In January 2017, the FDA published a proposed rule to limit the level of a naturally occurring chemical called N-nitrosonornicotine (NNN) in finished smokeless-tobacco products to one part per million. Smokeless manufacturers and industry advocates were quick to point out that such low levels would be impossible to achieve for the majority of smokeless tobacco products.
In a letter submitted to the FDA, NATO argued that because weather is a factor in NNN levels, “there is no means by which farmers and manufacturers can control the weather” and the rule would likely amount to a ban on all smokeless products—which is currently prohibited by law.
The FDA is reviewing this and more than 7,000 other comments submitted in response to the proposed rule. The agency will have to address those comments when it issues its final rule on NNN.
Recent history suggests it could be some time before the FDA issues that final rule: Nearly two years passed from when the public comment period closed on the deeming regulations in August 2014 to when the agency published the final rule in May 2016.