(24) Tobacco company documents indicate that 
young people are an important and often crucial seg-
ment of the tobacco market. Children, who tend to 
be more price-sensitive than adults, are influenced 
by advertising and promotion practices that result in 
drastically reduced cigarette prices. 
(25) Comprehensive advertising restrictions will 
have a positive effect on the smoking rates of young 
people. 
(26) Restrictions on advertising are necessary 
to prevent unrestricted tobacco advertising from un-
dermining legislation prohibiting access to young 
people and providing for education about tobacco 
use. 
(27) International experience shows that adver-
tising regulations that are stringent and comprehen-
sive have a greater impact on overall tobacco use 
and young people’s use than weaker or less com-
prehensive ones. 
(28) Text only requirements, although not as 
stringent as a ban, will help reduce underage use of 
tobacco products while preserving the informational 
function of advertising.
(29) It is in the public interest for Congress to 
adopt legislation to address the public health crisis 
created by actions of the tobacco industry. 
(30) The final regulations promulgated by the 
Secretary of Health and Human Services in the Au-
gust 28, 1996, issue of the Federal Register (61 
Fed. Reg. 44615–44618) for inclusion as part 897 
of title 21, Code of Federal Regulations, are con-
sistent with the First Amendment to the United 
States Constitution and with the standards set forth 
in the amendments made by this subtitle for the reg-
ulation of tobacco products by the Food and Drug 
Administration and the restriction on the sale and 
distribution, including access to and the advertising 
and promotion of, tobacco products contained in 
such regulations are substantially related to accom-
plishing the public health goals of this Act. 
(31) The regulations described in paragraph 
(30) will directly and materially advance the Federal 
Government’s substantial interest in reducing the 
number of children and adolescents who use ciga-
rettes and smokeless tobacco and in preventing the 
life-threatening health consequences associated with 
tobacco use. An overwhelming majority of Americans 
who use tobacco products begin using such products
while they are minors and become addicted to the 
nicotine in those products before reaching the age of 
18. Tobacco advertising and promotion plays a cru-
cial role in the decision of these minors to begin 
using tobacco products. Less restrictive and less 
comprehensive approaches have not and will not be 
effective in reducing the problems addressed by such 
regulations. The reasonable restrictions on the ad-
vertising and promotion of tobacco products con-
tained in such regulations will lead to a significant 
decrease in the number of minors using and becom-
ing addicted to those products. 
(32) The regulations described in paragraph 
(30) impose no more extensive restrictions on com-
munication by tobacco manufacturers and sellers 
than are necessary to reduce the number of children 
and adolescents who use cigarettes and smokeless to-
bacco and to prevent the life-threatening health con-
sequences associated with tobacco use. Such regula-
tions are narrowly tailored to restrict those adver-
tising and promotional practices which are most like-
ly to be seen or heard by youth and most likely to 
entice them into tobacco use, while affording tobacco 
manufacturers and sellers ample opportunity to con-
vey information about their products to adult con-
sumers. 
(33) Tobacco dependence is a chronic disease, 
one that typically requires repeated interventions to 
achieve long-term or permanent abstinence. 
(34) Because the only known safe alternative to 
smoking is cessation, interventions should target all 
smokers to help them quit completely. 
(35) Tobacco products have been used to facili-
tate and finance criminal activities both domestically 
and internationally. Illicit trade of tobacco products 
has been linked to organized crime and terrorist 
groups. 
(36) It is essential that the Food and Drug Ad-
ministration review products sold or distributed for 
use to reduce risks or exposures associated with to-
bacco products and that it be empowered to review 
any advertising and labeling for such products. It is 
also essential that manufacturers, prior to marketing 
such products, be required to demonstrate that such 
products will meet a series of rigorous criteria, and 
will benefit the health of the population as a whole, 
taking into account both users of tobacco products 
and persons who do not currently use tobacco prod-
ucts.
(37) Unless tobacco products that purport to 
reduce the risks to the public of tobacco use actually 
reduce such risks, those products can cause substan-
tial harm to the public health to the extent that the 
individuals, who would otherwise not consume to-
bacco products or would consume such products less, 
use tobacco products purporting to reduce risk. 
Those who use products sold or distributed as modi-
fied risk products that do not in fact reduce risk, 
rather than quitting or reducing their use of tobacco 
products, have a substantially increased likelihood of 
suffering disability and premature death. The costs 
to society of the widespread use of products sold or 
distributed as modified risk products that do not in 
fact reduce risk or that increase risk include thou-
sands of unnecessary deaths and injuries and huge 
costs to our health care system. 
(38) As the National Cancer Institute has 
found, many smokers mistakenly believe that ‘‘low 
tar’’ and ‘‘light’’ cigarettes cause fewer health prob-
lems than other cigarettes. As the National Cancer 
Institute has also found, mistaken beliefs about the 
health consequences of smoking ‘‘low tar’’ and 
‘‘light’’ cigarettes can reduce the motivation to quit
smoking entirely and thereby lead to disease and 
death. 
(39) Recent studies have demonstrated that 
there has been no reduction in risk on a population-
wide basis from ‘‘low tar’’ and ‘‘light’’ cigarettes and 
such products may actually increase the risk of to-
bacco use. 
(40) The dangers of products sold or distrib-
uted as modified risk tobacco products that do not 
in fact reduce risk are so high that there is a com-
pelling governmental interest in insuring that state-
ments about modified risk tobacco products are com-
plete, accurate, and relate to the overall disease risk 
of the product. 
(41) As the Federal Trade Commission has 
found, consumers have misinterpreted advertise-
ments in which one product is claimed to be less 
harmful than a comparable product, even in the 
presence of disclosures and advisories intended to 
provide clarification. 
(42) Permitting manufacturers to make unsub-
stantiated statements concerning modified risk to-
bacco products, whether express or implied, even if 
accompanied by disclaimers would be detrimental to 
the public health.
(43) The only way to effectively protect the 
public health from the dangers of unsubstantiated 
modified risk tobacco products is to empower the 
Food and Drug Administration to require that prod-
ucts that tobacco manufacturers sold or distributed 
for risk reduction be approved in advance of mar-
keting, and to require that the evidence relied on to 
support approval of these products is rigorous. 
SEC. 3. PURPOSE. 
The purposes of this Act are— 
(1) to provide authority to the Food and Drug 
Administration to regulate tobacco products under 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.), by recognizing it as the primary 
Federal regulatory authority with respect to the 
manufacture, marketing, and distribution of tobacco 
products; 
(2) to ensure that the Food and Drug Adminis-
tration has the authority to address issues of par-
ticular concern to public health officials, especially 
the use of tobacco by young people and dependence 
on tobacco; 
(3) to authorize the Food and Drug Adminis-
tration to set national standards controlling the 
manufacture of tobacco products and the identity,
public disclosure, and amount of ingredients used in 
such products; 
(4) to provide new and flexible enforcement au-
thority to ensure that there is effective oversight of 
the tobacco industry’s efforts to develop, introduce, 
and promote less harmful tobacco products; 
(5) to vest the Food and Drug Administration 
with the authority to regulate the levels of tar, nico-
tine, and other harmful components of tobacco prod-
ucts; 
(6) in order to ensure that consumers are better 
informed, to require tobacco product manufacturers 
to disclose research which has not previously been 
made available, as well as research generated in the 
future, relating to the health and dependency effects 
or safety of tobacco products; 
(7) to continue to permit the sale of tobacco 
products to adults in conjunction with measures to 
ensure that they are not sold or accessible to under-
age purchasers; 
(8) to impose appropriate regulatory controls on 
the tobacco industry; 
(9) to promote cessation to reduce disease risk 
and the social costs associated with tobacco related 
diseases; and
(10) to strengthen legislation against illicit 
trade in tobacco products. 
SEC. 4. SCOPE AND EFFECT. 
(a) INTENDED EFFECT.—Nothing in this Act (or an 
amendment made by this Act) shall be construed to—
(1) establish a precedent with regard to any 
other industry, situation, circumstance, or legal ac-
tion; or 
(2) affect any action pending in Federal, State, 
or Tribal court, or any agreement, consent decree, or 
contract of any kind. 
(b) AGRICULTURAL ACTIVITIES.—The provisions of 
this Act (or an amendment made by this Act) which au-
thorize the Secretary to take certain actions with regard 
to tobacco and tobacco products shall not be construed to 
affect any authority of the Secretary of Agriculture under 
existing law regarding the growing, cultivation, or curing 
of raw tobacco. 
SEC. 5. SEVERABILITY. 
If any provision of this Act, the amendments made 
by this Act, or the application of any provision of this Act 
to any person or circumstance is held to be invalid, the 
remainder of this Act, the amendments made by this Act, 
and the application of the provisions of this Act to any
other person or circumstance shall not be affected and 
shall continue to be enforced to the fullest extent possible. 
TITLE I—AUTHORITY OF THE 
FOOD AND DRUG ADMINIS-
TRATION 
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND 
COSMETIC ACT. 
(a) DEFINITION OF TOBACCO PRODUCTS.—Section 
201 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321) is amended by adding at the end the fol-
lowing: 
‘‘(nn)(1) The term ‘tobacco product’ means any prod-
uct made or derived from tobacco that is intended for 
human consumption, including any component, part, or 
accessory of a tobacco product (except for raw materials 
other than tobacco used in manufacturing a component, 
part, or accessory of a tobacco product). 
‘‘(2) The term ‘tobacco product’ does not mean—
‘‘(A) a product in the form of conventional food 
(including water and chewing gum), a product rep-
resented for use as or for use in a conventional food, 
or a product that is intended for ingestion in cap-
sule, tablet, softgel, or liquid form; or 
‘‘(B) an article that is approved or is regulated 
as a drug by the Food and Drug Administration.
‘‘(3) The products described in paragraph (2)(A) 
shall be subject to chapter IV or chapter V of this Act 
and the articles described in paragraph (2)(B) shall be 
subject to chapter V of this Act. 
‘‘(4) A tobacco product may not be marketed in com-
bination with any other article or product regulated under 
this Act (including a drug, biologic, food, cosmetics, med-
ical device, or a dietary supplement).’’. 
(b) FDA AUTHORITY OVER TOBACCO PRODUCTS.—
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.) is amended—
(1) by redesignating chapter IX as chapter X; 
(2) by redesignating sections 901 through 907 
as sections 1001 through 1007; and 
(3) by inserting after section 803 the following: 
‘‘CHAPTER IX—TOBACCO 
PRODUCTS 
‘‘SEC. 900. DEFINITIONS. 
‘‘In this chapter: 
‘‘(1) ADDITIVE.—The term ‘additive’ means 
any substance the intended use of which results or 
may reasonably be expected to result, directly or in-
directly, in its becoming a component or otherwise 
affecting the characteristic of any tobacco product 
(including any substances intended for use as a fla-
voring, coloring or in producing, manufacturing, 
packing, processing, preparing, treating, packaging, 
transporting, or holding), except that such term does 
not include tobacco or a pesticide chemical residue 
in or on raw tobacco or a pesticide chemical. 
‘‘(2) BRAND.—The term ‘brand’ means a vari-
ety of tobacco product distinguished by the tobacco 
used, tar content, nicotine content, flavoring used, 
size, filtration, or packaging, logo, registered trade-
mark or brand name, identifiable pattern of colors, 
or any combination of such attributes. 
‘‘(3) CIGARETTE.—The term ‘cigarette’ has the 
meaning given that term by section 3(1) of the Fed-
eral Cigarette Labeling and Advertising Act (15 
U.S.C. 1332(1)), but also includes tobacco, in any 
form, that is functional in the product, which, be-
cause of its appearance, the type of tobacco used in 
the filler, or its packaging and labeling, is likely to 
be offered to, or purchased by, consumers as a ciga-
rette or as roll-your-own tobacco. 
‘‘(4) CIGARETTE
TOBACCO.—The term ‘ciga-
rette tobacco’ means any product that consists of 
loose tobacco that is intended for use by consumers 
in a cigarette. Unless otherwise stated, the require-