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TOBACCO OUTLET BUSINESS
JULY/AUGUST 2012
FDA Dashboard
$300 million in revenue at retail. The
Tobacco Vapor Electronic Cigarette
Association estimates that there are
2.5 million e-cigarette users currently,
with top brands including NJoy, blu
and 21st Century.
The bad news is Wells Fargo
analysts do expect regulation of this
category to increase; but the good
news is they compared e-cigs in the
tobacco sector to energy drinks in
the beverage sector, saying e-cigs
are profitable, growing quickly and
gaining shelf space and consumer
acceptance, making it an important
new niche for retailers.
Tobacco Ingredients and Modified
Risk—
Early this spring, the FDA
issued two separate actions affecting all
tobacco products, as well as those that
want to be considered modified risk.
The first FDA draft guidance
directed tobacco companies to submit
the harmful and potentially harmful
chemicals—and the amount of each
one—contained in any tobacco
product. The FDA also established
a list of 93 harmful and potentially
harmful constituents (HPHCs) that
tobacco companies will be required to
report for every regulated product in
the U.S. Of those 93 HPHCs, which
include chemicals found in tobacco
naturally and those generated
when tobacco is smoked, the FDA
identified 20 that tobacco companies
will be required to report this year.
These first 20 include ammonia,
nicotine, formaldehyde and carbon
monoxide. The remaining HPHCs
will be phased in over time.
The agency’s ultimate goal on the
issue is to make the information on the
amount of HPHCs in specific products
available to the public in a consumer-
friendly format by April 2013.
In a second and separate draft
guidance, the FDA provided
companies the information needed
to submit an application to market
or advertise modified risk tobacco
products. It describes scientific
studies and analyses an applicant
must submit to demonstrate that
the product will, or is expected to,
significantly reduce harm or exposure
to individuals and benefit the health
of the population as a whole.
“The law sets a high standard to
make sure products marketed as
modified risk actually are,” stated
Dr. Lawrence Deyton, director of the
FDA’s Center for Tobacco Products,
in an industry conference call earlier
this year.
TOB
Continued from page 46
The first FDA draft guidance directed tobacco
companies to submit the harmful and
potentially harmful chemicals—and the amount
of each one—contained in any tobacco product.