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TOBACCO OUTLET BUSINESS
JULY/AUGUST 2012
N
early every seminar at this
year’s TMA show, held May
21-22 in Williamsburg,
Virginia, focused on—or at least
touched upon—the growing harm
reduction category of tobacco. Many
of those presenting and attending the
seminars expressed frustration over the
regulatory atmosphere around the harm
reduction or modified-risk tobacco
product category, which encompasses
smoke-free products such as snus and
e-cigarettes.
“It’s hard to understand how
prolonging the amount of time that
will pass before modified risk products
will be available in the market [can
be good],” Murray S. Kessler, CEO
of Lorillard Tobacco, told conference
participants in a speech at the opening
night dinner. While acknowledging
that the FDA has a challenging task in
regulating tobacco, Kessler added that
the seeming reluctance of regulators to
acknowledge the potential benefit of
embracing MRTPs rather than focus
exclusively on promoting abstinence
does a disservice to both consumers
and industry efforts to innovate in
order to reduce health risks associated
with tobacco. “We will make a mistake
if we waste years pursuing the old ‘all or
nothing’ approach,” he asserted.
The speech underscored points made
repeatedly throughout the first day’s
sessions as multiple presenters provided
evidence of the potential benefits of
switching from traditional cigarettes
to smokeless alternatives. Many went
on to express frustration that these
benefits cannot be communicated
to smokers due to current
restrictions.
Fueling debate around the
issue was the draft guidance
issued for comment by the
FDA’s Center for Tobacco
Products
in
March,
which offers “details for
those who seek to market
a tobacco product as
modified or lower risk including how
to organize and submit an MRTP
application, what scientific studies
and analyses should be submitted, and
what information should be collected
through post-market surveillance and
studies.”
Commenting on that document at
the TMA session on FDA Decision-
Making, Boston University Public
School of Health’s Dr. Michael
Siegel noted that the guidance
presents “insurmountable obstacles
to the development of modified risk
products.” In laying out onerous data
requirements for MRTP manufacturers
(i.e. requiring data on the number of
TMA Highlights
Harm Reduction
Top-of-Mind
at the TMA Conference
Presenters and attendees alike focused
on modified risk tobacco products.
“It’s hard to
understand how
prolonging
the amount of time
that will pass before
modified risk products
will be available
in the market
[can be good].”
—Lorillard’s Murray S. Kessler
Murray S. Kessler, CEO of Lorillard Tobacco