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TOBACCO BUSINESS INTERNATIONAL
JANUARY/FEBRUARY 2015
TMA REPORT
By FARRELL DELMAN
…The
Food
and
Drug
Administration’s (FDA) Center for
TobaccoProducts (CTP) issued
warning
letters
to six online retailers for selling
“not substantially equivalent” products
across state lines.
…FDA continues to review
tobacco
product marketing applications
. In
November 2014, 24 substantially
equivalent (SE) orders and six not
substantially equivalent (NSE) orders
were issued, while companies
withdrew 17 SE reports from the
review process.
…
The New York Times
reported
on Swedish Match North America’s
(SMNA)
modified-risk
tobacco
product
(MRTP) application that
requests FDA to remove two smokeless
warning labels and say that SMNA’s
snus presents lower health risks than
cigarettes. The newspaper said that
SMNA is raising a broader question
of whether the regulation of tobacco
products should align with the degree
of harm presented by a given product,
an issue that has split the public
health community, with some arguing
that replacing one harmful tobacco
product with another is wrongheaded,
while others are apparently endorsing
strategies to distinguish the “cleanest,
least harmful” methods of nicotine
delivery, even if doing so might result
in dual use.
…In a November letter, U.S. House
Speaker John Boehner, House
Majority Leader Kevin McCarthy and
Chair of the Energy and Commerce
Committee Fred Upton asked that
FDA change the
grandfather date for
proposed deeming regulations
(DR)
for currently unregulated tobacco
and e-vapor products from February
15, 2007 to either April 25, 2014 (the
date the DR proposal was published)
or to the effective date of the final DR.
The letter was addressed to Health
and Human Services Secretary Sylvia
Burwell and cited concerns that the
proposed grandfather date would
create
“unnecessary
regulatory
burdens” and discriminate against
unregulated products, making it
virtually impossible for current e-cigs
to claim substantial equivalence to a
predicate product. Commenting on
the request, Professor Michael Siegel
of Boston University’s School of Public
Health expressed agreement and
noted that he would go further, asking
that FDA not require new product
applications for any products, as the
new product application requirement
will stifle innovation and make it
difficult for newer, potentially safer
products to enter the market.
…CTP is establishing
a public
docket
(FDA-2014-N-1936-0001)
inviting interested parties to submit by
April 15, 2015 “comments, supported
by research and data, regarding
e-cigarettes and the public health.”
…CTP said it launched two
new
national advertisements
as part of
On the fda…
Farrell Delman,
President, TMA
Breaking News From the TMA
The following are excerpts from harm reduction,
tobacco regulation and other tobacco-related news.