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NATO NEWS
[
THOMAS A. BRIANT ]
[ 12 ]
TOBACCO BUSINESS
[
MAY
/
JUNE
|
17 ]
WHEN SPEAKING AT CONFERENCES
in the past, Mitch Zeller, the director of the
U.S. Food and Drug Administration’s Center
for Tobacco Products, has stated that prod-
uct standards are the most powerful tool that
Congress gave to the FDA to regulate tobacco
products. A product standard allows the FDA
to limit or prohibit an ingredient in a tobacco
product or a constituent in tobacco smoke.
In 2009, when Congress passed the Fami-
ly Smoking Prevention and Tobacco Control
Act (FSPTCA), which is the law that autho-
rizes the FDA to regulate tobacco products,
Congress itself enacted the first product
standard by prohibiting flavors in cigarettes
other than tobacco and menthol. Now, the
FDA has issued a proposed rule to establish
the agency’s first product standard. The pro-
posed rule would limit the level of N-nitro-
sonornicotine (NNN) in finished smokeless
tobacco products to 1 microgram per gram
(or 1 part per million) at any time through the
product’s labeled expiration date. The FDA
classifies NNN as a harmful or potentially
harmful constituent in tobacco products.
Under the FSPTCA, “smokeless tobacco”
is defined as “any tobacco product that con-
sists of cut, ground, powdered or leaf tobacco
and that is intended to be placed in the oral or
nasal cavity.” This includes moist snuff, snus,
dry snuff, chewing tobacco and some dissolv-
ables. This means that this proposed NNN
standard of 1 part per million would apply
to each of these different kinds of smokeless
tobacco products.
However, to clarify, the NNN in tobacco is
naturally occurring and can be formed while
being grown, cured, manufactured or sitting
in its package in a wholesale warehouse or on
a retail store shelf. In fact, the FDA recogniz-
es the variability of NNN in smokeless tobac-
co products when it states the following in the
proposed rule:
“NNN levels in tobacco can vary signifi-
cantly from year to year, intra-year and farm
to farm. Although tobacco plants inherent-
ly produce a small amount of NNN, 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
The FDA’s
First Product
Standard:
NNN in
Smokeless
Tobacco