Page 9 - TOB Magazine March/April 2013
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TOBACCO OUTLET BUSINESS
MARCH/APRIL 2013
TMA REPORT
comments to be submitted within 60 days of publication
of the notice.
…The FDA on January 28 posted on its Tobacco
Products News & Events page information on its new
national study called the
Population Assessment of
Tobacco and Health
(PATH), originally announced in
October 2011 and conducted with the National Institutes
of Health, that will monitor and measure why people
start using tobacco, quit using it, and resume using it,
the results of which will “inform and assess the impact of
tobacco product regulations in order to help improve the
health of Americans.”
…FDA Commissioner Dr. Margaret Hamburg
announced in an internal email on January 22 that
FDA Deputy Commissioner for Medical Products and
Tobacco
Dr. Stephen P. Spielberg
will be leaving the FDA
on February 15 due to an unspecified “family medical
issue,” and that Dr. Leona Brenner-Gati, now Associate
Commissioner for Medical Products and Tobacco, will take
over as Acting Deputy Commissioner until a permanent
replacement is found.
…The CTP says it will host on March 19-20 a public
workshop titled “Third Party Governance of Industry-
Sponsored Tobacco Product Research” to discuss the
Institute of Medicine’s recommendation that sponsors
of modified risk tobacco product applications use
independent third parties to undertake key functions in
tobacco product research.
…A notice by the FDA announces that a
proposed
collection of information
has been submitted to the Office
of Management and Budget for review and clearance on
“Pretesting of Tobacco Communications—(OMB Control
Number 0910-0674)—Extension,” to collect “knowledge
needed about target audiences” and allow the agency
to “assess the potential effectiveness of messages and
materials in reaching and successfully communicating
with their intended audiences.”
…The FDA sent a
warning letter
to PrivacyProtect.
org with reference number RW1300056, stating that
some of the cigarettes offered for sale to U.S. customers
on its website,
are
adulterated under the
Federal Food, Drug and Cosmetic
Act
, as amended by the
Family Smoking Prevention
and Tobacco Control Act
, because they are promoted
as modified risk tobacco products, with descriptors like
“Lights,” “Ultra Lights” and “More Subtle,” without an FDA
order that permits such promotion. Similar letters went
to
for cigarettes
sold at
with reference number
RW1200052.
…A study led by Jennifer Pearson, research investigator
for the Schroeder Institute for Tobacco Research and
Policy Studies at the American Legacy Foundation, found
that 46.7 percent of U.S. adults support a potential FDA
mandate to reduce levels of nicotine in cigarettes
,
while 16.5 percent are opposed, with African Americans,
Hispanics and those with lower education levels especially
supportive of such regulation.
…National Public Radio’s evening news program “All
Things Considered” reported on the 3,500-plus
new
product applications
U.S. tobacco product manufacturers
have submitted to the FDA, the industry’s growing
frustration as the FDA has not approved any of them even
though some have been pending for over a year and a
half, Lorillard’s petition calling the inaction a “de facto
embargo” on new product introductions, and FDA Center
for Tobacco Products director Dr. Lawrence Deyton’s
assertion that the agency is “absolutely not deliberately
trying to slow products from getting to market.”
…The FDA sent a warning letter to Dmitrii Strusovschii
of Edelveis Enterprises Limited, stating that some
of the cigarettes offered on his numerous websites
including
,
www.
eurocheapcigarettes.com,
,
net and
, are adulterated under
the
Federal Food, Drug and Cosmetic Act
, as amended
by the
Family Smoking Prevention and Tobacco Control
Act
, because they are promoted as modified risk tobacco
products, with descriptors like “Lights,” “Super Lights,”
“Ultra Lights” and “Premium Lights,” as well as claims
like “provides less harmful chemicals,” without an FDA
order in effect that permits such promotion. The FDA sent
similar letters to
,
,
and
.
…In its annual Regulatory Agenda, filed in 2012 for 2013
and much as it did in 2011 for 2012, the FDA said it intends
to issue by April 2013 a Notice of Proposed Rulemaking to
regulate other tobacco products
under the terms of the
Family Smoking Prevention and Tobacco Control Act
.
…Retailers are awaiting U.S. District Judge Gladys
Kessler’s decision on whether they need to display
statements from cigarette makers named in the U.S.
Department of Justice lawsuit claiming that the companies
misled the public about the dangers of smoking, as
her November 27 ruling ordered them to pay for the
“corrective statements”
and said the issue of retail store
signs for retailers that have agreements with companies
to sell their products “will be resolved in the near future.”
…California Assemblyman Richard Pan (D-Sacramento)
introduced a bill to prevent a provision in the
Federal
On other tobacco-related news…
