certified by the person to whom the item is pro-
vided, shall by itself be deemed to be a sufficient 
form of proof of age; and 
‘‘(B) In the case of items provided (or to be re-
deemed) at retail establishments, a manufacturer
109
shall be entitled to rely on verification of proof of 
age by the retailer, where such retailer is required 
to obtain verification under applicable Federal, State 
or local law. 
‘‘(n) BAN
ON
NON-TOBACCO
PRODUCT
BRAND 
NAMES.—
‘‘(1) Except as provided in paragraph (2), no 
manufacturer may, pursuant to any agreement re-
quiring the payment of money or other valuable con-
sideration, use or cause to be used as a brand name 
of any tobacco product any nationally recognized or 
nationally established brand name or trade name of 
any non-tobacco item or service or any nationally 
recognized or nationally established sports team, en-
tertainment group, or individual celebrity. 
‘‘(2) Paragraph (1) shall not apply to any to-
bacco product brand name in existence as of July 1, 
1998. 
‘‘(3) For the purposes of this section, the term 
‘other valuable consideration’ shall not include an 
agreement between two entities who enter into such 
agreement for the sole purpose of avoiding infringe-
ment claims. 
‘‘(o) LIMITATION ON THIRD PARTY USE OF TO-
BACCO BRAND NAMES.—
110
‘‘(1) No manufacturer may license or otherwise 
expressly authorize any third party to use or adver-
tise any brand name in a manner prohibited by this 
Act if done by such manufacturer itself. 
‘‘(2) Nothing in this subsection shall require 
any manufacturer to retrieve, collect, or otherwise 
recover any item that prior to the enactment of this 
chapter was marketed, distributed, offered, sold, li-
censed, or caused to be marketed, distributed, of-
fered, sold, or licensed by such manufacturer. 
‘‘(p) BAR ON PRODUCT PLACEMENT IN CERTAIN 
MEDIA.—
‘‘(1) Except as provided in paragraph (2), no 
manufacturer may make, or cause to be made, any 
payment or other consideration to any other person 
or entity to use, display, make reference to, or use 
as a prop any tobacco product, tobacco product 
package, advertisement for a tobacco product, or any 
other item bearing a brand name in any motion pic-
ture, television show, theatrical production or other 
live performance, live or recorded performance of 
music, commercial film or video, or video game 
(‘media’). 
‘‘(2) Paragraph (1) shall not apply to—
111
‘‘(A) media where the audience or viewers 
are within an adult-only facility (provided such 
media are not visible to persons outside such 
adult-only facility); 
‘‘(B) media not intended for distribution or 
display to the public; or 
‘‘(C) instructional media concerning non-
conventional tobacco products or tobacco prod-
ucts designated as reduced risk viewed only by 
or provided only to consumers who are adults. 
‘‘(q) SEVERABILITY.—If any provision of this section 
is held invalid, those subsections, and paragraphs which 
are not so held shall continue to be in effect. 
‘‘(r) EFFECTIVE DATES.—The provisions of this sec-
tion shall take effect on the date that is six months after 
the date of enactment of this section, except for the provi-
sions of subsections (e) and (k), which shall take effect 
on the date that is one year after the effective date of 
this section. 
‘‘SEC. 916. MANDATORY DISCLOSURES. 
‘‘(a) DISCLOSURE OF INGREDIENTS TO THE PUB-
LIC.—
‘‘(1) Not later than 12 months after the effec-
tive date of this section, the Secretary shall promul-
gate regulations requiring the disclosure to the pub-
112
lic on a brand-by-brand basis of the common or 
usual name of each ingredient of a tobacco product 
in descending order of predominance by weight, ex-
cept that spices, flavorings, and colorings may at the 
manufacturer’s election be designated as spices, 
flavorings, and colorings without naming each. Any 
ingredient that has been disclosed to the public pur-
suant to any other law or regulation with respect to 
a particular brand may be required to be disclosed 
for such brand pursuant to this subsection. 
‘‘(2) The regulations required by this subsection 
shall provide that incidental additives that are 
present in a tobacco product at insignificant levels 
and that do not have any technical or functional ef-
fect in the finished tobacco product shall be exempt 
from disclosure. 
‘‘(3) The requirement of this subsection to dis-
close ingredients in descending order of predomi-
nance shall not apply to ingredients in amounts of 
2 percent or less by weight when a listing of such 
ingredients is placed at the end of the ingredients 
statement following an appropriate quantifying 
statement, such as ‘contains ll percent or less of 
ll’, or ‘less than ll percent of ll’.
113
‘‘(4) Any disclosure required pursuant to this 
subsection may be required by appropriate means, 
except that, notwithstanding any other provision of 
this Act, the Secretary shall not require the listing 
of any ingredient on any package or in any adver-
tisement. 
‘‘(b) DISCLOSURE OF PERCENTAGE OF DOMESTIC 
AND FOREIGN TOBACCO.—Not later than 12 months after 
the effective date of this section, the Secretary shall pro-
mulgate regulations that require that each package of a 
tobacco product disclose, with respect to the tobacco con-
tained in that brand—
‘‘(1) the percentage of tobacco that is domestic 
tobacco; and 
‘‘(2) the percentage of tobacco that is foreign 
tobacco. 
‘‘(c) MANDATORY DISCLAIMER.—
‘‘(1) Any tobacco product advertising which in-
cludes a term classifying a brand of tobacco product 
according to its ‘tar’ yield or the yield to consumers 
of any substance, including but not limited to terms 
such as ‘light’, or ‘low tar’, shall also include the fol-
lowing disclaimer: ‘[Brand] not shown to be less 
hazardous than other [type of tobacco product]’. 
This section shall not be deemed to apply to the use
114
of the terms ‘filtered’ or ‘filter’. In no event shall 
any such disclaimer be required on any tobacco 
product package. 
‘‘(2) In addition to the provisions of paragraph 
(1), not later than 12 months after the effective date 
of this section, the Secretary shall promulgate regu-
lations relating to the use of such terms, to ensure 
that they are not false or misleading. 
‘‘(3) The Secretary may modify or waive any 
requirement under this subsection with respect to 
any product that has been designated by the Sec-
retary as a reduced risk product under section 
912.’’. 
SEC. 504. REGULATORY RECORD. 
Notwithstanding the provisions of subchapter II of 
chapter 5 of title 5, United States Code, in promulgating 
regulations under this chapter, the record developed and 
utilized by the Secretary for the purposes of promulgating 
subparts (B) and (D) of the regulations relating to the 
sale, distribution, and use of tobacco products on or about 
August 28, 1996, as reflected in articles IV and VI of the 
preamble to the 1996 Food and Drug Administration To-
bacco Rule (including public comments, Food and Drug 
Administration documents, and any other information 
generated or compiled for purposes of promulgating such
115
regulations), shall be deemed to have the same legal status 
as if such record had been developed under a rulemaking 
proceeding conducted pursuant to section 906(d)(1). In all 
other respects, including with respect to the issue of 
whether such regulations conform to section 906(d)(1), 
the procedural requirements of this chapter and the Ad-
ministration Procedure Act will apply. 
SEC. 505. CONFORMING AND OTHER AMENDMENTS TO GEN-
ERAL PROVISIONS. 
(a) AMENDMENT OF FEDERAL FOOD, DRUG, AND 
COSMETIC ACT.—Except as otherwise expressly provided, 
whenever in this section an amendment is expressed in 
terms of an amendment to, or repeal of, a section or other 
provision, the reference is to a section or other provision 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.).
(b) SECTION 301.—Section 301 (21 U.S.C. 331) is 
amended—
(1) in subsection (a), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(2) in subsection (b), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(3) in subsection (c), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’;
116
(4) in subsection (e), by striking ‘‘515(f), or 
519’’ and inserting ‘‘515(f), 519, or 909’’; 
(5) in subsection (g), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(6) in subsection (h), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(7) in subsection (j), by striking ‘‘708, or 721’’ 
and inserting ‘‘708, 721, 903, 904, 905, 906, 907, 
908, 909, 910, or 912’’; 
(8) in subsection (k), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(9) by striking subsection (p) and inserting the 
following: 
‘‘(p) The failure to register in accordance with section 
510 or 905, the failure to provide any information re-
quired by section 510(j), 510(k), 905(i), or 905(j), or the 
failure to provide a notice required by section 510(j)(2) 
or 905(j)(2).’’; 
(10) in subsection (q), by striking paragraph 
(1) and inserting the following: 
‘‘(1) The failure or refusal—
‘‘(A) to comply with any requirement prescribed 
under section 518, 520(g), 906(f), or 908;
117
‘‘(B) to furnish any notification or other mate-
rial or information required by or under section 519, 
520(g), 904, 906(f), or 909; or 
‘‘(C) to comply with a requirement under sec-
tion 522.’’; 
(11) in subsection (q)(2), by striking ‘‘device,’’ 
and inserting ‘‘device or tobacco product,’’; 
(12) in subsection (r), by inserting ‘‘or tobacco 
product’’ after ‘‘device’’ each time that it appears; 
and 
(13) by adding at the end the following: 
‘‘(aa) The sale of tobacco products in violation 
of a no-tobacco-sale order issued under section 
303(f).’’. 
(c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f)) 
is amended—
(1) by striking the subsection heading and in-
serting the following: 
‘‘(f) CIVIL
PENALTIES; NO-TOBACCO-SALE
OR-
DERS.—’’; 
(2) in paragraph (1)(A), by inserting ‘‘or to-
bacco products’’ after ‘‘devices’’; 
(3) by redesignating paragraphs (3), (4), and 
(5) as paragraphs (4), (5), and (6), respectively;
118
(4) by inserting after paragraph (2) the fol-
lowing: 
‘‘(3) If the Secretary finds that a person has 
committed repeated violations of restrictions promul-
gated under section 906(d) at a particular retail out-
let then the Secretary may impose a no-tobacco-sale 
order on that person prohibiting the sale of tobacco 
products in that outlet. A no-tobacco-sale order may 
be imposed with a civil penalty under paragraph 
(1).’’; 
(5) in subparagraph (A) of paragraph (4), as so 
redesignated—
(A) by striking ‘‘assessed’’ the first time it 
appears and inserting ‘‘assessed, or a no-to-
bacco-sale order may be imposed,’’; and 
(B) by striking ‘‘penalty’’ and inserting 
‘‘penalty, or upon whom a no-tobacco-order is 
to be imposed,’’; 
(6) in subparagraph (B) of paragraph (4), as so 
redesignated—
(A) by inserting after ‘‘penalty,’’ the fol-
lowing: ‘‘or the period to be covered by a no-to-
bacco-sale order,’’; and 
(B) by adding at the end the following: ‘‘A 
no-tobacco-sale order permanently prohibiting
119
an individual retail outlet from selling tobacco 
products shall include provisions that allow the 
outlet, after a specified period of time, to re-
quest that the Secretary compromise, modify, 
or terminate the order.’’; 
(7) by adding at the end of paragraph (4), as 
so redesignated, the following: 
‘‘(D) The Secretary may compromise, mod-
ify, or terminate, with or without conditions, 
any no-tobacco-sale order.’’; 
(8) in paragraph (5), as so redesignated—
(A) by striking ‘‘(3)(A)’’ and inserting 
‘‘(4)(A)’’; 
(B) by inserting ‘‘or the imposition of a 
no-tobacco-sale order’’ after ‘‘penalty’’ the first 
2 places it appears; 
(C) by striking ‘‘issued.’’ and inserting 
‘‘issued, or on which the no-tobacco-sale order 
was imposed, as the case may be.’’; and 
(9) in paragraph (6), as so redesignated, by 
striking ‘‘paragraph (4)’’ each place it appears and 
inserting ‘‘paragraph (5)’’. 
(d) SECTION 304.—Section 304 (21 U.S.C. 334) is 
amended—
120
(1) in subsection (a)(2), by striking ‘‘and’’ be-
fore ‘‘(D)’’; 
(2) in subsection (a)(2), by striking ‘‘device.’’ 
and inserting a comma and the following: 
‘‘(E) Any adulterated or misbranded to-
bacco product.’’; 
(3) in subsection (d)(1), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(4) in subsection (g)(1), by inserting ‘‘or to-
bacco product’’ after ‘‘device’’ each place it appears; 
and 
(5) in subsection (g)(2)(A), by inserting ‘‘or to-
bacco product’’ after ‘‘device’’ each place it appears. 
(e) SECTION
702.—Section 702(a) (21 U.S.C. 
372(a)) is amended—
(1) by inserting ‘‘(A)’’ after ‘‘(1)’’; and 
(2) by adding at the end thereof the following:
‘‘(B) For a tobacco product, to the extent feasible, 
the Secretary shall contract with the States in accordance 
with subparagraph (A) to carry out inspections of retailers 
in connection with the enforcement of this Act.’’. 
(f) SECTION 703.—Section 703 (21 U.S.C. 373) is 
amended—
(1) by inserting ‘‘tobacco product,’’ after ‘‘de-
vice,’’ each place it appears; and
121
(2) by inserting ‘‘tobacco products,’’ after ‘‘de-
vices,’’ each place it appears. 
(g) SECTION 704.—Section 704 (21 U.S.C. 374) is 
amended—
(1) in subsection (a)(1)(A), by inserting ‘‘to-
bacco products,’’ after ‘‘devices,’’ each place it ap-
pears; 
(2) in subsection (a)(1)(B), by inserting ‘‘or to-
bacco products’’ after ‘‘restricted devices’’ each place 
it appears; and 
(3) in subsection (b), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’. 
(h) SECTION
705.—Section 705(b) (21 U.S.C. 
375(b)) is amended by inserting ‘‘tobacco products,’’ after 
‘‘devices,’’. 
(i) SECTION 709.—Section 709 (21 U.S. C. 379) is 
amended by inserting ‘‘or tobacco product’’ after ‘‘device’’. 
(j) SECTION 801.—Section 801 (21 U.S.C. 381) is 
amended—
(1) in subsection (a), by inserting ‘‘tobacco 
products,’’ after ‘‘devices,’’ the first time it appears; 
(2) in subsection (a), by inserting ‘‘or sub-
section (j) of section 905’’ after ‘‘section 510’’;
122
(3) in subsection (a), by striking ‘‘drugs or de-
vices’’ each time it appears and inserting ‘‘drugs, de-
vices, or tobacco products’’; and 
(4) in subsection (e)(1), by inserting ‘tobacco 
product’ after ‘device’. 
(k) SECTION 1003.—Section 1003(d)(2)(C) (as re-
designated by section 101(a)) is amended—
(1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 
(2) inserting a comma and ‘‘and tobacco prod-
ucts’’ after ‘‘devices’’. 
(l) 
EFFECTIVE
DATE
FOR
NO-TOBACCO-SALE 
ORDER AMENDMENTS.—The amendments made by sub-
section (c), other than the amendment made by paragraph 
(2) thereof, shall take effect only upon the promulgation 
of final regulations by the Secretary—
(1) defining the term ‘‘repeated violation’’, as 
used in section 303(f) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 333(f)) as amended by 
subsection (c), by identifying the number of viola-
tions of particular requirements over a specified pe-
riod of time that constitute a repeated violation; 
(2) providing for notice to the retailer of each 
violation at a particular retail outlet; 
(3) providing that a person may not be charged 
with repeated violations at a particular retail outlet
123
unless the Secretary has provided notice of previous 
violations at that outlet; 
(4) establishing a period of time during which, 
if there are no violations by a particular retail out-
let, that outlet will not be considered to have been 
the site of repeated violations when the next viola-
tion occurs; and 
(5) providing that good faith reliance on false 
identification does not constitute a violation of any 
minimum age requirement for the sale of tobacco 
products. 
SEC. 506. CIGARETTE LABEL AND ADVERTISING WARNINGS. 
Section 4 of the Federal Cigarette Labeling and Ad-
vertising Act (15 U.S.C. 1333) is amended to read as fol-
lows: 
‘‘SEC. 4. LABELING. 
‘‘(a) LABEL REQUIREMENTS.—
‘‘(1) IN GENERAL.—It shall be unlawful for any 
person to manufacture, package, or import for sale 
or distribution within the United States any ciga-
rettes the package of which fails to bear, in accord-
ance with the requirements of this section, one of 
the following labels: 
‘‘WARNING: Cigarettes are addictive’’
124
‘‘WARNING: Tobacco smoke can harm your chil-
dren’’
‘‘WARNING: Cigarettes cause fatal lung disease’’
‘‘WARNING: Cigarettes cause cancer’’
‘‘WARNING: Cigarettes cause strokes and heart 
disease’’
‘‘WARNING: Smoking during pregnancy can harm 
your baby’’
‘‘WARNING: Smoking can kill you’’
‘‘WARNING: Tobacco smoke causes fatal lung dis-
ease in non-smokers’’
‘‘WARNING: Quitting smoking now greatly reduces 
serious risks to your health’’
‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—
‘‘(A) IN GENERAL.—Each label statement 
required by paragraph (1) shall be located in 
the upper portion of the front and rear panels 
of the package, directly on the package under-
neath the cellophane or other clear wrapping. 
Except as provided in subparagraph (B), each 
label statement shall comprise at least the top 
25 percent of the front and rear panels of the 
package. The word ‘‘WARNING’’ shall appear 
in capital letters and all text shall be in con-
spicuous and legible 17-point type, unless the
125
text of the label statement would occupy more 
than 70 percent of such area, in which case the 
text may be in a smaller conspicuous and leg-
ible type size, provided that at least 60 percent 
of such area is occupied by required text. The 
text shall be black on a white background, or 
white on a black background, in a manner that 
contrasts, by typography, layout, or color, with 
all other printed material on the package, in an 
alternating fashion under the plan submitted 
under subsection (b)(4). 
‘‘(B) FLIP-TOP BOXES.—For any cigarette 
brand package manufactured or distributed be-
fore January 1, 2000, which employs a flip-top 
style (if such packaging was used for that 
brand in commerce prior to June 21, 1997), the 
label statement required by paragraph (1) shall 
be located on the flip-top area of the package, 
even if such area is less than 25 percent of the 
area of the front panel. Except as provided in 
this paragraph, the provisions of this subsection 
shall apply to such packages.
‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU-
TION.—The provisions of this subsection do not 
apply to a tobacco product manufacturer or dis-
126
tributor of cigarettes which does not manufacture, 
package, or import cigarettes for sale or distribution 
within the United States. 
‘‘(b) ADVERTISING REQUIREMENTS.—
‘‘(1) IN GENERAL.—It shall be unlawful for any 
tobacco product manufacturer, importer, distributor, 
or retailer of cigarettes to advertise or cause to be 
advertised within the United States any cigarette 
unless its advertising bears, in accordance with the 
requirements of this section, one of the labels speci-
fied in subsection (a) of this section. 
‘‘(2) TYPOGRAPHY, ETC.—Each label statement 
required by subsection (a) of this section in cigarette 
advertising shall comply with the standards set forth 
in this paragraph. For press and poster advertise-
ments, each such statement and (where applicable) 
any required statement relating to tar, nicotine, or 
other constituent yield shall comprise at least 20 
percent of the area of the advertisement and shall 
appear in a conspicuous and prominent format and 
location at the top of each advertisement within the 
trim area. The Secretary may revise the required 
type sizes in such area in such manner as the Sec-
retary determines appropriate. The word ‘‘WARN-
ING’’ shall appear in capital letters, and each label
127
statement shall appear in conspicuous and legible 
type. The text of the label statement shall be black 
if the background is white and white if the back-
ground is black, under the plan submitted under 
paragraph (4) of this subsection. The label state-
ments shall be enclosed by a rectangular border that 
is the same color as the letters of the statements 
and that is the width of the first downstroke of the
capital ‘‘W’’ of the word ‘‘WARNING’’ in the label 
statements. The text of such label statements shall 
be in a typeface pro rata to the following require-
ments: 45-point type for a whole-page broadsheet 
newspaper advertisement; 39-point type for a half-
page broadsheet newspaper advertisement; 39-point 
type for a whole-page tabloid newspaper advertise-
ment; 27-point type for a half-page tabloid news-
paper advertisement; 31.5-point type for a double 
page spread magazine or whole-page magazine ad-
vertisement; 22.5-point type for a 28 centimeter by 
3 column advertisement; and 15-point type for a 20 
centimeter by 2 column advertisement. The label 
statements shall be in English, except that in the 
case of—
‘‘(A) an advertisement that appears in a 
newspaper, magazine, periodical, or other publi-
128
cation that is not in English, the statements 
shall appear in the predominant language of the 
publication; and 
‘‘(B) in the case of any other advertise-
ment that is not in English, the statements 
shall appear in the same language as that prin-
cipally used in the advertisement. 
‘‘(3) ADJUSTMENT BY SECRETARY.—The Sec-
retary may, through a rulemaking under section 553 
of title 5, United States Code, adjust the format and 
type sizes for the label statements required by this 
section or the text, format, and type sizes of any re-
quired tar, nicotine yield, or other constituent disclo-
sures, or to establish the text, format, and type sizes 
for any other disclosures required under the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.). The text of any such label statements or dis-
closures shall be required to appear only within the 
20 percent area of cigarette advertisements provided 
by paragraph (2) of this subsection. The Secretary 
shall promulgate regulations which provide for ad-
justments in the format and type sizes of any text 
required to appear in such area to ensure that the 
total text required to appear by law will fit within 
such area.
129
‘‘(4) MARKETING REQUIREMENTS.—
‘‘(A) The label statements specified in sub-
section (a)(1) shall be randomly displayed in 
each 12-month period, in as equal a number of 
times as is possible on each brand of the prod-
uct and be randomly distributed in all areas of 
the United States in which the product is mar-
keted in accordance with a plan submitted by 
the tobacco product manufacturer, importer, 
distributor, or retailer and approved by the Sec-
retary. 
‘‘(B) The label statements specified in sub-
section (a)(1) shall be rotated quarterly in al-
ternating sequence in advertisements for each 
brand of cigarettes in accordance with a plan 
submitted by the tobacco product manufacturer, 
importer, distributor, or retailer to, and ap-
proved by, the Secretary. 
‘‘(C) The Secretary shall review each plan 
submitted under subparagraph (B) and approve 
it if the plan—
‘‘(i) will provide for the equal distribu-
tion and display on packaging and the ro-
tation required in advertising under this 
subsection; and
130
‘‘(ii) assures that all of the labels re-
quired under this section will be displayed 
by the tobacco product manufacturer, im-
porter, distributor, or retailer at the same 
time.’’. 
SEC. 507. AUTHORITY TO REVISE CIGARETTE WARNING 
LABEL STATEMENTS. 
Section 4 of the Federal Cigarette Labeling and Ad-
vertising Act (15 U.S.C. 1333), as amended by section 
506, is further amended by adding at the end the fol-
lowing: 
‘‘(c) CHANGE IN REQUIRED STATEMENTS.—The Sec-
retary may, by a rulemaking conducted under section 553 
of title 5, United States Code, adjust the format, type size, 
and text of any of the warning label statements required 
by subsection (a) of this section subject to the limitation 
on proportional size of the warning contained in sub-
sections (a)(2) and (b)(2), or establish the format, type 
size, and text of any other disclosures required under the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.), if the Secretary finds that such a change would 
promote greater public understanding of the risks associ-
ated with the use of smokeless tobacco products.’’.
131
SEC. 508. SMOKELESS TOBACCO LABELS AND ADVERTISING 
WARNINGS. 
Section 3 of the Comprehensive Smokeless Tobacco 
Health Education Act of 1986 (15 U.S.C. 4402) is amend-
ed to read as follows: 
‘‘SEC. 3. SMOKELESS TOBACCO WARNING. 
‘‘(a) GENERAL RULE.— 
‘‘(1) It shall be unlawful for any person to man-
ufacture, package, or import for sale or distribution 
within the United States any smokeless tobacco 
product unless the product package bears, in accord-
ance with the requirements of this Act, one of the 
following labels: 
‘‘WARNING: This product can cause mouth cancer’’
‘‘WARNING: This product can cause gum disease 
and tooth loss’’
‘‘WARNING: This product is not a safe alternative 
to cigarettes’’
‘‘WARNING: Smokeless tobacco is addictive’’
‘‘(2) Each label statement required by para-
graph (1) shall be—
‘‘(A) located on the 2 principal display 
panels of the package, and each label statement 
shall comprise at least 25 percent of each such 
display panel; and
132
‘‘(B) in 17-point conspicuous and legible 
type and in black text on a white background, 
or white text on a black background, in a man-
ner that contrasts by typography, layout, or 
color, with all other printed material on the 
package, in an alternating fashion under the 
plan submitted under subsection (b)(3), except 
that if the text of a label statement would oc-
cupy more than 70 percent of the area specified
by subparagraph (A), such text may appear in 
a smaller type size, so long as at least 60 per-
cent of such warning area is occupied by the 
label statement. 
‘‘(3) The label statements required by para-
graph (1) shall be introduced by each tobacco prod-
uct manufacturer, packager, importer, distributor, or 
retailer of smokeless tobacco products concurrently 
into the distribution chain of such products. 
‘‘(4) The provisions of this subsection do not 
apply to a tobacco product manufacturer or dis-
tributor of any smokeless tobacco product that does 
not manufacture, package, or import smokeless to-
bacco products for sale or distribution within the 
United States. 
‘‘(b) REQUIRED LABELS.—
133
‘‘(1) It shall be unlawful for any tobacco prod-
uct manufacturer, packager, importer, distributor, or 
retailer of smokeless tobacco products to advertise or 
cause to be advertised within the United States any 
smokeless tobacco product unless its advertising 
bears, in accordance with the requirements of this 
section, one of the labels specified in subsection (a). 
‘‘(2) Each label statement required by sub-
section (a) in smokeless tobacco advertising shall 
comply with the standards set forth in this para-
graph. For press and poster advertisements, each 
such statement and (where applicable) any required 
statement relating to tar, nicotine, or other con-
stituent yield shall—
‘‘(A) comprise at least 20 percent of the 
area of the advertisement, and the warning area 
shall be delineated by a dividing line of con-
trasting color from the advertisement; and 
‘‘(B) the word ‘‘WARNING’’ shall appear 
in capital letters and each label statement shall 
appear in conspicuous and legible type. The text 
of the label statement shall be black on a white 
background, or white on a black background, in 
an alternating fashion under the plan submitted 
under paragraph (3).
134
‘‘(3)(A) The label statements specified in sub-
section (a)(1) shall be randomly displayed in each 
12-month period, in as equal a number of times as 
is possible on each brand of the product and be ran-
domly distributed in all areas of the United States 
in which the product is marketed in accordance with 
a plan submitted by the tobacco product manufac-
turer, importer, distributor, or retailer and approved 
by the Secretary. 
‘‘(B) The label statements specified in sub-
section (a)(1) shall be rotated quarterly in alter-
nating sequence in advertisements for each brand of 
smokeless tobacco product in accordance with a plan 
submitted by the tobacco product manufacturer, im-
porter, distributor, or retailer to, and approved by, 
the Secretary. 
‘‘(C) The Secretary shall review each plan sub-
mitted under subparagraph (B) and approve it if the 
plan—
‘‘(i) will provide for the equal distribution 
and display on packaging and the rotation re-
quired in advertising under this subsection; and
‘‘(ii) assures that all of the labels required 
under this section will be displayed by the to-
135
bacco product manufacturer, importer, dis-
tributor, or retailer at the same time. 
‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is 
unlawful to advertise smokeless tobacco on any medium 
of electronic communications subject to the jurisdiction of 
the Federal Communications Commission.’’. 
SEC. 509. AUTHORITY TO REVISE SMOKELESS TOBACCO 
PRODUCT WARNING LABEL STATEMENTS. 
Section 3 of the Comprehensive Smokeless Tobacco 
Health Education Act of 1986 (15 U.S.C. 4402), as 
amended by section 508, is further amended by adding 
at the end the following: 
‘‘(d) AUTHORITY
TO
REVISE
WARNING
LABEL 
STATEMENTS.—The Secretary may, by a rulemaking con-
ducted under section 553 of title 5, United States Code, 
adjust the format, type size, and text of any of the warn-
ing label statements required by subsection (a) of this sec-
tion, subject to the limitations on proportional size of the 
warning contained in paragraphs (2) and (3) of subsection 
(a), or establish the format, type size, and text of any 
other disclosures required under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary 
finds that such a change would promote greater public un-
derstanding of the risks associated with the use of smoke-
less tobacco products.’’.
136
SEC. 510. TAR, NICOTINE, AND OTHER SMOKE CON-
STITUENT DISCLOSURE TO THE PUBLIC. 
Section 4(a) of the Federal Cigarette Labeling and 
Advertising Act (15 U.S.C. 1333(a)), as amended by sec-
tion 506, is further amended by adding at the end the 
following: 
‘‘(4)(A) The Secretary shall, by a rulemaking 
conducted under section 553 of title 5, United 
States Code, determine (in the Secretary’s sole dis-
cretion) whether cigarette and other tobacco product 
manufacturers shall be required to include in the 
area of each cigarette advertisement specified by 
subsection (b) of this section, or on the package 
label, or both, the tar and nicotine yields of the ad-
vertised or packaged brand. Any such disclosure 
shall be in accordance with the methodology estab-
lished under such regulations, shall conform to the 
type size requirements of subsection (b) of this sec-
tion, and shall appear within the area specified in 
subsection (b) of this section. 
‘‘(B) Any differences between the requirements 
established by the Secretary under subparagraph (A) 
and tar and nicotine yield reporting requirements es-
tablished by the Federal Trade Commission shall be 
resolved by a memorandum of understanding be-