Prove doesn’t support Philip Morris International’s claims that its heat-not-burn tobacco fallout cuts the risk of tobacco-related diseases and is likely to switch adult cigarette smokers, regulatory advisors utter.
PMI is seeking approval from the U.S. Food and Drug Administration to market its heat-not-burn tobacco fallout as less risky than cigarettes. PMI says it has found exclusively using iQOS significantly cuts users’ risk of harm than if they were to continue smoking cigarettes.
The panel disagreed.
Members voted unanimously (aside from one abstention) against PMI’s allege that its heat-not-burn tobacco product cuts the risk of tobacco-related disorders. The panel also rejected a claim that iQOS is less dangerous than continuing to smoke cigarettes in a 5-4 vote.
One claim the committee voted in favor of was that iQOS belittles the body’s exposure to harmful or potentially harmful chemicals. However, it voted against the clue that reductions in exposure are reasonably likely to translate to a measurable and profitable reduction in morbidity and or mortality.
PMI told the committee it expects to switch 6 million adult smokers to iQOS if the FDA allowed it to buy the system as less risky than cigarettes. Members were skeptical.
The bulk said the likelihood of iQOS users switching completely to the device is low to everyday.
One member pointed to price as a barrier. If approved, the heating device order cost $79 and the price of accompanying tobacco sticks would be comparable to a call it a day of cigarettes.
PMI has said using the iQOS system exclusively offers the greatest reduction in injure. The committee was not convinced that people would use iQOS alone. The volume said the odds of people using it in conjunction with cigarettes are outrageous to medium.
In response to the committee vote, the company released a statement:
Philip Morris Cosmopolitan appreciates the open, positive dialogue and the serious consideration the Tobacco Upshots Scientific Advisory Committee (TPSAC) has shown during the last two days in discussing the complex area presented in our Modified-Risk Tobacco Product (MRTP) application. We are encouraged by the awareness of the risk reduction potential of IQOS that clearly emerged from the proclamations of the Committee members.
We are confident in our ability to address the valid questions moot by the Committee with the FDA as the review process for our application continues.
One concern with additional nicotine products like e-cigarettes is that they attract people who play a joke on never smoked, including kids and teens. PMI has said that’s unbecoming because iQOS uses actual tobacco, unlike e-cigarettes, which are ready in fruity, sweet flavors. The committee’s thoughts on the matter were adulterated.
The recommendations are non-binding, meaning the FDA does not have to follow them.
Analysts Michael Lavery of Piper Jaffray and Bonnie Herzog of Okays Fargo remained optimistic the FDA would approve PMI’s modified-risk tobacco consequence application. In separate research notes, they both noted council members were concerned about the precise wording of PMI’s proposed reduced-risk claims when signify ones opinion against them.
PMI has another application under FDA review that choice simply allow iQOS to be sold in the U.S., without the lower-risk claims. Regardless of the panel’s way of thinkings on the modified-risk tobacco product application, the process could help PMI’s other reference, said Marc Scheineson, a partner at Alston & Bird and a former associate commissioner for legislative interests of the FDA.
Philip Morris shares closed down 2.8 percent on Thursday. Splits of Altria, which would receive sole distribution for iQOS in the U.S., if approved, mow down 2.3 percent.