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a new Standard Reference Material
entitled “SRM 3222 Cigarette Tobacco
Filler” with certified amounts of nicotine
and two tobacco-specific nitrosamines—
NNN and NNK
—to help manufacturers
and importers meet the federal require-
ment for reporting harmful or potentially
harmful constituents (HPHCs) in tobac-
co products and tobacco smoke.
…In a September
Federal Register
notice, FDA requested
nominations for
voting membe
rs to serve on the
Tobacco
Products Scientific Advisory Commit-
tee
(TPSAC), with nominations received
on or before November 14 to be consid-
ered first, and those received later to be
considered as and when vacancies occur.
…In September, FDA released a pre-
liminary review that stated its doubts
on the post-marketing clinical trial data
that pharmaceutical firm
Pfizer
used for
its
Chantix smoking-cessation drug
, de-
creasing Pfizer’s chances of altering or
removing the black-box “serious” warn-
ing that is on the drug’s label.
ON OTHER TOBACCO NEWS…
…A
Roswell Park Cancer Institute
study,
authored by Dr. Maciej Gonie-
wicz and published in the journal
Nico-
tine & Tobacco Research
, measured seven
nicotine metabolites and 17 tobacco
smoke exposure biomarkers in the urine
samples of 20 Polish smokers before and
after they switched to pen-style M201 e-
cigs.The results found that two weeks af-
ter switching, nine participants (45 per-
cent) reported complete abstinence from
smoking, while the rest cut back from an
initial average of 16 cigarettes a day to
an average of just one a day. In addition,
while levels of total nicotine and some
polycyclic aromatic hydrocarbon metab-
olites remained unchanged, exposure to
known carcinogen NNK fell by 64 per-
cent, and the volatile organic compounds
acrolein, ethylene oxide, benzene, and
1,3-butadiene dropped by 56 percent, 61
percent, 76 percent and 84 percent, re-
spectively, after the second week.
…Commenting on the aforementioned
study,
Boston University School of Pub-
lic Health Prof. Michael Siegel
said, “If
anti-tobacco groups have any scientific
integrity, this study should put an end to
their misleading propaganda claiming or
implying that vaping is just as hazardous
as smoking, that switching from smok-
ing to vaping has not been shown to have
health benefits, and that we don’t know
enough about the health effects of vaping
to conclude that it is safer than smoking.”
…Renowned public health advocates
David Sweanor, professor at the Univer-
sity of Ottawa, and Ken Warner, profes-
sor at the University of Michigan, joined
forces to attack
North Dakota’s Mea-
sure 4 excise tax increase
on cigarettes,
smokeless tobacco and e-cigarettes
by ar-
guing that while the cigarette tax hike “of
at least $1.73 on cigarettes” is reasonable,
it makes no sense to comparably tax “less
harmful alternatives.”
…On August 31, FDA issued two
guidances, one of which was published
in the
Federal Register
on August 31 as
a draft guidance entitled
“Submission
of Warning Plans for Cigars,”
which,
when finalized, will “help those involved”
in the manufacture, distribution and sale
of cigars in the U.S. to understand the
new warning plan requirements for ci-
gars under FDA’s deeming rule.
…
Nevada Vaping Association Co-
Chair Alex Mazzola,
owner of Las
Vegas-based vape shop
Flavor Vapor
, is
claiming that FDA regulations have put
his three-year business in danger of go-
ing out of business. “FDA is portraying
this as unsafe for kids, but we don’t want
to sell to kids,” he says. “Two years ago,
Gov. Sandoval signed a law making it il-
legal to sell to anyone under 18. So FDA
can act like they are doing the healthy
thing, but they are just putting us out of
the game.”
TBI
If anti-tobacco groups have any scientific
integrity, this study should put an end
to their misleading propaganda claiming
or implying that vaping is just as
hazardous as smoking...”
TMA REPORT
BY FARRELL DELMAN
11
TOBACCO BUSINESS INTERNATIONAL
NOVEMBER/DECEMBER 2016