14
TOBACCO OUTLET BUSINESS
NOVEMBER/DECEMBER 2012
NEWS & TRENDS
On August 27, Representative Henry A. Waxman (D-California) submitted
a letter to Food and Drug Administration Commissioner Dr. Margaret
Hamburg arguing that the new CDC report on flavored cigar smoking
among U.S. adults highlights the need for the FDA to immediately issue
rules to subject products being used as cigarette substitutes to the same
regulations as cigarettes. Pointing out that another CDC report issued
earlier this month showed that the decline in cigarette use in recent years
has been largely offset by an increase in the use of cigars and pipe tobacco,
Rep. Waxman charged that these “developments are not accidental.
”
He went on to argue that tobacco companies have been manipulating
their products to exploit regulatory and tax loopholes, including the
introduction of new flavored cigar products that intend to circumvent the
FDA
’
s ban on flavorings in cigarettes and the relabeling of RYO tobacco as
pipe tobacco to avoid paying higher tax rates. The FDA should exercise its
authority under the
Family Smoking Prevention and Tobacco Control Act
to
“
stop the tobacco companies from exploiting loopholes and endangering
our youth,
”
Waxman wrote.
rep. Waxman Calls
For Fda Cigar regulation
Congressman seeks to close “loopholes”
by regulating more products
Judge denies Fda’s Motion
The fDA’s motion to dismiss manufacturer’s conflict
of interest case was denied.
U.S. District Court Judge Richard
Leon denied the FDA
’
s motion to
dismiss a lawsuit filed by Lorillard
and R.J. Reynolds alleging a
financial conflict of interest by
members of the FDA
’
s Tobacco
Products Scientific Advisory
Committee. The suit seeks to
stop the FDA from relying on the
committee
’
s recommendations,
charging that some committee
members were paid to be expert
witnesses in anti-tobacco lawsuits
and also have financial ties to
pharmaceutical companies that
sell smoking cessation products.
The FDA’s motion for dismissal
claimed that the panel meets
federal standards and that the
court lacks jurisdiction on the
matter. “Because of the limited
number of viewpoints on these
issues, the scientific—as opposed
to political—nature of those
viewpoints, and the distinct
responsibilities of the committee, I
believe I have sufficient standards
which I can evaluate the agency
’
s
discretion,” Judge Leon wrote in
his decision.
report says
Fda Has Failed
to articulate
standards
The fDA has made progress, but
has yet to define many standards
and criteria in enforcing the
fam-
ily Smoking Prevention and To-
bacco Control Act
.
The FDA has met Congressionally-imposed
deadlines, such as a ban on descriptors like
“
light” and “low tar,” reinstatement of most
of the marketing and sales restrictions in the
FDA’s original 1996 final rule designed to
reduce the number of new, young smokers,
and completion of a rulemaking requiring
graphic warning labels on all cigarette packs,
says a report by Mitch Zeller, senior vice
president of Pinney Associates. The agency
has also launched several initiatives including
commissioning a major longitudinal study of
tobacco use and behavior and releasing a
detailed statement of research priorities.
However, the agency has yet to “issue
any policy articulating binding standards and
criteria in three important areas: (1) issue
mandatory ‘product standards’ that would
limit the allowable levels of ingredients and
constituents in finished tobacco products
and the smoke of combusted products; (2)
promulgate binding policy explaining the
criteria it will use to determine whether an
application for a newproduct will be subjected
to a more robust premarket evaluation, or a
shortened process because the product is
substantially equivalent to an older tobacco
product that had been on the market as
of February 15, 2007; and (3) decide what
criteria will be used to determine whether
a manufacturer can make an exposure
reduction or risk reduction claim under the
provisions of the law governing so-called
‘
modified risk tobacco products.’”