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Viable Options
What can companies do in the face of poten-
tially business-threatening regulatory over-
reach? Haynes advises a pragmatic approach
to just how much time and energy to spend
applying for FDA approval. “They have a pro-
cess called refusal to file, which means they
take a quick peek [at your application] and if
you haven’t satisfied the basic requirements,
you lose,” he notes. “At the same time, this is
just guidance, so you don’t necessarily have to
satisfy
all
[of ] these requirements. In fact, in
the only pre-market tobacco application that
won approval so far, Swedish Match did not
give the FDA every single thing they were
looking for—that [fact] was acknowledged,
but there was an explanation for it.”
Another viable option is to look for ways
to work around the rules. “I’m a car guy, so
I put everything in car terms,” says Haynes.
“They want a Ferrari, but can you get by with
a Honda? Maybe. People ask, ‘If I spend this
time and money to build a Ferrari and send
it over there, will I be accepted?’ I say, ‘No,
there are no guarantees.’ They may say it’s got
too much horsepower; we would rather have
a Bentley.
“The other option is maybe you think about
anUber—something that is not quite inside the
box, maybe not sending FDA anything at all. I
have been working this industry for 13 years, I
have seen different regulations and I’ve seen the
industry adapt in interesting and unanticipated
ways. This happens all the time. The govern-
ment creates rules; the industry figures out dif-
ferent ways to live under them.”
TBI
Look for editorial
coverage of VEI’s
Industry Association
Panel and MSA’s
presentation on retail
trends at
tobonline.comand in the next issue
of
TBI
.
I have seen
different regulations
and I’ve seen the
industry adapt in
interesting and
unanticipated
ways. This happens
all the time. The
government creates
rules; the industry
figures out different
ways to live under
them.”
“
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TOBACCO BUSINESS INTERNATIONAL
JULY/AUGUST 2016