September 15, 2015

Stanton A. Glantz, PhD

FDA issues orders that will stop further U.S. sale and distribution of four R.J. Reynolds Tobacco Company cigarette products

As someone who has been critical of the FDA for not making any meaningful decisions that actually affect the cigarette market, I have to applaud their decision to block Reynolds from marketing four products with menthol "flavor capsules" in the filter. 
 
They did so by issuing a "not substantially equivalent" (NSE) order that concludes that these products are "not substantially equivalent" to products that were grandfathered into the market in the 2009 FDA law.  The companies have been using the "substantially equivalent" loophole to market thousands of new products, so this is an important step forward for the FDA. 
 
While the NSE order covers a wide range of issues, the FDA concluded that  the addition of "a capsule containing menthol in the filter of the new tobacco product" which "allows users to choose whether to smoke the new tobacco product with or without menthol, effectively creating an adjustable menthol/non-menthol cigarette.  In addition, non-menthol and menthol-smokers can share cigarette packs of the new tobacco product.  As a result, this difference in flavor delivery system between the new and predicate tobcco products may influence consumer perception and use by providing users with a novel, versatile flavor delivery system."
 
The differences in menthol, flavorings, and sweeteners make the new product have "different characteristics" that raise different questions of public health as compared to the predicate product.
 
The SE review report: is at http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvert... and the FDA press release is at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm462407.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

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