TOB Magazine

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TOBACCO BUSINESS INTERNATIONAL
MARCH/APRIL 2016
TMA REPORT By FARRELL DELMAN
…The FDA Center for Tobacco
Products will hold a public workshop
on “Biomarkers of Potential Harm”
on April 4-5 at its White Oak
Conference Center in Silver Spring,
Maryland. The workshop will “open
the discussion on how to identify
and implement the use of biomarkers
for the purposes of tobacco product
regulation,” with specific objectives
to identify 1) approaches to assess
and select biomarkers of potential
harm; 2) the processes for identifying
biomarkers of potential harm that
may be useful in tobacco product
regulation; and 3) research areas that
may further strengthen knowledge
about biomarkers of potential harm.
…The U.S. Senate Committee
on Health, Education, Labor and
Pensions voted to back Dr. Robert
Califf, President Barack Obama’s
nominee for FDA commissioner,
despite criticism from consumer
watchdogs that Dr. Califf has extensive
ties to the pharmaceutical industry.
However, U.S. Sen. Edward Markey
(D-Massachusetts) put a hold on the
nomination, saying that “FDA needs to
commit to shift the way it approaches
and evaluates addiction before I can
support Dr. Califf ’s nomination.”
Markey was referring to CDC data
showing that 19,000 deaths were linked
to misuse and abuse of prescription
painkillers in 2015, the highest-ever
recorded.
…Niels Frederiksen, CEO of
Danish cigar and pipe tobacco maker
Scandinavian Tobacco Group (STG)
A/S, said that the FDA’s proposal to
extend the pre-market approval process
to cigars is unlikely to affect STG as it
has been on the U.S. market since the
1950s and its products were launched
before 2007.
…Following U.S. District Judge
Amit Mehta’s statement that he
will not recuse himself from the
cigarette makers’ lawsuit over FDA’s
new labeling requirements, Altria
Group, Reynolds American, and ITG
Brands filed a request for a permanent
injunction against the agency to
prevent the implementation of the
new guidelines, which state that FDA
approval is required for changes to
labeling of tobacco products and
the quantities of products within
a package, even if the product’s
ingredients and characteristics remain
the same. The companies say that this
directive “disregards the clear statutory
distinction between the regulation of
tobacco products and regulation of
tobacco product labels.”
Overturning U.S. District Court
Judge Richard Leon’s 2014 ruling, Judge
Stephen Williams, on behalf of the U.S.
Court of Appeals for the District of
Columbia Circuit, upheld the FDA’s
right to use its Tobacco Products
Scientific Advisory Committee’s
menthol report. The report concluded
that menthol cigarettes are no more or
On the fda…
Farrell Delman,
President, TMA
Breaking News From the TMA
The following are excerpts from harm reduction,
tobacco regulation and other tobacco-related news.
Don’t miss TMA’s 101st
Annual Meeting and Conference!
Kingsmill Resort in Williamsburg, VA
When: M
Details: