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TOBACCO BUSINESS INTERNATIONAL
JULY/AUGUST 2014
reports entering the review process and
now plans to initiate evaluation of new
regular SE reports upon receipt, adding
that the review process has concluded
for 23.6 percent of the 981 regular SE
reports received before March 31, 2014,
and FDA intends to reach decisions on
the remaining reports as “expeditiously as
possible.”
…Reporting their
key takeaways from
TMA’s recent annual conference
on
“Evidence-Based Science, Electronic
Cigarettes, & Tobacco Harm Reduction”
in Williamsburg, Virginia, Goldman
Sachs said that: 1) evidence is building
around the safety and efficacy of e-cigs,
with some safety/risk assessment studies
suggesting that e-cigs can assist in
smoking cessation and reduction, while
combustible cigarettes lead to most of the
adverse health effects, but clinical studies
are still necessary to determine the longer
term effects of switching, along with
research on flavors and other ingredients
in e-cigs; and 2) “vaporizers and tanks
are all the rage,” as Management
Science Associates (MSA), which tracks
distributor shipment data, noted that the
e-liquid used in vaporizers, tanks and
mods accounts for 27 percent of total
e-vapor-related volume in stores that
carry the liquids, while some attendees
commented that there may be as many as
10,000 vape shops in the U.S. now, with
more than three stores opening every day.
…Also at the recent TMA conference,
many session participants agreed that
the
proposed e-cigarette regulations
in
their current form would bring an end
to smaller, independent manufacturers
because of the cost of compliance. They
raised concerns regarding the substantial
equivalence process under the current
proposal and its potential impact on
innovation, noting that current e-cigs
are not giving consumers the nicotine
hit that they desire, and that the majority
of category growth comes from open
tank systems, which offer a greater
nicotine hit. Industry participants urged
the U.S. government to follow the UK
example and take a more harm-reduction
regulatory approach rather than the “quit
or die” approach.
…David Abrams, director of research
at the American Legacy Foundation’s
Schroeder Institute for Tobacco Research
and Policy Studies, said that the single
biggest opportunity that comes with the
FDA’s
proposed deeming regulations
is
“a potential process for e-cig companies
to get the FDA’s approval to make claims
that their products are less dangerous
than ordinary cigarettes,” because
“then you can aggressively tell people
to switch completely.” That being said,
on page 28 of the rule, FDA makes
the claim that premarket applications
“can spur innovation” by allowing only
new products shown as likely to reduce
morbidity and mortality, and that the
process will also improve “consistency”
across products.
…A recent blog post by Michael
Siegel, professor at Boston University’s
School of Public Health, states that
placing Section 911, or
modified-risk
hurdles
, for e-cig statements that their
products are less harmful since they
contain no tobacco and generate a much
smaller number of chemicals is a “gift to
combustible tobacco.”
…The American Council on Science
and Health officials expressed relief that
their concerns that
“thehyper-regulatory
atmosphere”
at the FDA might lead to
a ban on e-cigs—either overtly or via a
stringent pharmaceutical-type approval
process—did not come to pass, and that
e-cigs will continue to be available on the
market. The council added that there is
still “plenty of bad news” in the proposed
deeming regulations, especially the
requirement that all new products apply
for FDA approval.
…National Center for Public Policy
Research Risk Analysis Director
Jeff Stier said that while these rules,
which are being described by FDA as
“foundational,” include some reasonable
provisions such as a
ban on sales to
minors
, the “devil will be in the details
of future regulatory decisions,” which,
if “too heavy-handed,” would have the
“deadly effect of preventing smokers
from quitting by switching to these
dramatically less harmful alternatives,”
adding that he is also concerned that the
“expensive and burdensome requirements
will heavily favor big companies at the
expense of smaller innovative ones,
thus slowing product improvements
that would make e-cigarettes a more
appealing alternative to even the most
addicted smokers.”
…CTP announced April 18 that
to “help improve the timeliness and
predictability of the review of certain types
of tobacco products currently regulated
by FDA,” the agency
established four
performance measures
and timeframes
for fiscal years 2015 to 2018: 1) for regular
SE reports, FDA’s performance goal is
to finalize jurisdiction and completeness
review, to issue letters as appropriate
within 21 days of FDA receipt, and to
review and act on an original SE report
within 90 days of receipt, while for regular
SE report resubmissions, the performance
goal is to review and act on it within 90
days of FDA receipt; 2) for review of
exemption from SE, the performance
goal is to review and act on it within 60
days of receipt; 3) for review of modified-
risk tobacco product applications, the
performance goal is to review and act on
a complete MRTPA within 360 days of
receipt; and 4) for meeting requests, the
performance goal is to respond to such
requests within 21 calendar days.
TBI
TMA REPORT
ON HARM REDUCTION…
