52
TOBACCO BUSINESS
JULY/AUGUST 2013
“In the area of modified risk tobacco
products (MRTP), we are aware of the
potential for certain products to reduce
risk at an individual level, but it is more
complicated than that,” Mitch Zeller,
the U.S. Food & Drug Administration’s
recently appointed director of the Center
for Tobacco Products (CTP), told
attendees of the 2013 TMA Conference
on May 16.
“Many of you have heard me say that
the typical pack-a-day smoker who
would never quit and who completely
substitutes
non-combustibles
for
traditional cigarettes will reduce risk. But
it gets complicated when we consider
the increased risk for those who initiate
or reintroduce tobacco use,” he noted.
“These are things we must take into
account.”
Increasingly, pointed out Zeller, the
FDA is struggling with what is, in
effect, a hierarchy of efficacy among risk
reduction behavior, the most effective
being to never start using products in the
first place. Second in the hierarchy is to
stop use as early as possible, and third is
to substantially reduce exposure to toxins
in tobacco products.
“Different products pose different
levels of risk to the individuals…it all
comes down to how they are used, by
whom and with what patterns of use,”
said Zeller. “We recognize that these
are complicated issues. The opportunity
rests with the products that have a real
potential to meet criteria for MRTP.
We encourage [manufacturers] to
submit applications for products that
substantially reduce toxicity,addictiveness
or appeal of tobacco products.”
For its part, the FDA needs to pursue a
collaboration between the center for drug
evaluation, the medical device center and
the CTP to develop a comprehensive
policy regarding MRTP, acknowledges
Zeller, who adds that the CTP is also
making regulatory science research a
priority. “We are investing in laboratory
science and in toxicity research and CDC
labs, as well as continuing our substantial
ongoing investment in Population
Assessment of Tobacco and Health
(PATH), a national longitudinal study
of tobacco use that examines what makes
people susceptible to use and evaluates
initiation and dual use and switching
between tobacco products.”
Ultimately, however, Zeller is calling
on the industry itself—across all fronts—
to make a compelling case for specific
tobacco products. “Someone recently
described [the rule-making process] as a
participatory sport,rather than a spectator
sport,” he said. “It’s a description I like
so much that I’ve appropriated it. The
agency takes the legal responsibility to
not just read, but seriously consider the
substantive comments that are filed on
proposed rulings. It is informed by all of
the submissions, comments and evidence
submitted. If you have a point of view, we
will consider it.”
This statement underscored a central
message running through Zeller’s
presentation, which was the agency’s
commitment to an open dialogue
between the industry and the CTP. As
Zeller put it, “One of my priorities is to
strengthen communications channels.
You may not always like what I have to
say, but we are absolutely committed to
an open dialogue.”
Thus far, he added, his efforts at CTP
have been focused on three critical
areas: menthol, deeming [regulations]
and substantial equivalency. “We have
made substantial progress on all three
issues,” he reports. “In case of substantial
equivalence we are getting close to
making an announcement. Once that has
been made, we will continue to release
decisions on a rolling basis until we catch
up to the backlog of applications.”
Zeller also chided the industry,
expressing hope that the quality of
submissions and “in particular the
completeness of submissions will
improve.”
TB
The FDA’s Mitch Zeller
on MRTP
FDA’s Mitch Zeller
A
cknowledging the potential health advantage of modified
risk tobacco products, the CTP’s director outlined the dilemma
facing his organization—and the industry.
