Tuesday, June 10, 2014

Swedish Match Files to Change Smokeless Tobacco Warnings

Swedish Match has filed a Modified Risk Tobacco Product (MRTP) application with the FDA Center for Tobacco Products (CTP).  The landmark event was announced in an AP story (here). 

The company wants to change three health warnings on ten of its snus products manufactured by the company in Gothenburg, Sweden and sold in the U.S.: 

1.  Remove the current warning, “This product can cause mouth cancer.”

2.  Remove the current warning, “This product can cause gum disease and tooth loss.”

3.  Replace the current warning, “This product is not a safe alternative to cigarettes,” with this text: “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.

4.  Retain the current warning, “Smokeless tobacco is addictive.”

Numerous studies document that the three targeted warnings have essentially no scientific basis (discussed here).  I previously noted the bogus nature of the mouth cancer warning, which was mandated in 1986, five years after Dr. Deborah Winn mischaracterized the magnitude and scope of smokeless tobacco’s mouth cancer risk (discussed previously in this blog here and here).  There is no foundation for an oral cancer warning for today’s American and Swedish smokeless products.

The gum disease/tooth loss warning is equally inappropriate.  Even in 1986, there was virtually no scientific evidence that smokeless tobacco was an independent risk factor for any dental problem.  The same is true today. 

The not-a-safe-alternative warning is particularly egregious.  The purpose of this 1986 warning was to deceive smokers into believing that smokeless tobacco was just as dangerous as smoking.  As I wrote in my book, “For Smokers Only” (here), this warning is simply ludicrous.

Swedish Match’s replacement warning is identical to a change requested by RJ Reynolds in a citizen petition filed with the FDA three years ago (discussed here).  The FDA ignored that petition, but it is obligated to consider the Swedish Match MRTP application.  After an administrative review for completeness, the agency must refer the application to the Tobacco Products Scientific Advisory Committee (TPSAC) and ask TPSAC to report its recommendations on the application to FDA within 60 days.  The FDA will also make the application public and request comments.  “FDA intends to act upon your MRTP application no later than 360 days after receipt…”

The misinformation in the current warnings has been shown to discourage smokers from switching (here). The welcome filing by Swedish Match could dramatically alter the landscape for tobacco harm reduction.

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