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
Event	General Snus (Swedish Match)	IQOS (PMI)	Camel Snus (R.J. Reynolds)	Copenhagen (US Smokeless Tobacco)
Submission Date	June 6, 2014	November 18, 2016	March 31, 2017	March 20, 2018
Time to:	2 months	6 months	9 months	6 months
FDA Filing	August 27, 2014	May 24, 2017	December 18, 2017	September 14, 2018
Cumulative time to:	10 months	14 months	18 months	11 months
TPSAC Meeting	April 8, 2015	January 24, 2018	September 13, 2018	February 6, 2019
Cumulative time to:	30 months	25 months and counting	21 months and counting
FDA Decision	December 14, 2016	---	---
Cumulative time to:	51 months
Amendment Filed	September 17, 2018
Cumulative time to:	56 months
TPSAC Meeting	February 6, 2019

Trials and Tribulations of Reduced Risk Tobacco Products

When Congress gave the FDA regulatory authority over tobacco in 2009, it provided a pathway for companies to obtain approval for “modified risk tobacco products (MRTPs)…, sold or distributed for use to reduce harm or the risk of tobacco-related disease…” (here).  While decades of epidemiologic studies prove that non-combustible tobacco products are vastly safer than those involving inhaled smoke laced with thousands of toxins, the legislation required proof from manufacturers that MRTPs must “benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.” (here)  In other words, MRTPs must benefit the 60 million Americans who smoke as well as 250 million American non-smokers.

Despite this challenge, tobacco manufacturers have made credible efforts to seek MRTP status.  Swedish Match in 2014 started down this pathway (here) to remedy inaccurate warning labels that are required on their smokeless tobacco products and marketing materials (here).  The FDA denied the company’s application in 2016 (here).

In November of that year, Philip Morris International (PMI) requested MRTP status for its IQOS heat-not-burn tobacco (here).  IQOS is already available in 31 other countries.  However, since it is an entirely new product, the company must also pursue an FDA premarket tobacco application (PMTA) before it can be sold in the U.S.

PMI seeks MRTP approval for any one of three messages:

“Switching completely from cigarettes to the IQOS system can reduce the risks of tobacco-related diseases.”

“Switching completely to IQOS presents less risk of harm than continuing to smoke cigarettes.”

“Switching completely from cigarettes to the IQOS system significantly reduces your body’s exposure to harmful and potentially harmful chemicals.”

Another manufacturer, R.J. Reynolds, filed an MRTP application in March 2017 for its Camel Snus products (here).  They, too, submitted three messages, 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.”

Despite a wealth of evidence to support such statements, FDA took two and a half years to reject the Swedish Match MRTP application (here), as can be seen in the following table.

Key Dates for General Snus, IQOS and Camel Snus MRTP Applications
Event	General Snus (Swedish Match)	IQOS (PMI)	Camel Snus (R.J. Reynolds)
Submission Date	June 6, 2014	November 18, 2016	March 31, 2017
Time to next step	2 months	6 months	9 months
FDA Acceptance	August 27, 2014	May 24, 2017	December 18, 2017
Time to next step	8 months	8 months	---
TPSAC Meeting	April 8, 2015	January 24, 2018	---
Time to next step	20 months	---	---
FDA Decision	December 14, 2016	---	---

In the 30 months it took the FDA to analyze and reject the first MRTP application, 1.2 million Americans died from smoking.  The agency must move faster in its evaluation of obviously lower-risk smoke-free tobacco products and give them MRTP status.