sociation’s Tony Abboud in a panel dis-
cussion about FDA’s final deeming rule
and shared their views on how manufac-
turers of newly regulated products will
respond to the announcement, what the
decision will mean for the competitive
landscape, and what the status is on efforts
to change the predicate date.
…
TheNewYorkTimes’
“RoomforDe-
bate” column
asked the question “How
will the FDA’s decision affect anti-smok-
ing efforts?” to four debaters. Kenneth E.
Warner, public health professor and for-
mer dean of the School of Public Health
at the University of Michigan, said that
the new FDA regulation “is likely to
squander an opportunity to hasten the
demise of the enormous toll of combust-
ed tobacco” because it is “hugely unbal-
anced, emphasizing the hypothetical risk
to children while ignoring the potential
harm-reduction benefits for adult smok-
ers.” Harold P. Wimmer, president and
chief executive of the American Lung
Association, said that the FDA’s new
rules represent “an important step for-
ward in protecting public health and pre-
venting a new generation of youth using
and becoming addicted to nicotine,” and
“[u]nproven claims that e-cigarettes can
help smokers quit are troubling.” Amy
L. Fairchild, professor of sociomedical
sciences at Columbia University’s Mail-
man School of Public Health, said even
if the final rule is so burdensome that
it effectively bans e-cigs, the document
also states FDA’s belief that “inhala-
tion of nicotine (i.e. nicotine without the
products of combustion) is of less risk to
the user than the inhalation of nicotine
delivered by smoke from combusted to-
bacco products,” and therefore stakehold-
ers need to use the FDA rule “as a lever
to elevate tobacco harm reduction as a
foundation of U.S. tobacco policy” and
a challenge to the abstinence-only scare
tactics approach. Delmonte Jefferson, ex-
ecutive director of the National African
American Tobacco Prevention Network,
said that the FDA rule “is a huge step in
tobacco prevention, and it will protect
underprivileged communities who dis-
proportionately suffer death and disease
due to these products,” but the agency
also needs to ban the “sale of mentholat-
ed tobacco products,” given that menthol
cigarettes are smoked by nearly 75 per-
cent of African American smokers.
…Major cigar associations are expect-
ed to gather shortly to plan out a strategy
to address the FDA’s final deeming rule
that includes premium cigars in its over-
sight. The
premium cigar industry
lob-
bied for several years for an exemption
from FDA regulations, and some indus-
try representatives, including Eric New-
man of J.C. Newman Cigar Company of
Tampa, Florida, said that they will meet
with members of Congress or take legal
action to fight the new rules.
…The bill H.R. 5054, introduced April
26 by U.S. Rep. Robert Aderholt (R-Ala.),
would make appropriations for Agricul-
ture, Rural Development, FDA, and Re-
lated Agencies programs for the fiscal year
starting October 1, 2016, and includes the
rider (originally proposed as H.R. 2058)
by U.S. Reps Cole (R-Okla.) and Bishop
(D-Ga.) to
change the February 15, 2007
predicate date
for currently unregulated
tobacco products that would be deemed
subject to FDA oversight. H.R. 5054
would also exempt “traditional large and
premium cigars” from FDA regulation
and require, no later than 12 months after
the date on which the deeming regula-
tions for e-vapor products are issued, that
a notice be issued of a proposal to estab-
lish a product standard for e-vapor prod-
uct batteries, with a final product standard
for such batteries to be published within
24 months.
It also sets marketing and sales regula-
tions for e-vapor products such as: ban-
ning ads in any publication other than
an “adult publication” (defined in the
amended rider); requiring retailer estab-
lishment sales of e-vapor products to be
in direct face-to-face exchanges without
the use of “any electronic or mechanical
device (such as a vending machine)…
that is not in an area restricted to those
over 18,” but exempts “mail-order” sales;
and requiring final regulations for the la-
beling of e-vapor products that would in-
clude the phrases “Keep Out of Reach of
Children,” “Underage Sale Prohibited,”
and an “accurate statement of nicotine
content.”Those who “own or operate an
establishment in any state engaged in the
retail sale of a vapor product” are required
to register with the Secretary of Health
and Human Services “within the later of
60 days after the date of enactment…or
30 days after first engaging in such retail
sale,” unless the establishment is already
under state regulation or is regulated un-
der Section 905 of the FD&C Act.
…The Keller and Heckman (K&H)
law firm, explaining what would have to
follow the April 19 vote on House Re-
port 114-531 by the U.S. House Appro-
priations Committee, a vote that took
TMA REPORT
BY FARRELL DELMAN
Major cigar
associations are
expected to gather
shortly to plan
out a strategy to
address the FDA’s
final deeming
rule that includes
premium cigars in
its oversight.
26
TOBACCO BUSINESS INTERNATIONAL
JULY/AUGUST 2016