24
TOBACCO BUSINESS
NOVEMBER/DECEMBER 2013
ofOTP,asevidencedbyrecentwarninglettersto
companies that the agency says are disguising
RYO tobacco as pipe tobacco and therefore fall
under its jurisdiction.
…The FDA recently began soliciting
proposals from private contractors to conduct
retail tobacco inspections
in Alaska, Florida,
Nebraska, Nevada, New York, North Dakota,
Oregon, South Dakota and Wyoming, the nine
states that have not entered into a contract with
the FDA to conduct such checks.
…The U.S. Department of Health’s National
Institutes of Health (NIH) announced a funding
opportunity for its Mentored Research Scientist
CareerDevelopmentAwardinT
obaccoControl
Regulatory Research
, which the Agency for
Health Care Research and Quality said “must
address the research priorities related to
the regulatory authority of the [FDA CTP] as
mandated by the
Family Smoking Prevention
and Tobacco Control Act
.”
…OnAugust 12, FDAdeclared that itsCenter
for Tobacco Products is initiating
enforcement
actionagainst online sellers
whohavebranded
roll-your-own tobaccoaspipe tobaccoallegedly
to evade the federal excise tax, which is higher
on RYO tobacco than on pipe tobacco, and to
skirt FDA tobacco regulations, which currently
applytoRYOtobaccobutnotpipetobacco.CTP
also issued its 10,000th tobacco retailer warning
letter following over 189,000 retailer inspections
conducted as of July 31, 2013.
…In an interview with
National Journal
,
CTP Director Mitch Zeller
said, among other
things, that the agency’s commitment to
tobacco use prevention is paramount, that the
CTP is “getting closer to being able to” expand
its regulatory authority over all products that
meet the definition of a tobacco product, and
that the FDA “has an opportunity to create a
comprehensive nicotine regulatory policy that
recognizes that…there’s a continuum of risk”
at the individual level and can drive “current
cigarette smokers who are unable or unwilling
to quit from the most harmful form of nicotine
delivery to the least harmful form.”
…The University of Wisconsin-Madison
Center for Tobacco Research and Intervention
received a $368,000 grant from the National
Heart, Lung and Blood Institutes and FDA to
“
study the use of menthol cigarettes
” and
contribute to FDA’s research to determine
whether, or how, to regulate the flavoring.…
U.S. Representatives Henry Waxman
(D-California), Diana DeGette (D-Colorado),
Frank Pallone, Jr. (D-New Jersey) and John
Dingell (D-Michigan) on September 16 sent a
letter toFDACommissionerMargaret Hamburg
urging her to “act quickly” to
regulate e-cigs
,
and another letter to House Committee on
Energy and Commerce Chairman Fred Upton,
Subcommittee on Oversight and Investigations
Chairman Tim Murphy, and Subcommittee on
Health Chairman Joe Pitts requesting a hearing
to examine alleged “public health threats posed
bytheincreaseduseofunregulatede-cigarettes,
cigars, and pipe tobacco, and FDA’s authority to
address the growing problem.”
…Coral Gartner of the University of
Queensland Centre for Clinical Research in
Australia is expected to soon begin a
trial of
1,600 smokers,
funded by the National Health
and Medical Research Council, to test the
safety and effectiveness of e-cigs for smoking
cessation compared with traditional cessation
aids like nicotine gumand inhalers.
…A September 16
New York Times
editorial
said that the recent Centers for Disease Control
and Prevention report showing that
e-cig use
hasmore thandoubledamongmiddleandhigh
school students in the U.S. from 2011 to 2012
(ES13-36) makes the case for regulating e-cigs,
adding that theFDA,which isexpected tounveil
its proposed e-cig regulatory plan, should ban
their sales and marketing to those under 18
and outlaw flavorings as e-cig companies are
“mounting a serious effort to attract young
smokerswith fruit andcandyflavors” and“have
begun aggressive marketing campaigns that
use celebrity endorsements and themes that
appeal to young people.”
…Retail giant WalMart is among a growing
number of companies across the U.S. that have
started imposing a
higher health insurance
premiumonemployees
whousee-cigs,asthey
consider e-cig use to be a form of tobacco use,
rather than a tool to quit smoking, according to
theweekly
ModernHealthcare
.
…
The Wall Street Journal
, citing people
familiar with the matter, reported that the FDA
has been meeting with executives of e-cig
companies to hear their views on its proposed
regulations for the industry and is considering
an online
ban of e-cigarette sales
, is looking
at a minimum legal purchase age of 18 or 19,
and is reviewing television, radio and print
advertising standards for the product, as part of
apackageof e-cigarette regulationproposals for
public comment that the agency was expected
to unveil in October. Wells Fargo analysts said
that if online sales of e-cigarettes are banned,
they would expect most of the online sales,
currently worth $500-625 million, to move to
traditional retailers, where e-cigarette sales are
estimated to have crossed $1 billion, adding
that they believe such a ban would be a “huge
positive” for manufacturers that are already
well-entrenched with retailers, including blu
eCigs (Lorillard) and NJOY, while Reynolds
American’s Vuse and Altria’s MarkTen e-cigs,
though still in limiteddistribution in testmarkets,
would also benefit given the companies’ strong
relationships with retailers, which the analysts
notedwould ensure that they have easy access
to shelf space when they prepare for a broader
product rollout.
…As the European Parliament considers
proposed revisions to the EU Tobacco
Product Directive
(TPD), some member states,
including France, Belgium, Finland, Ireland
and the UK, have expressed strong support
for the European Commission’s proposal,
but other nations, mostly from eastern and
southern Europe, are opposing the measure,
claiming it would harm their economies and
hurt thousands of families that depend on
tobacco cultivation for their living. EU Health
Commissioner Tonio Borg commented that he
is alarmed that economic concerns are starting
todominatewhat isprimarilyahealth issue, and
British MEP Linda McAvan, who is guiding the
legislation through Parliament, said she believes
the economic objections being used by other
members and states are actually coming from
the tobacco lobby.
…
Philip Morris USA
said a federal district
court judge in Wisconsin denied class
certification in theWyatt “Lights” cigarette case,
in which a proposed class of smokers in the
state who bought “Lights” and other low tar
cigarettes manufactured by Philip Morris since
June 16, 2003 sought to recover aportionof the
money they spent on the cigarettes.
TB
TMA REPORT
On Other tObaccO news…
