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TOBACCO BUSINESS INTERNATIONAL
MAY/JUNE 2015
TMA REPORT
By FARRELL DELMAN
…U.S. Rep. Bill Posey (R-Florida) has
introduced a bill to amend the Federal
Food, Drug, and Cosmetic Act to “clarify
the
Food and Drug Administration’s
jurisdiction over certain tobacco
products
, and to protect jobs and
small businesses involved in the sale,
manufacturing and distribution of
traditional and premium cigars,” with the
bill, which has 34 co-sponsors, referred
to the House Energy and Commerce
Committee.
…The FDA Tobacco Products
Scientific Advisory Committee (TPSAC)
has reviewed Swedish Match North
America’s application, filed in June 2014,
requesting that the agency approve
10
General-branded snus products
as
“modified risk.” Swedish Match failed
to get permission for a new label stating
that snus is addictive but substantially
less risky than smoking, and seeks
an exemption from a required health
warning relating to oral cancer.
…FDA launched a new “
Harmful
and Potentially Harmful Constituents”
(HPHCs) webpage with information
on the preliminary HPHC list, industry
reporting requirements and the agency’s
efforts to communicate to the public
about the “dangers of the chemicals
and chemical compounds in tobacco
products and smoke.”
…Center for Tobacco Products (CTP)
Director Mitch Zeller announced changes
in membership to the
Tobacco Products
Scientific
Advisory
Committee
,
including the resignation or termination
of Chairman Jonathan Samet, Claudia
Barone, Joanna Cohen and Suchitra
Krishnan-Sarin, and the addition of three
new members: Pebbles Fagan, Gary A.
Giovino and Thomas E. Novotny. The
changes follow U.S. District Court Judge
Richard Leon’s July 21, 2014 ruling
stemming from a 2011 lawsuit alleging
conflicts of interest in certain TPSAC
members, which requires the agency to
reconstitute the panel and bars the use of
TPSAC’s 2011 Menthol Report.
…Duke University cardiologist and
researcher
Dr. Robert Califf
, who is
currently overseeing FDA’s drug, medical
device and tobacco policy, has been
named deputy commissioner of the
agency, raising speculation that he may
eventually be nominated to lead FDA
after Commissioner Margaret Hamburg’s
departure at the end of March.
…U.S. Sens. Jeff Merkley (D-Oregon),
Richard Blumenthal (D-Connecticut) and
Ed Markey (D-Massachusetts) met with
FDA CTP Director Mitch Zeller in March
to call on the agency to finalize without
delay its
proposed deeming regulations
for currently unregulated tobacco
products including e-cigs, to strengthen
the proposed rules to address e-cig
flavorings and marketing that they allege
are designed to attract children, and to
mandate child-resistant packaging for
liquid nicotine.
…While keeping a bold-letter warning
about suicidal behavior and other
psychiatric side effects associated with
Pfizer’s smoking cessation drugChantix
,
FDA on March 9 outlined several updates
to its labeling. These include a new
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.