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EARLIER THIS YEAR, THE U.S. Food and Drug
Administration (FDA) issued a proposed rule to estab-
lish the agency’s first product standard that would
limit the level of N-Nitrosonornicotine (NNN) in fin-
ished smokeless tobacco products to one microgram
per gram (or one part per million). The FDA classifies
NNN as a harmful or potentially harmful constituent
in tobacco products.
Under the Family Smoking Prevention and Tobacco
Control Act, the FDA has the authority to adopt “prod-
uct standards,” which includes the authority to restrict
or ban an ingredient in a tobacco product or a constit-
uent in tobacco smoke. This NNN product standard
would apply to all finished smokeless products, including
moist snuff, snus, dry snuff and chewing tobacco.
However, to clarify, the NNN in tobacco is naturally
occurring and can be formed while the tobacco is being
grown, cured, manufactured or sitting in a package in
a wholesale warehouse or on a retail store shelf. In fact,
the FDA recognizes the variability of NNN in smoke-
less tobacco products when it states the following in the
proposed rule:
“ … a wide variety of factors can affect the final levels
of NNN found in the finished tobacco product. These
factors, which can either increase or decrease NNN lev-
els in smokeless tobacco products, include the tobacco
type (
i.e.,
dark air-cured tobacco, bright-leaf tobacco,
burley tobacco), growing conditions (
e.g.,
geographic
region, climate, rainfall), curing techniques (
e.g.,
fire, flue,
air, sun), production process (
e.g.,
additives) and storage
conditions (
e.g.,
temperature, humidity, duration).”
With the FDA acknowledging that “weather is a sig-
nificant factor in NNN production,” there is no means
by which farmers and manufacturers can control the
weather in an effort to comply with the proposed one
microgram per gram limitation.
NNN:
The
FDA’s
Proposed
Rule
for
Smokeless
Tobacco
In the proposed rule, the FDA states that “an NNN
level of 1.0 µg/g [one microgram per gram] of tobacco
has been achieved in some smokeless tobacco products
sold in the U.S.” and then claims that the proposed stan-
dard “is thus achievable using current technology” for
all smokeless tobacco products. In fact, the FDA further
states that the agency “may consider a lower NNN level
in the future.”
NATO submitted a set of comments in response to the
proposed NNN rule and posed several important ques-
tions to the FDA. In these comments, NATO inquired
about the FDA’s technical basis for reaching the conclu-
sion that current technology to limit the level of NNN in
one kind of smokeless tobacco product is transferable to
other kinds of smokeless tobacco products. This question
has been asked because manufacturers need to under-
stand that if existing technology used for one kind of
smokeless product cannot be adapted to other smokeless
tobacco products, then the NNN standard may not be
met for these other products.
In the event that the FDA issues a final rule adopt-
ing an NNN product standard, and assuming that any
number of smokeless tobacco products currently on the
market do not meet the NNN product standard, then
retailers who sell tobacco products would incur signifi-
cant financial harm.
The financial harm caused by the NNN product stan-
dard would be serious because a number of brands within
the smokeless category may not comply with the one
microgram per gram standard. The financial loss from
being unable to sell smokeless tobacco products cannot be
replaced by selling other products when a store relies on
the sale of tobacco products to remain profitable.
In the absence of technology to control the one fac-
tor that leads to the greatest variability of NNN levels
in smokeless tobacco products, namely the weather, and
due to questions of adapting current technology to other
kinds of smokeless tobacco products, NATO has asked
the FDA to give serious consideration to withdrawing the
proposed rule until such time as it is technically feasible
for all smokeless tobacco products to achieve any given
level of N-Nitrosonornicotine. Such a withdrawal would
alleviate the financial concerns that retailers have about
the ability to sell smokeless tobacco products.
TB
Thomas A. Briant is
executive director of the
National Association of
Tobacco Outlets (NATO).
NATO NEWS
[
TOM BRIANT ]
[ 34 ]
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