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 I 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 entire 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 

PM0000491: 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% 
 

FINDING OF NO SIGNIFICANT IMPACT 

Marketing Orders for 

VLNTM King and VLNTM Menthol King Cigarettes (Collectively “VLNTM Cigarettes”) 

Marketed by 22nd Century Group, Inc. 

The Center for Tobacco Products of the Food and Drug Administration (FDA) has carefully considered 

the potential environmental impact of these actions and has concluded that these actions will not have 

significant effects on the quality of the human environment. Therefore, environmental impact 

statements are not required. 

22nd Century Group, Inc. wishes to introduce two very low nicotine cigarettes into interstate commerce 

for commercial distribution in the United States and submitted to FDA premarket tobacco product 

applications to obtain marketing orders under the provisions of section 910 of the Federal Food, Drug, 

and Cosmetic Act. 

FDA prepared the programmatic environmental assessment (PEA), dated October 29, 2019, in 

accordance with the Council on Environmental Quality's regulations (40 CFR 1500-1508) implementing 

the National Environmental Policy Act (NEPA) and FDA’s NEPA regulations (21 CFR 25.40). The PEA 

concluded that the marketing orders would have no significant impact and is available to the public 

upon request. 

The PEA evaluates potential environmental effects due to manufacturing, use, and disposal of the new 

products. No increased or new types of environmental impacts due to manufacturing the new products 

are anticipated. FDA does not foresee that use of the new products would result in new or different 

environmental impacts. FDA believes that the disposal of the new products is the same as the disposal 

conditions of other combusted, filtered cigarettes that are currently marketed in the United States. 

Therefore, FDA does not foresee significant adverse impacts to the environment due to the proposed 

actions from manufacturing, use, and disposal of the new products. 

Approved by 

Kimberly Benson, Ph.D. 

Director 

Division of Nonclinical Science 

Office of Science 

Center for Tobacco Products 

U.S. Food and Drug Administration 

Digitally signed by Kimberly A. Benson -S 

Date: 2019.10.29 12:32:45 -04'00'