FDA Proposes Smokeless Product Standard

The standard would limit the level of N-nitrosonornicotine in finished smokeless tobacco products.

The National Association of Tobacco Outlets (NATO) has outlined FDA’s proposed product standard on N-nitrosonornicotine (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 dissolveables. 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 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).”

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.




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