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TOBACCO BUSINESS
MARCH/APRIL 2014
says that the device has the “potential
to make the combusting of tobacco
obsolete,” and that “tobacco control
experts must be open to new strategies” if
e-cigs represent the new frontier, though
“statements based on ideology and
insufficient evidence could prevent the
use of this opportunity”before it becomes
part of a harm-reduction strategy.
…The
American
E-Liquid
Manufacturing Standards Association
(AEMSA) had its third “listening
session” with the FDA on December 19,
at which Dr. Konstantinos Farsalinos,
a cardiologist recognized as a leading
e-cig medical researcher, made a primary
presentation on his study on plasma
nicotine absorption levels (PNLs), which
tested nicotine delivered from both
“cig-alikes” and representative PNLs
from a “new generation” device used
by experienced e-cig consumers and
novice e-cig users (tobacco smokers),
and found that “PNLs from cig-alikes
were dramatically lower as compared
to tobacco cigarettes” and that the new
generation device “showed evidence of
being more efficient at nicotine delivery
than the cig-alikes and came closer to
tobacco cigarette PNLs over time, yet
indicated tobacco cigarettes still deliver
substantively more nicotine puff-for-
puff,” while novice e-cig users’ PNLs
indicated less nicotine absorption
compared to experienced e-cig users.
…AEMSA’s president Lou Ritter
and counsel Azim Chowdhury of Keller
and Heckman met with representatives
at the U.S. Office of Management and
Budget’s (OMB) Office of Information
and Regulatory Affairs (OIRA) on
December 16, during which AEMSA
said that: the Family Smoking Prevention
and Tobacco Control Act broadly defines
“tobacco product” to include substances
that are derived from tobacco such as
nicotine, but that “products that only
contain such tobacco-derived substances
should not be regulated in the same
manner” as cigarettes, smokeless tobacco,
RYO tobacco and other products that
contain tobacco. Tobacco-containing
products, especially those that are
combusted, are the most harmful, while
e-cigs and the e-liquid used in them
are “demonstrably less harmful,” they
explained. AEMSA also opined that:
there is little to no evidence that e-cigs
are used as a “gateway” to conventional
cigarettes; the
premarket authorization
requirements
in the FSPTCA should
not apply to e-cigs and e-liquids; the
grandfather date of February 15, 2007 in
the FSPTCA should not apply to e-cigs
and other tobacco-derived products that
were not contemplated when Congress
was drafting the legislation; all e-cigs and
e-liquidscurrentlyonthemarketshouldbe
allowed to remain on the market without
obtaining premarket approval from
the FDA; and the deeming regulation
should allow for products already on
the market to smoothly transition
to fully regulated status and create a
reasonable premarket authorization
process for new products that focuses on
ingredient and manufacturing process
disclosures to ensure purity and safety.
…Wisconsin State Sen. Glenn
Grothman (R-West Bend), who has
introduced a bill thatwould
exempte-cigs
from the state’s 2010 public smoking
ban, commented that the bill is intended
to help smokers quit regular cigarettes.
…Sheriff Millard Gustafson of Gage
County, Nebraska said that he is
seeking
an exemption for e-cigs
at the Gage
County Detention Center from the ban
on tobacco products on county property.
…The FDA has launched its first
public health education campaign
called “The Real Cost,” aimed at
reducing and preventing youth tobacco
use through ads specifically targeting the
estimated 10 million young people aged
12-17 “who are open to trying smoking
or who have already smoked between one
puff and 99 cigarettes in their lifetime,”
with plans to evaluate the effectiveness
of the $115 million campaign with
a longitudinal study that will follow
8,000 youths over a two-year period.
…The FDA’s Center for Tobacco
Products (CTP) participated in the
annual meeting of the Society for
Research on Nicotine and Tobacco
(SRNT) February 5-8 in Seattle,
Washington. In a roundtable discussion,
CTP Director Mitch Zeller
joined
NJOY CEO Craig Weiss, OSH’s Tim
McAfee, Mayo Clinic’s Scott Leischow,
and the University of Minnesota’s
Dorothy Hatsukami in a discussion
led by the ACS’s Tom Glynn on the
potential health benefits of e-cigs.
…Until March 3, the FDA is accepting
applications for
the FDA Tobacco
Regulatory Science Fellowship
, which
offers mid-career professionals an
opportunity to spend a year at the Center
for Tobacco Products and “participate in
the development of science-based public
health strategies and serve as the lead
for defined projects, meet with policy
leaders, and develop new competencies.”
…Appearing on the January 21
episode of “The Diane Rehm Show” on
National Public Radio that discussed
the latest Surgeon General’s report
that expands the list of adverse health
effects caused by smoking, FDA Center
for Tobacco Products Director Mitch
Zeller said that the report “is a clarion
call that the real harms are associated
with the use of the combusted products
and principally cigarettes.” He then
noted that the FDA has an opportunity
under the Family Smoking Prevention
and Tobacco Control Act to
reduce
smoking-related
morbidity
and
mortality
by both informing the public
and using regulatory tools to try to shift
people away from the most harmful
forms of nicotine delivery, and further
TMA REPORT
ON THE FDA…
