48
TOBACCO BUSINESS
JULY/AUGUST 2013
A
catch-22 was the common
theme running through day
one of the TMA Conference
held in Williamsburg, Virginia in
May: e-cigarette manufacturers need to
demonstrate the health advantages of
their products through clinical testing,
but the kind of testing necessary to do
so is quite simply not possible.
“A clinical trial in which you start
off with maybe 200 young adult
nonsmokers, randomize half to
smoke two packs a day of a specified
[traditional] cigarette and the other
half to consume [e-cigarettes]—that
study would be ethically impermissible,”
noted Dr. Joel Nitzkin, a public health
physician board certified in preventive
medicine who serves as senior fellow in
tobacco policy for the R Street Institute.
Even if such a study weren’t legally
and ethically questionable, the long
latency period of smoking-related
diseases—or the fact that it takes 20,
30 or even 40 years before lung and
cardiovascular issues arise as a result
of smoking—also make clinical testing
virtually impossible. “It would require
large numbers of subjects with well-
matched confounding factors such as
age, sex, ethnicity, and other lifestyle
factors, as well as subject compliance
over a long period of time,” pointed out
Rafiqul Islam, director of bioanalytical
services at Celerion.
The bottom line? While e-cigarettes
very likely offer a substantial reduction
in harm for tobacco users, the companies
that make them face huge obstacles in
proving so to regulators, who continue
to regard the emerging category
with skepticism. In fact, the Smoke
Free Alternatives Trade Association
(SFATA), which represents distributors,
manufacturers, retailers and consumers
of Personal Electronic Vaporizing
Units, discourages its members from
even trying.
“We are very aware of the fact that
the majority of e-cigarette companies
do not have the infrastructure to pursue
an MRTP designation at this time,”
SFATA’s Cynthia Cabrera told attendees
of the TMA Conference. “There are so
many variables and unknowns and the
spectrum is so large it would be very
difficult for the vast majority of them to
go this route. We tell them there is just
no way.”
Day one wound down with a series
of academic researchers and contract
research operation companies presenting
on the existing research on e-cigarettes
and other potential modified risk
tobacco products and various ways of
conducting studies and analyzing data
to solve the catch-22 facing the industry
in moving forward with MRTPs.
By Jennifer Gelfand
Takeaways from TMA
E-Cigarettes Were the Focus at TMA Conference
SFATA’s Cynthia Cabrera
R Street Institute’s Joel Nitzkin
W
hile e-cigarettes are clearly the next big thing in tobacco, there are huge
potential hitches to the category while realizing its potential, agreed attendees.
