CASAA: Comment on FDA’s unreasonable smokeless tobacco rule

CASAA: Comment on FDA’s unreasonable smokeless tobacco rule

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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 1ppm of dry weight. Although some products do exist that would meet this arbitrary standard, the vast majority range somewhere between 1ppm and 10ppm.


Imposing a cap on NNN concentration at 1ppm 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.



Choose some points below to add to your comment:

  • Do you use smokeless tobacco as a form of tobacco harm reduction?

    • Do you use smokeless tobacco instead of smoking, or did you quit smoking by switching to smokeless tobacco?

    • Do you use smokeless tobacco in places where you cannot vape?

  • How important is the variety of smokeless tobacco products to you?

  • What will you do if you are unable to purchase smokeless tobacco in the United States?

    • Do you think you would return to smoking?

    • Will you shop online, overseas?

  • For more information:

    • Comment from Reason Foundation here.
    • Dr. Brad Rodu provides background and insights here, with links to other comments on the rule.
    • Dr. Carl Phillips has provided an in-depth analysis in a three part series here, here, and here.

* You are commenting on a publicly viewable docket on Regulations.gov. Any personal information you provide in your comment will be publicly available. The information you provide to CASAA in order to complete this engagement will not appear on Regulations.gov.


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