March 23, 2017
The FDA’s Proposed Product Standard on NNN in Smokeless
Tobacco
When speaking at NATO Shows in the past, Mitch Zeller, the Director of the U.S. Food and
Drug Administration’s Center for Tobacco Products, has stated that product 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.
Recently, the FDA issued a proposed rule to establish the agency’s first product standard. The
proposed rule would limit the level of N-nitrosonornicotine (NNN) in finished smokeless
tobacco products to one microgram per gram (or one 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 Family Smoking Prevention and Tobacco Control Act, “smokeless tobacco” is defined
as “any tobacco product that consists 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 dissolvables. This means that this proposed NNN standard of one
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 recognizes the variability of NNN in smokeless tobacco products
when it states the following in the proposed rule:
“NNN levels in tobacco can vary significantly from year to year, intra-year, and farmto-farm. Although tobacco plants inherently 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 decrease NNN levels in smokeless
tobacco products, include the tobacco type (e.g., 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).”
Tobacco farmers and manufacturers have been working for many years to limit the NNN levels
in smokeless tobacco products. With the FDA acknowledging that “[w]eather is a significant
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.
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 United States” and
then claims that the proposed standard “is thus achievable using current technology” for all
smokeless tobacco products. The FDA further states that the agency “may consider a lower
NNN level in the future.”
Several manufacturers that make smokeless tobacco products have submitted written responses
to the FDA asking the agency to: (1) withdraw the proposed rule to allow for further
consideration in light of President Donald Trump’s freeze on new federal regulations, (2)
withdraw the proposed rule because it fails to adequately consider such basic issues as whether
the proposed standard is even technically feasible for all smokeless tobacco products and the
economic impact on manufacturers and tobacco farmers, and (3) address the agency’s apparent
failure to consider the differences between various types of smokeless tobacco products.
Originally, the FDA planned to accept public comments on the proposed NNN product standard
until April 10, 2017. However, after manufacturers requested that the agency extend the
comment period for an additional 75 days to allow more time to compile comments to address
this complex issue, the FDA announced this week that the comment period has been extended an
additional 90 days until July 10, 2017. NATO is planning to submit comments to the FDA on
the NNN standard and its potential impact on retailers that sell tobacco products.
NATO Follows Up With FDA Director Zeller on Social Sources
Messaging
At the 2016 NATO Show, FDA Center for Tobacco Products Director Mitch Zeller spoke about
the initial findings of the agency’s Population Assessment of Tobacco and Health study. In his
presentation, Director Zeller included the accompanying Power Point slide, which shows that up
to 86% of youth obtain cigarettes from non-retail social sources. The study findings for the
percentage of youth reliance on social sources for other products included 89.5% for e-cigarettes,
79% for cigarillos, 88% for hookah tobacco, and 77% for smokeless tobacco.
During the follow up panel discussion on his presentation, Director Zeller stated that the FDA
would be working on a messaging campaign to urge adults not to be a social source of tobacco
for underage youth. Today, NATO sent the accompanying letter to Director Zeller inquiring
about the status of the social sources messaging campaign. The Federal Trade Commission has a
website at www.DontServeTeens.gov, which is a site to discourage adults from being a social
source of alcohol for underage persons. The NATO letter suggests that perhaps the
www.DontServeTeens.gov website could serve as a template for the FDA and its messaging on
social sources.
March 23, 2017
Director Mitch Zeller
U.S. Food and Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Springs, MD 20993-0002
RE: Social Sources Messaging
Dear Director Zeller:
You may recall that during your presentation at the 2016 NATO Show, you highlighted findings
from the Population Assessment of Tobacco and Health study. In the follow up panel
discussion, you mentioned that the Center for Tobacco Products would be developing messaging
to discourage adults from being a social source of tobacco for underage youth. I am writing to
inquire if messaging has been developed, or is in the process of being developed, regarding the
issue of social sources.
In a recent “This Week in CTP” bulletin, there was an article about the estimated impact of the
FDA’s first tobacco education campaign titled “The Real Cost”. With the substantial reliance of
underage youth on social sources to obtain tobacco products, I am wondering if the FDA’s
planned social sources messaging would incorporate a multi-media format similar to “The Real
Cost” campaign?
While walking through the Reagan National Airport recently, I noticed an advertisement from
the Federal Trade Commission with the message “We Don’t Serve Teens” and a website address
of www.wedontserveteens.gov. I visited the website and the main message on the home page of
the site reads as follows:
This website has tools and information to help parents and others reduce teen
drinking and related harm. Teens who drink usually get alcohol from “social
sources” – at parties, from older friends and family, or by taking it from a cabinet or
refrigerator without permission. Teen drinking is linked to injury and risky
behavior. We can reduce teen drinking by stopping teens’ easy access to alcohol.”
The website explains that the We Don’t Serve Teens is a consumer education campaign
developed by the Federal Trade Commission and recognized by the U.S. Senate, the U.S.
House of Representatives, the National Prevention Council, and representatives of more
than 40 states. The campaign website includes educational materials for schools, parents
and organizations.
Since the Federal Trade Commission has already developed a significant educational
campaign on social sources, perhaps the Center for Tobacco Products could utilize the We
Don’t Serve Teens website and materials as a template if a tobacco social sources
campaign will be initiated by the FDA.
Please reply at your earliest convenience and update me on the progress of the FDA’s
social sources messaging. Thank you.
Sincerely,
Thomas A. Briant
Executive Director, National Association of Tobacco Outlets
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YOUTH ACCESS TO TOBACCO PRODUCTS AMONG PAST
30-DAY USERS: WHERE DO YOUTH GET TOBACCO?
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April 21, 2016 | NATO