Environmental Assessment 

for Marketing Order for 

IQOS 3 Holder and Charger 

Manufactured by 

Philip Morris Products S.A. 

Prepared by: 

Center for Tobacco Products 

U.S. Food and Drug Administration 

October 6, 2020 
Table of Contents 

Table of Contents.......................................................................................................................................... 2 

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

1.2 Purpose of and Need for Action ......................................................................................... 3 

1.3 Related Actions ................................................................................................................... 3 

1.4 Scope of Environmental Assessment.................................................................................. 3 

2. Proposed Actions and Alternative ...................................................................................................... 4 

2.1 The Need for the Proposed Actions.................................................................................... 4 

2.2 No Action ............................................................................................................................ 5 

3. Potential Environmental Impacts........................................................................................................ 5 

4. List of Preparers ...................................................................................................................................... 5 

5. List of Agencies and Persons Consulted.............................................................................................. 6 

CONFIDENTIAL APPENDIX 1 .......................................................................................................................... 7 

Current and Projected First-, and Fifth-Year Market Volumes for the New and Original Products.............7 
 

 

 

 

 

 

 

 

 

 

 

 

 

1. Introduction 

1.1 Background 

On March 30, 2020 Philip Morris Products S.A. (PMP) submitted a supplemental premarket tobacco 

product application (PMTA) for the IQOS 3 Holder and Charger. In the PMTAs, PMP requests that the 

U.S. Food & Drug Administration (FDA) issue a marketing order for this new tobacco product under 

section 910(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (Public Law 111-31). 

Issuing a marketing order for a new tobacco product is a federal action for which FDA must consider 

environmental impacts before deciding to proceed, in accordance with the requirements of the National 

Environmental Policy Act (NEPA). FDA prepared this environmental assessment (EA) to evaluate the 

potential for significant environmental impacts from the proposed marketing order for the proposed 

new tobacco product. This EA conforms to the Council on Environmental Quality’s (CEQ’s) NEPA 

regulations applicable to all agencies (40 Code of Federal Regulations [CFR] Part 1500) and FDA’s 

agency-specific NEPA regulations (21 CFR Part 25). If an EA concludes that a proposed action would not 

have significant environmental impacts, then an agency issues a finding of no significant impact (FONSI) 

to document this conclusion, completing the NEPA process. If a potentially significant impact is 

identified, then the agency proceeds to prepare an environmental impact statement. 

Section 1 of this EA describes the purpose of and need for the action, identifies relevant laws and 

requirements, describes a related action, and summarizes the scope of this EA. Section 2 identifies the 

proposed and alternative actions. Section 3 presents the environmental impact analysis. Sections 4 and 

5 present the preparers and the agencies and persons consulted. 

1.2 Purpose of and Need for Action 

Purpose: Upon receipt of a PMTA, FDA considers the submission, using criteria detailed in section 910 of 

the FD&C Act, and issues an order that either allows or denies the marketing order for a new tobacco 

product. The purpose of FDA’s PMTA review is to determine if marketing the new tobacco product is 

appropriate for the protection of public health. 

Need: FDA is responsible for reviewing a PMTA, making a finding as described in the previous paragraph, 

and subsequently determining whether or not to issue a marketing order for the proposed new tobacco 

product. 

1.3 Related Actions 

On May 12, 2017, Philip Morris Products S.A. (PMP) submitted premarket tobacco product applications 

(PMTAs) for three flavors of heatsticks and the IQOS Holder and Charger. In the PMTAs, PMP requested 

the FDA to permit marketing of these new tobacco products by issuing marketing orders under section 

910 of the FD&C Act (Public Law 111-31). A PEA for the PMTAs was prepared as required by NEPA and 

marketing orders were granted on April 30, 2019. Additionally, a PEA for the Modified Risk Tobacco 

Product Applications (MRTPAs) was prepared as required by NEPA and modified risk orders were 

granted on July 7, 2020. 

1.4 Scope of Environmental Assessment 

Scoping is the process for determining the scope of issues to be addressed in a NEPA document and for 

identifying the significant issues related to a proposed action. For this EA, scoping methods consisted of 
internal Agency scoping, in w hich environmental and other scientific staff within the FDA Center for 

Tobacco Products reviewed the products' manufacturing, use, and disposal information to identify 

potential areas of environmental impact for review in this EA. 

The scope of a NEPA analysis is defined by the range of actions, alternatives, and impacts that are 

considered (40 CFR 1508.25). Using input from the scoping process described above, this EA evaluates 

the following: 

• The action in this EA is issuing a marketing order for a proposed new tobacco product. The 

decision on whether to take this action and issue the marketing order is a result of FDA' s 

reviews of the PMTA for the proposed new tobacco product and the PMTA and MRTPA for the 

original IQOS submission. FDA did not identify any other connected actions. 1 

1 Act ions are connected if they automat ically t rigger ot her act ions, cannot or will not proceed unless other act ions are taken 

previously or simultaneously, or are interdependent parts of a larger act ion and depend on t he larger act ion for t heir 

j ustifi cat ion (40 CFR 1508.25). 

Related future 

actions include marketing orders for PMTAs from this or other applicants for products that are 

similar or have similar environmental impacts, however, such actions are purely speculative. 

• The alternatives in this EA are the courses of action available to FDA under Chapter IX of the 

FD&C Act, described in detail in Sections 2.1 and 2.2. As the proposed actions, FDA may issue a 

marketing order for the proposed new tobacco product. The no-action alternative is FDA does 

not issue a marketing order for the proposed new tobacco product. 

• The impacts evaluated in this EA, described in Section 3, changes to the human environment 

from the proposed action or alternatives that are reasonably foreseeable and have a 

reasonably close causal relationship to the proposed action or alternatives, including 

those effects that occur at the same time and place as the proposed action or 

alternatives and may include effects that are later in time or farther removed in distance 

from the proposed action or alternatives.. 

2. Proposed Actions and Alternative 

2.1 The Need for the Proposed Actions 

Philip Morris Products S.A. submitted a supplemental PMTA for a heated tobacco product (described in 

Table 1) on March 30, 2020 to FDA seeking a marketing order under section 910(b)(1) of the FD&C Act. 

Table 1. Description of the New Tobacco Product 

STN* Name Description 

• Electronic heating unit meant to be used 

with IQOS heatsticks and charger to 

recharge the heating unit after each use 

PM0000634 IQOS 3 System Holder and Charger 

*STN = subm ission t racking number. 
 

 

 

 

 

 

 

The new tobacco product would be manufactured outside of the United States. The IQOS system and 

accessories are manufactured by a supplier on behalf of PMP. 

The IQOS 3 System is an upgraded version of the IQOS System, which is intended to be used with noncombustible heatsticks. The IQOS 3 System, similar to the IQOS System, contains two main components; 

the IQOS 3 Holder and the IQOS 3 Charger. The IQOS 3 Holder is an electrical heating unit in which the 

user inserts a heatstick. It is used to heat the tobacco in the heat stick via a heating blade. The holder is 

activated by the user pressing a button for a set period until the holder light blinks. The holder functions 

for approximately six minutes or a maximum of 14 puffs. The holder must be recharged after each use. 

The IQOS 3 Charger is a recharging case for the holder. The charger can recharge the holder 20 times 

before it needs to be recharged. The charger also holds the holder when not in use. The IQOS 3 System 

does not differ in the aerosol generation from the IQOS System. 

The differences between the IQOS System and the IQOS 3 System include ergonomic changes, a side 

opening door in the charger for the holder, orientation-free insertion of the holder into the charger, a 

magnetic connector between the holder and charger, improved charging time of the holder via an 

(b) (4)

2.2 No Action 

The no-action alternative is FDA does not issue a marketing order for the proposed new tobacco 

product. The proposed new tobacco product would not be marketed in the United States. 

3. Potential Environmental Impacts 

Potential impacts of the proposed action and no action, from product manufacturing, use, and disposal, 

are discussed in the PEA for the original IQOS System PMTA (STNs PM0000424, PM0000425, 

PM0000426 and PM0000479). The PEA discussed the potential impacts on environmental resources 

from product use and disposal under the proposed action and no action alternative. The tobacco 

product in this EA is slightly modified as compared to the tobacco product in the original PMTA with the 

above-mentioned differences. The Agency determined that, given the modifications are mainly 

aesthetic, the projected market volume (Confidential Appendix 1) is similar to that of the original IQOS 

System, (b) (4)

the environmental impacts of the new tobacco product are considered in the original 

PMTA PEA. Specifically, the Agency did not identify any significant environmental impacts from the 

proposed and alternative actions. 

4. List of Preparers 

The following individuals were primarily responsible for preparing and reviewing this PEA: 

Preparer: 

Shannon K. Hanna, Ph.D., Center for Tobacco Products 

Education: Ph.D. in Environmental Science and Management 

Experience: Four years in environmental science, three years in toxicology 
 

Expertise: Ecotoxicology of new substances and materials, bioaccumulation of 

chemicals including heavy metals, soil/sediment and water quality 

Reviewer: 

Hoshing W. Chang, Center for Tobacco Products 

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

Experience: Eleven years in FDA-related NEPA review 

Expertise: NEPA analysis, environmental risk assessment, wastewater treatment 

5. List of Agencies and Persons Consulted 

No agencies or persons were consulted during preparation of this PEA. All information was obtained 

from the applicant or publicly available information sources. 
CONFIDENTIAL APPENDIX 1 

Current and Projected First-, and Fifth-Year Market Volumes for the New and 

Original Products 

Market Volume (# of units) 

STN 

Current Projected First-Year Projected Fifth-Year 

PM0000634 

Original IQOS 

Total