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notoriously slow in acting on applications,”
he told his audience of vapor industry veter-
ans. “Many [tobacco companies] are still wait-
ing on applications submitted back in March
2011, but there have been no complaints [that]
those products can continue to be marketed.
Regulatory inertia works in that scenario. It
will not work for you. I suspect I will get a lot
of frantic calls in August of 2018 with people
saying, ‘FDA hasn’t ruled—what do I do?’”
Another surprise Haynes pointed to as
problematic is FDA’s decision to lump com-
ponents in with the regulated products. “In
layman’s terms that means anything used
with something derived from tobacco or is
expected to be used with something derived
from tobacco,” he explained, noting that he
expects to see this challenged in court. “If
you sell a vaporizer that doesn’t include any
tobacco-derived components, but is expected
to be used with tobacco-derived nicotine,
then it is regulated. I vehemently disagree
with that. I don’t think they have that author-
ity. I think it will be teed up in litigation and
hopefully whoever rules on the issue will see
it correctly, but it is the law of the land for
now, according to FDA.”
Courts to the Rescue (Not)
Acknowledging that several lawsuits have
already been filed challenging the regulation,
Haynes cautioned vapor companies against
counting on the courts coming to the rescue.
“It is too early to tell how these cases will
play out, but I can tell you from experience
that cases against the government are hard to
win,” he noted. “The rules are heavily skewed
toward the government.
“For example, you might argue that the
pre-market review process is unfair because
you are being treated differently from ciga-
rette companies—a good, persuasive, factual
argument with which I agree wholeheartedly.
The problem is that FDA will come and say,
‘Your challenge is right for a decision because
you haven’t yet submitted an application, and
we haven’t yet ruled on it.’ So until you go
through that process—spending all that time
and money—a court can’t look at your case.
That is a legitimate tactic that FDA and other
government agencies frequently rely on.”
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