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TOBACCO BUSINESS INTERNATIONAL
SEPTEMBER/OCTOBER 2014
NEWS & TRENDS
SEPTEMBER/OCTOBER 2014
U.S. District Court Judge Richard
Leon in Washington, D.C. recently
ruled that the Food and Drug Admin-
istration (FDA) can’t use an advisory
panel’s 2011 report on menthol ciga-
rettes due to conflicts of interest by
its members. The agency has since
conducted an independent review on
the public health impact of menthol
cigarettes; however, the ruling could
hamper the FDA in defending any
regulatory action on the category.
The court ruling is the result of
efforts by cigarette makers Loril-
lard and Reynolds American, who
sued the agency in 2011, alleging
conflicts of interest and bias by
several panel members. They ar-
gued that the panel failed to meet
the federal requirements that com-
mittee members should be fairly
balanced and not inappropriately
influenced by any special interest.
More specifically, the plaintiffs as-
serted that some committee mem-
bers had served as paid expert wit-
nesses in anti-tobacco lawsuits and
had financial ties to pharmaceutical
companies that make smoking ces-
sation products and therefore had
conflicts of interest.
The agency countered that the pan-
el met federal standards and that the
cigarette makers’ “alleged injuries are
entirely speculative.” But Judge Leon
ruled that FDA erred in determining
that the members didn’t have con-
flicts of interest and that FDA would
need to reconstitute the panel.
Menthol Report Dismissed as Biased
Challenges by cigarette makers have succeeded in banning the
FDA from use of an advisory panel’s 2011 report.
Twenty-nine state attorneys gen-
eral came together to urge the Food
and Drug Administration (FDA) to
strengthen its proposed regulations
on electronic cigarettes and vape de-
vices, which together comprise a $2.5
billion industry, according to Nielsen.
FDA has already proposed federal
restrictions that will ban the sale of
e-cigarettes to minors and require
age verification, but a letter from the
group of attorneys general charges
that these steps are insufficient.
“While the proposed rule address-
es some of our concerns, it fails to
address matters of particular con-
cern, such as characterizing flavors,
the marketing of e-cigarettes, and
the sale of tobacco products over
the Internet,” stated the letter. It went
on to call for the prohibition of the
sale of most e-cigarette flavoring—
a move that those in the e-cigarette
business say would devastate the
category.
The prevalence of e-cigarette and
liquid nicotine flavors like Choco-
late Chip Cookie Dough and Graham
Cracker are fueling the debate. In
2009, FDA banned the use of simi-
lar flavors in traditional cigarettes in
an effort to deter young people from
picking up the habit. The attorneys
general argue that the sheer breadth
of flavors available for vaping and e-
cigarette devices could make the cat-
egory appealing for children.
In addition to flavor restrictions, the
letter also urged advertising and mar-
keting restrictions on e-cigarettes to
bring the rules more in line with those
for traditional cigarette companies.
However, some public health experts
counter this argument, noting that
e-cigarettes appear to be a less dan-
gerous alternative to traditional to-
bacco products, and suggesting that
regulation that would threaten the
industry’s survival could potentially
deprive smokers from a healthier al-
ternative.
States Seek Stronger E-Cig Regs
Attorneys general band together to ask for stronger regulations of electronic cigarettes.
