Philip Morris submits 2 million page FDA application for new tobacco tech

When’s the last time you heard of anyone inventing something that might replace cigarettes and be at least marginally more safe from a health perspective? If you said e-cigarettes you’re close, but there are other options on the horizon. Philip Morris, the makers of Marlboro and a raft of other related brands and products, has finished development of something potentially groundbreaking. Rather than a heated nicotine liquid such as the vaping offerings use, they’ve figured out a way to “burn” actual tobacco without setting it on fire. And without the smoke it loses a lot of the toxins, not to mention the dangers of second hand smoke. (Business Wire)

Philip Morris International Inc. (“PMI”) (NYSE / Euronext Paris: PM) on Dec. 5 submitted a Modified Risk Tobacco Product (MRTP) application for its electronically heated tobacco product with the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products. This is consistent with the company’s stated goal of submitting its MRTP application in 2016. PMI anticipates the FDA taking a minimum of 60 days to complete an administrative review to determine whether to accept the application for substantive review.

Philip Morris published a number of papers behind the science of this new technology showing how it’s different than current e-cigarettes, but is still technically “smokeless” and doesn’t carry all of the normal, harmful byproducts that come with actually lighting a plant. In this one, Professor Osamu Fujita compiled his results. The science is fascinating.

He concludes that the EHTP generates no smoke but just aerosol as long as the EHTP is used as intended and heated in the Holder. Professor Fujita’s expert opinion is based on the following findings from his assessment:

• Results from aerosol formation simulations performed by PMI show that aerosol droplets are formed only in the presence of an aerosol former being mainly glycerol, but also nicotine and water. Minor compounds of the gas mixture were shown not to be able to reach supersaturation alone and therefore could not generate aerosol droplets from the multicomponent gas mixture at the operating conditions simulated.
• According to the definition of smoke, liquid or solid particulate material in smoke should be formed by condensation process of chemical compounds which are generated by combustion process (including pyrolysis process). As glycerin, water and nicotine are evaporated from the tobacco it can be concluded that EHTP generates no smoke.

Unfortunately for those hoping to check out this hopefully healthier alternative, you may have to wait awhile. In order to get the government to allow them to market this offering as a “Modified Risk” product which, while not health food, would be less harmful than cigarettes, they need approval from the FDA. If you followed our coverage of the battle that the Swedish smokeless product Snus has gone through, you know that can take a while. In some cases, a very long while and you might not get the approval anyway. And in the case of Philip Morris, we may be in for a long wait because their full application is literally more than two million pages long. (Bloomberg)

New York-based Philip Morris plans to file what’s known as a premarket tobacco application early next year. That’s required for any tobacco product introduced after February 2007. The FDA has said it rules on such cases within 180 days.

The company is also filing a so-called modified risk application by the end of this year to be able to designate that the product is less harmful than traditional cigarettes. The FDA’s response time for that application — which currently is between 2 million and 3 million pages — will probably take at least twice as long as the premarket filing.

If they get this done in under six months I would almost be willing to eat my fedora. But here’s hoping, anyway. If the FDA is in new hands next year we might actually begin to see a bit more cooperation with the free market on such requests.