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TOBACCO OUTLET BUSINESS
JULY/AUGUST 2012
warnings that were to be featured
on all cigarette packaging and
advertising by September 22, 2012.
Leon’s decision that the warning
labels—a combination of text and
graphic images showing that smoking
can disfigure and even kill people—
violate the First Amendment stalled
the implementation of that mandate.
Leon’s ruling came in response to a
lawsuit filed last summer by several
tobacco companies, including R.J.
Reynolds, Lorillard, Commonwealth
Brands and Liggett Group LLC.
In April, U.S. Court of Appeals
Judges Janice Rogers Brown and
Judith Rogers and Senior Judge
A. Raymond Randolph heard
arguments from both sides but did
not immediately rule on the appeal.
Two of them questioned how far the
government could go. Arguments on
the side of the FDA focused on the
fact that the images are accurate. A
lawyer representing R.J. Reynolds
said the labels cross the line from
fact-based to issue advocacy.
Commenting on the issue, anti-
smoking advocates contend that
public health concerns outweigh free
speech concerns.
But the conclusion of this debate is
not expected anytime soon. Industry
observers believe the graphic warning
cigarette labels issue will most likely
come before the U.S. Supreme Court
for a final ruling, which could take
years.
E-cigs—
Anti-smoking groups are
strongly encouraging the FDA to
ban e-cigarettes until they have been
shown to be “safe and effective,” but
that is not the appropriate standard
that the FDA must use in regulating
the device, since the DC Circuit
Court of Appeals (in December
2010) upheld the classification of
e-cigs as tobacco products, not drug
devices, which are the only products
that must follow the drug standard of
“safe and effective.”
Nevertheless, since they are
regulated as “tobacco products,” they
do, indeed, fall under the purview of
the FDA.
Professor Michael Siegel of Boston
University’s School of Public Health
is one that upholds that e-cigarettes
are alternative tobacco products
and should be allowed to remain
on the market, in the absence of
therapeutic claims by manufacturers.
Siegel has written in his blog that
the key question is whether e-cigs
are “relatively safe and effective”,
specifically if they are relatively
safe compared to conventional
cigarettes, and if they are relatively
effective in keeping smokers off
cigarettes compared to nicotine
replacement therapy. He says they
are unequivocally safer than tobacco
cigarettes and must continue to be
available to smokers and ex-smokers
while research is conducted as to
their effectiveness in keeping people
off cigarettes.
Meanwhile, Wells Fargo analysts
released a survey of retailers and
wholesalers in May, whereby the
majority of respondents believe
e-cigs are here to stay, with the
industry size estimated to be around
FDA Dashboard
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