22
TOBACCO BUSINESS INTERNATIONAL
SEPTEMBER/OCTOBER 2014
Rm. 1061, Rockville,MD 20852.
…
S&M Brands of Keysville
, Virginia
announced July 15 that it received
substantial equivalence (SE) orders from
the FDA on its redesigned Riverside
cigarette brands with old and new
paper suppliers; its products will now be
distributed to retailers and available to
consumers by October 15.
…The CTP issued
new guidance for
industry
entitled “Substantial Equivalence
Reports: Manufacturer Requests for
Extensions or to Change the Predicate
Tobacco Product,”with a 60-day comment
period until September 15, which
provides information on 1) new limits on
manufacturer requests for time extensions
to respond to deficiencies that CTP
identifies in substantial equivalent (SE)
reports (CTPnowplans togrant extensions
for provisional tobacco products in “very
limited instances where the manufacturer’s
rationale for the request demonstrates that
the extension is necessary, likely to result
in a complete response to all identified
deficiencies, and would not significantly
delay CTP’s continued review of the SE
report”), and 2) manufacturer requests to
change the predicate tobacco product in
submitted SE reports that have already
commenced CTP scientific review (CTP
now recommends that the SE report be
withdrawn and a new report be submitted
with the new predicate).
…The FDA issued a
final rule for
domestic manufacturers and importers
of cigarettes, snuff, chewing tobacco and
roll-your-own tobacco to submit the same
information that they had sent to the
United States Department of Agriculture
(USDA) before the tobacco buyout ended
to FDA beginning October 1. There was
no mention of how FDA will address
products now subject to the deeming
process that have no current federal excise
taxation, which is the existing formula that
USDA used for the buyout.
…After the FDA issued the
aforementioned rule in June 2014, it issued
50
substantial equivalent
(SE) orders
and six “refuse to accept” (RTA) letters,
while companies withdrew 19 SE reports
from the review process. Bill Godshall of
Smokefree Pennsylvania pointed out that
of the latest SE orders, 44 were issued for
Riverside and Valu Time cigarettes made
by S&M Brands.
…Clarence, New York-based plant
biotech company 22nd Century Group
said July 11 that it “engaged a major
contract research organization” (name
undisclosed) with experience in tobacco
exposure studies to assist 22nd Century in
certain FDA-related “regulatory activities”
on the development of potentially less
harmful or
modified-risk cigarettes.
…Reuters claims that documents
published June 24 in the
Federal Register
show that the review conducted by the
White House’s Office of Management
and Budget (OMB) prior to the release
in April of the FDA’s
proposed deeming
rule
resulted in the following changes:
creating the two-option possibility for
premium cigars with one option being
exemption; modifying or deleting sections
highlighting FDA concerns about the
safety of e-cigs, including manufacturing
quality; and editing the FDA proposal
to prohibit “non-face-to-face sales” of
e-cigs so that the ban would apply only
to vending machine sales and not online
sales.
…During an American Legacy
Foundation Kenneth E. Warner Lecture
entitled “One-On-One with
FDA CTP
Director Mitch Zeller,
” Zeller discussed
the CTP’s current work on user fees, the
deeming rule, continued menthol and
graphic warnings research,and highlighted
the CTP’s longer term “strategic priorities”
for the first time: 1) product standards to
ban or restrict products or designs through
rulemakingsthatfocusontheaddictiveness,
toxicity and appeal of various tobacco
products; 2) a comprehensive nicotine
policy across all forms of nicotine delivery
recognizing the relative risk continuum
of alternative nicotine delivery systems
TMA REPORT
