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This images shows the filtration zone where the ventilation occurs.

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Question - is this helpful?  Will need permission.  This is from the second reference.

This is an example for the required tobacco product categorization, property description, and design parameter information in an FDA marketing application for one type of tobacco product Cigarette. 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 products Premarket Authorization (PMTA) and Substantial Equivalence (SE) Pathways. The applicant submitting for SE and PMTAs should provide test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.

Tobacco Products (TO) is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. It is similar to Device Identifiers (DI) in function. 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, model (product) name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID) (similar to Sponsor Device Identifier (SPDEVID) a consistent variable, that is available for use in other domains where data pertaining to the product may be found.example illustrates the representation of a cigarette product's identifiers and descriptors using the TO domain. Note that this example uses TOSCAT (Subcategory of Tobacco Prod ID Element, a permissible variable) to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors. 

rowcaps
Dataset wrap
Nameto
Rows 1-4:Show the records for the product identifiers for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT IDENTIFIERS.
Rows 5-10:Show the records for the product descriptors for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT DESCRIPTOR.
Dataset2
RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOCATTOSCATTOVALTOVALU
1TOB07TOCIG01a

1

TBPRDCATTobacco Product CategoryNEW PRODUCTPRODUCT IDENTIFIER
Cigarette
Cigarettes
2TOB07TOCIG01a2TBPRSCATTobacco Product SubcategoryNEW PRODUCTPRODUCT IDENTIFIERFiltered
, Combusted

3TOB07TOCIG01a3MANUFManufacturerNEW PRODUCTPRODUCT IDENTIFIERJoes Cigs USA
4TOB07TOCIG01a4TRADENAMTrade NameNEW PRODUCTPRODUCT IDENTIFIERTreetop Menthol King Size
5TOB07TOCIG01a5PACKTYPPackage TypeNEW PRODUCTPRODUCT DESCRIPTORHARD PACK
6TOB07TOCIG01a6PRDQUANProduct QuantityNEW PRODUCTPRODUCT DESCRIPTOR20CIGARETTE
7TOB07TOCIG01a7LENGTHLengthNEW PRODUCTPRODUCT DESCRIPTOR86.0mm
8TOB07TOCIG01a8CIRCUMFCircumferenceNEW PRODUCTPRODUCT DESCRIPTOR26.0mm
9TOB07TOCIG01a9
VENTLTN
VENTLTOTTotal VentilationNEW PRODUCTPRODUCT DESCRIPTOR10.0%
10TOB07TOCIG01a10CHARFLAVCharacterizing FlavorNEW PRODUCTPRODUCT DESCRIPTORMENTHOL

The Tobacco Product Design Parameters (PD) represents the manufacturing parameter specifications of the cigarette tobacco product as used. The example below intended for use are represented in the PD domain  The following example shows the target, minimum, and maximum values associated with each of 19 23 separate design parameters. These parameters are defined as manufacturing guidelinesspecifications, not characteristics that are determined experimentally.

Note the use of the variable IGDCMPID (Ingredient or Component Identifier) in rows 5-6. This tobacco product had 2 tobacco ingredients with 2 different tobacco cut sizes. IGDCMPID identifies to which tobacco ingredient the cut size applies. IGDCMPID originates in the IT (Tobacco Ingredients) and IN (Non-Tobacco Ingredients) domains. See Section 3.1.3.1, Ingredients and Additives, for more information.

Dataset wrap
Namepd
Dataset2
47141618192122232526313233434652555861646769
RowSTUDYIDDOMAINSPTOBIDIGDCMPIDPDSEQPDTESTCDPDPARMCDPDTESTPDPARMPDCATPDVALTRGPDORRESPDVALMINPDORRESUPDSTRESCPDSTRESNPDSTRESUPDVALMAXPDVALUPDCOLSRT
1

TOB07

PDCIG01a


1

LENGTHLengthDESIGN PARAMETER SPECIFICATION

84

mm84

84

mm

TARGET2TOB07PDCIG01a2LENGTHLengthDESIGN PARAMETER SPECIFICATION

83

.5
mm83.583.5mmMINIMUM3TOB07PDCIG01a3LENGTHLengthDESIGN PARAMETER SPECIFICATION84

.5

mm84.584.5

mm

MAXIMUM
42TOB07PDCIG01a
2CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATION24.8mm24.824.8mmTARGET
5TOB07PDCIG01a5CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATION24.3mm24.324.3mmMINIMUM
6TOB07PDCIG01a6CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATION25.3mm25.325.
3mmMAXIMUM7TOB07PDCIG01a
3TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATION783mg783783mgTARGET8TOB07PDCIG01a8TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATION753mg753753814753mgMINIMUM
94TOB07PDCIG01a9TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATION813mg813813mgMAXIMUM
10TOB07PDCIG01a10MOISTUREMoistureDESIGN PARAMETER SPECIFICATION13%1313%TARGET
11TOB07PDCIG01a11MOISTUREMoistureDESIGN PARAMETER SPECIFICATION12.09%12.0912.09%MINIMUM

4MOISTUREMoisture131214%
512TOB07PDCIG01a12MOISTUREMoistureDESIGN PARAMETER SPECIFICATION13.91%13.9113.91%MAXIMUM

Burley tobacco

513TOB07PDCIG01a13TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION

22

cuts per inch

22

20

2422

cuts

per inch2
TARGET

/in

614TOB07PDCIG01a

Reconstituted tobacco

6TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION

27

mm

27

27

mmTARGET
15TOB07PDCIG01a15TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION20cuts per inch2020cuts per inch2MINIMUM

TOB07PDCIG01a16TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION

25

mm2525mmMINIMUM
17TOB07PDCIG01a17TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION24cuts per inch2424cuts per inch2MAXIMUM
18TOB07PDCIG01a

TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION29

mm

2929mmMAXIMUM
197TOB07PDCIG01a


7FLTRVENTVENTLFLTFilter VentilationDESIGN PARAMETER SPECIFICATION

30

%

30

30

%TARGET20TOB07PDCIG01a20FLTRVENTFilter VentilationDESIGN PARAMETER SPECIFICATION23%23

23

%MINIMUM

TOB07PDCIG01a21FLTRVENTFilter VentilationDESIGN PARAMETER SPECIFICATION37

%

3737%MAXIMUM
822TOB07PDCIG01a
8TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATION31mm3131mmTARGET23TOB07PDCIG01aTPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATION30mm3030mmMINIMUM24TOB07PDCIG01a24TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATION32mm3232mmMAXIMUM
259TOB07PDCIG01a
9CIGBPPORCBPPOR

Cigarette Base Paper Porosity

DESIGN PARAMETER SPECIFICATION

50

NACORESTA Unit (Cu)NANACORESTA Unit (Cu)TARGET26

45

55Cu
10TOB07PDCIG01a


10CIGBPPORCBPPERMCigarette Base Paper PermeabilityDESIGN PARAMETER SPECIFICATION

50

CORESTA Unit (Cu)

50

50

CORESTA Unit (Cu)TARGET
27TOB07PDCIG01a27CIGBPPORCigarette Base Paper PorosityDESIGN PARAMETER SPECIFICATIONNACORESTA Unit (Cu)NANACORESTA Unit (Cu)MINIMUM
28TOB07PDCIG01a28CIGBPPORCigarette Base Paper PermeabilityDESIGN PARAMETER SPECIFICATION

45

CORESTA Unit (Cu)4545CORESTA Unit (Cu)MINIMUM
29TOB07PDCIG01a29CIGBPPORCigarette Base Paper PorosityDESIGN PARAMETER SPECIFICATIONNACORESTA Unit (Cu)NANACORESTA Unit (Cu)MAXIMUM
30TOB07PDCIG01a30CIGBPPORCigarette Base Paper PermeabilityDESIGN PARAMETER SPECIFICATION

55CORESTA Unit (

Cu

)

5555CORESTA Unit (Cu)MAXIMUM31
11TOB07PDCIG01a
11BNDPORCPBPORCigarette Paper Band PorosityDESIGN PARAMETER SPECIFICATIONNACORESTA Unit (Cu) or cm2/sNANACORESTA Unit (Cu) or cm2/sTARGET32100.213Cu
12TOB07PDCIG01a
12BNDPERMCPBPERMCigarette Paper Band PermeabilityDESIGN PARAMETER SPECIFICATION10CORESTA Unit (Cu) or cm2/s1010CORESTA Unit (Cu) or cm2/sTARGET100.213Cu
1333TOB07PDCIG01a
13BNDDIF

CPBDIFF

Cigarette Paper Band DiffusivityDESIGN PARAMETER SPECIFICATIONNACORESTA Unit (Cu) or cm2/sNANACORESTA Unit (Cu) or cm2/sTARGET
34TOB07PDCIG01a34BNDPORCigarette Paper Band PorosityDESIGN PARAMETER SPECIFICATIONNACORESTA Unit (Cu) or cm2/sNANACORESTA Unit (Cu) or cm2/sMINIMUM
35TOB07PDCIG01a35BNDPERMCigarette Paper Band PermeabilityDESIGN PARAMETER SPECIFICATION0.2CORESTA Unit (Cu) or cm2/s0.20.2CORESTA Unit (Cu) or cm2/sMINIMUM
0.050.0010.100cm2/s
1436TOB07PDCIG01a36BNDDIFCigarette Paper Band DiffusivityDESIGN PARAMETER SPECIFICATIONNACORESTA Unit (Cu) or cm2/sNANACORESTA Unit (Cu) or cm2/sMINIMUM
37TOB07PDCIG01a37BNDPORCigarette Paper Band PorosityDESIGN PARAMETER SPECIFICATIONNACORESTA Unit (Cu) or cm2/sNANACORESTA Unit (Cu) or cm2/sMAXIMUM
38TOB07PDCIG01a38BNDPERMCigarette Paper Band PermeabilityDESIGN PARAMETER SPECIFICATION13CORESTA Unit (Cu) or cm2/s1313CORESTA Unit (Cu) or cm2/sMAXIMUM
39TOB07PDCIG01a39BNDDIFCigarette Paper Band DiffusivityDESIGN PARAMETER SPECIFICATIONNACORESTA Unit (Cu) or cm2/sNANACORESTA Unit (Cu) or cm2/sMAXIMUM
40TOB07PDCIG01a40CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATION

7

mm

7

7

mmTARGET
41TOB07PDCIG01a41CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATION6.7mm6.76.7mmMINIMUM
42TOB07PDCIG01a42CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATION7.3mm7.37.3mmMAXIMUM


14CPBWIDCigarette Paper Band Width

7

6.7

7.3

mm

1543TOB07PDCIG01a


15CPBNDSPCCPBSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATION

20

mm

20

20mmTARGET44TOB07PDCIG01a44CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATION

19.8

mm

19.819.8mmMINIMUM45TOB07PDCIG01a45CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATION20.2

mm

20.220.2mmMAXIMUM
1646TOB07PDCIG01a


16FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION

N/A

%

N/A

30

25

35N/A

%

TARGET
1747TOB07PDCIG01a47FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATIONN/A%N/AN/A%MINIMUM
48TOB07PDCIG01a48FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATIONN/A%N/AN/A%MAXIMUM


1749TOB07PDCIG01a49DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION444/filamentTARGET50TOB07PDCIG01a50DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION3.63.63.6/filamentMINIMUM51TOB07PDCIG01a51DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION4.44.44.4/filamentMAXIMUM


5218TOB07PDCIG01a


18TDENIERTotal DenierDESIGN PARAMETER SPECIFICATION30000g/9000 m

30000

30000

g/9000 mTARGET53TOB07PDCIG01a53TDENIERTotal Denier

DESIGN PARAMETER SPECIFICATION

29100

g/9000 m

2910029100g/9000 mMINIMUM54TOB07PDCIG01a54TDENIERTotal DenierDESIGN PARAMETER SPECIFICATION30900

g/

9000 m

9000m

3090030900g/9000 mMAXIMUM
1955TOB07PDCIG01a
19FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATION0.1234g/cm30.12340.1234g/cm3TARGET56TOB07PDCIG01a56FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATION0.105g/cm30.1050.105g/cm3MINIMUM57TOB07PDCIG01a57FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATION0.1419g/cm30.14190.1419g/cm3MAXIMUM
2058TOB07PDCIG01a
20FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATION25mm2525mmTARGET59TOB07PDCIG01a59FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATION24.5mm24.524.5mmMINIMUM60TOB07PDCIG01a60FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATION25.5mm25.525.5mmMAXIMUM
2161TOB07PDCIG01a
21FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATION60mm H2O6060mm H2OTARGET62TOB07PDCIG01a62FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATION51mm H2O5151mm H2OMINIMUM63TOB07PDCIG01a63FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATION69mm H2O6969mm H2OMAXIMUM
6422TOB07PDCIG01a
22TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATION0.2678g/cm30.26780.2678g/cm3TARGET65TOB07PDCIG01a65TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATION0.2437g/cm30.24370.2437g/cm3MINIMUM66TOB07PDCIG01a66TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATION0.2919g/cm30.29190.2919g/cm3MAXIMUM
2367TOB07PDCIG01a
23Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATION53mm5353mmTARGET68TOB07PDCIG01a68Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATION52mm525352mmMINIMUMTOB07PDCIG01a69Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATION54mm5454mmMAXIMUM

The Tobacco Product Testing (PT) Finally, the PT domain is used to represent the actual results of testing the manufactured cigarette product for conformance to the tobacco product design parameters shown in PD above. PTCAT is a Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. As described in the PD example, IGDCMPID is also used here to differentiate 2 records of the same test performed on each of 2 different types of tobacco that are ingredients of the tobacco product. 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.

PTTPTNUM
Dataset wrap
Namept
Dataset2
RowSTUDYIDDOMAINSPTOBIDIGDCMPIDPTSEQPTTESTCDPTTESTPTCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESU
PTSPECPTSPCCND
PTMETHOD
PTLLOQ
PTREPNUM
PTTPT
1TOB07PTCIG01a

1

LENGTHLengthDESIGN PARAMETER TESTING

83.9

mm

83.9

83.9

mm
1
Week 01
2TOB07PTCIG01a
2CIRCUMFCircumferenceDESIGN PARAMETER TESTING24.9mm24.924.9mm
1
Week 01
3TOB07PTCIG01a
3TBFLMASSTobacco Filler MassDESIGN PARAMETER TESTING779mg779779mg
1
Week 0

1
4TOB07PTCIG01a
4MOISTUREMoistureDESIGN PARAMETER TESTING13.1%13.113.1%
1
Week 01
5TOB07PTCIG01a

Burley tobacco

5
TOCUTSIZ1
TOCUTSIZTobacco Cut Size
1
DESIGN PARAMETER TESTING22cuts
per inch
/in2222cuts
per inch1Week 0
/in
1
6TOB07PTCIG01a

Reconstituted tobacco

6
TOCUTSIZ2
TOCUTSIZTobacco Cut Size
2
DESIGN PARAMETER TESTING27mm2727mm
1Week 0

1
7TOB07PTCIG01a
7
FLTRVENT
VENTLFLTFilter VentilationDESIGN PARAMETER TESTING35%3535%
1
Week 0
1
8TOB07PTCIG01a
8TPNPLGTHTipping Paper LengthDESIGN PARAMETER TESTING30mm3030mm
1
Week 01
9TOB07PTCIG01a
9
CIGBPPOR
CBPPORCigarette Base Paper PorosityDESIGN PARAMETER TESTING
N/ACORESTA Unit (Cu)N/AN/ACORESTA Unit (Cu)1
48Cu4848Cu
Week 0

1
10TOB07PTCIG01a
10
CIGBPPERM
CBPPERMCigarette Base Paper PermeabilityDESIGN PARAMETER TESTING50
cm2/sWeek 0
Cu5050
cm2/s1
Cu
1
11TOB07PTCIG01a
11
BNDDIF
CPBPORCigarette Paper Band PorosityDESIGN PARAMETER TESTING
N/ACORESTA Unit (Cu)N/AN/ACORESTA Unit (Cu)1
9.8Cu9.89.8Cu
Week 0

1
12TOB07PTCIG01a
12
BNDDIF
CPBPERMCigarette Paper Band PermeabilityDESIGN PARAMETER TESTING10
cm^2/s
Cu1010
cm2/s
Cu
1
Week 01
13TOB07PTCIG01a
13
BNDDIF
CPBDIFFCigarette Paper Band DiffusivityDESIGN PARAMETER TESTING
N/AN/AN/A1
0.06cm2/s0.060.06cm2/s
Week 0

1
14TOB07PTCIG01a
14
CPBNDWID
CPBWIDCigarette Paper Band WidthDESIGN PARAMETER TESTING7.1mm7.17.1mm
1Week 0

1
15TOB07PTCIG01a
15
CPBNDSPC
CPBSPCCigarette Paper Band SpaceDESIGN PARAMETER TESTING19.9mm19.919.9mm
1Week 0

1
16TOB07PTCIG01a
16FLTREFFFilter EfficiencyDESIGN PARAMETER TESTING
N/A
28%
N/A
2828
N/A
%
1
Week 01
17TOB07PTCIG01a
17DPFDenier Per FilamentDESIGN PARAMETER TESTING4.1
4.14.1
/filament1Week 0


1
18TOB07PTCIG01a
18
DENIER
TDENIERTotal DenierDESIGN PARAMETER TESTING29900g/9000m2990029900g/9000m
1
Week 01
19TOB07PTCIG01a
19FLTRDENFilter DensityDESIGN PARAMETER TESTING0.1112g/cm30.11120.1112g/cm3
1Week 0

1
20TOB07PTCIG01a
20FLTRLGTHFilter LengthDESIGN PARAMETER TESTING25mm2525mm
1Week 0

1
21TOB07PTCIG01a
21FLTPRDRPFilter Pressure DropDESIGN PARAMETER TESTING62mm H2O6262mm H2O
1Week 0

1
22TOB07PTCIG01a
22TORODDENTobacco Rod DensityDESIGN PARAMETER TESTING0.2701g/cm30.27010.2701g/cm3
1Week 0

1
23TOB07PTCIG01a
23CIGPLGTHCigarette Paper LengthDESIGN PARAMETER TESTING53mm5353mm
1Week 0

1

References:

  1. International Organization for Standardization. ISO 9512:2019(en) - Cigarettes — Determination of ventilation — Definitions and measurement principles. ISO; June 2019. Accessed October 15, 2023. https://www.iso.org/obp/ui/#iso:std:iso:9512:ed-3:v1:en
  2. Song M-A, Benowitz NL, Berman M, et al. Cigarette filter ventilation and its relationship to increasing rates of lung adenocarcinoma. J Natl Cancer Inst. 2017;109(12):djx075. https://wwwdoi.ncbi.nlm.nih.gov/pmc/articles/PMC6059254/org/10.1093/jnci/djx075