48
TOBACCO BUSINESS INTERNATIONAL
SEPTEMBER/OCTOBER 2014
“I think it is important for the industry
to consider what provisions of the rule
are appropriate and not appropriate for
cigars, handmade vs. machine-made,” he
said. “My company is hopeful that when
the CTP does issue final regulations it
takes these distinctions into consideration
and a reasonable regulation comes up
that will treat the different types of cigars
differently.”
Representing the little cigar category,
Cheyenne International’s Ralph Brown
asserted that little cigars also should not
be treated as cigarettes, even though they
are made by machine. “Cigarette smokers
smoke every day, in contrast as many as
three-fourths of cigar smokers only smoke
occasionally, and some only smoke a few
days a year,” he noted. “This difference
in frequency of exposure translates into
lower disease risk.”
neW CategoRies, neW
PRoblems
For manufacturers in the rapidly
growing e-cigarette and vaping market,
the substantial equivalence approval path is
particularly problematic. After all, as TBI’s
own Ed O’Connor noted in this issue’s
Publisher’s letter, no predicate product
against which to verify new product
substantial equivalence even exists for the
electronic tobacco category because the
category did not exist prior to February 11,
2007.
“Trying to force these products into the
Family Smoking Prevention and Tobacco
ControlActregulationsislikefittingasquare
peg into a round hole,” noted Lou Ritter,
founder of the AEMSA, who pointed out
that the Tobacco Control Act was written
and enacted without any consideration of
products under development.
Also of concern is that fact that many
of the manufacturers of e-cigarette and
vapor category products are entrepreneurial
ventures—far too small to undergo the
rigorous and prohibitively expensive FDA
navigating substantial eQuivalenCe
Many in the industry have been grappling with the prospect of gaining FDA
approval to market both new and existing products, and many more companies now
expect to be facing that challenge under the agency’s proposed deeming
regulations. Veterans of the process say that there is good reason for
concern.
“The FDA is increasing the rate at which they are rejecting incomplete
applications (or submissions), yet we don’t know what constitutes a
complete applicationbecause they have yet to tell us the criteria,”Lorillard
Tobacco’s Neil Wilcox told the TMA meeting’s attendees. “We’ve asked
in every way possible, but they will not answer the question.”
Given that lack of detail, Wilcox recommends following what
guidance there is vigilantly and including as much detail as possible.
“Pretend you’re the reviewer looking at your own submission, and make
sure that you’re communicating everything [that] they may want to
know,” he suggests, adding that responses to any ensuing queries should
be similarly thorough. “During the scientific review part of the process
with Newport, we received an advice verification letter, or request for
more information. We submitted an additional 3,000 pages to answer
those questions and then had a two-hour phone call [with the FDA] a
few months later.”
Attention to detail is also important, noted Carl Ioos of Republic Group, who has
been through the process and had several products approved. “If you are new to this
process or just getting ready, do it one product at a time,”he said, explaining that first-
time applicants will be able to apply their learnings to their future applications. “Be
careful to label the contents carefully—50,000 applications go into that one control
center each year.”
Finally, it’s important to be proactive. Don’t shy away from contacting the FDA
about your application, noted Ben Haas, a partner with Latham & Watkins law
firm. “If you get a letter [that] you don’t understand, pick up the phone and call the
regulatory process manager. If you get nowhere with that project manager, you have
the right to request the help of an ombudsman for the CTP.”
Founder and former pres-
ident of National Vapers
Club, Spike Babaian giv-
ing a presentation on the
evolving technology of
e-cigarettes and vaping
devices.
