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This example has been updated according to the approached discussed on the team call on 1/17. Additionally, we have simplified the Tobacco Product Identifiers and Descriptors (TO) domain by using parameters (TOPARM) instead of tests (TOTEST)

https://www.sciencedirect.com/science/article/pii/S004060311930752X


This is an example for the required tobacco product characterization, property description, and design parameter information in an FDA marketing application for one type of tobacco product Electronic Nicotine Delivery System (ENDS) (Vapes). There are many more and various types of tobacco products, and their parameters can be found in the in the FDA final rule and guidance documents for tobacco product Premarket Authorization (PMTA) and Substantial Equivalence pathways. The applicant submitting for SE and PMTAs may include test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.

Tobacco Product Identifier (TO) (similar to Device Identifiers (DI)) is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. The primary purpose of this dataset is to provide a list of the products used in an application or study and to provide identifying information for each product, such as product category type, manufacturer, properties, product name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID), a consistent variable, that is available for use in other domains where data pertaining to the product may be found.

Rows 1-4:Show the records for a tobacco product given SPTOBID of VAPE-Z27.
Rows 1-3:Show the tobacco product is a Electronic Nicotine Delivery Systems (ENDS) Vape closed e-cigarette.
Rows 5-8:Show the package type is a Box that contains 1 E-Cigarette that is 107.2 mm long and 9.0 mm in diameter.
Rows 9-12:Show the attributes or characteristics of the content of the e-liquid within the E-cigarette.
Rows 13-15:Show the attributes or characteristics of the heating element for the E-cigarette .

to.xpt

to.xpt

RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOCATTOVALTOVALU
1TOB09TOVAPE-Z27

1

TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERENDS (VAPES)
2TOB09TOVAPE-Z272TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERClosed E-Cigarette
3TOB09TOVAPE-Z273MANUFManufacturerPRODUCT IDENTIFIERJoes Vapes USA
4TOB09TOVAPE-Z274TRADENAMTrade NamePRODUCT IDENTIFIEREveryday Rich Tobacco
5TOB09TOVAPE-Z275PACKTYPPackage TypePRODUCT DESCRIPTORBOX
6TOB09TOVAPE-Z276PRDQUANProduct QuantityPRODUCT DESCRIPTOR1E-CIGARETTE
7TOB09TOVAPE-Z277LENGTHLengthPRODUCT DESCRIPTOR107.2mm
8TOB09TOVAPE-Z278DIAMETERDiameterPRODUCT DESCRIPTOR9mm
9TOB09TOVAPE-Z279NICTNCNCNicotine ConcentrationPRODUCT DESCRIPTOR2mg/L
10TOB09TOVAPE-Z2710PGVGRTPG/VG Ratio*PRODUCT DESCRIPTOR50/50
11TOB09TOVAPE-Z2711CHTRFLAVCharacterizing FlavorPRODUCT DESCRIPTORTOBACCO
12TOB09TOVAPE-Z2712VOLUMEEVolume, E-liquidPRODUCT DESCRIPTOR1mL
13TOB09TOVAPE-Z2713WATTWattagePRODUCT DESCRIPTOR5.2Watt
14TOB09TOVAPE-Z2714BATTCAPBattery CapacityPRODUCT DESCRIPTOR600mAh
15TOB09TOVAPE-Z2715DISPCRTGDisposable CartridgePRODUCT DESCRIPTORY
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The Product Design Parameters (PD) domain is used to represent design specification parameters of the tobacco product. Each property is identified using controlled terminology and is stored in PDPARMCD/PDPARM.

Rows 1-94:Show the design parameter specification with target, minimum, and maximum value reflected in the PDCOLSRT variable.
Rows 80-82:Show the design parameter specification with the test condition of 20 degrees Celsius using the PDTSTCND variable.

pd.xpt

pd.xpt

RowSTUDYIDDOMAINSPTOBIDPDSEQPDPARMCDPDPARMPDVALTRGPDVALMINPDVALMAXPDVALU
1TOB09PDVAPE-Z27

1

DRWRSTDraw Resistance 90.080.0120.0mm H2O
2TOB09PDVAPE-Z272PUFCNTPuff count (for full tank/cartridge)7311NUMBER COUNT
3TOB09PDVAPE-Z273CRTVOLCartridge volume315mL
4TOB09PDVAPE-Z274HTELNUMNumber of heating elements111NUMBER COUNT
5TOB09PDVAPE-Z275HTELGTHHeating element length324mm
6TOB09PDVAPE-Z276HTEDIAMHeating element diameter
325mm
7TOB09PDVAPE-Z277HTELRSTHeating element resistance0.750.251.5ohm
8TOB09PDVAPE-Z278HTELRNGHeating element range175100250C
9TOB09PDVAPE-Z279HTELCFGHeating element configurationSPIRALSPIRALSPIRAL
10TOB09PDVAPE-Z2710BTVLTORGBattery voltage operating range4.536V
11TOB09PDVAPE-Z2711BTCRTORGBattery current operating range10006501600mAh
12TOB09PDVAPE-Z2712BATCAPCBattery capacity11008003000mAh
13TOB09PDVAPE-Z2713BATNOMVBattery nominal voltage4.24.04.5V
14TOB09PDVAPE-Z2714BTCRTRTBattery Current Rating250020002800mA
15TOB09PDVAPE-Z2715BTCHTPLBattery Charging Temperature Limits200100315C
16TOB09PDVAPE-Z2716BTDCTMPLBattery Discharge Temperature Limits20-2060C
17TOB09PDVAPE-Z2717BTENDCVBattery end of discharge voltage3.02.03.5V
18TOB09PDVAPE-Z2718BTMXCHCBattery maximum charging current242030mA
19TOB09PDVAPE-Z2719BTMXDCCBattery maximum discharging current270024003000mA
20TOB09PDVAPE-Z2720BTULCHVBattery upper limits charging voltage4.24.14.3V
21TOB09PDVAPE-Z2721PDUVORPower Delivery Unit (PDU) voltage operating range3.73.24.2V
22TOB09PDVAPE-Z2722PDUCORPDU current operating range12008501800mA
23TOB09PDVAPE-Z2723PDUWTORPDU wattage operating range757080W
24TOB09PDVAPE-Z2724PDUTCTOFPDU temperature cut-off (if applicable)705565C
25TOB09PDVAPE-Z2725AIRFLRTAirflow rate720700740L/min
26TOB09PDVAPE-Z2726PDUCRCOFPDU current cut-off (if applicable)352050mA
27TOB09PDVAPE-Z2727INHAERTInhaled aerosol temperature373540C
28TOB09PDVAPE-Z2728VENTLTNVentilation504060%
29TOB09PDVAPE-Z2729ELQDVISCE-Liquid viscosity 500751130mPa/s
30TOB09PDVAPE-Z2730ELQDVOLE-liquid volume6010120mL
31TOB09PDVAPE-Z2731PNUMCNCParticle number concentration5001081010#/cm3
32TOB09PDVAPE-Z2732CTMDDIAMCount median diameter200150250nm
33TOB09PDVAPE-Z2733PMPM 2.5251235ug/m3

Dataset Debug Messages

  • There are two leading, trailing, or non-breaking spaces in the dataset.
  • Please remove all formatting (see How to Clear Formatting).
  • Please remove all paragraph and/or line breaks.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

*PG/VG Ratio = Propylene Glycol to Vegetable Glycerin Ratio



The Tobacco Product Testing (PT) (similar to the Laboratory Test Results (LB) domain) dataset shows the tobacco product test demonstrating the actual tests and test results for the specified Design Parameter Specification as noted in the DU dataset (??? PD dataset).

Rows 1-32:Show the tobacco design parameter specification test and the result in ORRES (needs populated).
Row 28:Shows the design parameter specification test condition of 20 degrees Celsius using the TTTSTCND variable for the E-Liquid Viscosity test.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDPTSEQPTREFIDPTTESTCDPTTESTPTTSTCNDPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTREPNUMPTTPTPTTPTNUM
1TOB09PTVAPE-Z27

1


DRWRSTDraw Resistance 
DESIGN PARAMETER TESTING

mm H2O

mm H2O1Week 01
2TOB09PTVAPE-Z272
PUFCNTPuff count (for full tank/cartridge)
DESIGN PARAMETER TESTING

NUMBER COUNT

NUMBER COUNT1Week 01
3TOB09PTVAPE-Z273
CRTVOLCartridge volume
DESIGN PARAMETER TESTING

mL

mL1Week 01
4TOB09PTVAPE-Z274
HTELNUMNumber of heating elements
DESIGN PARAMETER TESTING

NUMBER COUNT

NUMBER COUNT1Week 01
5TOB09PTVAPE-Z275
HTELGTHHeating element length
DESIGN PARAMETER TESTING

mm

mm1Week 01
6TOB09PTVAPE-Z276
HTELRSTHeating element resistance
DESIGN PARAMETER TESTING

ohm

ohm1Week 01
7TOB09PTVAPE-Z277
HTELRNGHeating element range
DESIGN PARAMETER TESTING

C

C1Week 01
8TOB09PTVAPE-Z278
HTELCFGHeating element configuration
DESIGN PARAMETER TESTING





1Week 01
9TOB09PTVAPE-Z279
BTVLTORGBattery voltage operating range
DESIGN PARAMETER TESTING

V

V1Week 01
10TOB09PTVAPE-Z2710
BTCRTORGBattery current operating range
DESIGN PARAMETER TESTING

mAh

mAh1Week 01
11TOB09PTVAPE-Z2711
BATCAPCBattery capacity
DESIGN PARAMETER TESTING

mAh

mAh1Week 01
12TOB09PTVAPE-Z2712
BATNOMVBattery nominal voltage
DESIGN PARAMETER TESTING

V

V1Week 01
13TOB09PTVAPE-Z2713
BTCRTRTBattery Current Rating
DESIGN PARAMETER TESTING

mA


1Week 01
14TOB09PTVAPE-Z2714
BTCHTPLBattery Charging Temperature Limits
DESIGN PARAMETER TESTING

C


1Week 01
15TOB09PTVAPE-Z2715
BTDCTMPLBattery Discharge Temperature Limits
DESIGN PARAMETER TESTING

C


1Week 01
16TOB09PTVAPE-Z2716
BTENDCVBattery end of discharge voltage
DESIGN PARAMETER TESTING

V


1Week 01
17TOB09PTVAPE-Z2717
BTMXCHCBattery maximum charging current
DESIGN PARAMETER TESTING

mA


1Week 01
18TOB09PTVAPE-Z2718
BTMXDCCBattery maximum discharging current
DESIGN PARAMETER TESTING

mA


1Week 01
19TOB09PTVAPE-Z2719
BTULCHVBattery upper limits charging voltage
DESIGN PARAMETER TESTING

V


1Week 01
20TOB09PTVAPE-Z2720
PDUVORPower Delivery Unit (PDU) voltage operating range
DESIGN PARAMETER TESTING

V


1Week 01
21TOB09PTVAPE-Z2721
PDUCORPDU current operating range
DESIGN PARAMETER TESTING

mA


1Week 01
22TOB09PTVAPE-Z2722
PDUWTORPDU wattage operating range
DESIGN PARAMETER TESTING

W


1Week 01
23TOB09PTVAPE-Z2723
PDUTCTOFPDU temperature cut-off (if applicable)
DESIGN PARAMETER TESTING

C


1Week 01
24TOB09PTVAPE-Z2724
AIRFLRTAirflow rate
DESIGN PARAMETER TESTING

L/min


1Week 01
25TOB09PTVAPE-Z2725
PDUCRCOFPDU current cut-off (if applicable)
DESIGN PARAMETER TESTING

mA


1Week 01
26TOB09PTVAPE-Z2726
INHAERTInhaled aerosol temperature
DESIGN PARAMETER TESTING

C


1Week 01
27TOB09PTVAPE-Z2727
VENTLTNVentilation
DESIGN PARAMETER TESTING

%


1Week 01
28TOB09PTVAPE-Z2728
ELQDVISCE-Liquid viscosityTest performed at 20 degrees CelsiusDESIGN PARAMETER TESTING





1Week 01
29TOB09PTVAPE-Z2729
ELQDVOLE-liquid volume
DESIGN PARAMETER TESTING

mL


1Week 01
30TOB09PTVAPE-Z2730
PNUMCNCParticle number concentration
DESIGN PARAMETER TESTING

#/cm3


1Week 01
31TOB09PTVAPE-Z2731
CTMDDIAMCount median diameter
DESIGN PARAMETER TESTING

nm


1Week 01
32TOB09PTVAPE-Z2732
PMPM 2.5
DESIGN PARAMETER TESTING

ug/m3


1Week 01

Dataset Debug Messages

  • There is a leading, trailing, or non-breaking space in the dataset.
  • Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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