Cross-referenced STN Primary STN(s) 

MR0000059 APPLIES TO PM0000424-PM0000426, PM0000479 

f U.S. FOOD & DRUG ? ... - ... 

.,,,4- ADMIN ISTRATION 

U.S. Food & Drug Administration 

Silver Spring, MD 20993 

www.fda.gov 

PMTA Coversheet: Environmental Science 

SUBMISSION INFORMATION 

Applicant Philip Morris Products S.A. 

Product Manufacturer Philip Morris Products S.A. 

Submission Date 05-15-2017 FDA Receipt Date I os-1s-2011 

Primary STN(s) PM0000424 Marlboro Heatsticks1 

PM0000425 Marlboro Smooth Menthol Heatsticks1 

PM0000426 Marlboro Fresh Menthol Heatsticks1 

PM0000479 IQOS System Holder and Charger1 

Cross-referenced 

Submission(s) 

MR0000060 

MR0000061 

MR0000133 

MF0000013 

I MF0000243 

I MF0000264 

1 May be sold individually or as co-packaged product. 

U.S. Food & Drug Administration 

10903 New Hampshire Avenue 10903 New Hampshire Avenue Silver Spring, MD 20993 

www.fda.gov 
STN PM0000424 - PM0000426, PM0000479 Page 2 of 4 

Amendments 

Amendment STN Primary STN Description FDA Receipt Date 

PM0000440 PM0000424-426, Resubmitted label images 06-21-2017 

PM0000479 

PM0000443 PM0000424-426, Request for A/ I Request letter 08-31-2017 

PM0000479 response extension; confirmed battery 

samples 

PM0000457 PM0000424-426, Response to 11/ 22/ 17 A/ I Request 12-26-2017 

PM0000479 letter 

PM0000458 PM0000424-426, Response to 11/ 22/ 17 A/ I Request 12-22-2017 

PM0000479 letter 

PM0000461 PM0000424-426, Ongoing study data 12-08-2017 

PM0000479 

PM0000464 PM0000424-426, Response to 3/ 2/ 18 EA A/ I Request 03-29-2018 

PM0000479 letter 

PM0000466 PM0000424-426, Pl Characterization study update 04-26-2018 

PM0000479 

PM0000467 PM0000424-426, Response to 4/ 23/ 18 A/I Request letter 05-23-2018 

PM0000479 

PM0000468 PM0000424-426, Response to 6/ 6/ 18 teleconference 06-13-2018 

PM0000479 questions 

PM0000475 PM0000424-426, Response to 7 / 18/ 18 teleconference 08-03-2018 

PM0000479 questions 

PM0000476 PM0000424-426, Response to 8/ 20/ 18 A/I Request 09-05-2018 

PM0000479 

PM0000478 PM0000424-426, Corrected versions of t wo study 09-25-2018 

PM0000479 reports 

Version Date: 08/15/2018 
STN PM0000424 - PM0000426, PM0000479 Page 3 of 4 

NEW TOBACCO PRODUCT 

STN PM0000424 

Product Name Marlboro Heatsticks1 

Product Category Cigarettes 

Product Sub-Category Non-Combusted 

Package Type Box 

Package Quantity 20 Heatsticks 

Characterizing Flavor None 

Length 45mm 

Diameter 7.42 mm 

Ventilation Not 2 Applicable

Source of Energy Electric (rechargeable battery)

3 

STN PM0000425 

Product Name Marlboro Smooth Menthol Heatsticks1 

Product Category Cigarettes 

Product Sub-Category Non-Combusted 

Package Type Box 

Package Quantity 20 Heatsticks 

Characterizing Flavor Menthol 

Length 45mm 

Diameter 7.42 mm 

Ventilation Not Applicable2 

Source of Energy Electric (rechargeable battery)3 

STN PM0000426 

Product Name Marlboro Fresh Menthol Heatsticks1 

Product Category Cigarettes 

Product Sub-Category Non-Combusted 

Package Type Box 

Package Quantity 20 Heatsticks 

Characterizing Flavor Menthol 

Length 45mm 

Diameter 7.42 mm 

Ventilation Not Applicable2 

Source of Energy Electric (rechargeable battery)

3 

STN PM0000479 

Product Name IQOS System Holder and Charger1 

Product Category Cigarettes 

Product Sub-Category Non-Combusted 

Package Type Box 

Package Quantity 1 Holder, 1 Charger 

2 For t his product neit her filter efficiency or ventilation are used to control aerosol deliveries. 

3 The components and assemblies control the delivery of energy. The critical items include the Heater Printed Circuit Board 

Assembly (PCBA) including the heating blade and the battery. 

Version Date: 08/15/2018 
STN PM0000424 - PM0000426, PM0000479 Page 4 of 4 

Characterizing Flavor None 

Length 93.60 mm (Holder) 

Diameter 15.04 mm (Holder) 

Length 112.50 mm (Charger) 

Width 51.20 mm (Charger) 

Ventilation Not Applicable2 

Source of Energy Electric (rechargeable battery)

3 

Additional Properties Depth: 21.86 mm (Charger) 

Battery Capacity:[(D ) -(4) I (Holder) 

Wattage:~bll4 (Charger)

4 l 

Battery Capacity: !(b) ( 4) I (Charger) 

4 Wattage provided for the charger battery 

Version Date: 08/15/2018 
 

FINDING OF NO SIGNIFICANT IMPACT 

Product Marketing Orders for 

Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, Marlboro Fresh Menthol 

Heatsticks, and IQOS System Holder and Charger 

Manufactured by Philip Morris Products S.A. 

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 

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

statements are not required. 

Philip Morris Products S.A. wishes to introduce four heated tobacco products 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 sections 910 of the Federal Food, Drug, 

and Cosmetic Act. 

FDA prepared the programmatic environmental assessment (PEA), dated March 15, 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 are anticipated. 

FDA does not foresee use of the new products to result in new or different environmental impacts. FDA 

believes that the disposal of the new products is the same as the disposal conditions of similar packaging 

waste, small consumer electronics, and currently marketed cigarette products. 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: 2019.03.15 15:09:54 -04'00'