Module 2.8 Environmental Impact Summary 

NJOY ACE 

 Confidential 

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TABLE OF CONTENTS 

TABLE OF CONTENTS............................................................................................................... 1 

LIST OF TABLES......................................................................................................................... 1 

LIST OF FIGURES ....................................................................................................................... 1 

LIST OF ABBREVIATIONS........................................................................................................ 3 

1 EXECUTIVE SUMMARY ............................................................................................... 4 

2 APPLICANT DETAILS.................................................................................................... 6 

3 PRODUCT INFORMATION............................................................................................ 7 

3.1 Product Name: NJOY ACE ............................................................................................ 7 

3.2 Product Identification...................................................................................................... 7 

3.2.1 NJOY ACE Device ...................................................................................................... 7 

3.2.2 NJOY ACE PODS ....................................................................................................... 9 

3.2.3 NJOY ACE Product Packages ................................................................................... 10 

4 REQUESTED APPROVAL ............................................................................................ 16 

5 PURPOSE AND NEED................................................................................................... 17 

6 ALTERNATIVES............................................................................................................ 18 

7 IDENTIFICATION AND CHARACTERIZATION OF INGREDIENTS OF INTEREST 

.......................................................................................................................................... 19 

8 POTENTIAL ENVIRONMENTAL IMPACTS OF THE PROPOSED ACTION 

ALTERNATIVE AND THE NO ACTION ALTERNATIVE........................................ 20 

9 CUMULATIVE IMPACTS............................................................................................. 21 

10 MITIGATION MEASURES ........................................................................................... 22 

11 REFERENCES ................................................................................................................ 23 

LIST OF TABLES 

Table 1 Location of Environmental Assessment Report For Each of the 10 SKUs ........... 5 

Table 2 Product SKUs – NJOY ACE Device and Pods ................................................... 16 

LIST OF FIGURES 

Figure 1 NJOY ACE Device ................................................................................................7 

Figure 2 NJOY ACE Device - Schematic ............................................................................ 8 

Figure 3 NJOY ACE POD ................................................................................................... 9 
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Figure4 NJOY ACE POD – Schematic............................................................................. 10 

Figure5 NJOY ACE Device – Packaging Image .............................................................. 11 

Figure6 NJOY ACE Device – User Guide........................................................................ 12 

Figure 7 NJOY ACE POD (as example) – Packaging Image ....... 13 

Figure8 NJOY ACE POD – Product Insert....................................................................... 14 

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LIST OF ABBREVIATIONS 

Abbreviation Definition 

CFR Code of Federal Regulations 

EA Environmental Assessment 

ENDS Electronic Nicotine Delivery System 

EPE expanded polyethylene 

FDA Food and Drug Administration 

FONSI Finding of No Significant Impact 

NEPA National Environmental Policy Act of 1969 

PMTA Pre-Market Tobacco Application 

SKU stock keeping unit 

U.S. United States 

w/w weight by weight 
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1 EXECUTIVE SUMMARY 

The Environmental Assessment (EA) has been prepared for the Proposed Action (manufacturing, 

use, and disposal of NJOY ACE products) in accordance with 21 Code of Federal Regulations 

(CFR) 25.20 and 25.40 and the United States (U.S.) Food and Drug Administration (FDA) and 

Council on Environmental Quality regulations implementing the National Environmental Policy 

Act of 1969 (NEPA). The EA is being submitted as part of the NJOY ACE Pre-Market Tobacco 

Application (PMTA). The format and content of the EA adhere to FDA’s guidance (FDA 1998, 

2015, 2019a, 2019b). The overall conclusion from the assessment is that there are no significant 

environmental risks, and a Finding of No Significant Impact (FONSI) for this EA of NJOY ACE 

products by FDA is warranted. 

A complete EA is provided in Module 7.11 for each of the 10 NJOY ACE stock keeping units 

(SKUs) as outlined below. All 10 SKUs are listed in Table 2. 

The organization of environmental assessments for each of the 10 SKUs within Module 7 is 

listed below. 

• 7.1 Need for the Proposed Actions

• 7.2 Potential Environmental Impacts of the Proposed Actions and Alternatives –

Manufacturing the New Products

• 7.3 Potential Environmental Impacts of the Proposed Actions and Alternatives – Use of

the New Products

• 7.4 Potential Environmental Impacts of the Proposed Actions and Alternatives – Disposal

of the New Products

• 7.5 Mitigation of Environmental Effects

• 7.6 Alternatives to the Proposed Actions

• 7.7 List of Preparers

• 7.8 Listing of Agencies and Persons Consulted

• 7.9 Other Documents Relating to Research [911(d)(5)] or [910(b)(1)]

• 7.10 Referenced Literature References

• 7.11 Environmental Impact Appendices

− Report

− Appendix A:

• 7.12 Environmental Assessment Confidential Appendices (marketing projections for

 years) 

For ease of review, Table 1 provides a direct link to the full Environmental Assessment report 

for each of the 10 SKUs in Module 7.11. 

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Table 1 Location of Environmental Assessment Report For Each of the 10 SKUs 

Module 7.11 NJOY ACE Device Environmental Assessment 

Module 7.11 NJOY ACE POD Environmental 

Assessment 

Module 7.11 NJOY ACE POD Environmental 

Assessment 

Module 7.11 NJOY ACE POD Environmental Assessment 

Module 7.11 NJOY ACE POD Environmental Assessment 

Module 7.11 NJOY ACE POD Environmental Assessment 

Module 7.11 NJOY ACE POD Environmental Assessment 

Module 7.11 NJOY ACE POD Environmental 

Assessment 

Module 7.11 NJOY ACE POD Environmental Assessment 

Module 7.11 NJOY ACE POD Environmental 

Assessment 

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2 APPLICANT DETAILS 

The EA was prepared in accordance with 21 CFR 25.40 and CFR 25.20. 

The applicant (NJOY, LLC [NJOY]) is seeking marketing authorization for its ACE Electronic 

Nicotine Delivery System (ENDS) products. One approved product, NJOY ACE POD 

 stock keeping unit [SKU] would be introduced into interstate 

commerce for commercial distribution in the U.S. The other approved products (9 SKUs) would 

be maintained on the market for sale and distribution in the U.S. 

> Applicant Name: NJOY, LLC

> Applicant Address:

> Applicant Contact:

> Manufacturing Address:

 China 

E-liquids are manufactured at in the U.S.; 

 and sales in the U.S. Product manufacturing flow is discussed in 

greater detail for each SKU in Module 7.2. 

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3 PRODUCT INFORMATION 

3.1 Product Name: NJOY ACE 

NJOY ACE product is a closed ENDS that heats an e-liquid to yield an inhalable aerosol. The 

NJOY ACE system consists of the NJOY ACE Device and the 9 NJOY ACE PODS products 

subject to this PMTA. The NJOY ACE device is sold separately from the NJOY ACE PODS, 

which are sold as packs consisting of 2 pods of the same flavor and strength. 

The NJOY ACE product e-liquid is manufactured in two nicotine concentrations (2.4% weight 

by weight [w/w] and 5%w/w nicotine) and contains 

The NJOY ACE product falls under the category of an ENDS product. The product is a “new 

tobacco product” under Section 910(a)(1) of the Federal Food, Drug, and Cosmetic Act, as it was 

not commercially marketed in the U.S. as of 15 February 2007. 

3.2 Product Identification 

Product Category: Electronic Nicotine Delivery System (ENDS) 

Product Subcategories: ENDS/closed E-cigarettes (for Device) 

ENDS/e-liquid (for PODS) 

3.2.1 NJOY ACE Device 

NJOY ACE Device (SKU Figure 1 and Figure 2) is a closed ENDS that heats 

an e-liquid to yield an inhalable aerosol. The NJOY ACE Device includes a rechargeable, 

 battery cell (which cannot be adjusted by the user) and a 

universal serial bus cable. 

Figure 1 NJOY ACE Device 

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Figure 2 NJOY ACE Device - Schematic 

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3.2.2 NJOY ACE PODS 

The NJOY ACE pod (Figure 3 and Figure 4) is a sealed, pre-filled, non-refillable, disposable 

container closure system that contains the heating element for the e-liquid. The NJOY ACE 

device is sold separately from the NJOY ACE PODS. The pods are manufacturer filled with 

1.9 milliliters of e-liquid. 

Figure 3 NJOY ACE POD 
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Figure 4 NJOY ACE POD – Schematic 

3.2.3 NJOY ACE Product Packages 
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The packaging material in direct contact with the NJOY ACE PODS consists of a 

 Details regarding these materials and the 

packaging process are available in Module 7.2 for each SKU. 

Figure 5 NJOY ACE Device – Packaging Image 

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Figure 6 NJOY ACE Device – User Guide 

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Figure 7 NJOY ACE POD (as example) – Packaging Image (b)(4) 
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Figure 8 NJOY ACE POD – Product Insert 

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4 REQUESTED APPROVAL 

NJOY seeks marketing authorizations that would permit continued marketing in interstate 

commerce of 9 NJOY ACE ENDS product SKUs under the provisions of Sections 910 and 905 

of the Federal Food, Drug, and Cosmetic Act (Table 2). 

Table 2 Product SKUs – NJOY ACE Device and Pods 

Product SKU 

In addition, the applicant seeks a marketing authorization to introduce the following NJOY ACE 

ENDS SKU into interstate commerce for commercial distribution in the U.S.: NJOY ACE PODS 

 SKU: 

Confidential marketing projections for the NJOY ACE product for the 

 years are presented in Module 7.12, Marketing Projections for NJOY ACE for 

each of the 10 SKUs. 

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5 PURPOSE AND NEED 

The need for the Proposed Action, requested by the applicant, is for the FDA to issue a 

marketing order for each of the 9 currently marketed SKUs (Table 2) after finding the new 

tobacco products would be appropriate for the protection of public health. The applicant wishes 

to introduce the ACE products into interstate commerce for commercial distribution in the U.S. 

In addition, the applicant seeks a marketing authorization to introduce the following NJOY ACE 

ENDS SKU into interstate commerce for commercial distribution in the U.S.: NJOY ACE PODS 

 SKU: 

The FDA shall review the PMTA, assess the Proposed Action, and subsequently determine 

whether or not to issue a marketing order for the NJOY product as a statutory requirement under 

section 910(c) of the FD&C Act. 

The Proposed Action would provide an alternative to combustible cigarettes. 

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6 ALTERNATIVES 

Potential alternatives were evaluated in the EA as required by Section 102(2)E of NEPA. The 

Proposed Action, or Proposed Action Alternative (ACE device and pods), and the No Action 

Alternative were compared to determine potential environmental impacts. The No Action 

Alternative is represented by no FDA approval and authorized marketing order for the Proposed 

Action in the U.S. 
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7 IDENTIFICATION AND CHARACTERIZATION OF 

INGREDIENTS OF INTEREST 

The process and results for the identification of ingredients contained in the Proposed Action 

products that were carried forward for evaluation in the EA are described in detail in the EA 

report (Module 7.11, Section 6, for each of the 10 SKUs; see links in Table 1). The selected 

ingredients were considered in potential discharge/spill release scenarios, and modeling was 

undertaken to determine estimated concentrations that could occur in the environment if a release 

were to occur. The results were then included in the environmental impacts assessment 

(Module 7.11, Section 7, for each of the 10 SKUs; see links in Table 1). 
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8 POTENTIAL ENVIRONMENTAL IMPACTS OF THE PROPOSED 

ACTION ALTERNATIVE AND THE NO ACTION ALTERNATIVE 

Potential environmental introductions resulting from manufacturing, use, and disposal were 

evaluated for the Proposed Action and No Action Alternative. A description of the affected 

environment (existing conditions) and environmental impacts from the Proposed Action and the 

No Action Alternative is provided in the environmental impacts assessment (Module 7.11, 

Section 7.1, for each of the 10 SKUs; see links in Table 1). 

The potential environmental impacts due to manufacturing were assessed at manufacturing 

facilities (including facilities outside of the U.S.). Waste generated at these facilities and its 

release into air, wastewater, and solid waste streams were characterized. Regulatory compliance 

information was provided by the applicant and its vendors. Compliance audits and inspections 

were not conducted as part of this assessment. 

The potential environmental impacts associated with manufacture, use, and disposal of ACE 

products under the Proposed Action were evaluated for the following subjects (Module 7.11, 

Section 7.2, for each of the 10 SKUs; see links in Table 1): 
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9 CUMULATIVE IMPACTS 

The effects on the environment that result from the incremental effect of the Proposed Action, 

when added to other past, present, and reasonably foreseeable future actions, were assessed. 

Other comparable products currently on the market represent present actions; those products that 

have been marketed and sold in the past but are not longer available to consumers represent past 

actions; and comparable products that will likely be on the market in the future represent 

reasonably foreseeable future actions. 

Overall, no adverse cumulative effects are anticipated as a result of the Proposed Action in 

combination with other past, present, or reasonably foreseeable future actions. There were no 

actions identified that, when considered with product manufacturing, use, and disposal under the 

Proposed Action, would lead to cumulative impacts. 

The incremental impacts from the Proposed Action do not contribute significantly to the overall 

cumulative impacts from other actions (past, present, or reasonably foreseeable future actions). 
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10 MITIGATION MEASURES 

During the review of the available information and the impact assessment, it was determined that 

no adverse environmental effects would occur due to the manufacture, use, and disposal of the 

Proposed Action products; thus, no mitigation measures are required. Manufacturing facility best 

management practices, including regulatory compliance measures and emergency response 

plans, would be sufficient to prevent adverse impacts to environmental resources. 

The overall conclusion from the assessment is that there are no significant environmental 

impacts, and a FONSI for this EA of NJOY ACE PODS and devices products by FDA is 

warranted. 
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11 REFERENCES 

FDA 1998. Guidance for Industry: Environmental Assessment of Human Drug and Biologics 

Applications. U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation 

and Research (CDER), Center for Biologics Evaluation and Research (CBER). CMC 6, Revision 

1. July.

FDA 2015. Guidance for Industry: National Environmental Policy Act; Environmental 

Assessments for Tobacco Products; Categorical Exclusions. Small Entity Compliance Guide. 

U.S. Department of Health and Human Services. October. 

FDA. 2019a. Premarket Tobacco Product Applications and Recordkeeping Requirements. 

Proposed Rule. U.S. Department of Health and Human Services. 21 CFR 1100, 1107, 1114. 84 

FR 50566. September 25. 

FDA 2019b. Deemed Tobacco Product Applications - A Public Meeting. October 28–29, 2019. 

Available at: https://www.fda.gov/tobacco-products/ctp-newsroom/deemed-tobacco-productapplications-public-meeting-10282019-10292019. Accessed February 2020.