22
TOBACCO BUSINESS INTERNATIONAL
JULY/AUGUST 2014
TMA REPORT
By FARRELL DELMAN
…The FDA has announced that to
consolidate all of its centers, it is moving
its
Center for Tobacco Products (CTP)
offices
from Rockville, Maryland to
the FDA White Oak campus in Silver
Spring, Maryland with the three-week
move to start on June 6, after which
all written correspondence should be
sent to FDA CTP Document Control
Center, Building 71, Room G335, 10903
New Hampshire Ave., Silver Spring,
Maryland, 20993-0002. CTP staff
e-mail addresses and phone numbers
will remain the same.
…FDA Commissioner Margaret
Hamburg wrote a letter clarifying an
assertion in
The New York Times’
May
4 article “Some E-Cigarettes Deliver a
Puff of Carcinogens,” which said that
the FDA’s focus is largely on
what
gets added to e-cigarettes
rather than
the content of the e-vapor emissions.
The letter stated that e-cig companies
will be required to report the levels
of harmful and potentially harmful
chemicals delivered by their products
once FDA’s e-cig regulations are
finalized, but the agency cannot enact
a rule on reporting or restricting e-cig
emissions until the “foundational rule-
making” process is completed, adding
that FDA is “committed to the science-
based regulation of these products,”
and is financing research to answer key
questions on e-cig safety and consumer
behavior, including four studies that will
focus on the contents of e-vapor.
…The Smoke Free Alternatives Trade
Association (SFATA) requested that its
members ask the FDA for an
extension
from 75 to 180 days
for public comment
on its proposed deeming rule. Seventy-
five days does not provide enough time
for adequate analysis of the 70 topics and
issues in the 240-page document, stated
SFATA.
…The Center for Tobacco Products
has released its
“Compliance and
Enforcement Report,”
which covers
the CTP Office of Compliance and
Enforcement’s (OCE) accomplishments
and activities from June 22, 2009
through
September
30,
2013,
including training sessions, webinars,
conferences, issuance of guidance
documents, retailer compliance check
inspections, manufacturing inspections,
and evaluation of sale, distribution,
marketing, advertising, and labeling
of regulated products. Among other
things, the report indicated that OCE
has conducted 221,774 inspections and
found 18,960 violations, of which 12,039
required warning letters and civil money
penalties (CMPs); the vast majority of
violations went to retail stores.
…Goldman Sachs said that the
Government Accountability Office’s
(GAO) testimony before the U.S. House
Energy and Commerce Committee’s
Subcommittee on Health hearing on the
implementation of the Family Smoking
Prevention and Tobacco Control Act
would focus on
spending of the FDA
user fees
($513 million or 46 percent of
the $1.1 billion collected through 2012,
and $1.42 billion or 81 percent of the
$1.75 billion collected through 2013)
and the substantial equivalence (SE)
review process (4,490 SE submissions
as of December 31, 2013, of which 17
have been approved and 13 denied).
The GAO is recommending that the
Center for Tobacco Products come up
with performance measures to assess
its progress, including timeframes
for making final decisions on SE
submissions.
Morgan Stanley said that the
GAO
testimony
before the subcommittee,
while unlikely to meaningfully impact
CTP’s behavior, made some “interesting
observations,” including that: 1) as of
December 31, 2013, the FDA had only
made final determinations on 0.067
percent, or 30, of the 4,490 outstanding
SE submissions; 2) CTP currently does
not have any performance measures to
assess its progress; 3) CTP spent less
than its industry-paid user fees to date,
though the spending rate is expected to
increase as it scales up its “Real Cost”
anti-tobacco media campaign; 4) the
number of premarket tobacco product
applications increased from zero as of
January 7, 2013, to four as of December
31, 2013, including alternatives to the
SE pathway such as modified-risk
tobacco products; and 5) a proposed
rule to regulate other tobacco products
including e-cigs was still under Office
of Management and Budget (OMB)
review as of April 2, 2014. Much time
was spent at the hearing as Republicans
and Democrats dueled over the hearing’s
scheduling and the inability of CTP to
attend,reportedly for the fourth time,due
to its rapid scheduling by Republicans.
The full video of the hearing is available
at tma.org.
…The Food and Drug Administration
has reported that as of March 24,2014,all
“regular”
SEreports
(for products that did
not enter the market between February
16, 2007 and March 21, 2011, and for
which an SE report was not submitted
by March 22, 2011) have entered into
FDA review “immediately.” The agency
has cleared the queue for regular SE
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.
