1

Programmatic Environmental Assessment for

Marketing Orders for

New Heated Tobacco Products

Manufactured by

Philip Morris Products S.A.

Prepared by Center for Tobacco Products

U.S. Food and Drug Administration

April 25, 2022
2

Table of Contents

1. Introduction .....................................................................................................................................3

1.1 Background .........................................................................................................................3

1.2 Applicant and Manufacturer Information ..........................................................................3

1.3 Product Information ...........................................................................................................3

2. The Need and Purpose for the Proposed Actions............................................................................4

3. Proposed Actions and Alternatives..................................................................................................4

4. Potential Environmental Impacts of the Proposed Actions and Alternatives – Manufacturing the 

New Products...................................................................................................................................4

5. Potential Environmental Impacts of the Proposed Actions and Alternatives – Use of the New 

Products...........................................................................................................................................5

5.1. Affected Environment.........................................................................................................5

5.2. Air Quality ...........................................................................................................................5

5.3. Environmental Justice.........................................................................................................6

5.4. Impacts from the No-Action Alternative ............................................................................6

6. Potential Environmental Impacts of the Proposed Actions and Alternatives – Disposal of the New 

Products...........................................................................................................................................6

6.1. Affected Environment.........................................................................................................6

6.2. Air Quality ...........................................................................................................................7

6.3. Biological Resources ...........................................................................................................7

6.4. Water Resources and Water Quality ..................................................................................7

6.5. Solid Waste and Hazardous Materials................................................................................8

6.6. Socioeconomics and Environmental Justice .......................................................................8

6.7. Impacts from the No-Action Alternative ............................................................................8

7. List of Preparers...............................................................................................................................9

8. A Listing of Agencies and Persons Consulted ..................................................................................9

9. References .......................................................................................................................................9

CONFIDENTIAL APPENDIX 1: Product Modifications .................................................................................12

CONFIDENTIAL APPENDIX 2: Comparability Aerosol Data..........................................................................13

CONFIDENTIAL APPENDIX 3: Market Volume Projections for the new and the authorized tobacco 

products.........................................................................................................................................19

CONFIDENTIAL APPENDIX 4: Heavy Metals within IQOS HeatSticks ..........................................................20

CONFIDENTIAL APPENDIX 5: Screening-level risk assessments of nicotine and heavy metals in IQOS 

HeatSticks for aquatic animals.......................................................................................................21


5

5. Potential Environmental Impacts of the Proposed Actions and Alternatives – Use of the New 

Products

Euromonitor reports show that in 2020, the retail value of heated tobacco products in the United 

states was approximately 21 million dollars accounting for a miniscule proportion of the tobacco 

product retail market. The retail value of HTPs is forecasted to grow to approximately 6.1 billion dollars 

by 2025 (Euromonitor International Ltd, 2021). HTP consumption in the United States to date has been 

modest compared to cigarettes, with consumption increasing from 12.3 million sticks in 2019 to 41.8 

million sticks in 2020 (Euromonitor International Ltd, 2021).

The Agency considered potential impacts to resources in the environment that could be affected by use

of the new IQOS HeatSticks and found no significant impacts based on Agency-gathered information and 

the applicant’s submitted information. Included in the information the Agency considered were - (1) 

potential impacts of the proposed action and no action, from product use discussed in the 

environmental assessment for the authorized IQOS HeatSticks (Marlboro Amber HeatStick; 

PM0000424); (2) the changes in the new IQOS HeatSticks in comparison to the authorized IQOS 

HeatSticks (Confidential Appendix 1); (3) comparison of mainstream aerosol data from the new and the 

authorized IQOS HeatSticks (Confidential Appendix 2); and (4) the projected market volumes 

(Confidential Appendix 3) for the first- and fifth year of marketing of the new IQOS HeatSticks.

5.1. Affected Environment

The affected environment includes human and natural environments in the United States because the 

marketing orders would allow for the new HeatSticks to be sold to consumers in the United States.

5.2. Air Quality

The Agency does not anticipate the release of new chemicals into the environment as a result of use of 

the new IQOS HeatSticks, relative to chemicals released into the environment due to use of other 

heated tobacco products already on the market because (1) the new IQOS HeatSticks consists of minor 

modifications to the authorized IQOS HeatSticks (Confidential Appendix 1); (2) the new IQOS HeatSticks

are similar to the authorized IQOS HeatSticks in terms of their chemical composition and constituents in 

mainstream aerosol emissions (Confidential Appendix 2); (3) the new IQOS HeatSticks are intended to 

compete with other currently marketed HTPs. 

The impacts from use of heated tobacco products include second and thirdhand aerosol exposure.

Secondhand aerosol is created when a HTP user exhales mainstream aerosol into the environment

(Hirano & Takei, 2020). Thirdhand aerosol is created when a HTP aerosol is inhaled and the chemicals in 

the vapor, exhaled by the user, deposit on surrounding surfaces. Available evidence indicate that HTP 

aerosols exposed users and bystanders to toxicants and affected indoor air quality, with potential health 

implications (Cancelada et al., 2019; Hirano & Takei, 2020; Ruprecht et al., 2017; Simonavicius et al., 

2019). However, more research is needed to determine the health implications that secondhand and 

thirdhand exposure from HTP aerosol has on public and environmental health (Hirano & Takei, 2020, 

2020; Ruprecht et al., 2017). 

Studies on aerosols of Marlboro HeatSticks showed that IQOS aerosols are free from metal emissions, in 

contrast to combustible cigarettes (Ruprecht et al., 2017). When using the non-mentholated HeatSticks, 

no systematic increase in the total volatile organic compounds above background concentrations was 
6

observed. Further, airborne compounds measured, other than nicotine, acetaldehyde and glycerin, 

remained below the reporting limits or at background levels (Mitova et al., 2016). 

The applicant submitted a comparison of the aerosol emissions in the new and authorized IQOS 

HeatSticks (Confidential Appendix 2). Negligible amounts of constituents change in the aerosols 

generated in the new IQOS HeatSticks compared with the authorized IQOS HeatSticks. Additionally, 

although there is a reduction in mainstream aerosol harmful and potentially harmful constituents 

(HPHCs), certain constituents, such as propylene glycol, butyrolactone, pyranone, and 2-furanmethanol, 

not listed on FDA’s HPHC list, had higher levels in IQOS HeatSticks when compared with a reference 

cigarette (St.Helen et al., 2018).

5.3. Environmental Justice

There are few available studies describing HTP use among Environmental Justice (EJ) populations.

National Youth Tobacco Survey data for 2019 and 2020 indicate that HTP product awareness and ever 

use did not differ by the race/ethnicity of middle school and high school students (Dai, 2020); however, 

current HTP-use prevalence was higher among Hispanic school students compared to non-Hispanic 

Whites (Dai, 2020; Gentzke et al., 2020). Among adults, 2019 Tobacco Use Supplement to the Current 

Population Survey data indicates that HTP product awareness and ever use did not differ based on 

race/ethnicity, income levels or education attainment (Azagba & Shan, 2021). Overall, these findings do 

not indicate disproportionately high HTP use prevalence among minorities and low-income groups. 

Therefore, the agency does not anticipate potential disproportionate environmental impacts on EJ 

populations from using the new IQOS HeatSticks.

5.4. Impacts from the No-Action Alternative

The environmental impacts of the no-action alternative would not change the existing condition of use 

of HTP because the authorized IQOS HeatSticks and many similar tobacco products would continue to be 

used in the United States.

6. Potential Environmental Impacts of the Proposed Actions and Alternatives – Disposal of the 

New Products

The Agency considered potential impacts to resources in the environment that could be affected by the 

disposal of the new IQOS HeatSticks and found no significant impacts based on Agency-gathered 

information and the applicant’s submitted information. Included in the information the Agency 

considered were - (1) potential impacts of the proposed action and no action, from product disposal 

discussed in the environmental assessment for the authorized IQOS HeatSticks (Marlboro HeatStick; 

PM0000424); (2) the changes in the new IQOS HeatSticks in comparison to the authorized IQOS

HeatSticks (Confidential Appendix 1); (3) comparison of heavy metals measured in the cast leaf of the 

new and authorized IQOS HeatSticks (Confidential Appendix 4); (4) the projected market volumes for the 

first- and fifth year of marketing of the new IQOS HeatSticks (Confidential Appendix 3); and (5) results of 

screening-level assessment of the cumulative acute toxicity risks to aquatic organisms from nicotine and 

heavy metals of concern in the new and authorized IQOS HeatSticks (Confidential Appendix 5).

6.1. Affected Environment

The affected environment includes human and natural environments in the United States because the 

marketing orders would allow for the new IQOS HeatSticks to be sold to consumers nationwide who 
7

would dispose of the used products and packaging as municipal solid waste (MSW), recycled material, or 

litter.

6.2. Air Quality

The Agency does not anticipate disposal of the new IQOS HeatSticks or the packaging material would 

lead to the release of new or increased chemicals into the air.

Studies describing air quality impacts from disposal of used heatsicks are currently not available. 

However, similar to cigarette butts, discarded heatstick may emit toxic chemicals such as nicotine into 

the air (Gong et al., 2017, 2020; Poppendieck et al., 2020). Airborne emissions from cigarette butts after 

disposal depend on the environmental conditions and the chemicals in the butts (Poppendieck et al., 

2020) as well as other factors, such as the cigarette brand, cigarette length, filter material, filler, 

ingredients in the cigarette, number of puffs, and the mass transfer behavior of combustion products 

along the cigarette (Gong et al., 2017). 

The Agency does not anticipate disposal of the new IQOS HeatSticks or the packaging material would 

lead to the release of new or increased chemicals into the air. No changes in air quality from disposal of 

the packaging materials in the new IQOS HeatSticks would be expected because (1) the paper and 

plastic components of the packages are more likely to be recycled or at least a portion of the packaging 

waste is likely to be recycled, (2) the packaging materials are commonly used in the United States, and 

(3) the waste generated due to disposal of the packaging is a minuscule portion of the MSW based on 

the projected market volume of the new IQOS HeatSticks.

6.3. Biological Resources

The proposed actions are not expected to change the continued existence of any endangered species or 

result in the destruction or adverse modification of the habitat of any such species, as prohibited under 

the U.S. Endangered Species Act. Proper disposal of the used new IQOS HeatSticks and packaging into 

MSW would not affect biological resources. If improper disposal as litter occurs, the new IQOS 

HeatSticks are not expected to result in new or additional compounds emitted to the environment. 

Unlike combusted tobacco products, smoldering of used products is not a major concern with disposal 

of the new IQOS HeatSticks. Therefore, the risk of fires from smoldering tobacco products and 

associated impacts to natural environments from littering are negligible. The Agency does not anticipate 

disposal of the new IQOS HeatSticks or the packaging material would lead to significant impacts on 

biological resources.

6.4. Water Resources and Water Quality

Proper disposal of the used new IQOS HeatSticks and packaging into MSW would not affect water 

resources and water quality. If improper disposal as litter occurs, the leaching of metals and nicotine 

poses a concern for potential impacts on aquatic organisms and water resources (Baran et al., 2019; 

Beutel et al., 2021; Koutela et al., 2020). Toxic compounds in littered HeatSticks can leach out into 

water, potentially threatening human health and the environment, especially marine ecosystems.

Recent literature shows a range of chemical constituents including metals such as chromium and lead 

leach from used HeatSticks and exhibit high toxicity to certain aquatic organisms (Baran et al., 2019; 

Koutela et al., 2020).
8

The Agency conducted a screening-level assessment of the cumulative acute toxicity risks to aquatic 

organisms from nicotine and heavy metals of concern in the new and authorized IQOS HeatSticks. The 

agency calculated Risk Quotients (RQ) from estimated aquatic expected environmental concentrations 

(EEC) of the chemicals of concern and their lowest acute toxicity endpoint values (Confidential Appendix 

5). The RQ values are several orders of magnitude lower than the Level of Concern for acute risks (high, 

restricted use or endangered species) to aquatic animals (US EPA, 2015) (Confidential Appendix 5). 

Based on the screening-level risk assessment, nicotine and heavy metals in the HeatSticks do not pose 

risks to aquatic animals. Therefore, no significant impacts on water resources and water quality from the 

disposal of new IQOS HeatSticks are expected.

6.5. Solid Waste and Hazardous Materials

Like cigarette butts, littered HeatSticks may present environmental effects from heated or unheated 

tobacco, filter and other polymer components. Used HeatSticks consist of heated tobacco, polymer, 

paper, and filters containing low-density cellulose acetate similar to conventional cigarettes (Schaller et 

al., 2016; Smith et al., 2016).

Concentrations of metals leaching out of HeatSticks are similar between unheated and heated tobacco,

and less than unused combustible cigarettes (Koutela et al., 2020). Particularly, chromium, arsenic 

cadmium, mercury, selenium, and lead, listed as hazardous constituents per the Resource Conservation 

and Recovery Act (40 C.F.R. § 261. Identification and Listing of Hazardous Waste, 2020) are found in the 

IQOS HeatStick and in negligible concentrations in the leachate from used HeatSticks (Koutela et al., 

2020). The Agency anticipates that the potential exposure of heavy metals from the disposal of the new 

tobacco products would be comparable to the authorized IQOS HeatSticks (Confidential Appendix 4).

Additionally, the Agency does not anticipate that new chemicals would be released into the 

environment as a result of disposal of the new IQOS HeatSticks because (1) the new IQOS HeatSticks

consists of minor modifications to the authorized IQOS HeatSticks; (2) the IQOS HeatSticks are intended 

to compete with other marketed HTPs.

The Agency does not foresee that the introduction of the new IQOS HeatSticks into the U.S. market 

would notably affect the nationwide waste generated from the use of HTP. The distribution of waste 

generated due to disposal of the new IQOS HeatSticks and packaging is anticipated to correspond to the 

pattern of the products use in the United States. Therefore, no significant environmental impacts due to 

solid waste and hazardous materials introduced from the disposal of new IQOS HeatSticks are expected.

6.6. Socioeconomics and Environmental Justice

The Agency does not anticipate changes in impacts on socioeconomic conditions or environmental 

justice from disposal of the new IQOS HeatSticks. The waste generated due to disposal of the new IQOS 

HeatSticks would be handled in the same manner as the waste generated from disposal of other HTP

products in the United States. No new emissions or effluents are expected due to disposal of the new

IQOS HeatSticks; therefore, there would be no disproportionate impacts on EJ populations.

6.7. Impacts from the No-Action Alternative

The environmental impacts of the no-action alternative would not change the existing condition of 

disposal of HTP products and their packaging, as the authorized IQOS HeatSticks and many other similar 

HTP products would continue to be disposed of in the United States.
9

7. List of Preparers

The following individuals were primarily responsible for preparing and reviewing this programmatic 

environmental assessment:

Preparer:

Dilip Venugopal, Ph.D., Center for Tobacco Products 

Education: M.S. in Ecology and Ph.D. in Entomology

Experience: Eighteen years in various scientific activities 

Expertise: NEPA analysis, environmental impact analysis and risk assessment, environmental health 

and justice, applied ecology, geo-statistics

Reviewer:

Susana Addo Ntim, Ph.D., Center for Tobacco Products

Education: Ph.D. in Environmental Science

Experience: Nine years in various scientific activities

Expertise: NEPA analysis; fate, transport, and ecotoxicology of new and emerging 

contaminants; applications and environmental implications of nanotechnology

8. A Listing of Agencies and Persons Consulted

Not applicable.

9. References

Azagba, S., & Shan, L. (2021). Heated tobacco products: Awareness and ever use among U.S. adults. 

American Journal of Preventive Medicine, 60(5), 684–691. 

https://doi.org/10.1016/j.amepre.2020.11.011

Baran, W., Madej-Knysak, D., Sobczak, A., & Adamek, E. (2019). The influence of waste from electronic 

cigarettes, conventional cigarettes and heat-not-burn tobacco products on microorganisms. 

Journal of Hazardous Materials, 121591. https://doi.org/10.1016/j.jhazmat.2019.121591

Beutel, M. W., Harmon, T. C., Novotny, T. E., Mock, J., Gilmore, M. E., Hart, S. C., Traina, S., Duttagupta, 

S., Brooks, A., Jerde, C. L., Hoh, E., Van De Werfhorst, L. C., Butsic, V., Wartenberg, A. C., & 

Holden, P. A. (2021). A review of environmental pollution from the use and disposal of cigarettes 

and electronic cigarettes: contaminants, sources, and impacts. Sustainability, 13(23), 12994. 

https://doi.org/10.3390/su132312994

Cancelada, L., Sleiman, M., Tang, X., Russell, M. L., Montesinos, V. N., Litter, M. I., Gundel, L. A., & 

Destaillats, H. (2019). Heated tobacco products: Volatile emissions and their predicted impact 

on indoor air quality. Environmental Science & Technology, 53(13), 7866–7876. 

https://doi.org/10.1021/acs.est.9b02544

Dai, H. (2020). Heated tobacco product use and associated factors among U.S. youth, 2019. Drug and 

Alcohol Dependence, 214, 108150. https://doi.org/10.1016/j.drugalcdep.2020.108150
10

Euromonitor International Ltd. (2021). Market share of tobacco products by retail value. 

https://www.euromonitor.com/tobacco-in-the-us/report

Gentzke, A. S., Wang, T. W., Jamal, A., Park-Lee, E., Ren, C., Cullen, K. A., & Neff, L. (2020). Tobacco 

product use among middle and high school students — United States, 2020. Morbidity and 

Mortality Weekly Report, 69(50), 1881–1888. https://doi.org/10.15585/mmwr.mm6950a1

Gong, M., Daniels, N., & Poppendieck, D. (2020). Measurement of chemical emission rates from 

cigarette butts into air. Indoor Air, 30(4), 711–724. https://doi.org/10.1111/ina.12648

Gong, M., Khurshid, S., & Poppendieck, D. (2017). What’s in a butt? Environmental contamination from 

airborne cigarette butt emissions. Integrated Environmental Assessment and Management, 

13(3), 549–551. https://doi.org/10.1002/ieam.1892

Hirano, T., & Takei, T. (2020). Estimating the carcinogenic potency of second-hand smoke and aerosol 

from cigarettes and heated tobacco products. International Journal of Environmental Research 

and Public Health, 17(22), 8319. https://doi.org/10.3390/ijerph17228319

40 C.F.R. § 261. Identification and Listing of Hazardous Waste, (2020). https://www.ecfr.gov/cgibin/text-idx?tpl=/ecfrbrowse/Title40/40cfr261_main_02.tpl

Koutela, N., Fernández, E., Saru, M.-L., & Psillakis, E. (2020). A comprehensive study on the leaching of 

metals from heated tobacco sticks and cigarettes in water and natural waters. Science of The 

Total Environment, 714, 136700. https://doi.org/10.1016/j.scitotenv.2020.136700

Mitova, M. I., Campelos, P. B., Goujon-Ginglinger, C. G., Maeder, S., Mottier, N., Rouget, E. G. R., Tharin, 

M., & Tricker, A. R. (2016). Comparison of the impact of the Tobacco Heating System 2.2 and a 

cigarette on indoor air quality. Regulatory Toxicology and Pharmacology, 80, 91–101. 

https://doi.org/10.1016/j.yrtph.2016.06.005

Poppendieck, D., Gong, M., & Pham, V. (2020). Influence of temperature, relative humidity, and water 

saturation on airborne emissions from cigarette butts. Science of The Total Environment, 712, 

136422. https://doi.org/10.1016/j.scitotenv.2019.136422

Ruprecht, A. A., De Marco, C., Saffari, A., Pozzi, P., Mazza, R., Veronese, C., Angellotti, G., Munarini, E., 

Ogliari, A. C., Westerdahl, D., Hasheminassab, S., Shafer, M. M., Schauer, J. J., Repace, J., Sioutas, 

C., & Boffi, R. (2017). Environmental pollution and emission factors of electronic cigarettes, 

heat-not-burn tobacco products, and conventional cigarettes. Aerosol Science and Technology, 

51(6), 674–684. https://doi.org/10.1080/02786826.2017.1300231

Schaller, J.-P., Pijnenburg, J. P. M., Ajithkumar, A., & Tricker, A. R. (2016). Evaluation of the tobacco 

heating system 2.2. Part 3: Influence of the tobacco blend on the formation of harmful and 

potentially harmful constituents of the tobacco heating system 2.2 aerosol. Regulatory

Toxicology and Pharmacology, 81, S48–S58. https://doi.org/10.1016/j.yrtph.2016.10.016

Simonavicius, E., McNeill, A., Shahab, L., & Brose, L. S. (2019). Heat-not-burn tobacco products: a 

systematic literature review. Tobacco Control, 28(5), 582–594. 

https://doi.org/10.1136/tobaccocontrol-2018-054419
11

Smith, M. R., Clark, B., Lüdicke, F., Schaller, J.-P., Vanscheeuwijck, P., Hoeng, J., & Peitsch, M. C. (2016). 

Evaluation of the tobacco heating system 2.2. Part 1: Description of the system and the scientific 

assessment program. Regulatory Toxicology and Pharmacology, 81, S17–S26. 

https://doi.org/10.1016/j.yrtph.2016.07.006

St.Helen, G., Iii, P. J., Nardone, N., & Benowitz, N. L. (2018). IQOS: examination of Philip Morris 

International’s claim of reduced exposure. Tobacco Control, 27(Suppl 1), s30–s36. 

https://doi.org/10.1136/tobaccocontrol-2018-054321

US EPA. (2015, August 3). Technical overview of ecological risk assessment: Risk characterization [Other 

Policies and Guidance]. US EPA. https://www.epa.gov/pesticide-science-and-assessingpesticide-risks/technical-overview-ecological-risk-assessment-risk

13

CONFIDENTIAL APPENDIX 2: Comparability Aerosol Data

The applicant submitted a comparison of mainstream aerosols generated by the user in the new and authorized IQOS HeatSticks presented in the 

tables below.

A. Comparison of Marlboro Sienna HeatSticks and Amber Authorized HeatSticks

HPHCs/Analytes Unit

Marlboro Sienna HeatSticks Marlboro Amber HeatSticks 

("Authorized HeatSticks")

% HPHCs Difference 

Marlboro Sienna Vs. 

Marlboro Amber 

HeatSticks” 

(“Authorized 

HeatSticks”)

Mean SD n Mean SD n

1,3-Butadiene μg/cig 0.199 0.0321 9 0.207 0.016 3 -3.86

1-Aminonaphthalene ng/cig 0.0356 0.007 9 0.0427 0.00513 3 -16.63

2-Aminonaphthalene ng/cig <0.012 NA* 9 0.0223 0.00321 3 -46.19

3-Aminobiphenyl ng/cig 0.00871 0.00176 9 0.007 0.003 3 24.43

4-(Methyl-nitrosamino)-1-(3-pyridyl)-1-

 (

ng/cig 7.09 0.808 9 7.8 0.423 3 -9.10

4-Aminobiphenyl ng/cig 0.00901 0.00178 9 0.0087 0.0012 3 3.56

Acetaldehyde μg/cig 214 9.79 9 192 11.6 3 11.46

Acetamide μg/cig 3.66 0.144 9 2.96 0.134 3 23.65

Acetone μg/cig 37.7 1.94 9 30.7 1.86 3 22.80

Acrolein μg/cig 9.62 0.892 9 8.32 0.755 3 15.63

Acrylamide μg/cig 1.73 0.104 9 1.58 0.0543 3 9.49

Acrylonitrile μg/cig 0.138 0.0111 9 0.145 0.0112 3 -4.83

Ammonia μg/cig 12.5 1.04 9 12.2 0.973 3 2.46

Arsenic ng/cig <1.2 NA 9 <0.36 (LOD) NA 3 233.33

Benz[a]anthracene ng/cig 1.67 0.187 9 2.65 0.0647 3 -36.98

Benzene μg/cig 0.527 0.012 9 0.452 0.0395 3 16.59
14

Benzo[a]pyrene ng/cig 0.656 0.06839 0.736 0.09733-10.87

Butyraldehyde μg/cig 20.6 0.8069 20.7 1.523-0.48

Cadmium ng/cig <0.09 NA9 <0.28 (LOQ) NA3-67.86

Carbon monoxide (CO) mg/cig 0.37 0.04389 0.347 0.04623 6.63

Catechol μg/cig 16.5 1.49 14 0.5223 17.86

Chromium ng/cig <3.31 NA9 <11.0 (LOQ) NA3-69.91

Crotonaldehyde μg/cig <3.29 NA9 <3.29 (LOQ) NA3 0.00

Dibenz[a,h]anthracene ng/cig <0.413 NA9 <0.124 (LOD) NA3 233.06

Ethylene oxide μg/cig 0.134 NA9 <0.119 (LOQ) NA3 12.61

Formaldehyde μg/cig 7.75 0.7229 14.1 0.433-45.04

Glycerol mg/cig 4.47 0.4349 5.02 0.1013-10.96

Hydrogen cyanide μg/cig 3.16 0.439 <1.75 (LOQ) NA3 80.57

Hydroquinone μg/cig 7.43 0.6789 6.55 0.4613 13.44

Isoprene μg/cig 2.04 0.1819 1.51 0.1293 35.10

Lead ng/cig <0.49 NA9 2.23 0.3513-78.03

m-Cresol μg/cig 0.027 0.005659 0.0424 0.00453-36.32

Mercury ng/cig 2.26 0.2079 1.38 0.1633 63.77

Methyl-ethyl-ketone (MEK) μg/cig 7.57 0.5499 10.1 0.7593-25.05

Nickel ng/cig <15.9 NA9 <15.9 (LOD) NA3 0.00

Nicotine mg/cig 1.31 0.07989 1.29 0.0473 1.55

Nitric oxide (NO) μg/cig 11.2 0.8479 12.6 0.4183-11.11

Nitro benzene μg/cig <0.011 NA9 <0.011 (LOD) NA3 0.00

Nitrogen oxides (NOx) μg/cig 12.4 0.8969 14.2 0.4133-12.68

N-nitrosoanabasine (NAB) ng/cig 2.86 0.3429 2.35 0.05893 21.70

N-nitrosoanatabine (NAT) ng/cig 19.1 2.289 14.7 1.253 29.93

N-Nitrosonornicotine (NNN) ng/cig 13.4 0.8119 10.1 0.2053 32.67
15

o-Cresol μg/cig 0.0499 0.00613 9 0.0779 0.0093 3 -35.94

o-Toluidine ng/cig 0.828 0.0396 9 1.1 0.0243 3 -24.73

p-Cresol μg/cig 0.0613 0.00889 9 0.0706 0.00816 3 -13.17

Phenol μg/cig 0.948 0.106 9 1.47 0.206 3 -35.51

Propionaldehyde μg/cig 13.3 0.907 9 10.8 0.675 3 23.15

Propylene oxide ng/cig 137 14 9 142.3 6.67 3 -3.72

Pyrene ng/cig 6.71 0.625 9 8.2 0.152 3 -18.17

Pyridine μg/cig 7.34 0.422 9 6.58 0.185 3 11.55

Quinoline μg/cig <0.011 NA 9 <0.011 NA 3 0.00

Resorcinol μg/cig <0.055 NA 9 <0.055 NA 3 0.00

Selenium ng/cig <0.83 NA 9 1.27 0.0577 3 -34.65

Styrene μg/cig 0.442 0.0302 9 0.577 0.0916 3 -23.40

Toluene μg/cig 1.63 0.038 9 1.42 0.162 3 14.79

Total Particulate Matter (TPM) mg/cig 52.5 1.35 9 50.9 2.9 3 3.14

Vinyl chloride ng/cig <2.19 NA 9 <0.657 (LOD) NA 3 233.33

Note 1: When the HPHCs yields for both IQOS System and the reference 3R4F reference cigarette are below LOD or LOQ, percent reductions are not calculated and 

NA(Not Applicable) are reported. For HPHCs below LOD or LOQ in the IQOS Systems, but not in the 3R4F reference cigarette, the percent reductions are calculated 

using the LOD or LOQ values, respectively. SD – standard deviation; n – sample size.

Note 2: * “NA” in place of standard deviation indicates the emissions levels for some or all replicates were below the limit of quantification (LOQ) of the analytical 

method. In these cases, instead of the mean, the median is reported for endpoints classified as being generally quantifiable, and the maximum value is reported 

for endpoints classified as being generally below the limit of quantification.

Note 3: ** 3R4F reference cigarette values from a research study (NS407) conducted in 2018 at Labstat International ULC
16

B. Comparison of Marlboro Bronze HeatSticks and Amber Authorized HeatSticks

HPHCs/ Analytes Unit

Marlboro Bronze HeatSticks Marlboro Amber HeatSticks” 

(“Authorized HeatSticks”) % HPHCs Difference 

Marlboro Bronze Vs. 

Marlboro Amber 

HeatSticks” 

(“Authorized 

HeatSticks”)

Mean SD n Mean SD n

1,3-Butadiene μg/cig 0.178 0.024 9 0.207 0.016 3 -14.01

1-Aminonaphthalene ng/cig 0.0327 NA* 9 0.0427 0.00513 3 -23.42

2-Aminonaphthalene ng/cig <0.012 NA 9 0.0223 0.00321 3 -46.19

3-Aminobiphenyl ng/cig 0.0074 0.00171 9 0.007 0.003 3 5.71

4-(Methyl-nitrosamino)-1-(3-pyridyl)-1- ng/cig 4.63 0.312 9 7.8 0.423 3 -40.64

4-Aminobiphenyl ng/cig 0.0094 0.00166 9 0.0087 0.0012 3 8.05

Acetaldehyde μg/cig 210 9.98 9 192 11.6 3 9.38

Acetamide μg/cig 3.32 0.106 9 2.96 0.134 3 12.16

Acetone μg/cig 36.8 2.25 9 30.7 1.86 3 19.87

Acrolein μg/cig 9.22 0.88 9 8.32 0.755 3 10.82

Acrylamide μg/cig 1.62 0.056 9 1.58 0.0543 3 2.53

Acrylonitrile μg/cig 0.119 NA 9 0.145 0.0112 3 -17.93

Ammonia μg/cig 10.6 1.44 9 12.2 0.973 3 -13.11

Arsenic ng/cig <1.2 NA 9 <0.36 (LOD) NA 3 233.33

Benz[a]anthracene ng/cig 2.07 0.0823 9 2.65 0.0647 3 -21.89

Benzene μg/cig 0.491 0.0453 9 0.452 0.0395 3 8.63

Benzo[a]pyrene ng/cig 0.75 0.0512 9 0.736 0.0973 3 1.90

Butyraldehyde μg/cig 21.1 0.762 9 20.7 1.52 3 1.93

Cadmium ng/cig <0.09 NA 9 <0.28 (LOQ) NA 3 -67.86
17

Carbon monoxide (CO) mg/cig 0.379 0.0439 9 0.347 0.0462 3 9.22

Catechol μg/cig 16.4 0.885 9 14 0.522 3 17.14

Chromium ng/cig <3.31 NA 9 <11.0 (LOQ) NA 3 -69.91

Crotonaldehyde μg/cig <3.29 NA 9 <3.29 (LOQ) NA 3 0.00

Dibenz[a,h]anthracene ng/cig <0.413 NA 9 <0.124 (LOD) NA 3 233.06

Ethylene oxide μg/cig <0.119 NA 9 <0.119 (LOQ) NA 3 0.00

Formaldehyde μg/cig 7.5 0.585 9 14.1 0.43 3 -46.81

Glycerol mg/cig 4.62 0.581 9 5.02 0.101 3 -7.97

Hydrogen cyanide μg/cig 2.5 0.593 9 <1.75 (LOQ) NA 3 42.86

Hydroquinone μg/cig 7.39 0.47 9 6.55 0.461 3 12.82

Isoprene μg/cig 1.66 0.135 9 1.51 0.129 3 9.93

Lead ng/cig <1.62 NA 9 2.23 0.351 3 -27.35

m-Cresol μg/cig 0.0256 0.00392 9 0.0424 0.0045 3 -39.62

Mercury ng/cig 2.04 0.0864 9 1.38 0.163 3 47.83

Methyl-ethyl-ketone (MEK) μg/cig 7.72 0.548 9 10.1 0.759 3 -23.56

Nickel ng/cig <15.9 NA 9 <15.9 (LOD) NA 3 0.00

Nicotine mg/cig 1.32 0.108 9 1.29 0.047 3 2.33

Nitric oxide (NO) μg/cig 8.63 0.675 9 12.6 0.418 3 -31.51

Nitro benzene μg/cig <0.011 NA 9 <0.011 (LOD) NA 3 0.00

Nitrogen oxides (NOx) μg/cig 9.84 0.734 9 14.2 0.413 3 -30.70

N-nitrosoanabasine (NAB) ng/cig 2.05 0.23 9 2.35 0.0589 3 -12.77

N-nitrosoanatabine (NAT) ng/cig 13.1 1.27 9 14.7 1.25 3 -10.88

N-Nitrosonornicotine (NNN) ng/cig 4.83 0.319 9 10.1 0.205 3 -52.18

o-Cresol μg/cig 0.0506 0.00569 9 0.0779 0.0093 3 -35.04

o-Toluidine ng/cig 0.682 0.0729 9 1.1 0.0243 3 -38.00
18

p-Cresol μg/cig 0.0565 0.00893 9 0.0706 0.00816 3 -19.97

Phenol μg/cig 0.959 0.0892 9 1.47 0.206 3 -34.76

Propionaldehyde μg/cig 12.8 0.897 9 10.8 0.675 3 18.52

Propylene oxide ng/cig 133 12.3 9 142.3 6.67 3 -6.54

Pyrene ng/cig 7.85 0.307 9 8.2 0.152 3 -4.27

Pyridine μg/cig 7 0.399 9 6.58 0.185 3 6.38

Quinoline μg/cig <0.011 NA 9 <0.011 NA 3 0.00

Resorcinol μg/cig <0.055 NA 9 <0.055 NA 3 0.00

Selenium ng/cig <0.83 NA 9 1.27 0.0577 3 -34.65

Styrene μg/cig 0.434 0.0254 9 0.577 0.0916 3 -24.78

Toluene μg/cig 1.52 0.181 9 1.42 0.162 3 7.04

Total Particulate Matter (TPM) mg/cig 54.6 2.03 9 50.9 2.9 3 7.27

Vinyl chloride ng/cig <2.19 NA 9 <0.657 (LOD) NA 3 233.33

Note 1: When the HPHCs yieldsfor both IQOS Systemand the reference 3R4F reference cigarette are below LOD or LOQ, percentreductions are not calculated and NA

(NotApplicable) are reported. ForHPHCsbelowLODor LOQin the IQOS Systems,but notin the 3R4F reference cigarette,the percentreductions are calculated using the

LOD or LOQ values, respectively. SD – standard deviation; n – sample size.

Note 2: * “NA” in place of standard deviation indicates the emissions levels for some or all replicates were below the limit of quantification (LOQ) of the analytical 

method. In these cases instead of the mean, the median is reported for endpoints classified as being generally quantifiable, and the maximum value is reported for 

endpoints classified as being generally below the limit of quantification.

Note 3: ** 3R4F reference cigarette values from a research study (NS407) conducted in 2018 at Labstat International ULC

20

CONFIDENTIAL APPENDIX 4: Heavy Metals within IQOS HeatSticks

Summary of results of the heavy metals measured in the cast leaf of each single batch of Sienna and Bronze HeatSticks

Tobacco 

Constituent Unit

Marlboro Sienna - Batch# 1 Marlboro Sienna - Batch# 2 Marlboro Sienna - Batch# 3

Mean SD n Mean SD n Mean SD n

ng/g

ng/g

Tobacco 

Constituent Unit

Marlboro Bronze - Batch# 1 Marlboro Bronze - Batch# 2 Marlboro Bronze - Batch# 3

Mean SD n Mean SD n Mean SD n

[ng/g]

[ng/g]

Tobacco 

Constituent Unit

Marlboro Amber (“Authorized 

HeatSticks”) - Batch# 1

Marlboro Amber (“Authorized 

HeatSticks”) - Batch# 2

Marlboro Amber (“Authorized HeatSticks”) 

- Batch# 3

Average SD n Average SD n Average SD n

[ng/g]

[ng/g]

Note: Note: SD – standard deviation; n – sample size.

(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4)
21

CONFIDENTIAL APPENDIX 5: Screening-level risk assessments of nicotine and heavy metals in IQOS HeatSticks for aquatic animals

The agency calculated risk quotients for nicotine, cadmium, and arsenic using estimated aquatic expected introduction concentration (EIC) and acute 

toxicity endpoint data (EC50/LC50) as shown in the table below.

Chemical Product

Aquatic 

Environmental

Introduction 

Concentration (μg/L)1

Lowest Acute Toxicity 

Endpoint Value 

(EC50/LC50) (μg/L)2

Species Risk 

Quotient3

Marlboro Bronze HeatSticks

Marlboro Sienna HeatSticks

Marlboro Amber HeatSticks (Authorized product)

Total

Marlboro Bronze HeatSticks

Marlboro Sienna HeatSticks

Marlboro Amber HeatSticks (Authorized product)

Total

Marlboro Bronze HeatSticks

Marlboro Sienna HeatSticks

Marlboro Amber HeatSticks (Authorized product)

Total

1

Expected Introduction Concentration (EIC)-aquatic (ppb or μg/L)=A*B*C*D; where A=kg/yr shipped quantity, B=1/1.214x1011 L/day entering POTW (Source:

1996 Needs Survey, Report to Congress), C=year/365, D=109 μg/kg (Source of EIC estimation equation: Guidance for Industry Environmental Assessment of Human Drug and 

Biologics Applications, 1998)

2

Lowest acute toxicity endpoint value and the corresponding species for each chemical obtained from U. S. Environmental Protection Agency’s ECOTOXicology 

Knowledgebase (ECOTOX) available at https://cfpub.epa.gov/ecotox/search.cfm (retrieved December 22, 2021). 

3 Risk Quotient (RQ) calculated as Expected Environmental Concentration (EEC)/LC50 or EC50 per U. S. Environmental Protection Agency methodology 

(https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/technical-overview-ecological-risk-assessment-risk). For calculating the RQ, the Agency 

assumed a worse-case scenario that the EEC is the same as the EIC.(b) (4)

(b) (4) (b) (4) (b) (4)