1

Environmental Assessment for

Marketing Order for a

New Heated Tobacco Product 

Manufactured by

Philip Morris Products S.A.

Prepared by Center for Tobacco Products

U.S. Food and Drug Administration

October 19, 2022
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 IQOS HeatSticks....................................................................................................................... 4

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

IQOS HeatSticks ............................................................................................................................... 4

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

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

5.3. Environmental Justice......................................................................................................... 5

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

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

IQOS HeatSticks ............................................................................................................................... 6

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

6.2. Air Quality ........................................................................................................................... 6

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

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

6.5. Solid Waste and Hazardous Materials................................................................................ 7

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

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

7. List of Preparers............................................................................................................................... 8

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

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

CONFIDENTIAL APPENDIX 1: Product Modifications.................................................................................. 11

CONFIDENTIAL APPENDIX 2: Market Volume Projections.......................................................................... 12

CONFIDENTIAL APPENDIX 3: Comparisons of user-generated aerosols due to use of the IQOS HeatSticks

....................................................................................................................................................... 13

CONFIDENTIAL APPENDIX 4: Screening-level risk assessments of nicotine and heavy metals in IQOS 

HeatSticks for aquatic animals....................................................................................................... 14
3 

1. Introduction

1.1 Background

On May 25, 2021, Philip Morris Products S.A. submitted a premarket tobacco product application 

(PMTAs) for a heated tobacco product (HTP). In the PMTA, Philip Morris Products S.A. requested the U.S. 

Food & Drug Administration to issue a marketing order under section 910 of the Federal Food, Drug, and

Cosmetic Act (FD&C Act) (Public Law 111-31). 

The new IQOS HeatSticks differ from the corresponding authorized IQOS HeatSticks (PM0000424) in 

composition of the tipping paper, plug wrap paper, adhesives, and tipping paper ink (Confidential 

Appendix 1).

This document reviews the potential environmental impacts from marketing the IQOS HeatStick in the 

United States and from the no-action alternative of the Agency not issuing a marketing order for the 

new IQOS HeatSticks. 

1.2 Applicant and Manufacturer Information

Applicant Name: Philip Morris Products S.A.

Applicant Address: Quai Jeanrenaud Neuchatel 2000 Switzerland

Manufacturer Information: Manufacturer 

Name

Product 

Manufacturing 

Location

Products Manufactured

Philip Morris 

Products S.A.

Quai Jeanrenaud 

Neuchatel 2000 

Switzerland 

Blending and grinding of 

tobacco leaf 

Philip Morris 

Manufacturing 

Bologna S.p.A.

Via Fratelli Rosselli 4 

40069 Zola Predosa 

Bologna – Italy 

IQOS HeatSticks

manufacturing and 

packaging operations 

1.3 Product Information

New Product Name and Submission Tracking Number (STN)

STN New Product New Product Name Authorized Product Name

PM0004691 – PD1 Marlboro Amber HeatSticks Marlboro Heatsticks

Product Identification

Product Category Heated Tobacco Product (HTP)

Product Subcategory HTP Consumable

Product Number per Retail 

Unit

Twenty IQOS HeatSticks per pack with ten packs per 

carton and 50 cartons per shipping case

Product Package The packaging consists of an inner frame, packing tape, 

and film overwrap.
2. The Need and Purpose for the Proposed Actions

Purpose: The applicant wishes to introduce the new IQOS HeatSticks in interstate commerce for 

commercial distribution in the United States and submitted a supplemental PMTA (sPMTA) to the 

Agency to obtain a marketing order. Upon receipt of an sPMTA, FDA considers the submission, using 

criteria detailed in section 910(b)(1) of the FD&C Act, to make a finding as to whether a marketing order 

for the product would be appropriate for the protection of public health.

Need: FDA’s responsibility to review an sPMTA, make a finding as described in the previous paragraph, 

and subsequently determine whether or not to issue a marketing order for the tobacco product is a 

statutory requirement under section 910(b)(1) of the FD&C Act.

3. Proposed Actions and Alternatives

The proposed actions, requested by the applicant, are for FDA to issue a marketing order under the 

provisions of section 910 of the FD&C Act for introduction or delivery for introduction of tobacco 

products into interstate commerce in the United States after finding the new IQOS HeatSticks would be 

appropriate for the protection of public health.

The no-action alternative is FDA does not issue a marketing order for the new IQOS HeatSticks. The 

products would not be marketed in the United States and, for the purposes of the analysis in this 

environmental assessment, it is assumed that there would be no changes to the current HTP market and

no changes to the current or future use of tobacco products.

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

the New IQOS HeatSticks

The applicant stated that the manufacturing facilities are in compliance with all the applicable 

environmental regulations. However, because the facilities are located outside the United States, the 

environmental impacts associated with manufacturing the new IQOS HeatSticks will not be discussed.

The projected first- and fifth-year market volumes are available in Confidential Appendix 2.

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

IQOS HeatSticks

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 the 

projected market volumes (Confidential Appendix 2) for the first- and fifth year of marketing of the new 

IQOS HeatSticks.
5

5.1. Affected Environment

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

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

5.2. Air Quality

The Agency does not anticipate that new chemicals would be released into the environment as a result 

of use of the new product, relative to chemicals released into the environment due to use of other HTPs

already on the market because (1) the new IQOS HeatSticks consist of minor ingredient changes in the 

acetate tow, plug wrap, adhesive, and tipping paper inks from the authorized IQOS HeatSticks

(Confidential Appendix 1), (2) aerosol emissions to the environment from the new IQOS HeatSticks are 

similar to the aerosol emissions of the authorized IQOS HeatSticks because the difference of mainstream 

aerosols from the authorized and new IQOS HeatSticks are negligible (Confidential Appendix 3), and (3) 

the new IQOS HeatSticks are expected to compete with, or replace, other currently marketed HTPs.

The impacts from use of HTPs include exposure to second and thirdhand aerosols. Secondhand aerosol

is created when an HTP user exhales mainstream aerosol into the environment (Hirano & Takei, 2020). 

Thirdhand aerosol is created when an 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 non-mentholated Marlboro IQOS HeatSticks (product names not provided) have 

shown that IQOS aerosols are free from metal emissions, in contrast to combustible cigarettes (Ruprecht 

et al., 2017). When using the non-mentholated IQOS HeatSticks, no systematic increase in the total

volatile organic compounds above background concentrations was observed. Furthermore, 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 user-generated aerosols in the new and authorized IQOS 

HeatSticks (Confidential Appendix 3). Negligible amounts of constituent change in the aerosols 

generated (exhaled) by the users when using 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 related to 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, or both, of middle school and high school students (Dai, 2020); 

however, current HTP-use prevalence was higher among Hispanic school students compared to nonHispanic 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 (or both), income levels or education attainment (Azagba & Shan, 2021). Overall, 
these findings do not indicate disproportionately high HTP use prevalence among minorities and lowincome 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 HTPs because the authorized IQOS HeatSticks and many other similar HTPs would continue to be used 

in the United States.

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

New IQOS HeatSticks

The Agency evaluated potential impacts to resources in the environment that may be affected by 

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 the projected market volumes (Confidential Appendix 2) for the first- and fifth year of 

marketing of the new IQOS HeatSticks.

6.1. Affected Environment

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

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

would dispose of the used product 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 characterizing air quality impacts from disposal of used IQOS HeatSticks are currently not 

available. However, similar to cigarette butts, discarded IQOS HeatSticks may emit toxic chemicals such 

as nicotine into the air (Gong, Daniels, & Poppendieck, 2020; Gong, Khurshid, & Poppendieck, 2017). 

Airborne emissions from cigarette butts after disposal depend on the environmental conditions and the 

chemicals in the butts (Poppendieck, Gong, & Pham, 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 would lead to the release of new or 

increased chemicals into the air because the new IQOS HeatSticks are made of minor ingredient changes 

from the authorized IQOS HeatSticks. The chemical constituents in the new IQOS HeatSticks are not 

likely to be emitted to the air in any distinguishable different amount. Additionally, 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, (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, and (4) the new IQOS 

HeatSticks are intended to replace the authorized IQOS HeatSticks.
7

6.3. Biological Resources

The proposed action is 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 Endangered Species Act. Proper disposal of the used new IQOS HeatSticks and packaging in the 

MSW stream would not affect biological resources. Improper disposal (littering) of the used new IQOS

HeatSticks could lead to terrestrial wildlife having direct exposure to the used IQOS HeatSticks and 

hazardous substances leaching to aquatic environments and soils. Unlike combusted tobacco products, 

smoldering of used IQOS HeatSticks is not a major concern; therefore, the risk of fires from smoldering 

tobacco products and associated impacts to natural environments from littering are negligible.

The Agency does not anticipate new chemicals would be released into the environment as a result of 

disposal of the new IQOS HeatSticks because (1) the tobacco blend is unchanged compared to the 

authorized IQOS HeatSticks, and (2) the new IQOS HeatSticks are expected to replace the authorized 

IQOS HeatSticks.

6.4. Water Resources and Water Quality

Proper disposal of the used new IQOS HeatSticks and packaging in the MSW stream would not affect 

water resources. Improper disposal (littering) of the used, new IQOS HeatSticks could result in 

hazardous substances leaching into water systems. If improper disposal (littering) 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 IQOS 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 IQOS HeatSticks and exhibit high toxicity to certain aquatic 

organisms (Baran et al., 2019; Koutela et al., 2020).

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 (RQs) from estimated aquatic expected environmental concentrations 

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

4). 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 4). 

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

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

from the disposal of new tobacco products are expected.

6.5. Solid Waste and Hazardous Materials

Littered IQOS HeatSticks may present environmental effects from heated or unheated tobacco, filter 

and other polymer components. Used IQOS 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 the IQOS HeatSticks are similar between unheated and heated 

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

cadmium, mercury, selenium, and lead are 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 HeatSticks tobacco in negligible concentrations in the leachate (Koutela et al., 2020)
from used IQOS HeatSticks. The Agency anticipates that the potential exposure of heavy metals from the 

new IQOS HeatSticks are comparable to the authorized IQOS HeatSticks because there is no change to 

the tobacco blend.

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 HTPs. The new IQOS HeatSticks

are expected to replace the authorized IQOS HeatSticks. 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.

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 HTPs in 

the United States. No new types of emissions are expected due to disposal of the new IQOS HeatSticks; 

therefore, there would be no disproportionate impacts on minority or low-income 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 HTPs and their packaging, as the authorized IQOS HeatSticks and many other similar HTPs

would continue to be disposed of in the United States.

7. List of Preparers

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

environmental assessment:

Preparer:

Bria J. Martin, B.S., Center for Tobacco Products

Education: B.S. in Biological Sciences

Experience: Five years in various scientific activities

Expertise: NEPA analysis, forestry, ecology and evolutionary studies

Reviewer:

Hoshing Chang, PhD, Center for Tobacco Products

Education: Ph.D. in Biochemistry, M.S. in Environmental Science

Experience: Thirteen years in FDA-related NEPA review

Expertise: NEPA analysis, environmental risk assessment, wastewater treatment

8. A Listing of Agencies and Persons Consulted

Not applicable.
9

9. References

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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

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 

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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. 

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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

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

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

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11

CONFIDENTIAL APPENDIX 1: Product Modifications

Component(s) Change from the Authorized IQOS HeatSticks

Acetate tow

Plug Wrap

Adhesive

Tipping Paper Inks

(b) (4)
CONFIDENTIAL APPENDIX 2: Market Volume Projections 

Product Unit 

Market Volume Projections

First-Year Fifth-Year

Marlboro Amber HeatSticks One HeatStick

(b) (4)
13

CONFIDENTIAL APPENDIX 3: Comparisons of user-generated aerosols due to use of the IQOS 

HeatSticks

The applicant submitted a comparison of aerosols generated by the user in the new and authorized 

HeatSticks. The comparison includes HPHCs, analytes and tobacco constituents. There are changes in the 

new and authorized IQOS HeatSticks (three batches evaluated for each); however, the differences are 

minor (see below). Values and percent changes are available in the table below.

Marlboro Amber HeatSticks

Note 1: The measurements of crotonaldehyde were below 3.29 μg/cig; therefore, percent changes were 

not calculated for the new and authorized IQOS HeatSticks.

Note 2: The measurements of 2-aminonaphthalene for the new IQOS HeatSticks were below 0.012 

ng/cig; therefore, 0.012 ng/cig was used to calculate the percent change. It is acknowledged that the 

percent change may be higher given the “less than” value.
CONFIDENTIAL APPENDIX 4: Screening-level risk assessments of nicotine and heavy metals in IQOS HeatSticks for aquatic animals 

The applicant provided the aquatic environmental introduction concentrations of for the corresponding authorized 

IQOS HeatStick (PM0000424) for Marlboro Amber HeatSticks (see table below). The applicant also stated that the tobacco blend (source of heavy 

metals) is not changing in the new and authorized IQOS HeatSticks.

Measured Levels in PM0000424 (authorized IQOS HeatStick)

(b) (4) (b) (4) (b) (4) (b) (4) (b) (4)
15

The Agency estimated in the risk quotients as indicated in the table below:

Chemical

Aquatic 

Environmental 

Introduction 

Concentration (μg/L)1

Lowest Acute 

Toxicity Endpoint 

Value (EC50/LC50) 

(μg/L)2

Species Risk 

Quotient3

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 Environmental Exposure Concentration (EEC)/LC50 or EC50 per U. S. Environmental Protection Agency methodology (https://www.epa.gov/pesticidescience-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 Environmental Introduction concentration. (b) (4)