The following example illustrates the representation of an ENDS tobacco product's identifiers and descriptors using the TO domain. Note that this example uses TOSCAT to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.
https://www.sciencedirect.com/science/article/pii/S004060311930752X
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This is an example for the required tobacco product characterization, property description, and design parameter information in an FDA marketing application for an Electronic Nicotine Delivery System (ENDS) (Vapes).
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| 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 9-13: | Show the attributes or characteristics of the content of the e-liquid within the E-cigarette. |
Rows 14-16: | Show the attributes or characteristics of the heating element for the E-cigarette . | | Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOPARMCD | TOPARM | TOCAT | TOSCAT | TOVAL | TOVALU |
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| 1 | TOB09 | TO | VAPE-Z27 | | TBPRDCAT | Tobacco Product Category | NEW PRODUCT | PRODUCT IDENTIFIER | Electronic Nicotine Delivery Systems (ENDS) ( |
VAPES| Vapes) |
| | 2 | TOB09 | TO | VAPE-Z27 | 2 | TBPRSCAT | Tobacco Product Subcategory | NEW PRODUCT | PRODUCT IDENTIFIER | Closed E-Cigarette |
| | 3 | TOB09 | TO | VAPE-Z27 | 3 | MANUF | Manufacturer | NEW PRODUCT | PRODUCT IDENTIFIER | Joes Vapes USA |
| | 4 | TOB09 | TO | VAPE-Z27 | 4 | TRADENAM | Trade Name | NEW PRODUCT | PRODUCT IDENTIFIER | Everyday Rich Tobacco |
| | 5 | TOB09 | TO | VAPE-Z27 | 5 | PACKTYP | Package Type | NEW PRODUCT | PRODUCT DESCRIPTOR | BOX |
| | 6 | TOB09 | TO | VAPE-Z27 | 6 | PRDQUAN | Product Quantity | NEW PRODUCT | PRODUCT DESCRIPTOR | 1 | E-CIGARETTE | | 7 | TOB09 | TO | VAPE-Z27 | 7 | LENGTH | Length | NEW PRODUCT | PRODUCT DESCRIPTOR | 107.2 | mm | | 8 | TOB09 | TO | VAPE-Z27 | 8 | DIAMETER | Diameter | NEW PRODUCT | PRODUCT DESCRIPTOR | 9 | mm | | 9 | TOB09 | TO | VAPE-Z27 | 9 | NICTNCNC | Nicotine Concentration | NEW PRODUCT | PRODUCT DESCRIPTOR | 2 | mg/L | | 10 | TOB09 | TO | VAPE-Z27 | 10 |
PG| PRPYLGLY | Propylene Glycol | NEW PRODUCT | PRODUCT DESCRIPTOR | 50 | % | | 11 | TOB09 | TO | VAPE-Z27 | 11 |
VG| VEGGLY | Vegetable Glycerin | NEW PRODUCT | PRODUCT DESCRIPTOR | 50 | % | | 12 | TOB09 | TO | VAPE-Z27 | 12 |
CHTRFLAV| CHARFLAV | Characterizing Flavor | NEW PRODUCT | PRODUCT DESCRIPTOR |
TOBACCO| Tobacco |
| | 13 | TOB09 | TO | VAPE-Z27 | 13 |
VOLUMEEVolume, liquidLiquid Volume | NEW PRODUCT | PRODUCT DESCRIPTOR | 1 | mL | | 14 | TOB09 | TO | VAPE-Z27 | 14 |
WATTWattage15 | TOB09 | TO | VAPE-Z27 | 15 | BATTCAP | Battery CapacityPRODUCT DESCRIPTOR | 5.2 | Watt | | NEW PRODUCT | PRODUCT DESCRIPTOR | 600 | mAh |
1616DISPCRTG| DSCRTIND | Disposable Cartridge Indicator | NEW PRODUCT | PRODUCT DESCRIPTOR | Y |
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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 represented in PDPARMCD/PDPARMmanufacturing parameter specifications of the ENDS product as intended for used are represented in the PD domain. The following example shows the target, minimum, and maximum values associated with each of 33 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | PDSEQ | PDPARMCD | PDPARM | PDVALTRG | PDVALMIN | PDVALMAX | PDVALU |
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| 1 | TOB09 | PD | VAPE-Z27 | | DRWRST | Draw Resistance | 90.0 | 80.0 | 120.0 | mm H2O | | 2 | TOB09 | PD | VAPE-Z27 | 2 | PUFCNT | Puff Count | 300 | 290 | 310 |
| | 3 | TOB09 | PD | VAPE-Z27 | 3 | CRTVOL | Cartridge Volume | 3 | 1 | 5 | mL | | 4 | TOB09 | PD | VAPE-Z27 | 4 | HTELNUM | Number of Heating Elements | 1 | 1 | |
| | 5 | TOB09 | PD | VAPE-Z27 | 5 | HTELGTH | Heating Element Length | 3 | 2.7 | 3.3 | mm | | 6 | TOB09 | PD | VAPE-Z27 | 6 | HTEDIAM | Heating Element Diameter | 3 | 2.9 | 3.2 | mm | | 7 | TOB09 | PD | VAPE-Z27 | 7 | HTELRST | Heating Element Resistance | 0.75 | 0.25 | 1.5 | ohm | | 8 | TOB09 | PD | VAPE-Z27 | 8 | HTELRNG | Heating Element Range | 175 | 100 | 250 | C | | 9 | TOB09 | PD | VAPE-Z27 | 9 | HTELCFG | Heating Element Configuration | SPIRAL | SPIRAL | SPIRAL |
| | 10 | TOB09 | PD | VAPE-Z27 | 10 | BTVLTORG | Battery Voltage Operating Range | 4.5 | 3 | 6 | V | | 11 | TOB09 | PD | VAPE-Z27 | 11 | BTCRTORG | Battery Current Operating Range | 1000 | 650 | 1600 | mAh | | 12 | TOB09 | PD | VAPE-Z27 | 12 | BATCAPC | Battery Capacity | 1100 | 800 | 3000 | mAh | | 13 | TOB09 | PD | VAPE-Z27 | 13 | BATNOMV | Battery Nominal Voltage | 4.2 | 4.0 | 4.5 | V | | 14 | TOB09 | PD | VAPE-Z27 | 14 | BTCRTRT | Battery Current Rating | 2500 | 2000 | 2800 | mA | | 15 | TOB09 | PD | VAPE-Z27 | 15 | BTCHTPL | Battery Charging Temperature Limits | 200 | 100 | 315 | C | | 16 | TOB09 | PD | VAPE-Z27 | 16 | BTDCTMPL | Battery Discharge Temperature Limits | 20 | -20 | 60 | C | | 17 | TOB09 | PD | VAPE-Z27 | 17 | BTENDCV | Battery End of Discharge Voltage | 3.0 | 2.0 | 3.5 | V | | 18 | TOB09 | PD | VAPE-Z27 | 18 | BTMXCHC | Battery Maximum Charging Current | 24 | 20 | 30 | mA | | 19 | TOB09 | PD | VAPE-Z27 | 19 | BTMXDCC | Battery Maximum Discharging Current | 2700 | 2400 | 3000 | mA | | 20 | TOB09 | PD | VAPE-Z27 | 20 | BTULCHV | Battery Upper Limits Charging Voltage | 4.2 | 4.1 | 4.3 | V | | 21 | TOB09 | PD | VAPE-Z27 | 21 | PDUVOR | PDU Voltage Operating Range | 3.7 | 3.2 | 4.2 | V | | 22 | TOB09 | PD | VAPE-Z27 | 22 | PDUCOR | PDU Current Operating Range | 1200 | 850 | 1800 | mA | | 23 | TOB09 | PD | VAPE-Z27 | 23 | PDUWTOR | PDU Wattage Operating Range | 75 | 70 | 80 | W | 24 | TOB09 | PD | VAPE-Z27 | 24 | PDUTCTOF | PDU Temperature Cut-off | 70 | 55 | 65 | C | | 2524 | TOB09 | PD | VAPE-Z27 | 2524 | AIRFLRT | Airflow Rate | 720 | 700 | 740 | L/min | | 2625 | TOB09 | PD | VAPE-Z27 | 2625 | PDUCRCOF | PDU Current Cut-off | 35 | 20 | 50 | mA | | 2726 | TOB09 | PD | VAPE-Z27 | 2726 | INHAERT | Inhaled Aerosol Temperature | 37 | 35 | 40 | C | | 2827 | TOB09 | PD | VAPE-Z27 | 2827 | VENTLTNVENTLTOT | Total Ventilation | 50 | 40 | 60 | % | | 2928 | TOB09 | PD | VAPE-Z27 | 2928 | ELQDVISC | E-Liquid Viscosity | 500 | 75 | 1130 | mPa/s | | 3029 | TOB09 | PD | VAPE-Z27 | 3029 | ELQDVOL | E-liquid Volume | 60 | 10 | 120 | mL | | 3130 | TOB09 | PD | VAPE-Z27 | 3130 | PNUMCNC | Particle Number Concentration | 500 | 108 | 1010 | /cm3 | | 3231 | TOB09 | PD | VAPE-Z27 | 3231 | CTMDDIAM | Count Median Diameter | 200 | 150 | 250 | nm | | 3332 | TOB09 | PD | VAPE-Z27 | 3332 | PM | PM2.5 | Particulate Matter PM 2.5 | 25 | 12 | 35 | ug/m3 |
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*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).Finally, the PT domain is used to represent the actual results of testing the manufactured ENDS product for conformance to the tobacco product design parameters shown in PD. PTCAT is a Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows.
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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.
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| Row | STUDYID | DOMAIN | SPTOBID | PTSEQ | PTREFID | PTTESTCD | PTTEST | PTTSTCND | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | |
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PTTPT | PTTPTNUM |
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| 1 | TOB09 | PT | VAPE-Z27 | |
| DRWRST | Draw Resistance |
| DESIGN PARAMETER TESTING |
| 91 | mm H2O | 91 | 91 | mm H2O |
1 | Week 0 | 1 | | 2 | TOB09 | PT | VAPE-Z27 | 2 |
| PUFCNT | Puff Count |
| DESIGN PARAMETER TESTING |
| 309 |
| 309 | 309 |
| 1 |
Week 01 | | 3 | TOB09 | PT | VAPE-Z27 | 3 |
| CRTVOL | Cartridge Volume |
| DESIGN PARAMETER TESTING |
| 3.09 | mL | 3.09 | 3.09 | mL |
1 | Week 0 | 1 | | 4 | TOB09 | PT | VAPE-Z27 | 4 |
| HTELNUM | Number of Heating Elements |
| DESIGN PARAMETER TESTING |
| 1 |
| 1 | 1 |
| 1 |
Week 0 | 1 | | 5 | TOB09 | PT | VAPE-Z27 | 5 |
| HTELGTH | Heating Element Length |
| DESIGN PARAMETER TESTING |
| 2.97 | mm | 2.97 | 2.97 | mm |
1 | Week 0 | 1 | | 6 | TOB09 | PT | VAPE-Z27 | 6 |
| HTEDIAM | Heating Element Diameter |
| DESIGN PARAMETER TESTING |
| 3.05 | mm | 3.05 | 3.05 | mm | | | 7 | TOB09 | PT | VAPE-Z27 | 7 |
| HTELRST | Heating Element Resistance |
| DESIGN PARAMETER TESTING |
| 0.77 | ohm | 0.77 | 0.77 | ohm | 1 |
Week 01 | | 8 | TOB09 | PT | VAPE-Z27 | 8 |
| HTELRNG | Heating Element Range |
| DESIGN PARAMETER TESTING |
| 174 | C | 174 | 174 | C | 1 |
Week 0 | 1 | | 9 | TOB09 | PT | VAPE-Z27 | 9 |
| HTELCFG | Heating Element Configuration |
| DESIGN PARAMETER TESTING |
| SPIRAL |
| SPIRAL | SPIRAL |
1 | Week 0 |
| 1 | | 10 | TOB09 | PT | VAPE-Z27 | 10 |
| BTVLTORG | Battery Voltage Operating Range |
| DESIGN PARAMETER TESTING |
| 4.6 | V | 4.6 | 4.6 | V | 1 |
Week 0 | 1 | | 11 | TOB09 | PT | VAPE-Z27 | 11 |
| BTCRTORG | Battery Current Operating Range |
| DESIGN PARAMETER TESTING |
| 997 | mAh | 997 | 997 | mAh | 1 |
Week 0 | 1 | | 12 | TOB09 | PT | VAPE-Z27 | 12 |
| BATCAPC | Battery Capacity |
| DESIGN PARAMETER TESTING |
| 1112 | mAh | 1112 | 1112 | mAh |
1 | Week 0 | 1 | | 13 | TOB09 | PT | VAPE-Z27 | 13 |
| BATNOMV | Battery Nominal Voltage |
| DESIGN PARAMETER TESTING |
| 4.18 | V | 4.18 | 4.18 | V |
1 | Week 0 | 1 | | 14 | TOB09 | PT | VAPE-Z27 | 14 |
| BTCRTRT | Battery Current Rating |
| DESIGN PARAMETER TESTING |
| 2488 | mA | 2488 | 2488 | mA | 1 |
Week 01 | | 15 | TOB09 | PT | VAPE-Z27 | 15 |
| BTCHTPL | Battery Charging Temperature Limits |
| DESIGN PARAMETER TESTING |
| 198 | C | 198 | 198 | C |
1 | Week 0 | 1 | | 16 | TOB09 | PT | VAPE-Z27 | 16 |
| BTDCTMPL | Battery Discharge Temperature Limits |
| DESIGN PARAMETER TESTING |
| 19 | C | 19 | 19 | C | 1 |
Week 0 | 1 | | 17 | TOB09 | PT | VAPE-Z27 | 17 |
| BTENDCV | Battery End of Discharge Voltage |
| DESIGN PARAMETER TESTING |
| 3.03 | V | 3.03 | 3.03 | V |
1 | Week 0 | 1 | | 18 | TOB09 | PT | VAPE-Z27 | 18 |
| BTMXCHC | Battery Maximum Charging Current |
| DESIGN PARAMETER TESTING |
| 23.5 | mA | 23.5 | 23.5 | mA | 1 |
Week 01 | | 19 | TOB09 | PT | VAPE-Z27 | 19 |
| BTMXDCC | Battery Maximum Discharging Current |
| DESIGN PARAMETER TESTING |
| 2696 | mA | 2696 | 2696 | mA |
1 | Week 0 | 1 | | 20 | TOB09 | PT | VAPE-Z27 | 20 |
| BTULCHV | Battery Upper Limits Charging Voltage |
| DESIGN PARAMETER TESTING |
| 4.21 | V | 4.21 | 4.21 | V |
1 | Week 0 | 1 | | 21 | TOB09 | PT | VAPE-Z27 | 21 |
| PDUVOR | PDU Voltage Operating Range |
| DESIGN PARAMETER TESTING |
| 3.65 | V | 3.65 | 3.65 | V | 1 |
Week 01 | | 22 | TOB09 | PT | VAPE-Z27 | 22 |
| PDUCOR | PDU Current Operating Range |
| DESIGN PARAMETER TESTING |
| 1202 | mA | 1202 | 1202 | mA |
1 | Week 0PDUWTOR | PDU Wattage Operating Range | DESIGN PARAMETER TESTING | 75 | W | 75 | 75 | W24 | TOB09 | PT | VAPE-Z27 | 24 | 1 | Week 0 | 1 | 25| PDUTCTOF | PDU Temperature Cut-off |
| DESIGN PARAMETER TESTING |
| 69.9 | C | 69.9 | 69.9 | C | 1 |
Week 0 | 1 | 2526| 24 |
| AIRFLRT | Airflow Rate |
| DESIGN PARAMETER TESTING |
| 727 | L/min | 727 | 727 | L/min | 1 |
Week 0 | 1 | 2627 | | 25 |
| PDUCRCOF | PDU Current Cut-off |
| DESIGN PARAMETER TESTING |
| 34.8 | mA | 34.8 | 34.8 | mA | 1 |
Week 0 | 1 | 2728| 26 |
| INHAERT | Inhaled Aerosol Temperature |
| DESIGN PARAMETER TESTING |
| 36.9 | C | 36.9 | 36.9 | C | 1 |
Week 0 | 1 | 28VENTLTN
| VENTLTOT | Total Ventilation |
| DESIGN PARAMETER TESTING |
| 51 | % | 51 | 51 | % | 1 |
Week 0 | 1 | 29 | 2930| 28 |
| ELQDVISC | E-Liquid Viscosity | Test performed at 20 degrees Celsius | DESIGN PARAMETER TESTING |
| 496 | mPa/s | 496 | 496 | mPa/s | 1 |
Week 0 | 1 | 3031| 29 |
| ELQDVOL | E-liquid Volume |
| DESIGN PARAMETER TESTING |
| 60.1 | mL | 60.1 | 60.1 | mL | 1 |
Week 0 | 1 | 31| 30 |
| PNUMCNC | Particle Number Concentration |
| DESIGN PARAMETER TESTING |
| 511 | /cm3 | 511 | 511 | /cm3 | 1 |
Week 0 | 1 | 32 | 3233| 31 |
| CTMDDIAM | Count Median Diameter |
| DESIGN PARAMETER TESTING |
| 202 | nm | 202 | 202 | nm | 1 |
Week 0 | 1 | 33PM | PM
| PM2.5 | Particulate Matter 2.5 |
| DESIGN PARAMETER TESTING |
| 24.4 | ug/m3 | 24.4 | 24.4 | ug/m3 |
1 | Week 0 |
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