Friday, December 14, 2018

Safer Tobacco Product Marathon: An Update


Smokers who are interested in vastly safer alternatives to cigarettes need to know that companies have filed four FDA applications seeking approval for advertising or marketing claims that their products are safer than cigarettes.  Technically, the companies are seeking “modified risk tobacco product”, or MRTP, approval.  Here are status updates on the applications.

General Snus 

Swedish Match submitted the first MRTP application for General Snus four and a half years ago, asking to change grossly inaccurate but federally mandated warning labels on its smokeless products (here).  The FDA rejected the application in December 2016, using flawed regulatory interpretations (here).  In September 2018, Swedish Match requested approval of this language: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” The term “lower risk” is an understatement, as the risk is almost zero. The FDA scientific advisory committee will consider this application on February 6, 2019.

IQOS 

Philip Morris International (PMI) filed an MRTP application for its IQOS heat-not-burn tobacco more than two years ago.  The FDA scientific advisory committee met in January and agreed that “Switching completely from cigarettes to the IQOS system significantly reduces your body’s exposure to harmful and potentially harmful chemicals.” (here)  However, the FDA hasn’t reached a decision about allowing this factually correct statement to appear.  Even worse, the FDA has yet to act on a separate PMI application to put IQOS on the market in the U.S., even though its availability in Japan and other markets are decimating cigarette sales (here).  Based on predictions from industry analysts, it appears that the agency is slow-walking the application (here).
 
Camel Snus

R.J. Reynolds filed an MRTP application in March 2017 for its Camel Snus products (here).  They requested approval for three statements, this being the most comprehensive: “Smokers who switch completely from cigarettes to Camel Snus can significantly reduce their risk of lung cancer, oral cancer, respiratory disease, and heart disease.”  The FDA’s scientific advisory committee reviewed the application in September; formal release of their recommendation is pending.

Copenhagen Moist Snuff

The U.S. Smokeless Tobacco Company in March this year submitted an MRTP application for Copenhagen fine cut snuff.  The company sought approval for a simple statement: “Switching completely to this product from cigarettes reduces risk of lung cancer.”  The FDA scientific advisory committee will consider this matter on February 6, 2019. 

The wheels of regulation grind slowly.  The months and years go by, and smokers continue to die.



Key Dates for General Snus, IQOS, Camel Snus and Copenhagen MRTP Applications





EventGeneral Snus (Swedish Match)IQOS (PMI)Camel Snus (R.J. Reynolds)Copenhagen (US Smokeless Tobacco)





Submission DateJune 6, 2014November 18, 2016March 31, 2017March 20, 2018
Time to:2 months6 months9 months6 months
FDA FilingAugust 27, 2014May 24, 2017December 18, 2017September 14, 2018
Cumulative time to:10 months14 months18 months11 months
TPSAC MeetingApril 8, 2015January 24, 2018September 13, 2018February 6, 2019
Cumulative time to:30 months25 months and counting21 months and counting
FDA DecisionDecember 14, 2016------
Cumulative time to:51 months



Amendment FiledSeptember 17, 2018


Cumulative time to:56 months



TPSAC MeetingFebruary 6, 2019

Tuesday, December 4, 2018

Who Smokes Menthol Cigarettes?


FDA Commissioner Scott Gottlieb recently said, “I’m deeply concerned about the availability of menthol-flavored cigarettes.”  He noted that menthol represents “one of the most common and pernicious routes by which kids initiate on combustible cigarettes” and “menthol products disproportionately and adversely affect underserved communities. And as a matter of public health, they exacerbate troubling disparities in health related to race and socioeconomic status that are a major concern of mine…we need to address the impact that menthol in cigarettes has on the public health.” (here)

In a similar vein, the Truth Initiative’s latest menthol screed suggests that menthol smokers are primarily teens, females, minorities and those with mental illness (here).  Is that accurate?

The answer for adults can be found in the National Health Interview Survey, the main instrument used by the CDC to track smoking in the U.S.  The NHIS collects information on menthol about every five years.  The chart at left presents the characteristics of menthol smokers in 2015, the most recent year for which NHIS data is available. 

Of the 36.5 million American adult smokers, about 10.7 million reported that they smoked menthol cigarettes (22.4 million preferred plain cigarettes and the rest were uncommitted).  Women outnumbered men by a small margin, and menthol smokers were broadly distributed across the age spectrum.  Racial distribution figures stand out.  Although Black/African American smokers overwhelmingly favored menthol cigarettes, they were far outnumbered by White menthol smokers.

Sixty-one percent of menthol smokers and 55% of plain cigarette smokers were in the lowest income group.  Any difference in income distribution between menthol and plain cigarette smokers may be explained by differences in age, sex or race.  The claim that menthol use reflects a socioeconomic disparity is not valid without further investigation.

Last year I published research showing that smoking may contribute to depression, anxiety, or emotional problems (here).  But the association has nothing to do with menthol.  In the 2015 NHIS 11% of menthol smokers reported difficulty with activities because of these conditions.  The rate was the same among plain cigarette smokers.

Five years ago I noted in this blog that an “FDA preliminary evaluation – reflecting data from numerous studies – does not provide evidence of any significant differences between menthol and regular cigarettes with respect to smoking initiation, addiction to nicotine or cessation.  There is no justification for an evidence-based decision by the FDA to ban or otherwise restrict the menthol content in cigarettes.” (here)  

It is not clear that a stronger scientific rationale for FDA action on e-cigarettes presently exists.  If action is taken, this blog post has described the characteristics of the 10.7 million smokers it will affect.