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TOBACCO OUTLET BUSINESS
JULY/AUGUST 2012
TMA Highlights
users who would have quit had the
product not been promoted and the
number of non-users who would start
using tobacco products because of the
production of the MRTP), the FDA
has effectively created a catch-22 for
manufacturers, explained Siegel.
“What do you need to do to
determine number of youths who will
start using your product if you market
it?” asked Dr. Siegel. “There is only one
way to find that out—and that’s to
market your product as a modified-risk
product.The same is true of getting the
number of smokers who would have
quit. So it’s a complete catch-22; in
order to market a product as an MRTP,
you must first have already marketed
the product as an MRTP.”
“I would call that unethical,” added
Siegel. “It deprives smokers of having
products that could save their lives.”
In a session on MRTPs later that day,
representatives of the FDA explained
their regulatory role with the category,
noting that the FDA must ensure that
the MRTP product “raises no new
questions of public health,” explained
Dr. Lawrence Deyton, director at the
FDA Center for Tobacco Products.
To fulfill that mission, the FDA must
ensure that MRTPs are essentially
harm-free—a directive that includes
assessing the products for negative
health effects as well as weighing the
possibility that non-smokers will be
lured into tobacco use, and the potential
for MRTPs actually even serving as
a “gateway” to smoking. “To issue an
order [to allow marketing an MRTP]
the FDA must be satisfied that the
product actually used by consumers will
significantly reduce harm,” elaborated
Rich O’Connor, a member of the FDA’s
Committee on Scientific Standards for
Studies on Modified Risk Tobacco
Products. “Novel MRTPs may be
positive for public health if they draw
substantial numbers of smokers away
from cigarettes. On the other hand,
novel MRTPs have the potential to
undermine [public health] if they draw
non-smokers [to use tobacco].”
This assertion was greeted with
skepticism by experts on the MRTP
category. Dr. Seigel summed up the
feelings of many in the audience when
he asked Dr. Deyton: “The FDA
regulatory guidance puts steep barriers
in front of marketing MRTPs, which
may present significantly less risk
than traditional products, for which,
in contrast, there are practically no
regulations…Do you think this makes
sense from a public health perspective?
Is there a benefit to public health by
requiring these products to go through
stringent [approval processes] or should
there be alternate requirements for
products especially given the need to
move smokers off cigarettes as quickly
as we can?”
Dr. Michael Siegel, professor
at Boston University’s Public School of Health
Dr. Lawrence Deyton,
director of the FDA’s Center for Tobacco Products
David Ashley, science director
of the FDA’s Center for Tobacco Products
“It’s a complete catch-22; in order
to market a product as an MRTP,
you must first have already
marketed the product as an MRTP.”
—Boston University’s Dr. Michael Siegel