We conducted laboratory studies to measure Harmful and Potentially Harmful Constituents in the inhalable aerosol of our Tobacco Heating System (THS) and compared them to the levels found in the smoke of a standard reference cigarette (3R4F). An average of 95% reduction of these HPHCs in THS' 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 with the levels found in smoke from a reference cigarette based on analyses performed by Labstat International ULC, an independent contract research organization. THS 2.2 is commercialized as IQOS in certain markets, while THS 3.0 is commercialized as Iluma in markets where it is available.

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 for THS 2.2

 

Yields obtained under the Health Canada Intense Testing regime show that in the laboratory, the levels of HPHCs in THS 2.2 aerosol were reduced by 95%, 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.

HPHCs/AnalytesUnitRef. cigarette meanTHS 2.2 meanTHS 2.2 SDTHS 2.2 nReduction vs ref. cigarette
Collected Mass (ACM) [mg/stk] 44.949.81.439
Nicotine [mg/stk] 1.861.210.04939
Glycerol [mg/stk] 2.263.530.1999
Carbon monoxide (CO) [mg/stk] 30.20.4470.0893998.50%
1,3-Butadiene [μg/stk] 98.50.2330.0185999.80%
Isoprene [μg/stk] 8941.750.148999.80%
Formaldehyde [μg/stk] 85.28.891.17989.60%
Acetaldehyde [μg/stk] 164121522.5986.90%
Acrolein [μg/stk] 15611.82.61992.40%
Butyraldehyde [μg/stk] 83.519.41.53976.80%
Acetamide [μg/stk] 12.93.580.172972.20%
Acrylamide [μg/stk] 4.461.390.06968.80%
Acrylonitrile [μg/stk] 24.50.115*7 9<LOQ8 
3-Aminobiphenyl [ng/stk] 4.180.00549<LOQ 
4-Aminobiphenyl [ng/stk] 2.830.00829<LOQ 
Pyridine [μg/stk] 29.76.480.504978.20%
Ammonia [μg/stk] 29.310.20.552965.20%
Benzene [μg/stk] 81.10.5330.0198999.30%
Toluene [μg/stk] 1371.80.11998.70%
N-Nitrosonornicotine (NNN) [ng/stk] 28312.30.869995.70%
4-(Methyl-nitrosamino)-1-(3-pyridyl)-1-butanone (NNK) [ng/stk] 2648.720.554996.70%
Phenol [μg/stk] 140.6730.14995.20%
Benzo[a]pyrene [ng/stk] 150.6210.0317995.90%
Acetone [μg/stk] 69036.14.7994.80%
Crotonaldehyde [μg/stk] 50.5<3.29 9<LOQ 
Propionaldehyde [μg/stk] 12314.22.19988.50%
Methyl-ethyl-ketone (MEK) [μg/stk] 1858.441.41995.40%
Ethylene oxide [μg/stk] 22.70.1550.0114999.30%
Propylene oxide [ng/stk] 11031335.08987.90%
Nitro benzene [μg/stk] <0.038 <0.011 9<LOQ 
1-Aminonaphthalene [ng/stk] 21.6<0.027 9<LOQ 
2-Aminonaphthalene [ng/stk] 16.2<0.012 9<LOQ 
o-Toluidine [ng/stk] 1050.6960.0689999.30%
Quinoline [μg/stk] 0.431<0.011 9<LOQ 
Vinyl chloride [ng/stk] 103<2.19 9<LOQ 
Nitric oxide (NO) [μg/stk] 50414.41.81997.10%
Nitrogen oxides (NOx) [μg/stk] 56015.82.29997.20%
Hydrogen cyanide [μg/stk] 3652.330.6999.40%
Styrene [μg/stk] 15.40.4290.0333997.20%
N-nitrosoanabasine (NAB) [ng/stk] 30.23.450.173988.60%
N-nitrosoanatabine (NAT) [ng/stk] 27023.71.94991.20%
Catechol [μg/stk] 89.814.90.869983.40%
m-Cresol [μg/stk] 3.51<0.019 9<LOQ 
p-Cresol [μg/stk] 8.63<0.034 9<LOQ 
o-Cresol [μg/stk] 4.150.02849<LOQ 
Hydroquinone [μg/stk] 89.15.120.647994.30%
Resorcinol [μg/stk] 1.79<0.016 9<LOQ 
Benz[a]anthracene [ng/stk] 27.11.480.13994.50%
Dibenz[a,h]anthracene [ng/stk] 0.853<0.124 9<LOQ 
Pyrene [ng/stk] 81.87.560.296990.80%
Arsenic [ng/stk] 7.9<0.75 9<LOQ 
Cadmium [ng/stk] 92.9<0.075 9<LOQ 
Chromium [ng/stk] <11 <2.5 9<LOQ 
Lead [ng/stk] 32.1<0.5 9<LOQ 
Mercury [ng/stk] 4.771.80.269962.30%
Nickel [ng/stk] <15.9 <5 9<LOQ 
Selenium [ng/stk] 1.95<0.4 9<LOQ 

 

* 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.

 

Health Canada Intense Testing Regime for THS 3.0

 

Yields obtained under the Health Canada Intense Testing regime show that in the laboratory, the levels of HPHCs in THS 2.2 aerosol were reduced by 95%, 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 3.0, the vent blocking does not apply as the ventilation holes are not accessible to the consumer during product use.  The holes are essential for the aerosol formation for THS 3.0: air intake through these holes provides the conditions necessary for the formation of aerosol droplets through condensation. 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.

HPHCs/AnalytesUnitRef. cigarette meanTHS 3.0 meanTHS 3.0 SDTHS 3.0 nReduction vs ref. cigarette
Collected Mass (ACM) [mg/stk] 44.947.51.329
Nicotine [mg/stk] 1.861.070.02189
Glycerol [mg/stk] 2.263.870.1619
Carbon monoxide (CO) [mg/stk] 30.20.3240.0501998.90%
1,3-Butadiene [μg/stk] 98.50.140.0162999.90%
Isoprene [μg/stk] 8941.540.154999.80%
Formaldehyde [μg/stk] 85.29.030.448989.40%
Acetaldehyde [μg/stk] 16411585.28990.40%
Acrolein [μg/stk] 1567.950.393994.90%
Butyraldehyde [μg/stk] 83.514.10.585983.10%
Acetamide [μg/stk] 12.92.040.19984.20%
Acrylamide [μg/stk] 4.460.7730.0656982.70%
Acrylonitrile [μg/stk] 24.5<0.107 9<LOQ 
3-Aminobiphenyl [ng/stk] 4.180.00419<LOQ 
4-Aminobiphenyl [ng/stk] 2.830.00539<LOQ 
Pyridine [μg/stk] 29.74.770.336983.90%
Ammonia [μg/stk] 29.3100.329965.90%
Benzene [μg/stk] 81.10.3480.0273999.60%
Toluene [μg/stk] 1371.080.0462999.20%
N-Nitrosonornicotine (NNN) [ng/stk] 28310.60.847996.30%
4-(Methyl-nitrosamino)-1-(3-pyridyl)-1-butanone (NNK) [ng/stk] 2648.950.708996.60%
Phenol [μg/stk] 140.9890.0514992.90%
Benzo[a]pyrene [ng/stk] 150.60.057996.00%
Acetone [μg/stk] 69025.41.12996.30%
Crotonaldehyde [μg/stk] 50.5<3.29 9<LOQ 
Propionaldehyde [μg/stk] 1238.830.486992.80%
Methyl-ethyl-ketone (MEK) [μg/stk] 1855.420.302997.10%
Ethylene oxide [μg/stk] 22.70.1650.00188999.30%
Propylene oxide [ng/stk] 11031229.83988.90%
Nitro benzene [μg/stk] <0.038 <0.011 9<LOQ 
1-Aminonaphthalene [ng/stk] 21.6<0.027 9<LOQ 
2-Aminonaphthalene [ng/stk] 16.2<0.012 9<LOQ 
o-Toluidine [ng/stk] 1050.8870.038999.20%
Quinoline [μg/stk] 0.431<0.011 9<LOQ 
Vinyl chloride [ng/stk] 103<0.657 9<LOQ 
Nitric oxide (NO) [μg/stk] 5048.950.528998.20%
Nitrogen oxides (NOx) [μg/stk] 5609.80.642998.20%
Hydrogen cyanide [μg/stk] 3652.620.241999.30%
Styrene [μg/stk] 15.40.2590.0279998.30%
N-nitrosoanabasine (NAB) [ng/stk] 30.22.570.322991.50%
N-nitrosoanatabine (NAT) [ng/stk] 27018.21.91993.30%
Catechol [μg/stk] 89.88.440.598990.60%
m-Cresol [μg/stk] 3.510.01989<LOQ 
p-Cresol [μg/stk] 8.630.04540.00607999.50%
o-Cresol [μg/stk] 4.150.04760.00458998.90%
Hydroquinone [μg/stk] 89.15.50.491993.80%
Resorcinol [μg/stk] 1.79<0.016 9<LOQ 
Benz[a]anthracene [ng/stk] 27.11.280.13995.30%
Dibenz[a,h]anthracene [ng/stk] 0.853<0.124 9<LOQ 
Pyrene [ng/stk] 81.85.260.484993.60%
Arsenic [ng/stk] 7.9<0.75 9<LOQ 
Cadmium [ng/stk] 92.9<0.075 9<LOQ 
Chromium [ng/stk] <11 <2.5 9<LOQ 
Lead [ng/stk] 32.1<0.5 9<LOQ 
Mercury [ng/stk] 4.771.620.166966.00%
Nickel [ng/stk] <15.9 <5 9<LOQ 
Selenium [ng/stk] 1.95<0.4 9<LOQ 

 

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.