Title : Trials and Tribulations of Reduced Risk Tobacco Products
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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.
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