We conducted laboratory studies to measure Harmful and Potentially Harmful Constituents in the inhalable aerosol of Platform 1 and compared them to the levels found in the smoke of a standard reference cigarette (3R4F). An average of 90-95% reduction of these HPHCs in Platform 1’s aerosol was observed.

Analysis of Philip Morris International THS 2.2 Aerosol

 

The following tables compare the levels of harmful and potentially harmful constituents (HPHCs) found in the aerosol of PMI’s THS 2.2 (commercialized as iQOS Marlboro Blue) with the levels found in smoke from a reference cigarette based on analyses performed by Labstat International ULC, an independent contract research organization.

Labstat International ULC is an independent ISO 17025 accredited laboratory in Kitchener, Ontario, Canada.

PMI 58 list of harmful

The PMI-58 list of harmful and potentially harmful constituents

 

Health Canada Intense Testing Regime

Yields obtained under the Health Canada Intense Testing regime show that in the laboratory, the levels of HPHCs in THS 2.2 (Platform 1) aerosol were reduced by more than 90%, on average, relative to the reference cigarette.

Prior to conducting the aerosol generation experiment, all test items were conditioned according to ISO 3402 conditions (22°C ± 1°C and 60% ± 2%). The laboratory condition set during the aerosol generation was maintained at 22°C ± 2°C and 60% ± 5% relative humidity.

All aerosol and smoke collections were performed according to the Health Canada Intense (HCI) machine-smoking protocol (55 mL puff volume, 30 seconds puff interval, 2 seconds puff, 100% vent blocking, butt length 23 mm for non-filter cigarettes or the length of filter overwrap plus 3 mm for filter brands) (Health Canada, 2000) on a linear smoking machine.

For the THS 2.2, the vent blocking does not apply as the tobacco sticks are not ventilated (no perforation at the filter level). The butt length does not apply either, as the sticks are not consumed by combustion and remain of the same size throughout use. The beginning and the end of the aerosol collection for the tobacco sticks differs from what is applied to a cigarette, as there is not ignition and the stick is not consumed by combustion. The aerosol collection starts after the pre-heating period (30 seconds) and stops at 6 minutes, which is the end of the heating period. This results in exactly 12 puffs under HCI.

HPHCsUnitsRef. Cigarette Mean

THS 2.2

Mean

THS 2.2

SD

THS 2.2

n

Reduction vs

ref.

cigarette

Nicotinemg/stk1.861.140.03329-
Ammoniaµg/stk29.310.51.63964%
Acrylamideµg/stk4.461.820.116959%
Pyridineµg/stk29.76.140.423979%
Acetamideµg/stk12.93.330.394974%
Butyraldehydeµg/stk83.520.30.586976%
Styreneµg/stk15.41.050.145993%
Pyreneng/stk81.88.390.796990%
Catecholµg/stk89.814.40.68984%
Formaldehydeµg/stk85.27.980.504991%
Propylene oxideng/stk110313619.9988%
N-nitrosoanabasine (NAB)ng/stk30.21.920.182994%
Benz[a]anthraceneng/stk27.12.080.148992%
N-Nitrosonornicotine (NNN)ng/stk28310.20.486996%
Acetaldehydeµg/stk16412177.85987%
Propionaldehydeµg/stk12313.60.662989%
Benzo[a]pyreneng/stk150.9390.0796994%
Phenolµg/stk141.120.0849992%
N-nitrosoanatabine (NAT)ng/stk270141.13995%
Hydroquinoneµg/stk89.17.20.391992%
Acroleinµg/stk1569.630.703994%
4-(Methyl-nitrosamino)-1-(3-pyridyl)-1-butanone (NNK)ng/stk2646.750.493997%
Methyl-ethyl-ketone (MEK)µg/stk1857.590.456996%
Acetoneµg/stk69035.51.84995%
Nitric oxide (NO)µg/stk50413.80.967997%
Nitrogen oxides (NOx)µg/stk56014.10.943997%
Tolueneµg/stk1371.820.163998.70%
o-Cresolµg/stk4.150.03930.0065999.10%
o-Toluidineng/stk1050.9050.102999.10%
Carbon monoxide (CO)mg/stk30.20.4360.0811998.60%
Acrylonitrileµg/stk24.50.1580.0122999.40%
Benzeneµg/stk81.10.5440.0312999.30%
1, 3-Butadieneµg/stk98.50.3420.0347999.70%
Isopreneµg/stk8942.150.202999.80%
HPHCs approaching the< limit of quantification or detection.*Units Reference Cigarette Mean

THS 2.2

Mean

THS 2.2

SD

THS 2.2

n

 

THS 2.2

Reduction vs. ref cigarette

1-Aminonaphthaleneng/stk21.60.04070.0103999.80%
2-Aminonaphthaleneng/stk16.20.02770.0091999.80%
3-Aminobiphenylng/stk4.180.01120.0031999.70%
4-Aminobiphenylng/stk2.830.00960.0014999.70%
Arsenicng/stk7.9<1.2*9NA
Cadmiumng/stk92.9<0.28*9>99.7%
Chromiumng/stk<LOQND*9NA
Crotonaldehydeµg/stk50.5<3.29*9>93%
Dibenz[a, h]anthraceneng/stk<LOQND*9NA
Ethylene oxideµg/stk22.70.2290.0126999.00%
Hydrogen cyanideµg/stk365<4.37*9>98.8%
Leadng/stk32.1<1.62*9>95%
m-Cresolµg/stk3.51<0.019*9>99.5%
Mercuryng/stk4.772.040.104957.20%
Nickelng/stk<LOQND*9NA
Nitro benzeneµg/stk<LOQND*9NA
p-Cresolµg/stk8.630.0456*999.50%
Quinolineµg/stk0.431<0.011*9>97%
Resorcinolµg/stk1.79<0.055*9NA
Selenium ng/stk1.951.570.1239NA
Vinyl chlorideng/stk103<2.19*9>98%

* The limit of quantification is the level below which the testing apparatus cannot reliably measure the levels of certain constituents. The level of detection is the level below which the testing apparatus cannot reliably detect the presence of certain constituents. In these situations, factors such as environmental contamination, laboratory reagents, and even the chemical composition of the tobacco leaf used in a product may trigger variations in the constituent levels. Constituents in this section, whilst they may be detected and/or quantifiable in one study, may not be detected and/or quantified in others.

 

FDA-18 HPHCs comparison of THS2.2 aerosol versus 3R4F reference cigarette smoke using the ISO regime

Yields were obtained under the ISO Testing regime show that THS2.2 reduced HPHC levels by about 88%, on average, relative to the reference cigarette.

HPHCsUnitsReference Cigarette Mean [2]

THS 2.2

Mean

THS 2.2

Standard Deviation

THS 2.2

Sample size

THS 2.2

Reduction vs

ref. cigarette [3]

Nicotinemg/cig0.6720.4190.034860- [4]
Formaldehydeµg/cig2612.30.3792153%
Ammoniaµg/cig10.42.530.4032176%
Acetaldehydeµg/cig6031296.982179%
Acroleinµg/cig54.44.450.3772192%
N-Nitrosonornicotine (NNN)ng/cig1043.540.5182197%
4-(Methyl-nitrosamino)-1-(3-pyridyl)-1-butanone (NNK)ng/cig1012.750.472197%
Tolueneµg/cig32.80.5410.07732198.00%
Benzeneµg/cig25.10.1730.02212199%
Isopreneµg/cig3150.7720.1052199.80%
Crotonaldehydeµg/cig12<LOQ[5]*[6]21> 73%
Benzo[a]pyreneng/cig5.330.36[7]*21> 93%
Carbon monoxide (CO)mg/cig10.8<LOQ[8]*60> 98%
Acrylonitrileµg/cig6.07<LOQ[9]*21> 98%
4-Aminobiphenylng/cig1.350.005[10]*21> 99.6%
1-Aminonaphthaleneng/cig10.7<LOQ[11]*21> 99.7%
1,3-butadieneµg/cig34.50.0998[12]*21> 99.7%
2-Aminonaphthaleneng/cig8.68<LOQ[13]*21> 99.9%

 

Note: The limit of quantification (LOQ) is the level below which the testing apparatus cannot reliably measure the levels of certain constituents. The level of detection (LOD) is the level below which the testing apparatus cannot reliably detect the presence of certain constituents. In these situations, factors such as environmental contamination, laboratory reagents, and even the chemical composition of the tobacco leaf used in a product may trigger variations in the constituent levels. Constituents in this section, whilst they may be detected and/or quantifiable in one study, may not be detected and/or quantified in others.

 

 

[1] Labstat International ULC is an independent ISO 17025 accredited laboratory in Kitchener, Ontario, Canada.

[2] Average value determined over 3 independent studies.

[3] The 3R4F reference cigarette is a standard cigarette used for research purposes. Reference cigarettes are managed by the Center for Tobacco Reference Products at the University of Kentucky. Read more at https://ctrp.uky.edu/.

[4] THS2.2 is designed as an acceptable alternative for adult smokers, who could otherwise continue to smoke cigarettes. It therefore delivers similar level of nicotine.

[5] 100% of values below the limit of quantification.

[6] A ‘* ‘in place of standard deviation indicates the constituent levels for some or all replicates were below the limit of quantification (LOQ) of the analytical method. In these cases the median is reported instead of the mean.

[7] 43% of values below the limit of quantification. Median reported in place of the mean.

[8] 92% of values below the limit of quantification.

[9] 100% of values below the limit of quantification.

[10] 38% of values below the limit of quantification. Median reported in place of the mean.

[11] 100% of values below the limit of quantification.

[12] 24% of values below the limit of quantification. Median reported in place of the mean.

[13] 76% of values below the limit of quantification.