The deadline for commenting on an FDA rule regarding product standards for smokeless tobacco (ST) is Monday, July 10th, 2017.

By way of background, the FDA published a rule for public comment on January 23, 2017 regarding a proposed standard for N-nitrosonornicotine (NNN) levels in ST products. The proposed limit for NNN concentration would be 1 ppm of dry weight. Although some products do exist that would meet this arbitrary standard, the vast majority range somewhere between 1 ppm and 10 ppm.

Imposing a cap on NNN concentration at 1 ppm of dry weight would:

  • Not result in a significant risk reduction. Any reduction in risk associated with forcing NNN levels to be reduced is likely to be zero and will be more than offset by the cost to consumers of limiting choice and destroying the diversity in the marketplace of these already incredibly low-risk products.


  • Set an unreasonable standard that most products–even if they were reformulated–would not be able to meet. Much like the PMTA issue with e-cigarettes, this would be a de facto ban on most ST products sold in the United States.
  • Reduce consumer access to the lowest risk tobacco products on the market today. This will have the effect of forcing U.S. consumers to shop overseas (increasing their cost), and for many, may cause them to replace their smokeless habit with smoking.

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