64
TOBACCO BUSINESS
SEPTEMBER/OCTOBER 2013
with the applicable federal laws pertaining
to cigarette manufacturers as administered
and enforced by the Alcohol, Tobacco Tax
and Trade Bureau (TTB), the Internal
Revenue Service, and the U.S. Food and
Drug Administration (FDA). Once again,
industry observers predicted this would be a
death blow for the RYO/MYO category.
Keep On Rolling
Yet Great Midwest has not only survived,
but continues to thrive, Ewald told
TB
recently [Editor’s Note: John Ewald left
Great Midwest Tube at press time. Neil
Wagoner is now the General Manager of
Great Midwest Tube.] “The operation has
grown substantially since
the last time we spoke
and it continues to grow,”
he says, admitting that
the path is not always
easy.“Therewere somany
machines out there when that legislation
went through that were all affected by it,”he
said. “And a lot of people [RYO customers]
did go to fourth-tier cigarettes,so our growth
has not been at the same pace as it was when
thosemachines were rolling.But our sales are
continuing in a positive direction.”
Like many in the industry, Great
Midwest’s growth has also been hampered
by the FDA’s inaction on the many
new products for which it has received
applications for approval.Of the approximate
4,000 products seeking FDA approval under
substantial equivalence provisions (which
allow tobacco companies to market new
products if they can prove they are similar
enough to products already on the market),
the FDA has only approved two Lorillard
non-menthol products. Great Midwest,
which manufacturers its tubes in Cincinnati,
is among the many manufacturers with new
products awaiting approval.
“We have several new private label
products tied up with the FDA waiting for
approval,” said Ewald, who pointed out that
the products are basically the same as those
currently on store shelves except for the name
and packaging.“Under FDA regulation even
if I take the same tube I am making and
selling now—such as our Hot Rod flagship
brand—and put it in a new carton, it is
deemed a new product even though just the
carton is the only new thing about it.”
More Challenges Ahead
Great Midwest continues to await the
approval of all the new products in its
pipeline—which are otherwise ready to
