TOB Magazine

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TOBACCO BUSINESS INTERNATIONAL
MARCH/APRIL 2016
less toxic than regular cigarettes, but the
flavor’s cooling and anesthetic properties
reduce the harshness of cigarette smoke,
thereby increasing their appeal to new
smokers. Morgan Stanley said that the
ruling increases the FDA’s “flexibility
around the menthol issue,” but menthol
regulation is expected to remain a
“gradual and manageable process” with
the industry retaining its ability to
challenge any ultimate menthol rule on
grounds of bias or insufficient scientific
evidence. RBC reported that the ruling
“likely will have no impact on whatever
plans the FDA has on regulating
menthol (if any),” and that FDA is
“likely to rely more on” its own menthol
assessment separate from the TPSAC
report, given that the TPSAC report
was created as a statutory requirement
of the Family Smoking Prevention and
Tobacco Control Act but does not have
to be used by FDA in proposing any
menthol regulation.
…Marking the first time that FDA
CTP jointly issued a warning letter
with another FDA center, CTP and
the Center for Drug Evaluation
and Research warned online retailer
that several of its
products for sale to consumers in the
country violate the Federal Food, Drug,
and Cosmetic Act (FD&C Act). The
letter cited the fact that the site “sells
and markets both violative tobacco
products and an unapproved drug/
device combination product,” such
as cigarettes and RYO tobacco with
characterizing flavors, cigarettes with
unauthorized modified-risk claims, and
cigarettes marketed as a drug/device
combination product to diagnose, cure,
mitigate, treat or prevent disease.
…An Administrative Law Judge
(ALJ) issued the first-ever No-
Tobacco-Sale Orders (NTSO) to four
retailers—C and C Supermarket of
Irvington, New Jersey; Family Food
Market of Detroit, Michigan; MFA
Petroleum Company of Columbia,
Missouri; and Mon-Jan of Baltimore,
Maryland—as a result of settlements
the retailers reached with FDA. In
October 2015, FDA initiated its first
NTSO complaint actions against eight
retailers found to be repeatedly violating
minimum purchase age requirements
and other rules on tobacco product
sales and distribution. The complaints
against the remaining four retailers are
still pending before the ALJ.
…In a January 7 blog post reflecting
on 2015, Acting FDA Commissioner
Stephen Ostroff, M.D. wrote that the
agency is preparing to publish the final
rule to extend its regulatory authority
over currently unregulated tobacco
products such as e-cigs, cigars, hookah
tobacco and pipe tobacco. Ostroff
said that the policy will be “based
on a thorough scientific evaluation
of how individual products in each
category may affect public health,”
adding that FDA also unveiled in 2015
a public education campaign aimed
at preventing and reducing tobacco
use among at-risk African American,
Hispanic and Asian American/Pacific
Islander youths aged 12-17.
…Sarasota, Florida-based Von Vape
reported meeting with U.S. Rep. Vern
Buchanan’s (R-Florida) staff to discuss
FDA’s deeming rule and U.S. Rep.
Tom Cole’s (R-Oklahoma) HR 2058,
TMA REPORT
October 2015, FDA initiated its first NTSO complaint actions against eight retailers
found to be repeatedly violating minimum purchase age requirements and other
rules on tobacco product sales and distribution.