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TOBACCO BUSINESS INTERNATIONAL
JULY/AUGUST 2015
TMA REPORT
flavors that clearly appeal to youth.”
…FDA on May 12 issued a draft
guidance titled “Determination of the
Period Covered by a No-Tobacco-Sale
Order [NTSO] and Compliance With an
Order” regarding the agency’s
authority
to issue NTSOs to retailers
who
repeatedly violate FDA restrictions on the
sale and distribution of certain tobacco
products. The draft covered topics
including when FDA may seek to issue
an NTSO, the applicable time period,
and how a consumer can find out which
retailers are under NTSOs, and provided
for a 45-day public comment period until
June 29, 2015.
…FDA denied a citizen petition from
R.J. Reynolds Tobacco Company and
American Snuff Company that asked
the agency to initiate a rule-making to
change the
current warning statement
on smokeless tobacco
that reads
“WARNING: This product is not a safe
alternative to cigarettes” to “WARNING:
No tobacco product is safe, but this
product presents substantially lower
risks to health than cigarettes,” as
FDA, after “thoroughly reviewing the
available scientific evidence and public
comments,” found “insufficient evidence
to demonstrate that a change in the
warnings would promote greater public
understanding of the risks associatedwith
the use of smokeless tobacco products.”
…FDA Center for Tobacco Products
issued an interim enforcement policy,
effective immediately until 30 days
after FDA issues a revised guidance,
while it considers new comments
to the recently issued guidance for
industry “Demonstrating the Substantial
Equivalence of a New Tobacco Product:
Responses to Frequently Asked
Questions” on how manufacturers may
submit streamlined SE reports for 1)
new tobacco products in which the
only modification is a label change that
creates a distinct product with identical
characteristics to a predicate product, or
2) new tobacco products in which only
the product quantity is modified.
…ITG Brands of Greensboro, North
Carolina, the U.S. division of
Imperial
TobaccoGroup
,announcednewexecutive
team members who will assume their
roles immediately “following the expected
completion of transactions, which remain
subject to regulatory approval and other
customary closing conditions”: 1) David
H. Taylor, earlier named president and
CEO of ITG Brands; 2) AdamBritner of ITG
as CFO and EVP of finance and planning;
3) Charles E. “Ned” Hennighausen of
Lorillard as EVP of production operations;
4) Ronald S. Milstein of Lorillard as EVP
of external affairs; 5) Randy B. Spell of
Lorillard as EVP of marketing and sales;
6) Robert D. Wilkey of Commonwealth-
Altadis as EVP of general counsel; 7)
William G. Crump of Lorillard as SVP of
human resources; 8) Kathleen A. Sparrow
of Lorillard as SVP of sales; 9) William R.
True of Lorillard as SVP of research and
development; and 10) Neil L. Wilcox of
Lorillard as SVP chief compliance officer.
…The revised
Advertisement Law
in China
approved by the Standing
Committee of the National People’s
Congress bans tobacco product
advertising in mass media, public places,
and on public transportation; prohibits
ads that target minors; and bans the use
of tobacco brand logos and trademarks
in other products and services, effective
September 1.
…The
Ontario, Canada
government
said that it will go ahead with Bill 45 to
further amend the Smoke-Free Ontario
Act to ban the sale of all flavored tobacco
products, prohibit e-cig sales to those
aged below 19 and outlaw e-cig use in
enclosed public places.
…After a review period of almost a
year, the Federal Trade Commission voted
3-2 to approve Reynolds American’s
proposed acquisition of Lorillard in
a transaction valued at $27.4 billion,
including debt, with RAI saying it is now
awaiting final court approval of the deal.
As part of the deal, RAI will be required
to divest its cigarette brands Winston,
Kool and Salem as well as LO’s Maverick
cigarette brand and blu e-cigs to Imperial
Tobacco Group, as well as sell LO’s
manufacturing facility and headquarters
in Greensboro, North Carolina to Imperial
and provide ITG with the opportunity to
hiremost of the existing LOmanagement,
staff and sales force. FTC’s proposed
consent agreement package will be
subject to public comment for 30 days
from May 26 to June 25, after which the
agency will decide whether to make the
proposed consent order final.
TBI
On Other tobacco news…