Basic HTML Version
26
TOBACCO OUTLET BUSINESS
MAY/JUNE 2012
TMA REPORT
FDA:
…The Food andDrugAdministration posted on itswebsite
its Tobacco Products Scientific Advisory Committee
report on
dissolvable tobacco products
(DTP), which
says “exclusive use of DTPs by an individual would greatly
reduce risk for smoking caused disease compared with
regular use of cigarettes” by decreasing the number of
smokersand lowering the riskof “tobaccocauseddisease.”
But the post also noted a concern that “the availability of
DTPs with lower risks to health than cigarettes might affect
the public perception of all tobacco products” and lead
to increased overall tobacco use. However, the American
Council on Science and Health (ACSH)’s Dr. Ross writing
in
Forbes
notes “The FDA’s position is that the benefits of
reduced risk products for harm reductionmust be ‘proven’
before they can be recommended to smokers in America
[so] here’s the catch-22: only the tobacco industry has the
requisite expertise and finances to perform the long-term,
large-scale, super-expensive studies needed to prove
the benefit of these products to the FDA’s satisfaction.
The tobacco industry is explicitly barred, however, from
supplying the needed data.”
…The U.S. Court of Appeals for the Sixth Circuit upheld
the
Family Smoking Prevention and Tobacco Control
Act’s
requirement that
warning images be displayed
on the top half of the front and back of cigarette packs,
finding that the labels “serve as disclaimers to the public
regarding the incontestable health consequences of using
tobacco,” but struck down as unconstitutional the law’s
provision barring companies from using color or imagery
in their advertisements, calling it “vastly over broad.”
The appeals court also affirmed the decision from the
Western District of Kentucky upholding the restrictions on
the marketing of modified risk tobacco products, bans on
event sponsorship, branding non-tobacco merchandise
and free sampling. Deutsche Bank analysts said the ruling
is “neutral to net positive” as it upholds a prior decision
on the manufacturers’ ability to use color ads, while the
marketing restrictions that were upheld are “mostly things
the industry had already lost.”
…Ina report recapping the status of
menthol regulation
,
Deutsche Bank analysts said the FDA’s “overdue” science
assessment report remains the largest potential source
of near-term stock volatility, with their “best estimate
remain[ing] a negatively-worded report on underage
smoking, but delayed action in favor of further studies,”
adding that there will be near-term upside for the tobacco
sector if the FDA “kicks the can” on the issue because the
threat of disrupting Lorillard’s market would be off the
table, and “it would portray a broader toothlessness at the
FDA.”
…The Tobacco Law Team of the law firm Troutman
Sanders states that a February report of an
electronic
cigarette exploding
in aman’s mouthmay have prompted
the FDA’s Center for Tobacco products to write letters
to e-cigarette companies requesting information on
customer complaints and “adverse event issues,” reports
of “customer misuse,” descriptions of product labeling,
and systems in place to review customer complaints.
…On March 5, the
Obama administration appealed
U.S. District Judge Richard Leon’s February 29 ruling that
the Food and Drug Administration’s regulation requiring
large, graphic health warnings on cigarette packs and ads
violates the industry’s free-speech rights under the U.S.
Constitution.
…Commenting on a cohort study of 4,854 largely
African Americans in 12 Southern states conducted
by FDA Center for Tobacco Products researcher Brian
Rostron, which found lower lung cancer mortality risk
among
menthol smokers
compared with non-menthol
smokers at age 50 and over, UBS analyst Nik Modi said
the conclusion is not surprising, and “the findings of this
study make us feel more confident that no draconian
actions will be taken on menthol.” Morgan Stanley
analysts said the study is “encouraging, [but] relative
disease risk may not be the focus of the FDA’s approach
to potential menthol cigarette regulation,” as the evidence
onmenthol cigarettes being nomore dangerous than non-
menthol cigarettes was referenced in TPSAC’s menthol
report but did not have a significant impact on the overall
thrust of its recommendations. Dr. Gilbert Ross of the
American Council on Science and Health said the FDA
study questions one of the key rationales for a menthol
ban, adding that it is even more important to remember
that banning menthol is likely to lead to unintended, but
dangerous consequences, such as the creation of a black
market, “which will provide minors with ready access to
smoking - something we’d all like to prevent.”
…Siding with cigarette makers, U.S. District Judge
Richard Leon ruled on February 29 that the Food and
Drug Administration’s regulation requiring
graphic health
warnings
on cigarette packs and advertising violates
free-speech rights under the U.S. Constitution, writing
that the government “failed to carry both its burden
of demonstrating a compelling interest and its burden