U.S. Food & Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

www.fda.gov 

PMTA Coversheet: Environmental Science 

SUBMISSION INFORMATION 

Applicant 22nd Century Group, Inc. 

Product Manufacturer NASCO Products, LLC 

Submission Date December 4, 2018 FDA Receipt Date December 4, 2018 

Cross-referenced 

Submission1 

1 The application contains a valid and active cross-reference, which contains appropriate authorization for the applicant to

reference the ent ire file or certain sections thereof. 

Cross-referenced STN Primary STN{s) 

�6)(4) I Applies to all STNs 

Amendments Amendment STN Primary STN FDA Receipt Date 

PM0000493 Applies to all STNs December 11, 2018 

PM0000497 Applies to all STNs January 10, 2019 

PM0000499 Applies to all STNs February 11, 2019 

PM0000502 Applies to all STNs February 25, 2019 

PM0000506 Applies to all STNs March 14, 2019 

PM0000507 Applies to all STNs March 15, 2019 

PM0000508 Applies to all STNs March 15, 2019 

PM0000509 Applies to all STNs March 20, 2019 

PM0000511 Applies to all STNs April 3, 2019 

PM0000514 Applies to all STNs June 27, 2019 

PM0000519 Applies to all STNs July 18, 2019 

PM0000524 Applies to all STNs August 7, 2019 

PM0000544 Applies to all STNs September 13, 2019 

PM0000549 Applies to all STNs October 2, 2019 

NEW TOBACCO PRODUCTS 

PM0000491: Moonlight®2 

2 On December 4, 2018, FDA received original PMTAs for VLNTM King and VLNTM Menthol. On October 2, 2019, the applicant 

submitted a proposed name change for the products to Moonlight and Moonlight Menthol, respectively. The scientific reviews 

reflect the proposed names (VLNTM and VLNTM Menthol) in the original PMTA submissions. 

Product Category Cigarettes 

Product Sub-Category Combusted, Filtered 

Package Type Hard pack 

Package Quantity 20 per pack 

Characterizing Flavor None 

Length 83mm 

Diameter 7.9mm 

Ventilation 13% 
STN PM0000491-PM0000492 

PM0000492: Moonlight® Menthol2 

Product Category Cigarettes 

Product Sub-Category Combusted, Filtered 

Package Type Hard pack 

Package Quantity 20 per pack 

Characterizing Flavor Menthol 

Length 83mm 

Diameter 7.9mm 

Ventilation 13% 

ii 
1 

Programmatic Environmental Assessment: 

Marketing Orders 

for 

VLNTM King and VLNTM Menthol King 

by

22nd Century Group, Inc. 

Prepared by Center for Tobacco Products 

U.S. Food and Drug Administration 

October 29, 2019 
2 

Table of Contents 

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

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

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

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

2. Purpose of and Need for Actions ..................................................................................................... 3 

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

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

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

4.1 Affected Environment ......................................................................................................... 4 

4.2 Air Quality ........................................................................................................................... 5 

4.3 Water Resources ................................................................................................................. 5 

4.4 Soil, Land Use, and Zoning .................................................................................................. 6 

4.5 Biological Resources ........................................................................................................... 6 

4.6 Regulatory Compliance ....................................................................................................... 6 

4.7 Socioeconomics and Environmental Justice ....................................................................... 6 

4.8 Solid Waste and Hazardous Materials ................................................................................ 6 

4.9 Floodplains, Wetlands, and Coastal Zones ......................................................................... 7 

4.10 Cumulative Impacts ............................................................................................................ 7 

4.11 Impacts from the No-Action Alternative ............................................................................ 7 

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

Products ........................................................................................................................................... 7 

5.1. Affected Environment ......................................................................................................... 7 

5.2. Air Quality ........................................................................................................................... 7 

5.3. Environmental Justice ......................................................................................................... 7 

5.4. Cumulative Impacts ............................................................................................................ 8 

5.5. Impacts from the No-Action Alternative ............................................................................ 9 

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

Products ........................................................................................................................................... 9 

6.1. Affected Environment ......................................................................................................... 9 

6.2. Air Quality ........................................................................................................................... 9 

6.3. Biological Resources .........................................................................................................10

6.4. Water Resources ...............................................................................................................10

6.5. Solid Waste .......................................................................................................................10

6.6. Socioeconomics and Environmental Justice .....................................................................10

6.7. Cumulative Impacts ..........................................................................................................11

6.8. Impacts from the No-Action Alternative ..........................................................................11

7. List of Preparers .............................................................................................................................11

8. A Listing of Agencies and Persons Consulted ................................................................................12

9. References .....................................................................................................................................12

CONFIDENTIAL APPENDIX 1 ........................................................................................................................14

Current Market Volume for NASCO’s Cigarettes, Market Volume Projections for the New Products, and 

Percentage of Cigarette Use in the United States Projected to be Attributed to the New Products

.......................................................................................................................................................14
1. Introduction 

1.1 Background 

On December 4, 2018, 22nd Century Group, Inc. (22nd Century) submitted premarket tobacco product 

applications (PMTAs) for two very low nicotine cigarettes, VLNTM King and VLNTM Menthol King Cigarettes 

(collectively "VLNTM Cigarettes"). In the PMTAs, 22nd Century requests the U.S. Food & Drug 

Administration (FDA) issue marketing orders under section 910 of the Federal Food, Drug, and Cosmetic 

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

This document reviews the potential environmental impacts from marketing VLNTM Cigarettes in the 

United States, and from the no-action alternative of the Agency not issuing marketing orders for the 

products. The Agency did not identify any significant environmental impacts from the proposed actions. 

1.2 Applicant and Manufacturer Information 

Applicant Name: 22nd Century Group, Inc. 

Applicant Address: 8560 Main Street, Suite 4 

Williamsville, NY 14221 

Manufacturer Name: NASCO Products, LLC 

Product Manufacturing 321 Farmington Road 

Location: Mocksville, NC 27028 

1.3 Product Information 

New Product Names and Submission Tracking Numbers (STNs) 

New Product Name STN New Product 

VLNTM King PM0000491 

VLNTM Menthol King PM0000492 

Product Identification 

Product Category Cigarette 

Product Subcategory Combusted filtered 

Product Number per Retail Twenty cigarettes per pack with ten packs per 

Unit paperboard carton 

Foil inner liner, inner frame paper, paperboard box, 

Product Package polypropylene outer wrap, polypropylene tear tape, 

paperboard carton, and cardboard shipping case. 

2. Purpose of and Need for Actions 

Purpose: The proposed actions, requested by the applicant, are for FDA to issue marketing orders under 

the provisions of section 910 of the FD&C Act after finding the new tobacco products would be 

appropriate for the protection of public health. The applicant wishes to introduce the new tobacco 

3 
4 

products into interstate commerce for commercial distribution in the United States and submitted to 

the Agency two premarket tobacco applications (PMTA) to obtain marketing orders. Upon receipt of a 

PMTA, FDA considers the submission, using criteria detailed in section 910(c) of the FD&C Act, to make a 

finding as to whether marketing orders for the new products would be appropriate for the protection of 

public health. 

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

subsequently determine whether or not to issue a marketing order for the new product is a statutory 

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

3. Proposed Actions and Alternatives 

FDA proposes to issue marketing orders authorizing introduction or delivery for introduction of the two 

new tobacco products into interstate commerce in the United States. The applicant’s PMTAs seek FDA’s 

marketing orders under section 910(c)(A)(i) of the FD&C Act for two VLNTM Cigarettes.

The no-action alternative is FDA does not issue marketing orders for the new tobacco products. The new 

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

programmatic environmental assessment, it is assumed that there would be no changes to the current 

combusted cigarette market; no changes to the current or future use of combusted cigarettes. 

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

the New Products 

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

manufacturing the new products and found no significant impacts based on the Agency-gathered 

information and the following applicant-submitted information: 

• Ingredients used in the new products are commonly used in other products manufactured at the 

facility. 

• Similar cigarettes are currently manufactured at the listed facility. 

• No facility expansion or new construction is expected due to manufacturing the new products. 

4.1 Affected Environment 

The affected environment includes human and natural environments surrounding the manufacturing 

facility. The new products are manufactured at NASCO Products’ (NASCO) facility at 321 Farmington 

Road, Mocksville, North Carolina (Figure 1). The facility is in an industrial area with U.S. Highway 40 to its 

southwest and northeast and woodland to the west. The facility is in the Yadkin watershed in Davie 

County.3, 

3 A watershed is an area of land where all bodies of water drain to a common outlet such as the outflow of a reservoir, mouth 

of a bay, or any point along a stream channel. Such bodies of water include the following: surface water from lakes, streams, 

reservoirs and wetlands; the underlying ground water; and rainfall. See https://water.usgs.gov/edu/watershed.html. 

4

4 USGS. National Water Information System: Mapper. Available at: https://water.usgs.gov/wsc/cat/03040101.html. Accessed 

April 18, 2019. 

The applicant stated that the facility’s designated boundaries do not include any recognized 

or controlled fisheries or wetlands. 

 
5 

Figure 1. Location of the Manufacturing Facility 

4.2 Air Quality 

The Agency does not anticipate that manufacturing the new products would cause the release of any 

new chemicals into the environment because (1) the facility is currently manufacturing similar cigarettes 

under the trade name SPECTRUM® and (2) the applicant stated that manufacturing the new products 

would not result in changes in air emissions. Accordingly, the applicant concluded that manufacturing 

the new products would not require any additional environmental controls for air emissions. 

4.3 Water Resources 

The Agency does not anticipate that manufacturing the new products would cause the discharge of any 

new chemicals into water. According to the North Carolina Department of Environmental Quality, water 

quality in the Yadkin River’s Headwaters watershed where the facility is located is relatively good 

compared to other sub basins in the greater Yadkin-Pee Dee River basin.5

5 North Carolina Department of Environmental Quality. Yadkin River Headwaters. Available at: 

https://files.nc.gov/ncdeq/Water%20Quality/Planning/BPU/BPU/Yadkin/Yadkin%20Plans/2010%20Plan/2_03040101%20Yadki

n%20River%20Headwaters-2010.pdf. Accessed April 18, 2019.

 The applicant stated that 

manufacturing the new products would not require any additional environmental controls for water 

discharges. 

 
6 

4.4 Soil, Land Use, and Zoning 

The Agency does not anticipate that manufacturing the new products would lead to changes in soil, land 

use, or zoning. There would be no expected facility expansion, no zone change or land conversion of 

prime farmland, unique farmland, or farmland of statewide importance to non-agricultural use. 

4.5 Biological Resources 

The Agency does not anticipate manufacturing the new products would jeopardize the continued 

existence of any listed species or result in the destruction or adverse modification of the habitat of any 

such species identified under the Endangered Species Act (ESA). The applicant reviewed the U.S. Fish 

and Wildlife Service’s (U.S. FWS) critical habitat and endangered species maps 6,

6 U.S. Fish and Wildlife Services (U.S. FWS), available at: https://www.fws.gov/endangered/. Accessed April 16, 2019. 

7

7 Critical habitat maps available at: https://databasin.org/datasets/d579d87eb54f4374a77ea53e7ef66449. Accessed April 16, 

2019.

 and stated that the 

manufacturing facility is not in a critical habitat area and its boundaries do not include any recognized or 

controlled fisheries or wetlands. The applicant stated there would be no anticipated changes in air 

emission or waste generation; accordingly, the applicant concluded that manufacturing the new 

products would not be expected to threaten any endangered species or critical habitat. Additionally, the 

applicant provided a certificate of compliance of the manufacturing and packaging materials suppliers 

with the convention on International Trade in Endangered Species of Wild Fauna and Flora and ESA. 

4.6 Regulatory Compliance 

The applicant stated that the manufacturing facility complies with all federal, state, and tribal 

environmental regulations and with the ESA. 

4.7 Socioeconomics and Environmental Justice 

No changes in socioeconomics, employment revenue, taxes, or impacts on minority populations would 

be expected due to manufacturing the new products because (1) the facility is located in an industrial 

zone with no residential housing or retail operations within its boundaries and (2) the facility is currently 

manufacturing similar cigarettes under the trade name SPECTRUM®. 

4.8 Solid Waste and Hazardous Materials 

The Agency does not foresee the introduction of the new products would notably affect the current 

manufacturing waste generated from the facility production of all combusted cigarettes. The Agency 

anticipates the waste generated due to manufacturing the new products would be released to the 

environment and disposed of in landfills in the same manner as any other waste generated from any 

other products manufactured in the same facility. The materials, ingredients, and tobacco used in the 

new products are being used in other cigarettes currently manufactured at the facility. Therefore, there 

would be no expected change in pattern, amount, or type of waste generated due to manufacturing the 

new products. 

 
7

4.9 Floodplains, Wetlands, and Coastal Zones

There would be no anticipated facility expansion due to manufacturing the new products and the 

applicant did not propose any land disturbance; therefore, there would be no effects on floodplains, 

wetlands, or coastal zones.

4.10 Cumulative Impacts

The Agency does not anticipate that the proposed actions will incrementally increase or change the 

chemicals released to the environment from the tobacco manufacturing facility. The applicant stated 

that manufacturing the new products would not require additional environmental controls for air 

emission, water discharge or solid waste disposal. Therefore, no cumulative impacts were identified.

4.11 Impacts from the No-Action Alternative

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

manufacturing cigarettes at the listed facility, as many similar tobacco products would continue to be 

manufactured.

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

Products

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

of the new products 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 for the new products and the documented decline in cigarette use in the 

United States.

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 tobacco products to be sold to consumers in the United 

States.

5.2. Air Quality 

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

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

cigarettes already on the market because (1) the combustion products from the new products would be 

released in the same manner as the combustion products from the any other marketed cigarettes; (2) 

the new products are expected to be used by consumers of other cigarettes, hence replace other 

currently marketed cigarettes; and (3) the ingredients in the new products are used in other currently 

marketed tobacco products.

5.3. Environmental Justice

No new emissions are expected due to use of the new products. Therefore, there would be no 

disproportionate impacts on minority or low-income populations.
8 

5.4. Cumulative Impacts 

The impacts from use of combusted tobacco products include exposure to secondhand smoke (SHS) 

produced from burned cigarettes. Particles emitted by smoking may remain on surfaces, be re-emitted 

back into the gas phase, or react with oxidants and other compounds in the environment to yield 

secondary pollutants, thirdhand smoke (THS). These pollutants coexist in mixtures in the environment 

alongside SHS (Burton, 2011; Matt et al., 2011). 

There is no safe level of exposure to SHS (U.S. Department of Health and Human Services, 2006a and 

2006b). Even low levels of SHS can harm children and adults in many ways, including the following: 

• The U.S. Surgeon General estimates that living with a smoker increases a nonsmoker's 

chances of developing lung cancer by 20 to 30% (U.S. Department of Health and Human 

Services, 2014). 

• Exposure to SHS increases school children's risk for ear infections, lower respiratory 

illnesses, more frequent and more severe asthma attacks, and slowed lung growth. It can 

cause coughing, wheezing, phlegm, and breathlessness (U.S. Department of Health and 

Human Services, 2006a and 2006b). 

• SHS causes more than 40,000 deaths a year (U.S. Department of Health and Human 

Services, 2014). 

However, the use of cigarettes in the United States is declining, per the U.S. Alcohol and Tobacco Tax 

and Trade Bureau (TTB) Statistical Release reports (Figure 2).8

8 U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) statistical data available at: https://www.ttb.gov/tobacco/tobaccostats.shtml. Accessed April 18, 2019. 

 This likely is responsible for the decline in 

SHS exposure observed in several studies that evaluated the levels of SHS exposure in children and 

nonsmokers living in homes of smokers (Homa et al., 2015; Yao et al., 2016). Despite the considerable 

ethnic and racial disparities in SHS exposure in vulnerable populations, data from the National Health 

and Nutrition Examination Survey showed a decline in SHS exposure from 1999-2000 to 2011-2012 with 

the highest prevalence of exposure among non-Hispanic subpopulations (46.8%), compared to Mexican 

Americans (23.9%) and non-Hispanic whites (21.8%) in 2011-2012 (Homa et al., 2015). There were also 

significant declines in SHS exposure prevalence noted in the 2000 and 2010 National Health Interview 

Survey Cancer Control Supplements. SHS exposure declined in Hispanics from 16.3% in 2000 to 3.1% in 

2010, non-Hispanic Asians from 13.4% in 2000 to 3% in 2010, and non-Hispanic blacks from 31.2% in 

2000 to 11.5% in 2010 as compared to exposures in non-Hispanic whites, which declined from 25.8% in 

2000 to 9.7% in 2010 (Yao et al., 2016). 

 
9 

Figure 2. Use of Cigarettes in the United States, 1984 – 2018 

As of March 2019, 28 states and the District of Columbia have implemented comprehensive smoke-free 

laws (American Lung Association, 2019). Such laws are expected to reduce the levels of non-user 

exposure to SHS and THS. 

5.5. Impacts from the No-Action Alternative 

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

of cigarettes because 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 evaluated potential impacts to resources in the environment that may be affected by 

disposal of the new products. The Agency found no significant impacts based on publicly available 

information such as the documented continuous decline in use of cigarettes in the United States, and 

the applicant’s submitted information, including the projected market volumes for the new products. 

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 tobacco products to be sold to consumers in the United 

States. 

6.2. Air Quality 

The Agency does not anticipate disposal of the products or the packaging material would lead to the 

release of new or increased chemicals into the air. 

0

100

200

300

400

500

600

700

1984 1987 1990 1993 1996 1999 2002 2005 2008 2011 2014 2017

Billion Pieces

Year

Total Consumed Cigarettes (Billion Pieces)
10

No changes in air quality are anticipated from disposal of the cigarette butts of the new products. The 

chemicals in the cigarette butts are commonly used in other currently marketed cigarettes. Because the 

new products are anticipated to be used by consumers of other marketed cigarettes, the butt waste 

generated from the new products would replace the same type of waste. Therefore, the fate and effects 

of any materials emitted into the air from disposal of the new products are anticipated to be the same 

as any materials from other cigarettes disposed of in the United States. 

No changes in air quality from disposal of the packaging materials of the new products 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 municipal solid waste per FDA’s experience in evaluating the packaging waste 

generated from cigarettes. 

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. ESA. Although disposal of smoldering cigarettes has been implicated in many fire incidents,9,

9 National Fire Protection Association. The smoking-material fire problem. Available at: https://www.nfpa.org/News-andResearch/Data-research-and-tools/US-Fire-Problem/Smoking-Materials. Accessed April 16, 2019. 

10

10 UC Davis Health News. Available at: https://www.ucdmc.ucdavis.edu/publish/news/newsroom/2763. Accessed April816 

2019. 

the new products are not expected to change the fire frequency as (1) the disposal of the new products 

would be the same as the disposal of cigarettes that are currently marketed in the United States, and (2) 

there would be no anticipated increase in number of cigarettes being disposed of because the new 

products are anticipated to be used by consumers of other currently marketed cigarettes. 

6.4. Water Resources 

No changes in impacts on water resources are expected due to disposal of the cigarette butts and 

packaging from the new products because the chemicals and packaging materials in the new products 

would be used in currently marketed cigarettes. 

6.5. Solid Waste 

The Agency does not foresee that the introduction of the new products would notably affect the current 

cigarette butt and packaging waste generated from all combusted, filtered cigarettes. The waste 

generated due to disposal of the new products would be released to the environment and disposed of in 

landfills in the same manner as any other waste generated from any other combusted, filtered 

cigarettes in the United States. The number of cigarette butts generated is equivalent to the market 

projections (Confidential Appendix 1) and a portion of those would continue to be littered. 

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 products. The waste generated due to disposal of the new products 

 
11

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

United States. No new emissions are expected due to disposal of the new products; therefore, there 

would be no disproportionate impacts on minority or low-income populations. 

6.7. Cumulative Impacts 

A major existing environmental consequence of the use of the new products and other conventional 

cigarettes is littering of discarded cigarette filters or butts, which can persist in the environment 

(Novotny and Zhao, 1999). Cigarette butts are among the most common forms of litter found on 

beaches (Claereboudt, 2004; Smith et al., 1997), near streams, night clubs (Becherucci and Pon, 2014), 

bus stops (Wilson et al., 2014), roads, and streets (Healton et al., 2011; Patel et al., 2013). Cigarette 

butts have been found at densities averaging more than four cigarette butts per meter squared of urban 

environments (Seco Pon and Becherucci, 2012). 

Compounds in cigarette butts can leach out into water, potentially threatening human health and the 

environment, especially marine ecosystems (Kadir and Sarani, 2015). The environmental toxicity of 

cigarette butts due to air emissions is not well studied. The chemicals in cigarette butts can be the 

original chemicals in the unsmoked cigarettes or the pyrolysis and distillation products deposited in the 

cigarette butts. Airborne emissions from cigarette butts after disposal depend on the environmental 

conditions and the chemicals in the butts. These emissions can be influenced by several factors, such as 

the cigarette brand, cigarette length, filter material, types of tobacco, ingredients in the cigarette and 

tobacco filler, number of puffs, and the mass transfer behavior of combustion products along the 

cigarette.11

11 NIST Technical Report 8147 available at: http://dx.doi.org/10.6028/NIST.IR.8147. Accessed January 8, 2019. 

However, the cumulative impacts from cigarette butts is declining because the use of cigarettes in the 

United States is declining. 

6.8. Impacts from the No-Action Alternative 

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

disposal of cigarette butts and cigarette packaging, as many other similar tobacco products 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: 

Rudaina Alrefai-Kirkpatrick, Ph.D., Center for Tobacco Products 

Education: Ph.D. in Plant Molecular Biology and Virology 

Experience: Forty-two years in various scientific activities including eight years in NEPA practice 

Expertise: NEPA analysis, environmental risk assessment, evidence-based assessment of health 

technologies, NEPA Implementation 

 
12

Reviewer:

Hoshing W. Chang, Ph.D., Center for Tobacco Products

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

Experience: Ten 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. References

American Lung Association. 2019. Smokefree Air Laws (last updated March 8, 2019). www.lung.org/ourinitiatives/tobacco/smokefree-environments/smokefree-air-laws.html. Accessed April 22, 2019.

Burton B. Does the smoke ever really clear? Thirdhand smoke exposure raises new concerns. 

Environmental Health Perspectives. 2011;119(2):A70-A74. 

Becherucci ME, Pon JPS. What is left behind when the lights go off? Comparing the abundance and 

composition of litter in urban areas with different intensity of nightlife use in Mar del Plata, Argentina. 

Waste Management. 2014;34(8):1351-1355.

Claereboudt MR. Shore litter along sandy beaches of the Gulf of Oman. Marine Pollution Bulletin.

2004;49(9-10):770-777.

Healton CG, Cummings KM, O'Connor RJ, Novotny TE. Butt really? The environmental impact of 

cigarettes. Tobacco Control. 2011;20:I1-I1.

Homa DM, Neff LJ, King BA, Caraballo RS, Bunnell RE, Babb SD, Garrett BE, Sosnoff CS, Wang L. Vital 

signs: disparities in nonsmokers’ exposure to secondhand smoke —United States, 1999–2012. MMWR 

Morbidity Mortality Weekly Report. 2015;64(4), 103-108. 

Kadir AA, Sarani NA. Cigarette butts pollution and environmental impact - a review. Applied Mechanics 

and Materials. 2015;773-774:1106-1110.

Matt GE, Quintana PJE, Destaillats H, Gundel LA, Sleiman M, Singer BC, Jacob P, Benowitz N, Winickoff

JP, Rehan V, Talbot P, Schick SF, Samet J, Wang Y, Hang B, Martins-Green M, Pankow JF, Hovell ME. 

Thirdhand tobacco smoke: emerging evidence and arguments for a multidisciplinary research agenda. 

Environmental Health Perspectives. 2011;119(9):1218-1226. 

Novotny TE, Zhao F. Consumption and production waste: Another externality of tobacco use. Tobacco 

Control. 1999;8(1): 75-80.

Patel V, Thomson GW, Wilson N. Cigarette butt littering in city streets: A new methodology for studying 

and results. Tobacco Control. 2013;22(1):59-62.

Seco Pon JP, Becherucci ME. Spatial and temporal variations of urban litter in Mar del Plata, the major 

coastal city of Argentina. Waste Management. 2012;32(2):343-348.
13

Smith CJ, Livingston SD, Doolittle DJ. An international literature survey of "IARC Group 1 carcinogens" 

reported in mainstream cigarette smoke. Food and Chemical Toxicology. 1997;35(10-11):1107-1130.

U.S. Department of Health and Human Services. 2014. The Health Consequences of Smoking—50 Years 

of Progress. A Report of the Surgeon General. Centers for Disease Control and Prevention, National 

Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. Atlanta, 

GA.

U.S. Department of Health and Human Services. 2006a. The Health Consequences of Involuntary 

Exposure to Tobacco Smoke: A Report of the Surgeon General. Centers for Disease Control and 

Prevention, National Center for Chronic Disease Prevention and Health Promotion, Coordinating Center 

for Health Promotion, Office on Smoking and Health. Atlanta, GA.

U.S. Department of Health and Human Services. 2006b. The Health Consequences of Involuntary 

Exposure to Tobacco Smoke: A Report of the Surgeon General—Secondhand Smoke: What It Means to 

You (Consumer Booklet). Centers for Disease Control and Prevention, National Center for Chronic 

Disease Prevention and Health Promotion, Coordinating Center for Health Promotion, Office on Smoking 

and Health. Atlanta, GA.

Wilson N, Oliver J, Thomson G. Smoking close to others and butt littering at stops: Pilot observational 

study. PeerJ. 2014;2.

Yao T, Sun HY, Wang Y, Lightwood J, Max W. Sociodemographic differences among U.S. children and 

adults exposed to secondhand smoke at home: National Health Interview Surveys 2000 and 2010. Public 

Health Reports. 2016;131:357-366.
CONFIDENTIAL APPENDIX 1 

Current Market Volume for NASCO's Cigarettes, Market Volume Projections for the New Products, 

and Percentage of Cigarette Use in the United States Projected to be Attributed to the New Products 

Market volume projections for the VLNTM Cigarettes were compared to the total forecasted use of 

cigarettes in the United States.12 

12 The Agency used historical data regarding total use of cigarettes from 2002 to 2018 to mathematically estimate the total 

number of cigarettes used in the United States. Using the best fit trend line with an R

2 value of 0.9814, the forecasted number 

of cigarettes that would be used in the United States is estimated at 221.946 billion cigarettes in 2020 and 196.411 billion 

cigarettes in 2025. 

The projected use of the VLNTM Cigarettes account for a minute fraction 

of a percent of the forecasted cigarette use in the United States. In addition, the applicant stated that 

the VLNTM Cigarettes would replace other currently marketed cigarettes. 

Product 

NASCO's 

Cigarettes 

VLNTM King 

VLN

TM 

Menthol 

King 

Total 

Current Market 

Volume 

Current Product 

(# of Cigarettes) 

Projected Market Volumes13 

Year2020 Year2025 

New Product 

(# of Cigarettes) 

New Product 

as a Percent 

of Total 

Cigarettes 

Used14 

New Product 

(# of Cigarettes) 

New Product 

as a Percent 

of Total 

Cigarettes 

Used15 

13 The applicant provided market volume projections for VLNTM Cigarettes in 2020 and 2025. 

14 Projected Market Occupat ion of the New Product in the United States (%)= 

Projected Market Volume of the New Products (cigarette pieces) lOO Projected Use of Cigarettes in United States (cigarette pieces) X 

15 Ibid 

14