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ON THE FDA…
…CSP Daily News offered takeaways
from the first day of
CSP’s Total Nico-
tine Conference:
1) According to the
FDA’s own estimates, it will take one
full-time person 10.5 months to com-
plete one pre-market tobacco applica-
tion; 2) National Association of Tobacco
Outlets’ executive director Thomas Bri-
ant does not believe the Cole-Bishop
Amendment to push the predicate date
to August 8 will ever get to the president
given the gridlock in Congress; and 3) A
national law to raise the minimum age
to buy tobacco products to 21 is unlikely.
…On August 16, U.S. District Judge
Amit Mehta vacated a portion of the
FDA Center for Tobacco Products’ reg-
ulation regarding the agency’s authority
to pre-clear any tobacco product that has
had significant modifications made to
its labeling, such as changes in color or
logo. Judge Mehta, however, specifically
stated that FDA could require clearance
for a tobacco product that changes the
quantity within its package as it “neces-
sarily entails a change in the amount of
constituent ingredients and additives.”
Also, the judge said that the law could
have “explicitly stated” that a
labeling
modification
would trigger a regulatory
approval requirement, but did not. The
ruling resulted from a 2015 lawsuit filed
by Imperial Brands, Reynolds American
and Altria Group. Altria spokesperson
Brian May said that his company was
satisfied with Judge Mehta’s ruling, but
is still contemplating as to whether it
will appeal the judge’s decision concern-
ing the quantity change.
…In its response to a
legal challenge
to the FDAdeeming rules
filed by
Nico-
pure Labs
, FDA said August 17 that
all vapor products “present significant
risks to the public health” even when
nicotine-free liquids are used, and that
the “only nicotine-free e-liquids that
the rule brings under the FDA’s regula-
tory authority are those that are made or
derived from a tobacco product, or that
otherwise meet the definition of a ‘com-
ponent’ or ‘part.’”
…Showing an inconsistency in
FDA’s
regulation of cigars,
University of Lou-
isville Prof. Brad Rodu pointed out that
FDA claims that “cigar smoking carries
many of the same health risks as ciga-
rette smoking” and therefore requires ci-
gar packages and ads to display six new
warnings, including labels stating that
“cigar smoking can cause cancers of the
mouth and throat, even if you do not in-
hale,” and “cigar smoking can cause lung
cancer and heart disease,” while FDA’s
own research shows that cigar smokers
consume about 1.5 cigars per day on av-
erage and that smoking up to two cigars
daily is associated with “minimal signifi-
cant health risks.”
…As part of its release of a full list-
ing of all retailers that were assigned civil
money penalties and no-tobacco-sale
orders, FDA said that it recently issued
55 warning letters
to retailers that sold
the newly deemed cigars, e-cigs and e-
liquids to minors.
…The
National Institute of Stan-
dards andTechnology
(NIST) issued
TMA REPORT
BY FARRELL DELMAN
Farrell Delman,
President, TMA
BREAKING NEWS FROM THE TMA
The following are excerpts from harm reduction,
tobacco regulation and other tobacco-related news.
10
TOBACCO BUSINESS INTERNATIONAL
NOVEMBER/DECEMBER 2016