Page 12 - TOB Magazine March/April 2013

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TOBACCO OUTLET BUSINESS
MARCH/APRIL 2013
should not group all the products
together in one category.
But that is a possibility—
with “deeming regulation” being
the probability of what one
legal counsel believes is around
the corner for cigars. At the
Tobacco Plus Expo (TPE 2013),
Tobacco Outlet Business caught up
with Nancyellen Keane of counsel
at Troutman Sanders LLP. Here are
some of the highlighted points of her
perceived cigar regulation preparation:
Last year we heard the FDA was
going to take jurisdiction of cigars
and other tobacco products. “But we
didn’t know when it was going to be,
and now we’re in the same position as
last year, except the FDA has notified
the industry in several ways that they’re
really going to do it by this year—take
jurisdiction of OTP,” Keane said. “They
have not been specific, but in various
statements, it sounds like they’re
looking at cigars and e-cigarettes for
additional regulation.”
It’s not clear yet which kinds of
cigars will be covered; no one really
knows. “The premium cigar folks
have been getting more proactive;
they’ve gone to Congress and they’ve
introduced a bill last year, and they’re
re-introducing it this year. Then there
are the other cigar manufacturers, the
machine-made category—those will
probably be more likely to become
regulated, we just can’t say with any
certainty that the premiums will not as
well. It could be all.”
What I tell people is those
regulations will be very similar to,
if not the exact same as, the ones for
cigarettes—they call it a deeming
regulation. “And deeming regulation
means using the existing ones used for
cigarettes, smokeless, etc., and then you
just add the definition of whatever the
‘new’ tobacco products are and apply
it to them—the cigar people and the
e-cigarette people and the pipe people
have heard all of this, but it’s never
really happened to them directly, so it
will hit the fan and we’ll all have a lot
of questions,” Keane explained. “If the
FDA is true to form, I doubt there will
be a whole lot of change in what they’ll
actually do and what they’ve already
said. They tend to just do the same,
repeat.”
If you asked me three years
ago when the FDA happened to
cigarettes—how to get prepared,
I wish we knew then what we
know now. “We would have
told manufacturers to get your
brands out to market—the ones
you really want to grow out—
we’d tell them don’t waste any
time,” she reasoned. “Because the
people in the cigarette realm, they
were stuck with their grandfathered
products or else they had a small
window of opportunity for new ones.
They could have changed their product
or added a new product between the
grandfathering date in 2007 and the
date in 2011 when the reports had to be
filed. Ultimately, they just wished they
had more products. Because getting a
new product approved has proved to be
impossible; none have been approved in
three years.The FDA has not approved
any product, nor have they disapproved
any either.
“And the same is likely to occur with
these other newly regulated products—
new to the FDA, that is—cigars,
e-cigarettes and pipe tobacco. We don’t
know what the grandfathering date will
be for those, and we won’t know until
April.”
We know the premium cigar
industry has done an awful lot to try
to avoid the regulation. As already
indicated, “they have introduced
bills into Congress, there are some
interesting arguments they’re making,
but the question still remains—will