My statement this morning to FDA's TPSAC (actually to Mitch Zeller, who was sitting there) is below.
I’m Bill Godshall, founder and executive director of SmokeFree Pennsylvania, which has campaigned to reduce cigarette smoking since 1990 by reducing secondhand smoke exposures, reducing cigarette marketing to youth, holding cigarette companies accountable, and increasing cigarette taxes.
Since 2004, we’ve also informed the public that cigarettes cause >99% of all tobacco attributable morbidity, disability, mortality and healthcare costs, and that smokefree alternatives are below 2 on the Continuum of Risk in which cigarettes are 100 and NRT products are 1.
We’ve also advocated keeping ALL low risk smokefree alternatives legal to manufacture, market and use, which is why we opposed the Tobacco Control Marlboro Monopoly Act that was negotiated and agreed to in 2004 by Philip Morris, RWJF financed Matt Myers and then-GSK lobbyist Mitch Zeller, which banned sales of new smokeless tobacco products more than a decade ago.
We also opposed Josh Sharfstein’s unlawful cigarette protecting 2009 FDA e-cigarette import ban, and Mitch Zeller’s 2016 cigarette protecting Deeming Rule that banned sales of all new vapor products 18 months ago, banned truthful health claims for vapor products, and bans all vapor products in the near future (unless the Deeming Rule is significantly changed).
For disclosure, neither I nor SmokeFree Pennsylvania have ever received any funding the US DHHS or from any tobacco, drug or vapor company. So no financial conflicts.
Recent studies indicate Marlboro HeatSticks & IQOS are about 90% less harmful than cigarettes. But far more extensive scientific and empirical evidence has consistently found snus, moist snuff, dissolvables and vapor products are about 99% less harmful than cigarettes.
So why is FDA considering approving MRTPs for Philip Morris Marlboro products that appear 90% less harmful than cigarettes after FDA banned the sale of vapor products that appear 99% less harmful than cigarettes, have already helped millions of Americans quit smoking (something FDA & CDC have refused to acknowledge), and have helped cut youth smoking in half since 2010?
And why has FDA refused to accept 367 PMTAs, but is considering PMTAs for Marlboro HeatSticks?
A key reason is because Philip Morris and Altria spent hundreds of millions of dollars lobbying to enact the 2009 Tobacco Control Act and to impose FDA’s 2016 Deeming Rule because both policies protect Marlboro’s Cigarette Monopoly and Marlboro HeatSticks from market competition by thousands of small smokeless tobacco and vapor companies that cannot afford $100 million to submit PMTA and MRTP applications.
If FDA approves MRTPs and PMTAs for Marlboro HeatSticks, PM and Altria will spend hundreds of millions of dollars more to protect their new Marlboro HeatStick Monopoly by lobbying to keep vapor products banned, including the Cole-Bishop bill in Congress.
Before creating another multi billion dollar Marlboro monopoly, the FDA should rescind its disastrous Deeming Rule that bans millions of lifesaving vapor products, and begin to truthfully inform the public that ALL smokefree tobacco/nicotine alternatives are far less harmful than cigarettes.
