IQOS Continued to Drive Down Japan Cigarette Sales in 2020; U.S. Cigarette Sales Steady

 

Japan is experiencing an unprecedented decline in cigarette consumption.  Japan Tobacco International reports (here) that cigarette sales dropped 8% in 2020, largely due to sales of reduced-risk products.  The dominant such product in Japan is Philip Morris International’s IQOS heat-not-burn HeatSticks.

U.K. veteran tobacco harm reduction advocate Clive Bates opined: “The only mystery is why the skies over Tokyo are not dark with chartered planes bringing officials from WHO, FDA, Truth Initiative, the Campaign for Tobacco-Free Kids, the European Commission and others on an emergency mission to learn about this most extraordinary shift.  What is the secret they would find? ‘Do nothing, stay out of the way....’  There was very little involvement from tobacco control – the demise of cigarettes in Japan has been driven by the market and consumer preference.” 

Meanwhile, the U.S. FDA finally authorized IQOS as a reduced exposure alternative to cigarettes on July 7, 2020, greenlighting these claims:

“AVAILABLE EVIDENCE TO DATE:

• The IQOS system heats tobacco but does not burn it.
• This significantly reduces the production of harmful and potentially harmful chemicals.
• Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

The FDA advised that its approval “is expected to benefit the health of the population as a whole.”

The Covid-19 pandemic is hurting U.S. IQOS marketing and sales.  PMI’s retail program requires smokers to visit an IQOS store to get educated about the system and purchase the hardware.  After that, smokers can buy the heat sticks in convenience stores and other outlets.  PMI’s program aims to suppress teen adoption, but the added inconvenience has slowed adoption by adult smokers.  The Wall Street Journal reports that the decades-long decline of cigarette sales has ended. One hopes the trend line will improve again as the pandemic comes under control and smokers make the effort to learn about this new smoke-free alternative.

 

FDA Awards “Modified Risk” Status to General Brand Snus Products from Swedish Match

“The U.S. Food and Drug Administration announced [on October 22] that, for the first time, it has authorized the marketing of products through the modified risk tobacco product (MRTP) pathway. The authorizations are for eight Swedish Match USA, Inc. snus smokeless tobacco products sold under the ‘General’ brand name” (from the FDA press release). 

The FDA authorization allows Swedish Match to use this statement: “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 approval will be in place for five years, but the agency can remove it at any time if it decides that it “no longer benefits the health of the population as a whole.”

It took the FDA over five years (during which 2.56 million American smokers died prematurely) to approve this truthful statement that I have documented for 25 years.  Note, however, that the tobacco control act stacked the deck against harm reduction by mandating the term “modified risk” instead of the more accurate “reduced risk.”

The FDA announcement received favorable media attention, with one analyst calling it a “gamechanger.”  While that may be true, there are some important things to remember.

1. The company filed its original application in 2014 to change the FDA’s mandated but grossly inaccurate smokeless tobacco warning labels.  The FDA, using flawed analysis, rejected that application in December 2016, and signaled that it would not jettison the required warnings, “cause mouth cancer” and “not a safe alternative to cigarettes.”  Swedish Match then filed an amended application with the statement that was approved.

2. The approved warning refers to “lower” risk of disease, which implies that risks are still present, when, in fact, snus has no risk for mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.  Even worse, the FDA’s “not safe alternative” warning covering a large part of the package and advertisements annuls the “lower” risk statement from Swedish Match. 

3. Swedish Match’s success was supported by a wealth of published epidemiologic research demonstrating snus’s negative impact on smoking and smoking-related diseases among Swedish men.  While Swedish boys use snus just like their fathers, use among American youth is nearly nonexistent.  These factors set a high standard of evidence for other current MRTP applications from Philip Morris International (IQOS), Reynolds (Camel snus) and and US Tobacco (Copenhagen moist snuff).   

• IQOS heat-not-burn tobacco.  Years of extensive research demonstrate that IQOS vapor is vastly less hazardous than smoke.  However, there is no epidemiology on the health effects of IQOS use, and there won’t be any for at least two decades.  In other countries, PMI sells IQOS devices only to adult smokers in special stores, so youth don’t have access.  PMI’s FDA application is now almost three years old (corresponding to 1.44 million dead smokers).

• Camel snus.  Produced in the same manner as Swedish snus, Reynolds’s Camel product should qualify for MRTP status with similar labeling, but Reynolds has no epidemiology for a product introduced in the U.S. around 2005.  The MRTP application is two and a half years old (1.24 million dead smokers).

• Copenhagen moist snuff.  The U.S. Smokeless Tobacco Company took a minimalist approach in its FDA MRTP application for this statement: “Switching completely to this product from cigarettes reduces risk of lung cancer.”  Still, the FDA, concerned with under-age use of dip products, claims that 350,000 “youth under 18 years of age use smokeless tobacco for the first time” yearly.  The agency will likely cite the youth issue to deny any statement about vastly lower risks, including lung cancer.  The MRTP application is one year, seven months old (760,000 dead smokers).

• E-cigarettes and vapor products.  The chances of these products getting an MRTP are approximately zero.  Research at American universities funded by the federal government is focused only on risks, epidemiologic studies are nonexistent, and federal officials consider vape products to be the cause of an exaggerated teen epidemic and mischaracterize them as the cause of lung injuries and deaths.  Manufacturers must first navigate widespread flavor and product bans, and then complete Premarket Tobacco Product Applications, a feat accomplished only by Swedish Match for General Snus and PMI for IQOS. 

Swedish Match should be commended for establishing a precedent for successfully navigating the Reduced (not merely modified) Risk Tobacco Product Pathway. 

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