(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 play 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.