NNN: The FDA’s Proposed Rule for Smokeless Tobacco

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NATO NNN Smokeless Tobacco

Earlier this year, the U.S. Food and Drug Administration (FDA) issued a proposed rule to establish the agency’s first product standard that would limit the level of N-Nitrosonornicotine (NNN) in finished 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 “product standards,” which includes the authority to restrict or ban an ingredient in a tobacco product or a constituent 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 smokeless 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 levels 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 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 U.S.” and then claims that the proposed standard “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 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.

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