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FDA’s Proposed Product Standard on NNN in Smokeless Tobacco

The agency clarifies the variability of the nitrosamine in smokeless tobacco.
June 15, 2017

​WASHINGTON – Recently, the U.S. Food and Drug Administration (FDA) issued a proposed rule to establish the agency’s first product standard. The proposed rule would restrict the N-nitrosonornicotine (NNN) level 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 agency places NNN as a harmful or potentially harmful constituent in tobacco products. 

The Family Smoking Prevention and Tobacco Control Act defines “smokeless tobacco” 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.” The category includes chewing tobacco, dry snuff, moist snuff, snus and some dissolveables. The proposed NNN standard would be applied to each of these smokeless tobacco products.

The NNN in tobacco is naturally occurring, and can happen while the product is grown, cured, manufactured or sitting on a shelf in a package. The FDA acknowledged that variability in the proposed rule: “NNN levels in tobacco can vary significantly from year to year, intra-year, and farm-to-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).”

For many years, tobacco farmers and manufacturers have been trying to limit the NNN levels in smokeless tobacco products. The proposed rule 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.” The agency then claims that the proposed standard “is thus achievable using current technology” for all smokeless tobacco products, adding that the FDA “may consider a lower NNN level in the future.” 

Smokeless tobacco manufacturers have submitted responses to the agency asking it to: 

  1. Withdraw the proposed rule because of President Trump’s freeze on new federal rules;
  2. Withdraw the proposed rule because it doesn’t consider whether it’s even technically feasible for all smokeless tobacco products or the economic impact such a rule would have on manufacturers and tobacco farmers; and 
  3. Address why the FDA doesn’t appear to consider the differences of smokeless tobacco products.

The agency has extended the public comments period on this proposed rule until July 10, 2017.