Tuesday, January 23, 2018

Japan’s IQOS Experience Suggests Product Could Reduce U.S. Cigarette Consumption



An FDA advisory committee this week will vote whether to recommend that the FDA grants modified risk status to Philip Morris International’s IQOS heat-not-burn tobacco product (here).  A positive vote would acknowledge that the product poses a lower risk and/or lower exposure to toxins than cigarettes.

The committee’s activity is garnering considerable media attention, but the larger issue is: Will the FDA permit IQOS sales in the U.S.?  In order for that to happen, the agency must approve the company’s premarket tobacco application (PMTA).

IQOS is already available in 31 countries, with Japanese sales initiated in 2016.  The chart at left shows that Japanese consumption of IQOS heat sticks (green) in 2017 coincided with a 14% annual decline in cigarette consumption (red), compared with 2-3% decline in cigarette sales over the previous 5 years.

The Japanese experience suggests that IQOS MRTP designation by the FDA could have a significant downward effect on American cigarette consumption.





Thursday, January 18, 2018

1.7 Million High Schoolers Vaped in 2016, As Both Vaping and Smoking Declined



The Centers for Disease Control and Prevention 2016 National Youth Tobacco Survey (NYTS) shows that 1.08 million (7.2%) American high school students used e-cigarettes in the past 30 days, 580,000 (3.9%) smoked, and 660,000 (4.4%) used both products.

Compared with 2015, smoking declined by about 14% and vaping by 28%.
The apparent spike in e-cigarette use from 2013 to 2014 was partially due to what scientific researchers refer to as an artifact, as it stemmed from a change in the survey design.  Questions about e-cigarette use were bundled with those for other rarely used tobacco products until 2014, when they appeared in a separate section. 

The NYTS also collected information on how many days e-cigarettes were used in the past month.  The chart below shows that 7 out of 10 students who vaped but did not smoke used e-cigarettes five days or fewer.  This is basically “party” or “weekend” vaping, rather than regular use.  While half of high school students who vaped and smoked used e-cigs five or fewer days, 22% used them all 30 days.





Last June, the CDC published selected information from the 2016 NYTS (here), listing smoking and vaping rates separately, effectively double-counting the 660,000 high-schoolers who vaped and smoked.  The CDC only released the full NYTS data set earlier this month (here).
   
The federal data confirm that e-cigarette experimentation by youth since 2011 has not produced an epidemic of smoking.  In fact, the decline in youth smoking accelerated to a record low rate.

Thursday, January 11, 2018

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




EventGeneral Snus (Swedish Match)IQOS (PMI)Camel Snus (R.J. Reynolds)




Submission DateJune 6, 2014November 18, 2016March 31, 2017
Time to next step2 months6 months9 months
FDA AcceptanceAugust 27, 2014May 24, 2017December 18, 2017
Time to next step8 months8 months---
TPSAC MeetingApril 8, 2015January 24, 2018---
Time to next step20 months------
FDA DecisionDecember 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.