1 Approved and 2 Rejected Claims From IQOS MRTP By FDA
Two out of three claims made by Philip Morris International (PMI) have been disapproved by FDA. Claims were made for PMI’s IQOS to be USA’s first secure alternate to normal smoking but they claims have been weakened down.
PMI claimed that IQOS systems are having reduced side effects of tobacco related diseases but it was turned down with a vote of 8-0 (with one vote absent) by Tobacco Products Scientific Advisory Committee (TPSAC).
The other claim which got rejected had a 5 – 4 voting completion claimed that continued smoking present higher risks than switching to IQOS. The committee has already shown concerns in a briefing to FDA over IQOS going for the use of both cigarettes at the same time.
No doubt the third claim by IQOS was approved with 8 – 1 vote support which says that the body is exposed to very lesser harmful chemicals if we switch completely to IQOS system from normal cigarettes. These decision are temporary though but expected to become permanent.
Probable Advantage
Altria, the US partner of PMI can publicize the advantage of e-cigarettes on their packing if any single application is successful in PMI’s claims. It is a big advantage over normal cigarette makers as they are not allowed to make any such claims.
If Altria and PMI want to sell IQOS in USA, a successful PMTA needs to be filed and succeeded. Though it easier than getting a MRTP status.
IQOS is already enjoying wide success in most of the Europe, Korea and Japan where it has launched successfully.
Both the partners witnessed a drop in the price of their in NY Stock Exchange market with this news but the prices soon began to recover back.
What Now?
This news will weaken the strong image of IQOS built over months even if PMI got 12 votes of 26 for approval of all the claims which gives a good idea that there is some truth to their claims and they would have been supported with scientific reasoning as well.
Hopefully PMI will come up with a better application and will win at their claims. It is of importance to know that TPSAC did consider that this event was in close quarters of chemical exposure and harmful effects of smoking in clear words rather than talking about them in other softer words like long term health differences. The latest report on e-cigarettes was a high profile case and National Academies of Sciences, Engineering, and Medicine (NASEM) dealt with the long term effects of smoking with a detailed grip.
Conclusion
The apparent significant setback to PMI seems to be turning around in the future as the third claim was widely supported by the TPSAC and FDA approved it as well. So a successful claims set by PMI is expected to come soon.
