148
SEC. 205. 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 203, 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 label 
requirements, require color graphics to accompany the 
text, increase the required label area from 30 percent up 
to 50 percent of the front and rear panels of the package, 
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.’’. 
SEC. 206. 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 201, is further amended by adding at the end the 
following:
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‘‘(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-
tween the Secretary and the Federal Trade Commis-
sion. 
‘‘(C) In addition to the disclosures required by 
subparagraph (A) of this paragraph, the Secretary 
may, under a rulemaking conducted under section 
553 of title 5, United States Code, prescribe disclo-
150
sure requirements regarding the level of any ciga-
rette or other tobacco product constituent including 
any smoke constituent. Any such disclosure may be 
required if the Secretary determines that disclosure 
would be of benefit to the public health, or otherwise 
would increase consumer awareness of the health 
consequences of the use of tobacco products, except 
that no such prescribed disclosure shall be required 
on the face of any cigarette package or advertise-
ment. Nothing in this section shall prohibit the Sec-
retary from requiring such prescribed disclosure 
through a cigarette or other tobacco product pack-
age or advertisement insert, or by any other means 
under the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.). 
‘‘(D) This paragraph applies to a retailer only 
if that retailer is responsible for or directs the label 
statements required under this section, except that 
this paragraph shall not relieve a retailer of liability 
if the retailer sells or distributes tobacco products 
that are not labeled in accordance with the require-
ments of this subsection.’’.
151
TITLE III—PREVENTION OF IL-
LICIT 
TRADE 
IN 
TOBACCO 
PRODUCTS 
SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPEC-
TION. 
Chapter IX of the Federal Food, Drug, and Cosmetic 
Act, as added by section 101, is further amended by add-
ing at the end the following: 
‘‘SEC. 921. LABELING, RECORDKEEPING, RECORDS INSPEC-
TION. 
‘‘(a) ORIGIN LABELING.—The label, packaging, and 
shipping containers of tobacco products for introduction 
or delivery for introduction into interstate commerce in the 
United States shall bear the statement ‘sale only allowed 
in the United States.’
‘‘(b) REGULATIONS CONCERNING RECORDKEEPING 
FOR TRACKING AND TRACING.—
‘‘(1) IN GENERAL.—Not later than 9 months 
after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, the Secretary 
shall promulgate regulations regarding the establish-
ment and maintenance of records by any person who 
manufactures, processes, transports, distributes, re-
ceives, packages, holds, exports, or imports tobacco 
products.
152
‘‘(2) INSPECTION.—In promulgating the regula-
tions described in paragraph (1), the Secretary shall 
consider which records are needed for inspection to 
monitor the movement of tobacco products from the 
point of manufacture through distribution to retail 
outlets to assist in investigating potential illicit 
trade, smuggling or counterfeiting of tobacco prod-
ucts. 
‘‘(3) CODES.—The Secretary may require codes 
on the labels of tobacco products or other designs or 
devices for the purpose of tracking or tracing the to-
bacco product through the distribution system. 
‘‘(4) SIZE OF BUSINESS.—The Secretary shall 
take into account the size of a business in promul-
gating regulations under this section. 
‘‘(5) RECORDKEEPING
BY
RETAILERS.—The 
Secretary shall not require any retailer to maintain 
records relating to individual purchasers of tobacco 
products for personal consumption. 
‘‘(c) RECORDS INSPECTION.—If the Secretary has a 
reasonable belief that a tobacco product is part of an illicit 
trade or smuggling or is a counterfeit product, each person 
who manufactures, processes, transports, distributes, re-
ceives, holds, packages, exports, or imports tobacco prod-
ucts shall, at the request of an officer or employee duly
153
designated by the Secretary, permit such officer or em-
ployee, at reasonable times and within reasonable limits 
and in a reasonable manner, upon the presentation of ap-
propriate credentials and a written notice to such person, 
to have access to and copy all records (including financial 
records) relating to such article that are needed to assist 
the Secretary in investigating potential illicit trade, smug-
gling or counterfeiting of tobacco products. 
‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.—If 
the manufacturer or distributor of a tobacco product has 
knowledge which reasonably supports the conclusion that 
a tobacco product manufactured or distributed by such 
manufacturer or distributor that has left the control of 
such person may be or has been—
‘‘(A) imported, exported, distributed or of-
fered for sale in interstate commerce by a per-
son without paying duties or taxes required by 
law; or 
‘‘(B) imported, exported, distributed or di-
verted for possible illicit marketing, 
the manufacturer or distributor shall promptly notify the 
Attorney General of such knowledge. 
‘‘(2) KNOWLEDGE DEFINED.—For purposes of 
this subsection, the term ‘knowledge’ as applied to 
a manufacturer or distributor means—
154
‘‘(A) the actual knowledge that the manu-
facturer or distributor had; or 
‘‘(B) the knowledge which a reasonable 
person would have had under like circumstances 
or which would have been obtained upon the ex-
ercise of due care.’’. 
SEC. 302. STUDY AND REPORT. 
(a) STUDY.—The Comptroller General of the United 
States shall conduct a study of cross-border trade in to-
bacco products to—
(1) collect data on cross-border trade in tobacco 
products, including illicit trade and trade of counter-
feit tobacco products and make recommendations on 
the monitoring of such trade; 
(2) collect data on cross-border advertising (any 
advertising intended to be broadcast, transmitted, or 
distributed from the United States to another coun-
try) of tobacco products and make recommendations 
on how to prevent or eliminate, and what tech-
nologies could help facilitate the elimination of, 
cross-border advertising. 
(b) REPORT.—Not later than 18 months after the 
date of enactment of this Act, the Comptroller General 
of the United States shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and
155
the Committee on Energy and Commerce of the House 
of Representatives a report on the study described in sub-
section (a).
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