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Philip Morris could win even if its iQOS marketing application fails

  • Philip Morris International wants to make a claim that using its heat-not-burn tobacco product, iQOS, is safer than smoking cigarettes.
  • FDA approval would be required for such a claim.
  • PMI presented its case to an independent advisory committee this week.
  • Swedish Match's failed application could be a roadmap for PMI's iQOS, said Marc Scheineson, a former FDA official.
Customers try IQOS device during demonstration at IQOS store in Tokyo, Japan on July 31, 2017.
Shiho Fukada | Washington Post | Getty Images

A failed attempt to market iQOS as safer than cigarettes could still be a win for Philip Morris International, says a former FDA official.

PMI wants to claim that using its heat-not-burn tobacco product, iQOS, is safer than smoking cigarettes. An independent committe voted on whether evidence backs PMI's claims, already striking down a few. These are only recommendations to the FDA, and the agency is not required to follow them.

Marc Scheineson, a partner at Alston & Bird and a former associate commissioner for legislative affairs of the FDA, said there is "little to no chance" the committee will approve PMI's modified-risk tobacco product application because there's not enough data to meet the strict standards.

He pointed to Swedish Match presenting a plethora of clinical data for its product, called snus, yet being denied when it went through the same application process. The FDA later approved Swedish Match's premarket tobacco application.

That could be the roadmap for PMI, Scheineson said. PMI has also applied for premarket tobacco approval, which would allow iQOS to be sold in the U.S. That procedure doesn't include a public hearing, so he said applying for the modified-risk tobacco product designation gives PMI a chance to publicly make its case to consumers and regulators.

"I think that's absolutely what the strategy is here," Scheineson said. "Philip Morris has made the determination that this is good, free publicity. It's covered here in a scientific forum discussing how the new device works and how it's different than e-cigs."

In response to the committee vote, the company released a statement:

Philip Morris International appreciates the open, positive dialogue and the serious consideration the Tobacco Products Scientific Advisory Committee (TPSAC) has shown during the last two days in discussing the complex science presented in our Modified-Risk Tobacco Product (MRTP) application. We are encouraged by the recognition of the risk reduction potential of IQOS that clearly emerged from the statements of the Committee members.

We are confident in our ability to address the valid questions raised by the Committee with the FDA as the review process for our application continues.