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TOBACCO BUSINESS INTERNATIONAL
MARCH/APRIL 2015
TMA REPORT
By FARRELL DELMAN
…Capitol Hill (also known as “The
Hill”) reports that the FDA’s regulatory
oversight on e-cigs, cigars and pipe
tobacco is among the rules that
Obama
administration officials
are trying to
finalize before his term runs out.
…Writing in The Hill’s Congress
Blog, Gregory Conley, president of the
American Vaping Association, said that
the FDA’s proposed deeming regulations,
which would
classify e-cigs as tobacco
products
and require every product
currently on the market to go through
a multi-million dollar approval process,
threaten to stifle a fast-growing industry.
He added that e-cigs are helping smokers
transition away from cigarettes, and that
the proposed regulations would turn
a vapor industry served by thousands
of independent and family-owned
businesses “over to companies that have
long exhibited a lack of regard for public
health—Big Tobacco.”
…Not enough smokers are switching
to e-cigs despite their “relative safety”
due to “news about inaccurate labeling,
shoddy counterfeits and poorly made
[e-cigs] that emit toxins,” along with the
lack of an effective regulatory regime
to “distinguish the good from the bad,”
says Sally Satel, a resident scholar
at the American Enterprise Institute.
Satel called on FDA, which last year
proposed deeming regulations on
currently unregulated tobacco products
including e-cigs but has not issued a
final rule, to give smokers confidence
in the product by setting
“interim
safety guidelines.”
These could include
basic good manufacturing practices
for e-cigs and e-liquids, requirements
that manufacturers make all “batches of
chemicals” traceable and all hardware
sources known, verification that e-cig
batteries can be charged safely and
operate safely, childproof packaging, a
mechanism for reporting adverse effects,
and permission for e-cig companies
to tell smokers about the “benefits of
switching to vaping products” since the
pre-market testing route would be cost-
prohibitive, especially for smaller players.
…On January 26, FDA Center for
Tobacco products (CTP) announced Ella
Yeargin as the center’s new ombudsman.
…FDA said February 5 that
Commissioner Margaret Hamburg, who
was nominated by President Obama and
confirmed by the U.S. Senate in May
2009, shortly before the agency was
given regulatory authority over cigarettes
and smokeless tobacco under the Family
Smoking Prevention and Tobacco
Control Act, is stepping down at the
end of March. Agency chief scientist Dr.
Stephen Ostroff will fill her position until a
new commissioner is named. Many FDA
observers reportedly believe that Robert
Califf, a Duke University cardiologist
and researcher who was appointed
FDA Deputy Commissioner for Medical
Products and Tobacco in January, is Dr.
Hamburg’s potential successor.
…The office of U.S. Senator Edward
Markey (D-Massachusetts) said February
3 that he, along with Democratic
Senators Jeff Merkley (Oregon), Barbara
Boxer (California), Richard Blumenthal
On the fda…
Farrell Delman,
President, TMA
Breaking News From the TMA
The following are excerpts from harm reduction,
tobacco regulation and other tobacco-related news.