22
TOBACCO BUSINESS
NOVEMBER/DECEMBER 2013
anyone under 18 and the requirement that
retailers request
photo identification from
customers
under 27. The video is available at
the FDA’swebsite.
…The FDA and the National Institutes of
Health announced September 19 that as part
of an ongoing interagency partnership, they
awarded $53 million to
fund tobacco-related
research
in fiscal year 2013, with a potential
total of $273+million over the next five years,
to create 14 Tobacco Centers of Regulatory
Science.
…In a notice published in the
Federal
Register
onSeptember 11, theFDAannounced
a 60-day extension to November 22 of the
comment period for the Advance Notice of
Proposed Rulemaking (ANPRM), requesting
comments regarding
menthol in cigarettes
,
including “comments on the FDA’s preliminary
evaluation, and data, research, or other
information that may inform regulatory actions
that FDAmight take with respect to menthol in
cigarettes.”
…Goldman Sachs said that while nothing
newwas presented at the Food, Drug and Law
Institute’s September 11 webinar entitled “
FDA
Regulation of Menthol in Tobacco Products
,”
key takeaways include: 1) current science does
not support a menthol ban as menthol itself is
generally recognized as safe by the FDA, and
current studies generally support the view
that menthol cigarettes are no more harmful
than regular cigarettes; 2) Lorillard, who was
represented by Patricia Kovacevic, director of
regulatory affairs, estimates that 72 percent of
current menthol sales would go to the black
market; 3) FDA is in “knowledge gathering”
mode; and 4) the EU Tobacco Products
Directive, with a proposed flavor/menthol
ban, remains controversial, though the TPD’s
outcome is not expected to influence U.S.
menthol policy.
…Harvard University Prof. Greg Connolly,
who served on the CTP’s Tobacco Products
Scientific Advisory Committee, pronounced
that the
future of e-cigs in the U.S.
, where
annual sales are projected to reach $1.7 billion
by the end of 2013, hinges on how the FDA
regulates them, noting that the product “could
be a tool—if it’s regulated correctly—to help
end dependence on cigarettes and nicotine,”
though the agency “seems to be poised to
ban Internet sales, which is exactlywhat [major
manufacturers] want,” as Connolly believes
that such a move would “destroy competition
and hand themarket over” to them.
…Along with its September 5 publication in
the
Federal Register
, the FDA CTP posted its
GuidanceforIndustry:TobaccoRetailerTraining
Programs on its “
Guidance, Regulations &
Compliance
” webpage, which is intended
to assist retailers in implementing training
programsforemployeestocomplywithfederal
laws restricting advertising, promotion, sales
and distribution of cigarettes and smokeless
tobacco products, including youth access
bans. Similarly, on August 21 the CTP issued
its “Guidance for Industry: Compliance with
RegulationsRestrictingtheSaleandDistribution
of Cigarettes and Smokeless Tobacco to
Protect Children and Adolescents,” which is
intended to help manufacturers, distributors,
retailers and others who sell cigarettes and/or
smokeless tobacco in understanding the final
regulations on this topic.
…The FDA CTP announced August 28 that
it issued
additional tobacco product review
decisions
by denying themarketing and sale of
four new tobacco products (names withheld)
through thesubstantial equivalence (SE) review
path, finding them to be “not substantially
equivalent” (NSE) to the predicate products the
unknown applicants presented, and updated
the agency’s “Tobacco Product Marketing
Orders” webpage to bring the total number of
NSE orders to eight. Stifel analysts said that the
denial of another four SE applications means
theindustryisbatting.200withtwoapplications
approved (for Lorillard’s Newport Gold
products), eight denied, and 136 withdrawn,
adding that CTP is expected tocontinue issuing
SE decisions “with some regularity.”
…In a clarification issued regarding an
August 22
Wall Street Journal
report that said
the FDA is considering
banning online sales of
e-cigs
as part of a package of e-cig regulatory
proposals that the agency was expected to
unveilforpubliccommentinOctober,Centerfor
Tobacco Products DirectorMitch Zeller said the
FDAmet with executives of e-cig companies to
hear their concerns or views on its proposed
regulations, but FDA “did not raise or weigh
in on potential regulatory options—including
any potential restrictions on e-cigarettes or
any other particular product category—during
these listening sessions,” adding that “[a]ny
details about the agency’s intent to regulate
additional categories of tobacco products will
be made publicly available to all interested
parties at the same time, through the issuance
of a proposed rule.”
…The CTP’s “Tobacco-Related Health
Fraud” webpage warns that
any claim of less
harm
or reduced risk of disease from using
tobacco products misleads consumers to
think that the products are safe to use and is
considered “health fraud” by the agency, and
urges the public to report any retailers that
market or promote their products to be safer to
consume in any facet.
…The World Trade Organization said it
will send to arbitration a dispute concerning
potential retaliatory measures that Indonesia
is seeking against the U.S. over the
clove
cigarette ban
included in the
Family Smoking
Prevention and Tobacco Control Act,
as the
WTO’s Appellate Body in April 2012 upheld
a WTO panel decision that the U.S. law’s
prohibition on all cigarette flavorings except
menthol discriminates against Indonesian
clove kreteks and is inconsistent with the U.S.’s
obligations under the Agreement on Technical
Barriers to Trade.
…The FDA Center for Tobacco Products on
August 19updated the“
State, Local, Tribal and
Territorial Governments
” section of its website
to increase understanding of how the
Family
Smoking Prevention and Tobacco Control Act
may impact local government programs and
how the FDA’s authority over tobacco products
compareswith laws in local jurisdictions.
…
The New York Times
has reported on
the current availability of f
lavored cigars and
cigarillos
in the U.S. since the
Family Smoking
Prevention and Tobacco Control Act
of 2009
banned all flavors of cigarettes except for
menthol but did not ban flavors in other
tobacco products (OTP), which has led to anti-
smoking advocates contending that the FDA’s
inactiononOTPflavorsthusfarthreatensrecent
progress in reducing smoking among young
people, though FDA appears to be wrestling
withhow toexercise its authority over the array
TMA REPORT
