22
TOBACCO OUTLET BUSINESS
NOVEMBER/DECEMBER 2012
TMA REPoRT
…
The FDA Center for Tobacco Products sent a
warning letter
to Madeleine Rausis of Lausanne, Switzerland, stating that some
of the cigarettes offered for U.S. customers on her websiteswww.
smoke-cigs.com and
www.tobacco4you.com
are adulterated
because they are promoted as modified risk products, with
descriptors “Lights” or “Ultra Lights,” without an FDA order that
permits such promotion.
…
Questioning the emerging consensus that the current
warning label “controversy”
would go to the U.S. Supreme
Court, Morgan Stanley analysts write that media reports on a
“
conflict” between the D.C. Circuit Court of Appeals’ August 24
ruling and the Sixth Circuit’s March 19 ruling on FDA’s graphic
warning labels are “somewhat misplaced,” as the Sixth Circuit
ruling upheld the FDA warning label legislation in general, while
the D.C. Circuit ruling rejected the specific proposed labels and
the underlying evaluation process, thereby allowing for the two
rulings to coexist.
…
The Institute of Medicine (IOM) and the FDA Center for
Tobacco Products (CTP) announced that Atanaska Dineva,
communications associate at the Johns Hopkins Bloomberg
School of Public Health’s Institute for Global Tobacco Control,
Candice Jongsma, research scientist at ConocoPhillips in
Bartlesville, Oklahoma, and Elizabeth Laposata, research analyst
at the Center for Tobacco Control Research and Education at the
University of California, San Francisco, have been selected for the
2012-13
inaugural FDA Tobacco Regulatory Science Fellowship
Program
awards, which “aims to provide an opportunity for mid-
career professionals to gain experience and expertise to further
define and develop the field of regulatory science as it relates
to tobacco products and FDA’s new authorities…” under the
Tobacco Control Act
.
…
Japan Tobacco Inc. received its first
drug approval
from
the FDA on August 27 when it approved a new AIDS pill that
combines four compounds, including a substance called
elvitegravir, discovered by JT and licensed to California-based
Gilead Sciences Inc., which will sell it under the Stribild name in
the US.
At the August 23 FDA Center for Tobacco Products-National
Institutes of Health webinar detailing the
P50 process to be used
by NIH
to award grants of CTP funds to research organizations
interested in developing Tobacco Centers of Regulatory Science
(
TCORS), Cathy Backinger, deputy director of CTP’s Office
of Science, confirmed that tobacco companies acting either
individually or as a consortium are eligible to apply for the NIH
grants and would be subject to the same NIH application and
review and peer review processes as would any other research
groups, in applications that encourage both collaboration and
educational trainingacross thevariousTCORS tobeestablished, a
point that caused UCSF engineer and aggressive tobacco control
advocate Stanton Glantz to complain during the webinar that
requiring UCSF to collaborate with an industry that he claimed
was being monitored as “racketeers” would be sufficient cause
for UCSF to drop out of consideration for these grants, something
he said that he thought would also impact other institutions. Dr.
Kay Wanke of NIDA, who spoke for NIH, then noted that whether
given institutions elect to collaborate on research with the
tobacco industry is decided by the given institutions, a point that
Glantz then said could jeopardize other research dollars received
from sources that ban such collaboration.
…
At another CTP webinar, this one further elucidating the
status of CTP’s review of thousands of
Substantial Equivalence
applications
received through July 1, 2012, Dr. David Ashley,
CTP director of the Office of Science, said the CTP had received
390
regular SE reports (those filed between 3/23/11—7/1/12)
in addition to 3,126 “provisional” reports (those sent prior to
3/23/11)
and was focusing on the former which has yielded
133 “
completeness reviews” given that a positive response to
a regular report is needed for the given product to appear on
the market while the products associated with the “provisional”
reports can remain on the market unless there were noted
problems in the given report filed.
…
The CTP sent a
warning letter
to
www.vietnamtobacco
.
net of Ho Chi Minh City, Vietnam, stating that the Marlboro Gold
cigarettes the site offers to US customers are “adulterated” given
their use of the “light” descriptor, in violation of the Federal FD&C
Act as amended by the
Family Smoking Prevention and Tobacco
Control Act,
which bans the introduction of any modified risk
product without an FDA order allowing such promotion.
…
The U.S. Court of Appeals for the District of Columbia Circuit
ruled 2-1 against the Food andDrugAdministration’s requirement
that cigarette makers place
graphic warnings
on their packs,
upholding Judge Richard Leon’s lower court ruling that the rule
violates the First Amendment’s free speech protections, with
Appellate Judge Janice Rogers Brown writing that the case
raises “novel questions about the scope of the government’s
authority to force the manufacturer of a product to go beyond
making purely factual and accurate commercial disclosures and
undermine its own economic interest—in this case, by making
‘
every single pack of cigarettes in the country [a] mini billboard’
for the government’s anti-smokingmessage,”while the FDA “has
not provided a shred of evidence” showing that the warnings will
“
directly advance” its interest in cutting smoking.
…
Deutsche Bank analysts argue that the
U.S. Court of
Appeals’
ruling is “even harder on FDA” than the Leon ruling, and
note two implications: 1) the agency may still eventually get to
have graphic labels on packs, but only in a weaker form at least
one to two years away, and 2) the industry is having success
defending First Amendment issues and making effective use
of the courts, while the FDA “is looking ineffectual in defending
its proposals or providing evidence.” Morgan Stanley analysts
said the Appellate Court’s ruling does not change the general
requirements of the FDA bill, including the mandate for graphic
warning labels covering 50% of the front and back of the packs,
but it requires the agency to revise its proposed warning labels
and “reinforces our view that the FDA had overextended its ability
to restrict commercial free speech.”
…
The Food and Drug Administration’s Center for Tobacco
Products on August 15 announced the
Tobacco Product
Manufacturing Facility Visits program,
which is not intended
to include or replace official FDA inspections of facilities, but is
intended to give FDA staff an opportunity to visit facilities involved
in tobacco product manufacturing, observe the manufacturing
operations from the receipt of rawmaterials to the distribution of
finished products, and learnmore about manufacturing practices