20
TOBACCO BUSINESS
SEPTEMBER/OCTOBER 2013
TMA REPORT
By FARRELL DELMAN
…Out of 300 smokers participating in
a clinical trial of the safety and efficacy
of e-cigs
, 8.7 percent quit smoking as
a result of participation, reports Dr.
Riccardo Polosa, MD, accompanied
by Dr. Michael Siegel of Boston
University’s School of Public Health.
Seventy percent of those who quit did
so using the e-cig itself, while another
10 percent reduced daily cigarette use
by more than 50 percent.
…Chester, England-based e-cigarette
retailer E-Cig Cavern says it supports the
UK Medicines and Healthcare Products
Regulatory Agency’s (MHRA)
efforts
to regulate e-cigs
given the availability
of e-liquids made in factories with
“severely lacking” health and safety
standards. The retailer also voiced
concerns that both the “pharmaceutical
industry and the MHRA have direct,
financial interest” in seeing e-cigs
removed from the market.
…University of Louisville Prof. Brad
Rodu said the
UK MHRA’s proposal to
regulate e-cigs
as medicine “is likely
to limit or eliminate the availability of
these popular and far safer smoking
alternatives” and will only encourage
smokers to continue smoking, “making
the UK government a culpable enabler
of this deadly habit,” while adding that
“[t]he only consolation is that there will
be five to ten million British e-cigarette
users in 2016, a formidable political
force that may not tolerate a regulatory
barrier to the continued supply of
these life-saving products.”
…
The Economist
reports that
e-cigs “have provoked
criticism
from all sides.
” Health lobbyists
worry that the device may encourage
higher nicotine consumption or make
smoking socially acceptable again;
pharmaceutical companies object
to consumers using e-cigs—instead
of the nicotine patch or gum—to
cut down on cigarette smoking;
governments lose revenue from
taxes on tobacco products, and “real”
cigarette smokers hold “vapers” in
contempt because “fake puffs are
naff,” and that “overly strict regulation
could snuff out a new industry with
the potential to save smokers from a
lot of harm.”
…The FDA has updated its web
page on
Guidance, Regulations and
Compliance
with lists of downloadable
“Rules and Regulations” and “Guidance”
documents sortable by type, title and
date.
…On July 18, the FDA’s Center
for Tobacco Products (CTP) held a
public workshop and webcast on the
“
Electronic Submission of Tobacco
Product Applications
and Other
Information;” visit
to see
the webcast.
…The FDA CTP sent a
warning letter
with reference number RW1300087
to
stating that
some of the cigarettes offered at www.
adilacoffee.com are adulterated because
they are promoted as modified risk
products with no FDA order permitting
such promotion, while the sale of clove
cigarettes on the website violates a
provision against characterizing flavors.
…The FDA issued a notice (OMB
Control Number–0910–New) soliciting
public comments, until September 3, on
“
Copy Testing of FDA’s General Market
On harm reduction…
Farrell Delman,
President, TMA
Breaking News From the TMA
The following are excerpts from harm
reduction, tobacco regulation and other
tobacco-related news.
On THE FDA…
