Page 8 - TOB Magazine March/April 2013

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TOBACCO OUTLET BUSINESS
MARCH/APRIL 2013
TMA Reports...
TMA REPORT By FARRELL DELMAN
On harm reduction…
…In North Dakota, a House Concurrent Resolution
introduced by State Rep. Blair Thoreson (R-Fargo) would call
for the Legislative Management to study ways to reduce the
risk of death and disease among smokers by considering
tobacco harm reduction strategies that encourage smokers
to switch to “less-risky tobacco products and by accurately
informing the public of the health risks posed by smokeless
tobacco products, vapor products and tobacco-derived
products relative to cigarettes.”
…In a special supplemental article on snus published
by Parliament magazine, which covers EU news, politics
and public policy, University of Louisville’s Prof. Brad Rodu
says that even though studies have shown that snus poses
“minuscule health risks that are barely measurable with
modern epidemiologic tools,” the EU continues to deny
smokers this “vastly safer” product, which serves as a viable
alternative to cigarettes for Swedish men, who for 50 years
“have smoked less and used more smokeless tobacco than
in any other developed country, resulting in the lowest rates
of lung cancer, indeed of all smoking-related deaths.”
…The FDA Center for Tobacco Products said on February
12 that it posted a new page to the manufacturer section
of its web site regarding the agency’s regulatory authority
over certain tobacco products, namely “cigarettes,
cigarette tobacco, smokeless tobacco, and roll-your-own
tobacco” and its intent to propose a regulation to extend its
authority to all products that meet the statutory definition
of “tobacco product,” along with a new e-mail address
NicotineInquiries@fda.hhs.govfor questions related to
regulation applicable to a particular product.
…Speaking at the summit meeting of the Smoke-Free
Alternative Trade Association (SFATA) in Las Vegas on
January 28 and addressing a crowd consisting largely of
e-cigarette purveyors, former FDA Chief Counsel Ralph
Tyler said it is doubtful that the FDA will approve modified
risk tobacco products (MRTPs) any time soon.
…Further adding to the January 31 excoriating letter by
Dr. RuthMalone to CTP Director Deyton explaining why she
is declining the FDA-CTP’s invitation to speak at a March
19 “facilitated discussion” with the tobacco industry and
regulators on the IOM’s recommendation that tobacco
industry research relevant to FDA policy-making be done
with an independent third party, Dr. Malone responded
to CTP’s adjusted program of having the industry speak
on one day and tobacco control on another, by writing
“it remains the same meeting, with the same agenda and
purpose, merely rearranging the program” leading her to
“respectfully and regretfully decline” the invitation.
…A notice published on February 8 in the Federal
Register and made available online on February 7 covers
the availability of a draft guidance for industry “Civil Money
Penalties for Tobacco Retailers: Responses to Frequently
Asked Questions” [Docket No. FDA-2012-D-1083], and
provides responses to questions the FDA has received
regarding civil money penalties for violations.
…With the FDA announcement in December that it
would issue a proposed rule in April to extend oversight
to currently unregulated tobacco products, U.S. Rep. Bill
Posey (R-Florida) is expected to reintroduce a law in the
113rd Congress legislation that would prevent the agency
from regulating “traditional large and premium cigars,” said
Bill Spann, CEO of the International Premium Cigar and
Pipe Retailers Association (IPCPR), who explains that “[o]
ur product is not desired by, it is not marketed to, nor is it
affordable by underage youth.”
…A Washington Post editorial called on the FDA,
which currently regulates only cigarettes, RYO tobacco
and smokeless tobacco products, to extend oversight
to other tobacco products such as cigars, pipe tobacco
and electronic cigarettes, saying that without broader
jurisdiction, the agency “can’t compel the examination
of ingredients and assess their relative lethality, let alone
regulate more aggressively.”
…A notice by the FDA announced that the agency is
establishing a public docket [Docket No. FDA-2012-N-1032]
to “obtain comments, supported by scientific evidence,
regarding what changes to the smokeless tobacco
product warnings, if any, would promote greater public
understanding of the risks associated with the use of
smokeless tobacco products,” with electronic or written
Farrell Delman,
President, TMA
On FDA regulation…