50
TOBACCO OUTLET BUSINESS
MAY/JUNE 2013
The governmental agency is taking
comments on its website, www.
regulations.gov, through September 30,
2013.
This comes after the FDA issued
draft guidelines on submitting a
Modified Risk Tobacco Product
Application in March of 2012,
which was not deemed favorable for
the category. Prof. Michael Siegel
of Boston University’s School of
Public Health recently commented
on his website (
blogspot.com)
that
last
year’s
guidance on MRTPs harms public
health by “ensuring that the most
hazardous tobacco product will remain
unchallenged by much safer ones,”
and that the modified risk guidance
makes the successful development
and marketing of new reduced-risk
products “almost impossible.” He
added that under the FDA guidelines
it is extremely difficult for existing
potentially reduced risk products to
successfully achieve a modified risk
status or modified exposure status.
Dissolvable
Tobacco
Products
—
Proof of Siegel’s statement above
can be found in the fact that Star
Scientific Inc. pulled out of the
smokeless tobacco business at the
close of 2012, reportedly discouraged
by the regulatory environment for its
Ariva and Stonewall Hard dissolvable
tobacco products. The company’s
board said that restrictions under the
Family Smoking Prevention and Tobacco
Control Act
of 2009 have prohibited
the company from making statements
about the comparative safety of its
smokeless tobacco products.
Star Scientific said it will continue
to explore licensing opportunities for
its patented StarCured tobacco curing
products and for its “low-TSNA”
dissolvable modified risk tobacco
products, including Ariva BDL and
Stonewall BDL. The acronym stands for
“below detectable levels”of certain cancer-
causing chemicals in tobacco, particularly
when burned as part of smoking.
Nicotine
Replacement
Therapy
(NRT)
—It is no secret that the NRT
category is struggling, especially
in light of e-cigs and other THR
alternatives. While NRT products are
not typically sold in tobacco outlet
stores, it is worth mentioning here
because some believe it has recently
received a potential competitive boost
from the government.
In early April, the FDA stated that
it believes certain label warnings and
directions for use of the products are no
longer necessary in their current form.
Specifically, the FDA recommended:
1) deleting the “Do not use” statement
that warns consumers against using
NRT if they “continue to smoke, chew
tobacco, use snuff or use [a different
NRT product] or other nicotine
containing products;” 2) changing
one of the “Directions” for use from
“stop smoking completely when you
begin using [the NRT product]” to
“begin using [the NRT product] on
your quit day;” and 3) deleting from
the “Directions” the sentence “Stop
using [the NRT product] at the end
of [a specified number of ] weeks.”
Manufacturers of NRT products
must obtain FDA approval to change
existing labels and directions of use.
The governmental agency invited
manufacturers to submit supplemental
new drug applications to the Center
for Drug Evaluation and Research to
modify the existing labeling statements.
Tommy Payne, president of
Niconovum USA, a subsidiary of
Reynolds American Inc. that markets
Zonnic nicotine gum in Iowa, praised
the FDA’s recommended changes
as “a very beneficial step” that will
“provide individuals who desire to stop
smoking more realistic ways to do so.”
Niconovum introduced Zonnic 2mg
and 4mg mint nicotine gum in Iowa in
September 2012.
TOB
Under the FDA guidelines it is extremely
difficult for existing potentially reduced risk
products to successfully achieve a modified
risk status or modified exposure status.
