NNN: The FDA’s Proposed Rule for Smokeless Tobacco

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NATO submitted a set of comments in response to the proposed NNN rule and posed several important questions to the FDA. In these comments, NATO inquired about the FDA’s technical basis for reaching the conclusion 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 understand 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 adopting 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 significant financial harm.

The financial harm caused by the NNN product standard 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 factor 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.

Story contributed by Thomas A. Briant, the executive director
of the National Association of Tobacco Outlets (NATO)

This story first appeared in the September/October 2017 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.