The FDA’s First Product Standard: NNN in Smokeless Tobacco

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 1 microgram per gram limitation.

In the proposed rule, the FDA states that “an NNN level of 1.0 ug/g [1 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.”

To put this in perspective and understand how much 1 microgram per gram is, consider that 1 gram of sugar by volume equals one-quarter of a teaspoon. Now, on a very simplistic level, take one-millionth of a quarter of a teaspoon and that is the maximum level of NNN that the FDA is proposing for finished smokeless tobacco products.

Several manufacturers of 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 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 by 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 by 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.

– Contributed by Thomas A. Briant, Executive Director of the National Association of Tobacco Outlets (NATO).

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