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VAPOR BUSINESS TRADE SHOW
JULY/AUGUST 2016
The Good, the Bad
and the Mostly Ugly
“I’ve spent every waking moment—and a
lot of sleeping moments—thinking about
deeming regulations over the last six weeks,”
said Troutman Sanders’ Bryan Haynes, who
kicked off VEI with an educational session on
industry regulation and taxation. His state-
ment got a lot of rueful smiles from audience
members in the packed session room, most of
whom had done exactly the same.
Haynes went on to offer a detailed analysis
of the deeming regulations, beginning with
the good—yes, there is some—points. First
and foremost, of course, was the absence of
bans on flavors and on open systems, which
would have decimated the industry.
Haynes also found other points to cel-
ebrate. “FDA did not impose user fees on this
industry, which might be regarded as a posi-
tive,” he pointed out. “There are some provi-
sions for small entity compliance that might
ostensibly help some folks in this room, and
FDA gave the industry some time for the
pre-market review process. Also, there had
been concern that all the products currently
on the market would need to come off of store
shelves as of the effective date of the regula-
tions—that didn’t happen.”
By now, those in the vapor business are
bound to be familiar with some of the not-
so-positive provisions of the regulations, such
as the need for age verification and warning
labels, the requirement to test products for
harmful constituents and to list ingredients
with FDA, as well as the bans on free samples,
on modified-risk claims and on adulterated or
misbranded items. And then there’s the big-
gie: the need for pre-market review and au-
thorization of “new” tobacco products.
“There were lots of things FDA could have
done differently with pre-market review—
what they did was about as bad as it could
have been,” said Haynes.
“
There were lots of
calls to shift the grandfather date to the date
of the FDA regulations, [but] they didn’t do
that. There is also an extremely limited win-
dow (through August 8, 2016) to get products
to market so that you can sell them without
getting FDA’s approval first. By comparison,
when the Tobacco Control Act passed in 2009,
companies had until 2011 to provisionally get
products to market.”
What’s more, newly regulated companies
back then could continue to market their
products until they were given the thumbs
down from FDA. By contrast, FDA now says
that “if they haven’t acted on your applica-
tion within a year, thereafter your product
is subject to enforcement action,” explained
Haynes, who sees this as a surprising and
unwelcome change in procedure. “What does
that mean? I don’t know.”
Haynes sees a distinct possibility of many
vapor product reviews still pending a year after
the application deadline. “FDA has been
MSA’s Don Burke
(L to R) Troutman Sanders’ Bryan Haynes, AVA’s Greg Conley, VTA’s Tony Abboud, TMA’s Farrell Delman
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TOBACCO BUSINESS INTERNATIONAL
JULY/AUGUST 2016