22
TOBACCO BUSINESS
SEPTEMBER/OCTOBER 2013
Youth Tobacco Prevention Campaigns.
”
…On June 25, the FDA announced
issuing
Substantial Equivalence (SE)
Marketing Orders for Lorillard Tobacco
Co.’s Newport Non-Menthol Gold
Box and Newport Non-Menthol Gold
Box 100s. The agency concluded that
while the new products have different
characteristics than thepredicateproduct
offered by LO, the new lower nicotine
and non-menthol products do not raise
questions of public health. The FDA said
it denied the marketing of four others
(names not released by law) through the
SE pathway, withdrew 136 SE Reports
at the request of the applicants, and
refused to accept 20 SE Exemption
Requests because the manufacturers
did not meet the requirements for
the exemption. Lorillard Chairman/
President/CEO Murray Kessler said LO
is “proud to be the first company…to
begin marketing these new products in
the U.S. through the FDA’s substantial
equivalence pathway” and “intends to
introduce its new products to adult non-
menthol smokers in the near future.”
…Arguing that while
menthol
products currently on the market
may
not be an issue, Stifel Nicolaus analysts
write that FDA’s approvals of two non-
menthol additions to the Newport line
that usedapredicatementhol variantwith
higher nicotine levels that is no longer on
the market suggests that bringing new
menthol line extensions to market may
prove difficult. The analysts cited FDA’s
“conclusions and recommendations”
language in its approval: “…menthol
added as a characterizing flavor to
cigarettes compared to equivalent
cigarettes without menthol…supports
the premise of an increased likelihood of
initiation, level/severity of dependence,
and/or decreased likelihood of cessation
success” suggesting that the converse
is an easier path and that launching a
menthol variant places a burden on
applicants to prove the negative—that
such a product would not enhance
initiation, increase addiction, or reduce
cessation—at a time when the data
surrounding menthol appears to be at a
stalemate.
…At its June 25 media briefing,
FDA
Commissioner Margaret Hamburg and
CTP Director Mitch Zeller
explained that
the two SE approvals and four NSE (not
substantially equivalent) orders came
from the 500 regular SE applications,
and that CTP coordinated well across
FDA in its decision-making. At its
subsequent industry briefing with Dr.
David Ashley, director of the CTP Office
of Science, Zeller said CTP intends to
issue more SE decisions on a “periodic
basis” in a “consistent, transparent and
predictable manner,” but did not indicate
timeframes or number of approvals/
denials to be expected at one time. It is,
however, giving priority to the regular SE
applications over the 3,500 provisional
applications for products already on
the market about which Dr. Ashley said
FDA’s reviews have commenced and
that use of LIP paper, as was the case in
the Newport Gold Box decisions, did not
increase HPHC concerns.
…The FDA updated its “
Tobacco
Product Marketing Orders
” page, listing
the number of SE Orders issued to
date (2), number of NSE orders issued
to date (4), SE report withdrawals
(136), copies of the FDA Order Letters,
and the number of Refusal To Accept
(RTA) letters for Exemption Requests
(20). Among the reasons given for
NSEs were lack of predicate validation
and inadequate information on design
features, the types of tobacco used, and
HPHCs/added chemicals being present
in higher quantities than in the predicate
with inadequate confirmation that the
product was no more harmful than its
predicate.
…In a separate notice the same day,
the FDA announced the availability of
grant funds to support the
Center for
Tobacco Products’ Building Research
Capacity
in the Global Tobacco Product
Regulation Program with the agency
saying it intends to accept and consider
a single source application for award to
the World Health Organization (WHO) to
coordinate and promote research efforts
relating to tobacco control regulations
in foreign countries that will directly
inform and support FDA’s exercise of
its regulatory authority over tobacco
products in the U.S. The FDA expects
to provide up to $1 million in funding
in FY13 and anticipates the possibility
of additional funding of up to $1 million
per year for four more years until FY17
depending on the program’s successful
performance and the availability of
funding.
…Goldman Sachs analysts said
they expect the
FDA to begin issuing
updates
on key pending issues “in the
near term” as June 22 marks the four-
year anniversary of the
Family Smoking
Prevention and Tobacco Control Act.
…In an analysis published in the
American Journal of Preventive
Medicine
, John Kraemer from the
Georgetown University School of
Nursing & Health Studies says that
when the FDA develops new cigarette
warnings, it can survive a
First
Amendment challenge to the labels
,
which are most likely to be analyzed by
courts under the rational basis review
and intermediate review, if the agency
depicts actual health consequences of
smoking, avoids images that could be
interpreted as opinions instead of facts,
and provides clear evidence of the labels’
impact on smoking rates themselves or
for the causal mechanism by which they
reduce smoking.
…The FDA’s Solicitation Number
FDA-SOL-13-1116875, posted on fbo.
gov, seeks a vendor to
mine commercial
shipping data
going back to 2007 to
identify any oddities that might indicate
illegal sales or trafficking in cigarettes
TMA REPORT
