February 26, 2017

Stanton A. Glantz, PhD

FDA Should Not Extend the Comment Period for its Proposed Product Standard Limiting NNN Levels in Finished Smokeless Tobacco

We submitted this public comment to the FDA last week.  The tracking number is 1k1-8uvs-bibu.  A PDF version is available here.
FDA Should Not Extend the Comment Period for its Proposed Tobacco Product Standard Limiting NNN Levels in Finished Smokeless Tobacco Products
Docket Number: FDA-2016-N-2527
Benjamin Chaffee, Wendy Max, Lauren Lempert, Stanton Glantz
February 22, 2017
Because it is an urgent matter of public health, UCSF TCORS (which includes dental, medical, nursing, and public health professionals, scientists, economists, and lawyers) opposes any extension of time to comment on FDA’s proposed rule limiting NNN levels in smokeless tobacco products.   Rather, FDA should keep its April 10, 2017 deadline for the comment period, and quickly finalize the proposed rule without delay. 
As the proposal states, “NNN is a potent carcinogenic agent found in smokeless tobacco products and is a major contributor to the elevated cancer risks associated with smokeless tobacco.”  The science is undeniable.  UCSF TCORS will submit comprehensive comments before the April 10 deadline providing further scientific evidence supporting the proposed rule.
Each day 1,315 kids on average aged 12-17 use smokeless tobacco for the first time.[1]  If FDA implements Altria’s, Reynolds American, Inc.’s (RAI), and National Tobacco Company’s (NTC) requests to extend the comment period an additional 75 days, this means that nearly 100,000 kids who previously were not users will initiate smokeless tobacco use and increase their risks of oral and other cancers.
The U.S. Smokeless Tobacco Company (USSTC), now a subsidiary of Altria, is the biggest smokeless tobacco company in the U.S. and controls more than half (55.2%) of the moist snuff tobacco market (with leading premium brands Skoal and Copenhagen).[2]  RAI owns the second largest smokeless tobacco company in the U.S., American Snuff Company (formerly Conwood Tobacco Company), the makers of Grizzly and Kodiak, which holds more than one-third of the moist snuff market.[3] NTC, maker of Beech-Nut chaw and other products, is another leading maker of chewing tobacco in the U.S., and has a business relationship with Swedish Match North America, manufacturer of Snus.  As leading U.S. manufacturers and distributors of smokeless tobacco products, surely Altria, RAI, and NTC are well aware of the cancer risks of NNN, and do not need extra time to consider the scientific evidence supporting the proposed rule.
Altria, RAI, and other tobacco interests have the resources necessary to submit their comments in a timely manner.  Delaying the end of the public comment period will only delay the rule at the cost of more disease and death for U.S. youth. 

[1] Substance Abuse and Mental Health Services Administration (SAMHSA), HHS, Results from the 2015 National Survey on Drug Use and Health, NSDUH: Detailed Tables, 2016. http://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2015/NSDUH-...

[2] Altria Group, Inc., Form 10-K, 2014 Annual Report, filed February 25, 2015,

[3] Reynolds American, Inc., Form 10-K, 2014 Annual Report, filed February 10, 2015,


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