20
TOBACCO OUTLET BUSINESS
NOVEMBER/DECEMBER 2012
TMa reports...
TMA REPoRT
BY FARRELL DELMAN
ON FDA REGULATION…
…
A Food and Drug Administration notice (Docket No. FDA-
2012-
N-0001) published in the
Federal Register
on October
5
requests
nominations for voting members
to serve on the
agency’s Tobacco Products Scientific Advisory Committee and
specifies that it seeks to include the views of women and men,
members of all racial and ethnic groups, and individuals with and
without disabilities on its advisory committees.
…
Another FDA notice (Docket No. FDA-2012-N-0001)
published in the
Federal Register
on October 5 says it is accepting
nominations for an upcoming vacancy for a non-voting industry
representative to represent tobacco growers on the TPSAC, and
requests that industry organizations interested in participating in
the selection notify the agency in writing.
…
The FDA currently has the following
Federal Register
notices
open for comment:
1)
FDA-2012-N-0853, Tobacco Product
Manufacturing Facility Visits program, 2) FDA-2012-N-0876,
Agency Information Collection Activities; Proposed Collection;
Comment Request; Pretesting of Tobacco Communications, and
3)
FDA-2012-N-0977: Agency Information Collection Activities;
Proposed Collection; Comment Request; Regulations Restricting
the Sale and Distribution of Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents.
…
In response to
U.S. Rep. Henry Waxman
’
s (D-California)
August 27 letter to FDA Commissioner Margaret Hamburg
urging the agency to assert jurisdiction over cigars and pipe
tobacco, Phoenix, Arizona-based cigar manufacturer Prime Time
International sent its own letter to the FDA to “correct the record
in regard to certain of Rep. Waxman’s statements,” stating among
other things that the U.S. Alcohol and Tobacco Tax and Trade
Bureau’s statistics “clearly show that cigar products are not being
used in any material way as a replacement product that decreases
in cigarette sales experienced in recent years.”
…
Commenting on
U.S. Rep. Henry Waxman’
s (D-California)
August 27 letter to Food and Drug Administration Commissioner
Margaret Hamburg, which urged the agency to assert jurisdiction
over cigars and pipe tobacco, the Tobacco Team of the law firm
Troutman Sanders said that Waxman wants the FDA to deem
as “misbranded” products that are “mislabeled as pipe tobacco
or large cigars” even if the products satisfy appropriate Internal
Revenue Code definitions, and questioned the congressman’s
assertion that cigars and pipe tobacco are being used to evade the
Tobacco Control Act
’
s ban on flavored cigarettes, since that law’s
proscription on flavors applies only to cigarettes.
…
The U.S. Food and Drug Administration has selected the
following six agencies to work on a new
five-year anti-smoking
initiative
with a spending ceiling of $390 million: Campbell-Ewald
Company, True North Communications, Grey Global Group, Inc.,
American Legacy Foundation, Mullen Communications, and
Riester Corporation.
…
After the Lorillard stock underperformed the market and its
rivals Altria and Reynolds American on September 24 by 260 bps
and 290 bps, respectively, UBS analysts said that while the LO sell-
off appears to have been triggered by investors’ concerns that a
potential ban on cigarette flavorings
,
including menthol, in the
European Union may set a precedent for a menthol ban in the
US, they do not expect the FDA to ultimately ban the flavoring as
“
there is no track record of the US following EU policies related
to tobacco,” citing the example of the snus ban in the EU, except
Sweden.
…
According to a national survey conducted by researchers at
the Schroeder Institute for Tobacco Policy and Research Studies
at the American Legacy Foundation published September 20
in the
American Journal of Public Health
, 28.8%
of Americans
polled opposed a
ban on menthol-flavored cigarettes
while 20%
supported a ban, and nearly 40% of menthol smokers said they
would quit smoking if menthol cigarettes were no longer available.
…
FDA’s CTP is seeking comments on collecting voluntary
tobacco product
adverse event
information
as a potential “rational
questionnaire” that would add additional tobacco product related
questions to the existingMedWatch paper forms used for tobacco
product adverse reporting.
…
According to an analysis of FDA Center for Tobacco Products
data by the
We Card Program
,
the number of tobacco compliance
checks this year throughAugust 31 totaled 67,096, up sharply from
35,462
in 2011 and just 507 in 2010, while the number of warning
letters totaled 2,845 compared with 1,734 in 2011 and 24 in 2010.
…
Anopinionpieceby
Slate
writerMarkJosephStern in the
Wall
Street Journal
supports the D.C. Circuit Court of Appeals’ August
24
ruling upholding a Federal district court’s decision to
reject
the FDA’s graphic cigarette warning labels
,
saying “commercial
speech, like any other speech, deserves full First Amendment
protections,” adding that tobacco companies “may be despicable,
their product malignant, [but] outrage over their existence or their
conduct does not justify infringement on their rights.”
…
The FDA CTP sent a
warning letter
to Achmad Fakhri of
Jateng, Indonesia, stating that several of the cigarettes offered
for U.S. customers on his website
www.coffeecigarette.com
are
adulterated under the
Federal Food, Drug, and Cosmetic Act
,
as
amended by the
Family Smoking Prevention and Tobacco Control
Act
,
as they are promoted as modified risk products, with the
qualifiers “mild” and “low tar and nicotine,” without an FDA order
that permits such promotion.
Farrell Delman,
President, TMA