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72
TOBACCO OUTLET BUSINESS
JULY/AUGUST 2012
In response, Dr. Deyton
noted only that the FDA
is charged with the
“review of individual
products, not classes
of products,” so
the
“scientific
evidence we have
articulated in this
draft guidance is for
specific products.”
F r u s t r a t i o n
among those in the
industry was evident—
particularly
when
panelists from the FDA
left the conference at 5 p.m.
without taking questions from the
audience, with FDA representatives
citing the need “to get back home for
a meeting.”
The FDA panel discussion came
in the wake of several seminars
featuring speakers offering evidence
of the MRTP category’s success in
reducing tobacco-related health issues
in Sweden and research supporting its
potential. For example, Dr. Lars M.
Ramstrom, director of the Institute
for Tobacco Studies in Stockholm
Sweden, presented his analysis of the
concern over whether the use of snus
could have negative effects on public
health. Looking at market data in
Sweden, where snus use is common,
he found that snus use has “served as
a diversion from smoking, not as a
gateway to smoking.” Furthermore, the
prevalence of snus has not contributed
to young people using tobacco.
In fact, in the vast majority of cases,
said Dr. Ramstrom, snus use:
•has not resulted in dual use [with
cigarettes];
•has either been replacing smoking
or serving as a stepping-stone towards
quitting all tobacco use, and
•has not perpetuated nicotine
dependence.
“These findings suggest that the
use of snus in Sweden has yielded
benefits for public health,” said Dr.
Ramstrom, who expressed the concern
that these positive effects will not be
seen in the U.S. unless manufacturers
are able to educate consumers on
the potential health benefits of snus.
“The transferability of the Swedish
experience appears not to be blocked
by absence of tradition, but hampered
by misunderstandings about relative
risks.”
Medical experts at the event also
echoed the concern that U.S. smokers
are unaware of the relative risk of
MRTPs versus traditional cigarettes
and that regulations requiring
manufacturers to gain FDA approval
to market their products as modified
risk is hindering adoption. “The
dominant public health message
in the U.S. [is] that cigarettes and
smokeless are equally dangerous
products,” noted Senator Ignazio
Marino, M.D., a surgeon (University
of Pittsburgh) and member of Italy’s
Senate. Marino presented findings
from the European Union’s testing of
ingredients and constituents.
“We actually surveyed our own medical
staff…and found that 45 percent of them
believe that smokeless tobacco is just as
dangerous, if not more dangerous, than
smoking. If the health science faculty
doesn’t have it right, how can we expect
smokers to have it right?”
“The transferability of the Swedish experience
appears not to be blocked by absence of
tradition, but hampered by misunderstandings
about relative risks.”
—The Institute of Tobacco
Studies’ Dr. Lars Ramstrom
TMA Highlights
“The dominant public
health message in the
U.S. [is] that cigarettes
and smokeless are equally
dangerous products.”
—Italy’s Senator Ignazio Marino