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TOBACCO BUSINESS INTERNATIONAL
JANUARY/FEBRUARY 2015
The Genius of Option 3
PUBLISHER’S LETTER
BY ed o’connor
T
he proposed Food and Drug Administration (FDA)
deeming regulations on all tobacco products have
been announced and, since then, commented upon
by the industry. Had the decision been solely the FDA’s,
absent the public and legislative pressures foisted upon
the agency, it’s not unreasonable to believe that extending
control over the plethora of other tobacco products (OTP)
would have occurred. The Family Protection and Tobacco
Control Act (FPTCA) was written specifically with ciga-
rettes as the focus. The tobacco category was tarred (no
pun here) with the same brush without regard to scientific-
based risk continuums associated with different methods
of tobacco use. However, a unique codicil of the act specifi-
cally prohibited the outright ban of all tobacco products (in-
cluding menthol), and of reducing nicotine levels to zero.
Despite prohibiting the ban of all tobacco products,
the inconsistency of the act provides for protocols al-
lowing the equivalent of “death [of tobacco] by a thou-
sand cuts.” As it turns out, this is especially true for OTP.
It could be argued in court that the nearly-impossible to
impossible FDA rules, protocols and regulations effec-
tively constitute a ban, which, per the act, is illegal. It’s a
fact that no predicate product against which to verify new
product substantial equivalence even exists for the elec-
tronic tobacco category because the category did not ex-
ist prior to February 11, 2007. This alone testifies to the
dated covenants of the FPTCA. To be decided: when do
impossible-to-meet standards become a de facto ban?
At this time, an option 3 doesn’t exist. The FDA properly
maintains that they must follow the written letter of the
law. Given the agency’s angst historically and the length
of time that it took to get the law enacted, there may be
little FDA desire for wiggle room. In reality, the kind and
extent of the options required may be beyond FDA control.
Enter Option 3
Consider that each tobacco product category is uniquely
experienced by a wide range of demographic and psycho-
graphic profiles. Assembling all elements of legal nicotine
usage could theoretically establish a grid of the varying de-
gree of risk and population impact, but it could never be
scientifically verified. Scientifically quantifying the impact
on the total population by the various tobacco categories is
likely an impossible, expensive dream akin to proving that
the earth is flat.
In the absence of a third option, the only way out of
the conundrum—short of absolutely nothing at all hap-
pening as in the situations with menthol and substantial
equivalence—is legislative mitigation of the FPTCA. It
was designed and enacted with cigarettes in mind and
unless it’s now true that “one size fits all,” which it’s not,
then FDA, the industry and the legislators need to go
back to the drawing board to craft
reasonable
regula-
tions addressing each tobacco segment. The genius of
option 3 heads off “death by a thousand cuts” which,
if challenged in court as a de facto ban on tobacco and
is ruled to be so, would render FDA mute just as in the
case of declaring electronic-cigarette-delivered nicotine
a tobacco product and not a drug.” Option 3 is advanta-
geous to all stakeholders. We look to FDA to assume a
leadership role.
Write your legislators,
This letter originally appeared in the July/August issue
of
TBI
. We are reprinting it in our TPC 2015 show issue
as a call to action for the industry.