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.

1 comment:

Bill Godshall said...

Unfortunately for tobacco consumers, vapers and public health, the same MRTP claims that SM and BAT/Reynolds have applied to FDA to make also accurately describe the health benefits of several hundred different smokeless tobacco products and 3 million vapor products that are now on the US market, and that are registered with the FDA.

Unfortunately, the several thousand manufacturers of vapor products cannot afford the $100 million or more it could cost to submit PMTA and MRTP applications to FDA (that FDA would actually review) for any of their 3 million products.

And if FDA approves PMI/Altria's PMTA and MRTP for IQOS (which will grant PMI/Altria a legal monopoly to truthfully market the only lower risk alternative to cigarettes), PMI and Altria will spend billions of more dollars protecting their new multi billion dollar monopoly (by lobbying to preserve FDA's Deeming Rule that bans >99.999 of competitive vapor products).

That's why PM/Altria negotiated and agreed to the TCA with CTFK's Matt Myers and then GSK lobbyist Mitch Zeller in 2003/2004, and why they combined forces to lobby Congress to enact the TCA from 2004 to 2009, and why Altria (and Reynolds) urged FDA to impose the Deeming Rule.

While IQOS should be legal to sell in the US (and PMI could have began selling it in the US before the Deeming Rule's 8/8/2016 deadline kicked in), creating a legal monopoly for IQOS would make it far more difficult and expensive for THR advocates and the vaping industry to convince Congress to repeal/amend the TCA and/or convince FDA to repeal/amend the Deeming Rule to allow vapor products to compete against IQOS on the legal market.

Similarly, if FDA approves MRTPs for SM's General Snus and/or BAT/Reynolds Camel Snus products, SM and/or Reynolds will spend a lot more money to lobby (along with PMI and Altria lobbyists) to keep the TCA and Deeming Rule intact (in order to ban competitive vapor products and their manufacturers).

The only silver lining in this situation is that black markets for vapor products may render (and may be already rendering) FDA's vapor Deeming Rule as ineffective as the federal law banning marijuana.