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This images shows the filtration zone where the ventilation occurs.

Image Removed

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.

Steve H's suggestion of combining our  previous product identifiers and product descriptors into a single dataset. This is a more traditional findings dataset structure. Advantages: it doesn't break any rules. SPTOBID is the Sponsor-defined Tobacco Product Identifier, and serves as the "subject" of all records since these are not (human) subject-level data.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. 

Rows 1-4:
Dataset wrap
Nameto
Rowcaps
TOSTRESU
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
RowSTUDYIDDOMAINSPTOBIDTOSEQ
TOTESTCD
TOPARMCD
TOTEST
TOPARMTOCAT
TOORRES
TOSCAT
TOORRESUTOSTRESCTOSTRESN
TOVALTOVALU
1TOB07TOCIG01a

1

TBPRDCATTobacco Product CategoryNEW PRODUCTPRODUCT IDENTIFIER
Cigarette
Cigarettes
Cigarette

2TOB07TOCIG01a2TBPRSCATTobacco Product SubcategoryNEW PRODUCTPRODUCT IDENTIFIER
Filtered, Combusted
Filtered
, Combusted

3TOB07TOCIG01a3MANUFManufacturerNEW PRODUCTPRODUCT IDENTIFIERJoes Cigs USA
Joes Cigs USA

4TOB07TOCIG01a4TRADENAMTrade NameNEW PRODUCTPRODUCT IDENTIFIER
Treetop Menthol King Size
Treetop Menthol King Size
5TOB07TOCIG01a5PACKTYPPackage TypeNEW PRODUCTPRODUCT DESCRIPTOR
HARD PACK
HARD PACK
6TOB07TOCIG01a6PRDQUANProduct QuantityNEW PRODUCTPRODUCT DESCRIPTOR
20CIGARETTE20
20CIGARETTE
7TOB07TOCIG01a7LENGTHLengthNEW PRODUCTPRODUCT DESCRIPTOR86.0mm
86.0
86.0mm
8TOB07TOCIG01a8CIRCUMFCircumferenceNEW PRODUCTPRODUCT DESCRIPTOR26.0mm
26.0
26.0mm
9TOB07TOCIG01a9
VENTLTN
VENTLTOTTotal VentilationNEW PRODUCTPRODUCT DESCRIPTOR
10.0%10.0
10.0%
10TOB07TOCIG01a10CHARFLAVCharacterizing FlavorNEW PRODUCTPRODUCT DESCRIPTOR
MENTHOL
MENTHOL

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
710131932344249
RowSTUDYIDDOMAINSPTOBIDIGDCMPIDPDSEQPDTESTCDPDPARMCDPDTESTPDPARMPDCATPDVALTRGPDORRESPDVALMINPDORRESUPDSTRESCPDSTRESNPDSTRESUPDVALMAXPDVALUPDCOLSRT
1

TOB07

PDCIG01a


1

LENGTHLengthDESIGN PARAMETER SPECIFICATIONmmmm

84

83.5

84.5

mm

TARGET

2TOB07PDCIG01a
2LENGTHLengthDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM3TOB07PDCIG01a3LENGTHLengthDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM4TOB07PDCIG01a4CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATIONmmmmTARGET5TOB07PDCIG01a5CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM6TOB07PDCIG01a6CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATION24.824.625mm
3mmmmMAXIMUM7TOB07PDCIG01a
3TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATION783mgmgTARGET8TOB07PDCIG01a8TBFLMASSTobacco Filler Mass753814DESIGN PARAMETER SPECIFICATIONmgmg
4MINIMUM9TOB07PDCIG01a9TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATIONmgmgMAXIMUM10TOB07PDCIG01a
4MOISTUREMoistureDESIGN PARAMETER SPECIFICATION%%TARGET11TOB07PDCIG01a11MOISTUREMoistureDESIGN PARAMETER SPECIFICATION%%MINIMUM12TOB07PDCIG01a12MOISTUREMoistureDESIGN PARAMETER SPECIFICATION%%MAXIMUM131214%
513TOB07PDCIG01a

Burley tobacco

TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONcuts per inch2cuts per inch2TARGET14TOB07PDCIG01a145TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION

22

mmmmTARGET15TOB07PDCIG01a15TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONcuts per inch2cuts per inch2

20

24

cuts/in

6MINIMUM16TOB07PDCIG01a16TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM17TOB07PDCIG01a17

Reconstituted tobacco

6TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONcuts per inch2cuts per inch2MAXIMUM18TOB07PDCIG01a18TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONmm

27

25

29

mm

7mmMAXIMUM19TOB07PDCIG01a


7FLTRVENTVENTLFLTFilter VentilationDESIGN PARAMETER SPECIFICATION

30

%

23

%TARGET20TOB07PDCIG01a20FLTRVENTFilter VentilationDESIGN PARAMETER SPECIFICATION%%MINIMUM2137

%

8TOB07PDCIG01a21FLTRVENTFilter VentilationDESIGN PARAMETER SPECIFICATION%%MAXIMUM
822TOB07PDCIG01a22TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATION31mmmmTARGET23TOB07PDCIG01a23TPNPLGTHTipping Paper Length3032DESIGN PARAMETER SPECIFICATIONmmmmMINIMUM
249TOB07PDCIG01a24TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM
9CBPPOR25TOB07PDCIG01a25CIGBPPOR

Cigarette Base Paper Porosity

DESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu)CORESTA Unit (Cu)TARGET26TOB07PDCIG01a26CIGBPPORCigarette Base Paper PermeabilityDESIGN PARAMETER SPECIFICATION

50

45

55Cu
10CORESTA Unit (Cu)CORESTA Unit (Cu)TARGET27TOB07PDCIG01a27CIGBPPORCigarette Base Paper PorosityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu)CORESTA Unit (Cu)MINIMUM


10CBPPERM28TOB07PDCIG01a28CIGBPPORCigarette Base Paper PermeabilityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu)CORESTA Unit (Cu)MINIMUM29TOB07PDCIG01a29CIGBPPORCigarette Base Paper PorosityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu)CORESTA Unit (Cu)MAXIMUM

50

45

55

Cu

1130TOB07PDCIG01a30CIGBPPORCigarette Base Paper PermeabilityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu)CORESTA Unit (Cu)MAXIMUM
11CPBPOR31TOB07PDCIG01a31BNDPORCigarette Paper Band PorosityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm2/sCORESTA Unit (Cu) or cm2/sTARGET100.213Cu
1232TOB07PDCIG01a
12BNDPERMCPBPERMCigarette Paper Band PermeabilityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm2/sCORESTA Unit (Cu) or cm2/sTARGET33TOB07PDCIG01a33BNDDIFCigarette Paper Band DiffusivityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm2/sCORESTA Unit (Cu) or cm2/sTARGET34100.213Cu
13TOB07PDCIG01a
13BNDPOR

CPBDIFF

Cigarette Paper Band PorosityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm2/sCORESTA Unit (Cu) or cm2/sMINIMUM35TOB07PDCIG01a35BNDPERMCigarette Paper Band PermeabilityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm2/sCORESTA Unit (Cu) or cm2/sMINIMUM36TOB07PDCIG01a36BNDDIFCigarette Paper Band DiffusivityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm2/sCORESTA Unit (Cu) or cm2/sMINIMUM37TOB07PDCIG01a37BNDPORCigarette Paper Band PorosityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm2/sCORESTA Unit (Cu) or cm2/sMAXIMUM38Diffusivity0.050.0010.100cm2/s
14TOB07PDCIG01a38BNDPERMCigarette Paper Band PermeabilityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm2/sCORESTA Unit (Cu) or cm2/sMAXIMUM39TOB07PDCIG01a39BNDDIFCigarette Paper Band DiffusivityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm2/sCORESTA Unit (Cu) or cm2/sMAXIMUM


14CPBWIDCigarette Paper Band Width

7

6.7

7.3

mm

1540TOB07PDCIG01a40CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATIONmmmmTARGET41TOB07PDCIG01a41CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM42TOB07PDCIG01a


15CPBNDWIDCPBSPCCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM43TOB07PDCIG01a43CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATIONmmmmTARGET44TOB07PDCIG01a44CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATIONmmSpace20

19.8

20.2

mm

16mmMINIMUM45TOB07PDCIG01a45CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM


1646TOB07PDCIG01a46FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION

30

%%TARGET47TOB07PDCIG01a47FLTREFFFilter Efficiency

25

35DESIGN PARAMETER SPECIFICATION

%

%
17MINIMUM48TOB07PDCIG01a48FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION%%MAXIMUM49TOB07PDCIG01a


17DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION/filamentTARGET43.64.4


1850TOB07PDCIG01a50DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION/filamentMINIMUM51TOB07PDCIG01a51DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION/filamentMAXIMUM


1852TOB07PDCIG01a52TDENIERTotal DenierDESIGN PARAMETER SPECIFICATIONg/9000 mg/9000 mTARGET53TOB07PDCIG01a53TDENIERTotal Denier

30000

29100

30900DESIGN PARAMETER SPECIFICATION

g/

9000 m		g/9000 mMINIMUM54

9000m

19TOB07PDCIG01a54TDENIERTotal DenierDESIGN PARAMETER SPECIFICATIONg/9000 mg/9000 mMAXIMUM
1955TOB07PDCIG01a55FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATIONg/cm3g/cm3TARGET56TOB07PDCIG01a56FLTRDENFilter Density0.12340.1050.1419DESIGN PARAMETER SPECIFICATIONg/cm3g/cm3MINIMUM
5720TOB07PDCIG01a57FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATIONg/cm3g/cm3MAXIMUM
2058TOB07PDCIG01a58FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATIONmmmmTARGET59TOB07PDCIG01a59FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATION2524.525.5mm
21mmmmMINIMUM60TOB07PDCIG01a60FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM
2161TOB07PDCIG01a61FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATIONmm H2Omm H2OTARGET62TOB07PDCIG01a62FLTPRDRPFilter Pressure Drop605169DESIGN PARAMETER SPECIFICATIONmm H2Omm H2OMINIMUM
6322TOB07PDCIG01a63FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATIONmm H2Omm H2OMAXIMUM
2264TOB07PDCIG01a64TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATIONg/cm3g/cm3TARGET65TOB07PDCIG01a65TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATION0.26780.24370.2919g/cm3g/cm3MINIMUM
6623TOB07PDCIG01a66TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATIONg/cm3g/cm3MAXIMUM
23CIGPLGTH67TOB07PDCIG01a67Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATIONmmmmTARGET68TOB07PDCIG01a68Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM69TOB07PDCIG01a69Cigarette Paper LengthCIGPLGTH53DESIGN PARAMETER SPECIFICATION52mm54mmMAXIMUM

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.

Dataset wrap
Namept
TOCUTSIZ2
Dataset2
RowSTUDYIDDOMAINSPTOBIDIGDCMPIDPTSEQPTTESTCDPTTESTPTCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTMETHODPTREPNUM
1TOB07PTCIG01a

1

LENGTHLengthDESIGN PARAMETER TESTING

83.9

mm

83.9

83.9

mm
1
2TOB07PTCIG01a
2CIRCUMFCircumferenceDESIGN PARAMETER TESTING24.9mm24.924.9mm
1
3TOB07PTCIG01a
3TBFLMASSTobacco Filler MassDESIGN PARAMETER TESTING779mg779779mg
1
4TOB07PTCIG01a
4MOISTUREMoistureDESIGN PARAMETER TESTING13.1%13.113.1%
1
5TOB07PTCIG01a

Burley tobacco

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

Reconstituted tobacco

6TOCUTSIZTobacco Cut Size
2
DESIGN PARAMETER TESTING27mm2727mm
1
7TOB07PTCIG01a
6

7
FLTRVENT
VENTLFLTFilter VentilationDESIGN PARAMETER TESTING35%3535%
1
8TOB07PTCIG01a
7

8TPNPLGTHTipping Paper LengthDESIGN PARAMETER TESTING30mm3030mm
1
9TOB07PTCIG01a
8

9
CIGBPPOR
CBPPORCigarette Base Paper PorosityDESIGN PARAMETER TESTING
CORESTA Unit (Cu)
48Cu4848Cu
1
CORESTA Unit (Cu)
10TOB07PTCIG01a
8

10
CIGBPPERM
CBPPERMCigarette Base Paper PermeabilityDESIGN PARAMETER TESTING
cm2/s
50Cu5050Cu
1
cm2/s
11TOB07PTCIG01a
9

11
BNDDIF
CPBPORCigarette Paper Band PorosityDESIGN PARAMETER TESTING
CORESTA Unit (Cu)
9.8Cu9.89.8Cu
1
CORESTA Unit (Cu)
12TOB07PTCIG01a
9

12
BNDDIF
CPBPERMCigarette Paper Band PermeabilityDESIGN PARAMETER TESTING
cm^2/s
10Cu1010Cu
1
cm2/s
13TOB07PTCIG01a
9

13
BNDDIF
CPBDIFFCigarette Paper Band DiffusivityDESIGN PARAMETER TESTING0.06cm2/s0.060.06cm2/s
1
14TOB07PTCIG01a
10

14
CPBNDWID
CPBWIDCigarette Paper Band WidthDESIGN PARAMETER TESTING7.1mm7.17.1mm
1
15TOB07PTCIG01a
11

15
CPBNDSPC
CPBSPCCigarette Paper Band SpaceDESIGN PARAMETER TESTING19.9mm19.919.9mm
1
16TOB07PTCIG01a
12

16FLTREFFFilter EfficiencyDESIGN PARAMETER TESTING28%2828%
1
17TOB07PTCIG01a
13

17DPFDenier Per FilamentDESIGN PARAMETER TESTING
/filament
4.1
4.14.1

1
18TOB07PTCIG01a
14

18
DENIER
TDENIERTotal DenierDESIGN PARAMETER TESTING29900g/9000m2990029900g/9000m
1
19TOB07PTCIG01a
15

19FLTRDENFilter DensityDESIGN PARAMETER TESTING0.1112g/cm30.11120.1112g/cm3
1
20TOB07PTCIG01a
16

20FLTRLGTHFilter LengthDESIGN PARAMETER TESTING25mm2525mm
1
21TOB07PTCIG01a
17

21FLTPRDRPFilter Pressure DropDESIGN PARAMETER TESTING62mm H2O6262mm H2O
1
22TOB07PTCIG01a
18

22TORODDENTobacco Rod DensityDESIGN PARAMETER TESTING0.2701g/cm30.27010.2701g/cm3
1
23TOB07PTCIG01a
19

23CIGPLGTHCigarette Paper LengthDESIGN PARAMETER TESTING53mm5353mm
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