Convenience Store News - July 2017 - 78

OUTABOUT
&

Spotlighting major industry events

A Time of Change
& Frustration

Tobacco Merchants Association Conference navigates the new normal
By Melissa Kress

T

he Tobacco Merchants Association (TMA) held
its 102nd Annual Meeting and Conference in
May with a new president and CEO, Chris
Greer, at its helm. And it seems only appropriate that
the tobacco group moves forward with new leadership as the tobacco industry and the Food and Drug
Administration (FDA) - which regulates it - face
changes of their own.
"Change is the focus of our conference, relative
to our members and the environment they work in,"
Greer told attendees, pointing to several new developments in the first few months of 2017 such as elections
in the United States and Europe,
Tobacco Merchants and confirmation of Scott
Association 102nd Gottlieb as FDA commissioner.
Annual Meeting
Keynote speaker Mitch
& Conference
Zeller, director of the FDA's
Chantilly, Va.
Center for Tobacco Products
May 10-12, 2017
(CTP), agreed that this year's
theme, "Understanding,
Navigating and Embracing Change," was timely.
"What does the change in government mean for all of
us? The answer is TBD," Zeller said. "It's still very early
days; the new commissioner is being sworn in today."
New leadership aside, the CTP is continuing its
work regulating tobacco products, adding newly
deemed products to its roster. Since the Aug. 8 effective date of the final deeming rule, the Center has
issued several guidances to help the industry grapple
with the changes - including guidances on Premarket
Tobacco Applications, cigar warning labels, and vape
shop activities.
Additionally, in May, the agency issued a guidance delaying some deadlines set in the final deeming
rule by 90 days, beginning with May 10, 2017 deadlines. The move, made in accordance with the FDA's
agreement in a legal challenge brought by the cigar
industry, does not apply to deadlines that went into
effect before May 10.
As for the deeming rule, the CTP director acknowl-

78 Convenience Store News | JULY 2017 | WWW.CSNEWS.COM

Mitch Zeller, director of the Food & Drug Administration's Center for
Tobacco Products, served as keynote speaker.

edged backlash. "To state the obvious, there was a lot
of reaction to what the agency did," Zeller said.
One of the key components for manufacturers
of newly regulated products under the deeming rule
is getting FDA approval to keep their offerings on
the market - a move that can come either through
Substantial Equivalency (SE) or Premarket Tobacco
Application (PMTA).
During the TMA event, Matthew Holman, the new
director of the FDA's Center for Tobacco Products' Office
of Science, outlined the pathways, noting that the SE process - for products that are substantially equivalent to
those on the market before the Feb. 15, 2007 predicate
date - "is evolving and getting more mature."
Calling the SE pathway "still very new," he
acknowledged it's a work in progress. "Our goal is to
make the process more transparent and more predictable," Holman said.
The evolving process, however, is causing frustration
among tobacco companies, with some manufacturers
voicing concerns over the agency's approval process.
Gerry Roerty, vice president and general counsel at
Swedish Match North America, noted that it "troubles" him to hear the FDA and CTP say they have
learned as they go. "It should be let's learn, then go;
not let's go, then learn," he said, adding that there was
time to get meaningful feedback and issue meaningful
guidance before finalizing the deeming rule. CSN


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Table of Contents for the Digital Edition of Convenience Store News - July 2017

Contents
Convenience Store News - July 2017 - Intro
Convenience Store News - July 2017 - Cover1
Convenience Store News - July 2017 - Cover2
Convenience Store News - July 2017 - 3
Convenience Store News - July 2017 - 4
Convenience Store News - July 2017 - 5
Convenience Store News - July 2017 - Contents
Convenience Store News - July 2017 - 7
Convenience Store News - July 2017 - 8
Convenience Store News - July 2017 - 9
Convenience Store News - July 2017 - 10
Convenience Store News - July 2017 - 11
Convenience Store News - July 2017 - 12
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Convenience Store News - July 2017 - 15
Convenience Store News - July 2017 - 16
Convenience Store News - July 2017 - 17
Convenience Store News - July 2017 - 18
Convenience Store News - July 2017 - N1
Convenience Store News - July 2017 - N2
Convenience Store News - July 2017 - 19
Convenience Store News - July 2017 - 20
Convenience Store News - July 2017 - 21
Convenience Store News - July 2017 - 22
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Convenience Store News - July 2017 - Cover3
Convenience Store News - July 2017 - Cover4
Convenience Store News - July 2017 - U1
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