TOB Magazine

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TOBACCO BUSINESS INTERNATIONAL
SEPTEMBER/OCTOBER 2015
TMA REPORT By FARRELL DELMAN
…Some were expecting to see a final
rule from the FDA Center for Tobacco
Products on currently unregulated
tobacco products by the end of June.
Instead, the CTP issued an Advance
Notice of Proposed Rulemaking
(ANPRM) on July 1 addressing nicotine
itself,more specifically “nicotine exposure
warnings and child-resistant packaging
for liquid nicotine, nicotine containing
e-liquid(s), and other tobacco products”
defined to at least include “dissolvables,
lotions, gels and drinks.” CTP seeks
further comments, data, research, etc.
as an evidence base to take regulatory
actions regarding nicotine exposure per
se, something CTP says is not addressed
in its April 24, 2014 NPRM with respect
to unregulated products.
…Commenting on the ANPRM,
American Vaping Association (AVA)
President Gregory Conley said that the
agency is “jumping the gun by moving on
this issue before the deeming regulation
has been finalized.” He added that
while the AVA supports child-resistant
packaging, which is already in use by the
vast majority of e-liquid manufacturers,
the group is concerned about the labeling
proposal, as poorly designed warnings
could mislead adult smokers about the
relative risks of vaping versus smoking.
Conley is also concerned that FDA is
“inquiring about placing color warnings
on vapor products when they haven’t
even fulfilled their duty to Congress
to require graphic warnings on deadly
combustible cigarettes.”
…FDA’s CTP and the National
Academy of Medicine (formerly
the Institute of Medicine) named
the five 2015-16 FDA Tobacco
Regulatory Science Fellows, who will
be assigned to an office within CTP,
lead specific projects related to tobacco
product regulation, participate in the
“development of science-based public
health strategies,”and receive mentorship
from senior CTP staff.They are Amanda
Berger, a postdoctoral research fellow
at Oak Ridge Institute for Science and
Education in Maryland; Shari Feirman,
project director for regulatory science and
policy at Legacy’s Schroeder Institute for
Tobacco Research and Policy Studies in
Washington, D.C.; Jose Medina Torres,
health communications specialist at the
D.C.-based marketing firm Penngood;
Alexandra Merceron, visiting professor
at Georgetown University’s department
of public relations and corporate
communications; and Kimberly Snyder,
program and policy analyst at The
Nemours Foundation of Wilmington,
Delaware.
…FDA said that it continues to review
tobacco product marketing applications
and issued last month 125 Substantially
Equivalent (SE) orders, eight Not-SE
orders, and one Refuse-to-Accept letter
for SE, while companies withdrew 190
SE reports from the review process.
The U.S. Food and Drug
Administration announced that it is
reopening the public comment period,
for 30 days until August 31, 2015,
on modified-risk tobacco product
applications (MRTPAs) submitted by
Swedish Match North America for 10
tobacco products.
…CTP issued a warning letter to
Luis Neves Ferreira of Puros Premium
Cigars, saying that the cigarette
tobacco/RYO tobacco products sold on
his company’s websites cigars-habanos.
com, and are
misbranded. Golden Virginia “premium
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.