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FDA ‘s Adjudication:The Turning Point of Heat Not Burn Product

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FDA ‘s Adjudication:The Turning Point of Heat Not Burn Product

  • 2018-12-19

Since modern electric cigarette was invented in 2003 by Chinese Pharmacist Hon Lik,it unveiled the prologue of new tobacco product era.But since then,there have not been many new members joined in the tobacco product family,this industry lacks vitality until the appearance of heat not burn product,which brings in new blood to this industry.While heat not burn product is enlarging its market share,new electric cigarette represented by JUUL pulled this industry to another lane.

As another kind of tobacco alternative,electric cigarette is pioneering in exploring a new method of smoking,it took most of the market share of new tobacco product,but its growth was slowing down these years,and the market had witnessed a multiple growth of heat not burn product,which of them will be dominating depends on the American and Chinese market to a large extent.



The American electric cigarette market changed a lot,the four leading brands in this industry in 2016 are Vuse of Reynolds Tobacco,Blu of Imperial Tobacco,Logic of Japan Tobacco Industry and MarkTen of Altria Group,the sales of these four brands made up 77.6% of the total,they are all big companies,benefited from their reputation,cash flow and supply chain management system and relatively high barriers of entry in the US.

By the first quarter of 2018 JUUL has rose sharply and took 68% of the market share in America.According to its experience,the unique design and convenient refillable cartridge make it popular among consumers.So the leading five brands in America are all electric cigarette manufactures by now,for heat not burn product is not allowed to enter the American market.The way was blocked by FDA,and relevant companies like Philip Morris International have been trying to persuade FDA of the safety of heat not burn product.

Take PMI for example,to get the identification from FDA,it consecutively submitted two materials,PMTA(Premarket Tobacco Product Application)and MRTP(Modified Risk Tobacco Product).

Generally speaking, the difference between them is that PMTA is a selling license of tobacco product,if got recognized by FDA,then PMI can sell heat not burn product labeled as tobacco product,and if WRTP got recognized,not only will the market influence of such products rise,but also a greater taxation reduction.



Whether the PMTA application will be approved is up to FDA,and more public opinions and expertise are needed on WRTP..According to PMI,the PMTA application is likely to get reply at the end of the year,while the scientific identification of WRTP is still in processing.It’s doubtless that the adjudication of FDA will have a decisive effect on the fate of heat not burn product.The possible outcome including:



1.The PMTA and MRTP application got approved,then IQOS will be the first heat not burn product on the US market,along with the characteristic of risk-reduction,it’s able to compete with JUUL.

2.Only the PMTA application got approved,although it is contradict to design a smoke-free future,at least it got the chance to enter the American market,it is expected to become a member of “Leading Companies Club”。

3.Neither of these two applications got recognized,then relevant companies are gonna wait.



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