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TOBACCO BUSINESS INTERNATIONAL
SEPTEMBER/OCTOBER 2014
the same time, regulators are concerned that
as both restrictions on cigarette smoking
and taxes on cigarettes escalate, smokers
may opt to switch to cigars.
Cigars account for just six percent of
total tobacco sales,Altadis’s Barry Schaevitz
pointed out to TMA attendees, adding
that large cigars are less than one-half of 1
percent of total tobacco sales. “That really
amounts to a niche segment, and we hope
that the FDA looks at premium cigars in
that context,”he asserted.
As a category that thrives on limited
releases and flavored products, it would face
enormous hurdles tomeet any requirements
demanding consistency in ingredients to
gain pre-market FDA approval. “This may
be the biggest concern facing large cigars,”
noted Schaevitz. “It’s a direct threat to the
industry’s ability to get new products on the
shelf,making the process cumbersome, time
consuming and very expensive.”
Currently, FDA requirements for
regulated tobacco products call for any
product introduced to the market after
February 15, 2007 to go through one of
two paths to be approved for sale—either
being deemed substantially equivalent to an
existing product on the market or gaining
premarket authorization from the FDA.
“The biggest concern here is that the look-
back period for cigars would be almost 10
years,”notes Schaevitz,noting that the sheer
number of cigars introduced to the market
since 2007 and therefore needing to submit
applications to the FDA would overwhelm
regulators.
“We went through that with smokeless
tobacco, which the FDA didn’t implement
until 2011,” agreed Christopher Casey of
Swisher International. “With smokeless,
the FDA received more than 3,000
applications in what was roughly a four-
year period. Imagine how many they’ll get
with a 10-year window.You’re talking about
thousands and thousands of applications.”
What’s more, the FDA has been
notoriously slow to review applications,
added Scandinavian Tobacco’s Daniel
McGee, who notes that of thousands of
applications submitted, only 21 products
have received approval under the FDA’s
substantial equivalence requirements.
“Looking at industry data, the three
largest premium cigar manufacturers
have approximately 6,000 active SKUs in
circulation—each year you have between
600 and 700 new products come into the
market,”saidMcGee.“That means between
5,000 and 10,000 new applications.”
Due to factors like these, McGee
expressed optimism that the FDAwill come
to recognize that different products need to
be regulateddifferently—evengoingso far as
to suggest that premium cigars be regulated
differently than their machine-made peers.
Attendees from e-Nicotine Technology
Tobacco Associates’ Kirk and Linda Wayne
Kretek’s Noah Steinsapir and
Specialty Tobacco Council’s Henry C. Roehmer
SFATA’s Cynthia Cabrera with
TMA’s Michelle Parisi
Philip Morris’s Moira Gilchrist and Shawnmarie
Maryand-Chung with Swedish Match’s Jim Solyst
