22
TOBACCO OUTLET BUSINESS
MAY/JUNE 2013
are safe in an absolute sense,” with
the main health concerns related
to e-cigarette use being the risks
associated with the potential inhalation
of formaldehyde and the long-term
inhalation of propylene glycol, but “[i]
f an excipient can be found which
allows vaporization of nicotine but
avoids propylene glycol and limits
the formation of carbonyl compounds
such as formaldehyde, it will be a
huge advance and may lead to the
development of an electronic cigarette
product that is not merely safer than
smoking, but is essentially safe as well.”
…Prof. Brad Rodu of the University of
Louisville said that the
American Dental
Association’s new brochures on mouth
cancer and smokeless tobacco
“show
significant improvement” over its past
publications, as the new pamphlet on
mouth cancer “accurately” describes
the disease as occurring “most often in
people who smoke cigarettes, cigars,
or pipes and drink heavily (30 drinks or
more per week),” while the brochure
on smokeless tobacco has dropped
“unscientific allegations” that appeared
in earlier versions, adding however that
the smokeless brochure is still flawed
because it contains “questionable
statements” including that “[o]ne can
of smokeless tobacco has as much
nicotine as 60 cigarettes or three packs”
and “[p]eople may think that smokeless
means harmless, but nothing could be
further from the truth.”
…A Nicoventures-sponsored survey
of UK general practitioners (GPs) and
smokers seeking opinions on smoking
cessation options found among other
things that 68 percent of GPs would
prescribe e-cigarettes if they were
regulated, 44 percent of smokers would
try e-cigarettes if their GP prescribed
the device, and seven in 10 smokers
want to quit but find it difficult with
available cessation products.
…Given mixed reports on the
health implications of e-cigarettes,
research fellow Coral Gartner of the
University of Queensland’s Centre for
Clinical Research in Australia will soon
begin a Federal government-funded
trial with 1,600 smokers to test the
efficacy of e-cigarettes as long-term
substitutes for cigarettes, while the
Australian Department of Health said
it has “commissioned a regulatory
impact statement on options for further
regulation of electronic nicotine delivery
systems, including electronic cigarettes
and smokeless tobacco products.”
…A Mayo Clinic study of
81 users
of chewing tobacco or snuff
with no
intention of quitting, published in the
February issue of
Addictive Behaviors
,
found that they cut back consumption
when they were given tobacco-
free snuff or nicotine lozenges, and
sustained that reduction through the
end of the two-month study.
…In North Dakota, a House
Concurrent Resolution introduced by
State Rep. Blair Thoreson (R-Fargo)
would call for the Legislative
Management to study ways to reduce
the risk of death and disease among
smokers by considering
tobacco harm
reduction strategies
that encourage
smokers to switch to “less-risky
tobacco products and by accurately
informing the public of the health risks
posed by smokeless tobacco products,
vapor products and tobacco-derived
products relative to cigarettes.”
…In an April 5
Federal Register
notice
(Docket No. FDA-2012-N-0977), the FDA
announced that it was submitting to the
Office of Management and Budget to
review and clear its estimated burden
on industry to carry out the disclosure
and recordkeeping requirements to
comply with the already announced
cigarette and smokeless advertising
constraints
.
…In an April 2
Federal Register
notice
with Docket No. FDA-2013-N-0341,
the US Food and Drug Administration
said that in light of currently available
evidence, it believes that certain label
warnings and directions for use for
OTC nicotine replacement therapy
products
, related to concomitant
use with other nicotine-containing
products and duration of use, are no
longer necessary in their current form
to ensure the safe and effective use of
NRT products for their intended use
as cessation aids. The FDA invited
manufacturers to submit to the Center
for Drug Evaluation and Research
supplemental new drug applications to
modify these statements in the labeling
of their drug products. Tommy Payne,
president of Niconovum USA (RAI),
which markets
Zonnic
nicotine gum
in Iowa, said the FDA’s recommended
change is “a very beneficial step” and
will “provide individuals who desire to
stop smoking more realistic ways to do
so.”
…U.S. Attorney General Eric Holder
said in a letter obtained by
The
Associated Press
that the Food and
Drug Administration will not appeal the
2012 ruling by the US Court of Appeals
for the DC Circuit that rejected the
agency’s
proposed graphic cigarette
health warnings
, and will instead go
back to the drawing board and propose
new labels. Floyd Abrams, a First
Amendment lawyer who represented
Lorillard Tobacco Co. in challenging the
labels, said he was not surprised by the
FDA’s decision as the graphic warnings,
which also were to be accompanied by
text warnings and the 800 number for a
cessation hotline, were “constitutionally
indefensible.”
…In its weekly update, the FDA
Center for Tobacco Products on March
3 welcomed its new director
Mitch
Zeller
, saying “[t]obacco regulation
is his passion” and calling him a
“champion for tobacco control and
public health” who has been working
on FDA issues for over 30 years.
The
Washington Post
reported that when
Zeller, who helped spearhead efforts
to regulate the tobacco industry in the
1990s under then FDA Commissioner
David Kessler, returns to the agency as
TMA REPORT
ON THE FDA…
