TOB Magazine

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ing rules apply because they are con-
sidered a component of a tobacco prod-
uct that can alter the composition, per-
formance or characteristic of the product
and is intended for human consumption.
On questions about what to do with
existing products after August 8, 2016,
FDA said that they can be marketed
for up to three years while a pre-market
authorization application is submitted
within 24 months and reviewed, report-
edly, within 12 months thereafter with
the Center for Tobacco Products (CTP)
to decide on a case-by-case basis, should
its review be incomplete, whether to al-
low the product to remain on the market.
On questions about self-service displays,
FDA said that the ban on self-service
displays does not apply to newly deemed
products. FDA also repeated that manu-
facturers have to register with FDA, but
retailers do not.
…Some of the claims that FDA has
made in relation to its final deeming rule
are already being challenged: 1) Regard-
ing a CTP spokeswoman’s claim that
“we’re talking about products that kill
people,”which she stated on a Texas Pub-
lic Radio news show The Source, Boston
University’s Prof. Michael Siegel said,
“products that kill people…are not called
e-cigarettes, they’re called real tobacco
cigarettes.” 2) University of Ottawa
adjunct law professor David Sweanor
countered CTP Director Mitch Zeller’s
explanation during an FDA media brief-
ing that the UK Royal College of Phy-
sicians’ findings of the harm reduction
benefits of vaping did not apply in the
U.S. because “[w]e have skyrocketing use
of e-cigarettes by kids.” Sweanor noted
that the difference is not in youth vap-
ing, but in how the data is tracked, since
nearly 80 percent of youth who have
tried vaping say they used a non-nicotine
variety, so “say[ing] that this is a huge
problem is pretty ridiculous.”
…FDA said in a Twitter exchange
with Jeff Stier at the National Center
for Public Policy Research that it “rec-
ognizes that some tobacco products have
the potential to be less harmful than oth-
ers, but more research is needed” when
asked whether e-cigs are safer than regu-
lar cigarettes. Stier responded by charg-
ing that FDA “set up an alternate uni-
verse detached from reality, in which it
categorizes e-cigarettes as tobacco prod-
ucts and effectively bans them.”
…Center for Tobacco Products an-
nounced May 12 that the University of
Kentucky’s Center for Tobacco Refer-
ence Products has produced 50 million
“reference cigarettes” called 1R6F, de-
veloped under a cooperative agreement
with CTP, that “resembles the types of
cigarettes commonly sold in the U.S.”
The reference cigarette comes with a
certificate of analysis on measurements
of its chemical and physical proper-
ties, including harmful and potentially
harmful constituents (HPHCs), and can
provide reference points for comparison
to help manufacturers gather accurate
data about the content of their own ciga-
rettes, CTP said.
…Clarityse, a strategic consultancy for
the “self-care” sector and an advocate of
consumer empowerment, said that the
UK Royal College of Physicians’ report
endorsing vaping as a form of harm re-
duction is “great news for vapers,” but
FDA’s final deeming rule is “potentially
disastrous” and “effectively amounts to
prohibition” of e-vapor products because
of the sheer scale of the regulatory bur-
den.The FDA rule does not mean all va-
pers will stop vaping, however, since what
happens in response to prohibition is that
vapers will find a way around the law,
giving rise to a black market of “criminal
behavior, no controls, way poorer quality
products and no reliable data regarding
what’s going on,” Clarityse said.
…American Enterprise Institute resi-
dent scholar and Forbes contributor Sally
Satel writes that in the UK, policymakers
are “years ahead of [the U.S.] in pursu-
ing…a revolution in nicotine delivery,”
while in the U.S., FDA is protecting the
cigarette market and crushing the e-va-
por industry with its final deeming rule
on products that were not previously reg-
ulated. U.S. Department of Health and
Human Services Director Sylvia Bur-
well’s statement about “a new generation
of Americans who are at risk of addic-
tion,” and her apparent exclusion of adult
smokers who could benefit from e-vapor
products echoes the “ill-founded rheto-
ric” of CDC Director Tom Frieden, the
Campaign for Tobacco-Free Kids, and
other anti-vaping groups that are “largely
fixated on a yet-to-be demonstrated im-
pact on children, yet pay little attention
to the established benefit to smokers,”
Satel said.
…Vapor Expo International 2016
),which
took place June 15-16 at the Donald E.
Stephens Convention Center Hall A
in Rosemont, Illinois, featured TMA
President Farrell Delman, Smoke-Free
Alternatives Trade Association’s Cap
O’Rourke,American Vaping Association’s
Greg Conley, and Vapor Technology As
TMA REPORT BY FARRELL DELMAN
Stier responded by
charging that FDA
“set up an alternate
universe detached
from reality, in
which it categorizes
e-cigarettes as
tobacco products
and effectively
bans them.”
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TOBACCO BUSINESS INTERNATIONAL
JULY/AUGUST 2016