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ON THE FDA…
…Commenting on the FDA’s response
to a small business owner’s question as to
whether e-cigs that do not contain nico-
tine or any other tobacco extracts are also
covered by the deeming rules and will re-
quire pre-market approval like products
that contain nicotine,
BostonUniversity
Prof. Michael Siegel
said that the an-
swer to this “simple and straightforward
question” seems to be “no.” However, he
noted, FDA “hides this answer in such
a stream of incomprehensible gibberish
that the poor small business owner (or
even the large business owner) is more
confused after having asked the question
than they were before.” Siegel suggested
that plaintiffs suing the agency could use
the FDA’s own response to “demonstrate
the arbitrariness and capriciousness of
the regulations, as well as their undue
complexity and burden on small busi-
ness owners.” The FDA response stated
that “if your zero-nicotine product is not
made or derived from tobacco, it may
still be a tobacco product subject to FDA
regulation if it is intended or reasonably
expected to be used with or for the hu-
man consumption of a tobacco product.”
…Taking FDA to task for its NSE
order on
Maverick Menthol Silver
Box 100s
, Prof. Siegel writes that FDA’s
claim that its “rigorous science-based
review” to “protect the public from the
harms caused by tobacco use” fails to ac-
knowledge the presence of all other ciga-
rette brands on the market.
Reactions to the FDA’s deeming rule,
which took effect August 8, continue to
percolate. Emille Mustafa of Cordoba &
Morales in Casselberry, Florida said that
the new regulations “would put us out of
business,” while Jeff Borysiewicz of Co-
rona Cigar Co. in Orlando said that the
FDA action is “government overreach”
since “nobody’s chain-smoking two box-
es of cigars a day.”
…Citing concerns about the burdens
that the FDA deeming rule places on
small e-vapor businesses, along with
likely unintended negative health con-
sequences for consumers who return to
conventional cigarettes,
U.S. Sen. Ron
Johnson
(R-Wisconsin), chairman of
the Senate Committee on Homeland
Security and Governmental Affairs, sent
a third letter to FDA Commissioner
Robert Califf to demand additional an-
swers to the questions he posed on May
17. These included a request for data on
the economic effects of the rule on e-va-
por businesses and whether FDA would
issue a revised rule if data demonstrates
that vaping is a safer alternative to ciga-
rette smoking. Despite Johnson’s request
for concrete data on the rule’s efficacy,
he said that he received an “inadequate
response” in June that “raises questions
about the adequacy of the FDA’s justifi-
cation of the rule,” he said.
…FDA announced that in line with
its
good guidance practices
(GGP)
regulation, the agency is issuing a revised
Guidance for Industry titled “Registra-
tion and Product Listing for Owners
and Operators of Domestic Tobacco
Product Establishments,” which reflects
changes in FDA authority over deemed
tobacco products and is intended to as-
sist persons making tobacco product
establishment registration and product
listing submissions to FDA.
…Noting comments that
NuMark/
Altria Client Services
submitted to
FDA on pre-market tobacco applica-
tion (PMTA) requirements for e-vapor
products, including that the rules are not
aligned with the Tobacco Control Act’s
goal of promoting public health and will
force some existing products off the mar-
BREAKING NEWS FROM THE TMA
The following are excerpts from harm reduction,
tobacco regulation and other tobacco-related news.
TMA REPORT
BY FARRELL DELMAN
Farrell Delman,
President, TMA
22
TOBACCO BUSINESS INTERNATIONAL
SEPTEMBER/OCTOBER 2016