Next year could be the year the entire electronic cigarette market is turned upside down. The leading devices on the market at the start of 2018 could become second-tier ones by the end, and Philip Morris International (NYSE:PM) could end up dominating the entire field.

It's not hyperbole to say so. While the JUUL electronic cigarette device has come out of nowhere to topple Reynolds American's Vuse as the best-selling e-cig on the market, the landscape may shift once again if Philip Morris' gets FDA approval to market its heat-not-burn iQOS device.

Man hold signs saying FDA Approved

Image source: Getty Images.

The new year will bring change

The regulatory agency's Tobacco Products Scientific Advisory Committee has scheduled a public hearing on Jan. 24 to decide the modified risk application Philip Morris submitted for its iQOS device, which will be marketed under Altria's (NYSE:MO) Marlboro brand as Heatsticks.

The iQOS is already on sale in a number of countries, such as Japan, where the device already has an 11.9% share of the entire cigarette market, and Philip Morris has been ramping up production capacity. At the end of 2016, it was able to produce 15 billion units, and it expects to hit 60 billion units by the end of this year.

British American Tobacco (NYSEMKT: BTI) has developed a competing heat-not-burn device called the iFuse glo that is now available in five countries. It estimates it has gained a 2.7% share of the market in Japan,  and it plans to submit an application to the FDA to sell it in the U.S. in 2018.

A question of safety

The linchpin of the FDA hearing will be whether Philip Morris can claim its e-cig is a safer alternative to traditional combustible cigarettes. Although there is a mountain of evidence suggesting so because they produce a vapor instead of smoke, and the vast majority of toxic chemicals associated with cigarettes are found in smoke, the FDA hasn't allowed any company to claim that yet.

iQOS electronic cigarette

Image source: Philip Morris International.

The iQOS device is the first one being considered under the new regulations the agency issued last year, and there's a good reason more companies haven't filed applications: The labyrinthine rules a manufacturer has to follow are costly and time consuming.

Philip Morris' application is so large the FDA was unable to post all of the documents at once on its website, but slowly rolled portions out over time. It took the agency from December 5, 2016, when Philip Morris first submitted its application, to November 28, 2017 to get them all online. The tobacco company's executive summary of why the iQOS should be granted a modified risk designation alone runs more than 200 pages.

A backup plan

The onerous regulatory process ensures that only the biggest, most financially sound manufacturers will be able to comply with the process, and it would give Philip Morris a massive competitive advantage if it's able to claim its product is safer for smokers to use. Philip Morris has also submitted a second application to market the iQOS without the designation just in case.

If the reduced-risk label is denied, Philip Morris can still come out ahead because the heat-not-burn technology that it and British American have developed is seen as superior to existing e-cigs that heat e-liquids because by using real tobacco, the devices give users the flavor and nicotine hit they seek.

JUUL electronic cigarette plugged into USB port of laptop

Image source: Juul Labs.

The e-cig wild card

However, it will set up a showdown with the e-cig device from Juul Labs, which uses a different technology altogether. Rather than the "freebase" nicotine used by traditional e-cigs, the JUUL uses naturally occurring nicotine salts to produce a nicotine effect far closer to combustible cigarettes.

While freebase nicotine is reportedly easier to vaporize than using salts, JUUL's patented formula containing benzoic acid makes the experience closer to smoking cigarettes. With a design resembling that of a flash drive, the device even looks different than other e-cigs.

All of which could be why the JUUL has rocketed to the forefront. According to Nielsen data, JUUL captured a 32% share of the market in October, generating some $224 million in annual sales, but it had grown that to 40% by the beginning of December. Reynolds' Vuse brand, which was once the leading e-cig on the market, has seen its share fall from over 27% down to 24.3%, while Altria's MarkTen XL trails far behind in third place with 13.7%.

A lot is riding on the FDA hearings. Philip Morris either stands to gain a competitive advantage by being able to say its product is safer than any other product out there, or it's able to market a device that has proved extremely popular where introduced because its technology uses real tobacco. And with the marketing muscle of Altria's Marlboro brand behind it, Philip Morris International may end up owning the electronic cigarette market either way.

Rich Duprey has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.