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TOBACCO BUSINESS
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What You Need toKnow
About
Federal Regulation
Retailers and manufacturers alike should be
watching these five hot-button regulatory issues.
BY NOAH STEINSAPIR, GENERAL COUNSEL, KRETEK INTERNATIONAL
LEGISLATIVE MATTERS
1. 2.
WITH SO MANY DIFFERENT governmen-
tal bodies (i.e., federal, state and local) regulat-
ing tobacco, we are often asked which mandates
concern us the most. We closely scrutinize all
the laws, rules and regulations to ensure that
we are compliant, but some have more serious
ramifications than others. Below is a list of the
top five federal level issues that concern both
tobacco manufacturers and retailers.
DR. SCOTT GOTTLIEB
APPOINTED TO HEAD THE FDA:
Perhaps nothing is more important to man-
ufacturers and retailers than the recent ap-
pointment of Dr. Scott Gottlieb to head the
U.S. Food and Drug Administration (FDA).
Everyone is reading the tea leaves attempting
to determine how Gottlieb will impact the
current regulatory scheme and, in particular,
the deeming regulations. Some of Gottlieb’s
opinions of how the FDA should regulate to-
bacco are well-documented. For example, in
August 2012, Gottlieb authored a
New York
Post
article wherein he claimed that the FDA
deeming cigars to fall under the 2009 Fami-
ly Smoking Prevention and Tobacco Control
Act: (1) would be an overreach of the FDA’s
power (2) misses the mark, as the FDA has re-
fused to accept that alternative tobacco prod-
ucts pose a much lower health risk than cig-
arettes and (3) would needlessly result in loss
of tens of thousands of jobs due to regulation.
Gottlieb also purportedly has an interest in a
vapor-related entity, which he has promised
to divest from. Time will tell the impact of
this appointment.
PENDING LITIGATION
AND CONTINUATION OF
COMPLIANCE DATES:
On July 15, 2016, the Cigar Association of
America (CAA), Cigar Rights of America
(CRA) and the International Premium Cigar
and Pipe Retailers Association (IPCPR) jointly
filed suit against the FDA challenging the
core of the deeming regulations, including
requiring any covered tobacco product not on
the market as of Feb. 15, 2007, to undergo the
overly burdensome and costly premarket review
process in order to remain on the market.
On Feb. 13, 2017, the three groups filed a
motion for summary judgment seeking a de-
termination of various issues presented in the
case. In response, the Department of Justice,
with a deadline of May 1, 2017, to file an op-
position to the group’s motion, stated that they
required more time to respond. As a result, on
May 1, 2017, through an order jointly filed by
the three groups and the Department of Jus-
tice granting a 90-day continuance, the FDA
announced that it was extending and defer-
ring enforcement of all upcoming compliance
deadlines relating to the deeming regulations
by three months to permit new leadership, in-
cluding Health and Human Services Secretary
Tom Price, to fully assess and consider the
issues presented in the lawsuit.
The
FDA has agreed to roll back the
enforcement of all compliance deadlines occ-
urring on May 10, 2017, or later by three
months. As such, the new upcoming compli-
ance deadlines under the deeming regulations
are
Aug. 10, 2017:
submission of rotational
warning plans for cigars;
Sept. 30, 2017:
deadline for registration of domestic estab-
lishments and product registration;
Nov.
8, 2017
: deadline for listings of ingredients
for tobacco products and deadline to submit
substantial equivalence exemption requests;