TOB Magazine

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TOBACCO BUSINESS INTERNATIONAL
JULY/AUGUST 2015
TMA REPORT By FARRELL DELMAN
On the FDA…
…In April, a group of tobacco
companies, including R.J. Reynolds
Tobacco, Lorillard Tobacco, Philip Morris
USA, U.S. Smokeless Tobacco, and
American Snuff Company, filed suit in
the U.S. District Court for the District
of Columbia against the FDA. The suit
charged that the agency’s guidance
for industry released in March 2015,
presumably on demonstrating the
substantial equivalence of a new tobacco
product, violates their free speech rights
by mandating pre-market approval of
labeling changes and creating “specific
legal obligations with clear and draconian
consequences for violations,” including
civil or criminal penalties.
…In its latest update, FDA CTP
announced issuing warning letters to
Vaperz , Knoxville Vapor
, and Dr. K
) for making statements
on their websites that “convey, or would
mislead consumers into believing that
[their e-cig or e-liquid] products are
endorsed by the FDA or that the products
are safe or less harmful by virtue of
regulation by FDA.” These statements
would be in violation of the Federal Food,
Drug, and Cosmetic Act, as amended
by the Family Smoking Prevention and
Tobacco Control Act (FSPTCA). The
update also announced the launch of two
publicly searchable databases (www.
accessdata.fda.gov/scripts/ctpocerl/
index.cfm) to provide access to publicly
releasable, commonly requested data on
U.S. tobacco establishments registered
with FDA and tobacco products listed
with FDA.
…Professor Gary Giovino, chairman
of the department of community health
and health behavior at the University
at Buffalo School of Public Health and
Health Professions in New York, has been
appointed to the FDA Tobacco Products
Scientific Advisory Committee.
…Commenting on the FDA TPSAC’s
April 10 conclusion that Swedish
Match North America’s General brand
snus should not be allowed to carry
modified-risk tobacco product (MRTP)
warning labels, the financial company
Nomura assessed the current ruling as
“a negative,” with any potential future
positive outcome from modifications to
the current application or a re-application
likely to be delayed for another 18 to 36-
plus months. The firm added that the
“biggest question this [TPSAC vote] may
raise for the majors is the likely success
of MRTP applications for e-cigarettes/
next-generation heat-not-burn [products],
which do have the potential to be
significant profit drivers in the years
ahead.” It also noted that the other majors
might have a better chance of success if
they apply only for modified-risk status,
given that SMNA may have impeded its
MRTP application by not separating it
from the application for a warning label
change.
…The investment banking firm Stifel
recently noted that while FDA will be
the “ultimate decider” on the MRTP
applications, TPSAC’s votes on three
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.