20
TOBACCO BUSINESS INTERNATIONAL
SEPTEMBER/OCTOBER 2014
TMA REPORT
By FARRELL DELMAN
…A court agreed with Lorillard (LO)
and Reynolds American (RAI) that three
of the nine original voting members of the
FDATobaccoProductsScientificAdvisory
Committee (TPSAC), researchers Neal
Benowitz,JackHenningfield and Jonathan
Samet, had
conflicts of interest
due to
their receipt of funds from pharmaceutical
companies making nicotine replacement
therapies, as well as their participation
in tobacco litigation as expert witnesses.
Washington, D.C. U.S. District Court
Judge Richard Leon ordered the FDA
to reconstitute the panel and barred the
agency from using TPSAC’s March 2011
menthol report, which said that removing
menthol cigarettes from the market would
benefit public health.
…Morgan
Stanley
said
Judge
Leon’s decision that the FDA cannot
use TPSAC’s report on menthol is
“unambiguously favorable” and increases
the market’s confidence that
disruptive
menthol legislation is unlikely
, but it
is still likely to be difficult to successfully
challenge potential FDA menthol
rulemaking given the need to show that
the FDA acted in an arbitrary manner
and/or that such regulations would not
benefit public health.
…During the public comment period
on the FDA’s proposed regulations for
additional tobacco products,
J.C.Newman
Cigar Company
fought to save its family-
owned factory in Ybor City, Florida by
having its products included in a proposed
exemption for premium cigars. The
company has backing from Florida Gov.
Rick Scott and U.S. Rep. Kathy Castor
(D-Fla.).
…Reuters reports that its
review of
confidential scores
—given by a National
Institutes of Health (NIH) review panel
to more than 50 research proposals aimed
at helping shape tobacco regulation—
found that the FDA in September 2013
recommended that millions of research
dollars be awarded to scientists who serve
on the Center for Tobacco Products’
(CTP) Tobacco Products Scientific
Advisory Committee, even as it rejected
several projects that the NIH panel
found to have greater scientific merit.
Reuters says that this raises concern that
the process lacked transparency, though
the FDA says no favoritism was involved
with David Ashley, director of the Office
of Science at CTP, and that the grant
awards to TPSAC members were “purely
coincidental.”
…The CTP announced a
Site
Tours Program
for its scientific and
regulatory staff to help them gain a
better understanding of the industry
and its operations by visiting facilities
involved in the cultivation, processing, and
manufacturing of tobacco or currently-
regulated tobacco products. Interested
companies should submit a request for
participation by September 15, 2014 with
a description of the facility and a list of
all tobacco products processed and/or
manufactured there to regulations.gov or
to the Division of Dockets Management
(HFA-305), FDA, 5630 Fishers Lane,
On the fda…
Farrell Delman,
President, TMA
Breaking news From the tma
the following are excerpts from harm reduction,
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