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TOBACCO BUSINESS INTERNATIONAL
SEPTEMBER/OCTOBER 2014
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 submitted for public comment. Had the deci-
sion 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 cigarettes as the focus. The tobacco cat-
egory was tarred (no pun here) with the same brush with-
out regard to scientific-based risk continuums associated
with different methods of tobacco use. However, a unique
codicil of the act specifically prohibited the outright ban of
all tobacco products (including 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 happening
as in the situations with menthol and substantial equiva-
lence—is legislative mitigation of the FPTCA. It was de-
signed and enacted with cigarettes in mind and unless it’s
now true that “one size fits all,” which it’s not, then the
FDA, the industry and the legislators need to go back to the
drawing board to craft
reasonable
regulations 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 the FDA mute just as in the case declaring electron-
ic-cigarette-delivered nicotine a tobacco and not a drug.
Option 3 is advantageous to all stakeholders. We look to
the FDA to assume a leadership role.
Write your legislators,
