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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. 

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.Cigarette
Dataset wrap
Nameto
Rowcaps
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:
TOSTRESU
Dataset2
RowSTUDYIDDOMAINSPTOBIDTOSEQ
TOTESTCD
TOPARMCD
TOTEST
TOPARMTOCAT
TOORRES
TOSCAT
TOORRESUTOSTRESCTOSTRESN
TOVALTOVALU
1TOB07TOCIG01a

1

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

3TOB07TOCIG01a3MANUFManufacturerNEW PRODUCTPRODUCT IDENTIFIER
Joes 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 PRODUCT
DESCRIPTOR20CIGARETTE
PRODUCT DESCRIPTOR
20
20CIGARETTE
7TOB07TOCIG01a7LENGTHLengthNEW PRODUCTPRODUCT DESCRIPTOR86.0mm
86.0
86.0mm
8TOB07TOCIG01a8CIRCUMFCircumferenceNEW PRODUCT
DESCRIPTOR26.0mm
PRODUCT DESCRIPTOR
26.0
26.0mm
9TOB07TOCIG01a9
VENTLTN
VENTLTOTTotal VentilationNEW PRODUCTPRODUCT DESCRIPTOR10.0%
10
.010.0
%10
TOB07TOCIG01a10CHARFLAVCharacterizing 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
71017193246MINIMUM5569
RowSTUDYIDDOMAINSPTOBIDIGDCMPIDPDSEQPDTESTCDPDPARMCDPDTESTPDPARMPDCATPDVALTRGPDORRESPDVALMINPDORRESUPDVALMAXPDSTRESCPDSTRESNPDSTRESUPDCOLSRTPDVALU
1

TOB07

PDCIG01a


1

LENGTHLengthDESIGN PARAMETER SPECIFICATION

84

83.5

84.5mm

mm

TARGET
2TOB07PDCIG01a
2LENGTHLengthDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM3TOB07PDCIG01a3LENGTHLengthDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM4TOB07PDCIG01a4CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATIONmmmmTARGET5TOB07PDCIG01a5CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM6TOB07PDCIG01a6CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATION24.824.625mm
3mmmmMAXIMUM7TOB07PDCIG01a
3TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATION783mgmgTARGET8TOB07PDCIG01a8TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATIONmgmgMINIMUM9753814mg
4TOB07PDCIG01a9TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATIONmgmgMAXIMUM10TOB07PDCIG01a
4MOISTUREMoistureDESIGN PARAMETER SPECIFICATION%%TARGET11TOB07PDCIG01a11MOISTUREMoistureDESIGN PARAMETER SPECIFICATION%%MINIMUM12TOB07PDCIG01a12MOISTUREMoistureDESIGN PARAMETER SPECIFICATION%%MAXIMUM131214%
513TOB07PDCIG01a13TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONcuts per inchcuts per inch2TARGET

Burley tobacco

514TOB07PDCIG01a14TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION

22

mmmmTARGET15TOB07PDCIG01a15TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONcuts per inchcuts per inch2

20

24

cuts/in

6MINIMUM16TOB07PDCIG01a16TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM17TOB07PDCIG01a

Reconstituted tobacco

6TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONcuts per inchcuts per inch2MAXIMUM18TOB07PDCIG01a18TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONmmmm

27

25

29

mm

7MAXIMUM19TOB07PDCIG01a


7FLTRVENTVENTLFLTFilter VentilationDESIGN PARAMETER SPECIFICATION

30

%%TARGET20TOB07PDCIG01a20FLTRVENTFilter Ventilation

23

37DESIGN PARAMETER SPECIFICATION

%

%MINIMUM
218TOB07PDCIG01a21FLTRVENTFilter VentilationDESIGN PARAMETER SPECIFICATION%%MAXIMUM
822TOB07PDCIG01a22TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATION31mmmmTARGET23TOB07PDCIG01a23TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM3032mm
924TOB07PDCIG01a24TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM25TOB07PDCIG01a25CIGBPPOR
9CBPPOR

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)MAXIMUM30

50

45

55

Cu

11TOB07PDCIG01a30CIGBPPORCigarette 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/sTARGET32100.213Cu
12TOB07PDCIG01a
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/sTARGET100.213Cu
1334TOB07PDCIG01a34BNDPORCigarette 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/sMINIMUM
13

CPBDIFF

36TOB07PDCIG01a36BNDDIF

Cigarette 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/sMAXIMUM0.050.0010.100cm2/s
1438TOB07PDCIG01a38BNDPERMCigarette 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


14CPBWID40TOB07PDCIG01a40CPBNDWIDCigarette Paper Band Width

7

6.7

7.3

mm

15DESIGN PARAMETER SPECIFICATIONmmmmTARGET41TOB07PDCIG01a41CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM42TOB07PDCIG01a42CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM43TOB07PDCIG01a43


15CPBSPCCPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATIONmmmmTARGET44TOB07PDCIG01a44CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATIONmm20

19.8

20.2

mm

16mmMINIMUM45TOB07PDCIG01a45CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM46TOB07PDCIG01a


16FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION

30

%%TARGET47TOB07PDCIG01a47FLTREFFFilter Efficiency

25

35DESIGN PARAMETER SPECIFICATION

%

%
1748TOB07PDCIG01a48FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION%%MAXIMUM


1749TOB07PDCIG01a49DPFDenier 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 mMAXIMUM55TOB07PDCIG01a
19FLTRDENFilter 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 Density0.26780.24370.2919DESIGN PARAMETER SPECIFICATIONg/cm3g/cm3MINIMUM66
23TOB07PDCIG01a66TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATIONg/cm3g/cm3MAXIMUM67TOB07PDCIG01a67Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATIONmmmmTARGET68TOB07PDCIG01a68Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM69TOB07PDCIG01a
23CIGPLGTHCigarette 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
PTSPCCND
Dataset2
RowSTUDYIDDOMAINSPTOBIDIGDCMPIDPTSEQPTTESTCDPTTESTPTCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESU
PTSPEC
PTMETHOD
PTLLOQ
PTREPNUM
PTTPTPTTPTNUM1
1TOB07PTCIG01a

1

LENGTHLengthDESIGN PARAMETER TESTING

83.9

mm

83.9

83.9

mm
1Week 0

1
23
2TOB07PTCIG01a
2CIRCUMFCircumferenceDESIGN PARAMETER TESTING24.9mm24.924.9mm
1
Week 01
3TOB07PTCIG01a
3TBFLMASSTobacco Filler MassDESIGN PARAMETER TESTING779mg779779mg
1
Week 014
4TOB07PTCIG01a
4MOISTUREMoistureDESIGN PARAMETER TESTING13.1%13.113.1%
1Week 0

1
5
5TOB07PTCIG01a

Burley tobacco

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

Reconstituted tobacco

6
TOCUTSIZ2
TOCUTSIZTobacco Cut Size
2
DESIGN PARAMETER TESTING27mm2727mm
1
Week 01
7
7
TOB07PTCIG01a
7
FLTRVENT
VENTLFLTFilter VentilationDESIGN PARAMETER TESTING35%3535%
1Week 0

1
8
8TOB07PTCIG01a
8TPNPLGTHTipping Paper LengthDESIGN PARAMETER TESTING30mm3030mm
1Week 0

1
9
9TOB07PTCIG01a
9
CIGBPPOR10
CBPPORCigarette Base Paper PorosityDESIGN PARAMETER TESTING
N/ACORESTA Unit (Cu)N/AN/ACORESTA Unit (Cu)1Week 01
48Cu4848Cu
1
10TOB07PTCIG01a
10
CIGBPPERM
CBPPERMCigarette Base Paper PermeabilityDESIGN PARAMETER TESTING50
cm2/sWeek 0
Cu5050
cm2/s1
Cu
1
11
11TOB07PTCIG01a
11
BNDDIF
CPBPORCigarette Paper Band PorosityDESIGN PARAMETER TESTING
N/ACORESTA Unit (Cu)N/AN/ACORESTA Unit (Cu)1Week 01
9.8Cu9.89.8Cu
1
12
12TOB07PTCIG01a
12
BNDDIF
CPBPERMCigarette Paper Band PermeabilityDESIGN PARAMETER TESTING10
cm^2/s
Cu1010
cm2/s13
Cu
1
Week 01
13TOB07PTCIG01a
13
BNDDIF
CPBDIFFCigarette Paper Band DiffusivityDESIGN PARAMETER TESTING
N/AN/AN/A1Week 01
0.06cm2/s0.060.06cm2/s
1
14
14TOB07PTCIG01a
14
CPBNDWID
CPBWIDCigarette Paper Band WidthDESIGN PARAMETER TESTING7.1mm7.17.1mm
1Week 0

1
15
15TOB07PTCIG01a
15
CPBNDSPC
CPBSPCCigarette Paper Band SpaceDESIGN PARAMETER TESTING19.9mm19.919.9mm
1
Week 01
16
16
TOB07PTCIG01a
16FLTREFFFilter EfficiencyDESIGN PARAMETER TESTING
N/A
28%
N/A
2828
N/A
%
1
Week 0

1
17
17
TOB07PTCIG01a
17DPFDenier Per FilamentDESIGN PARAMETER TESTING4.1
4.14.1
/filament


1
Week 0118
18TOB07PTCIG01a
18
DENIER
TDENIERTotal DenierDESIGN PARAMETER TESTING29900g/9000m2990029900g/9000m
1Week 0

1
1920
19TOB07PTCIG01a
19FLTRDENFilter DensityDESIGN PARAMETER TESTING0.1112g/cm30.11120.1112g/cm3
1
Week 01
20TOB07PTCIG01a
20FLTRLGTHFilter LengthDESIGN PARAMETER TESTING25mm2525mm
1
Week 0121
21TOB07PTCIG01a
21FLTPRDRPFilter Pressure DropDESIGN PARAMETER TESTING62mm H2O6262mm H2O
1Week 0

1
22
22TOB07PTCIG01a
22TORODDENTobacco Rod DensityDESIGN PARAMETER TESTING0.2701g/cm30.27010.2701g/cm3
1
Week 023
1
23TOB07PTCIG01a
23CIGPLGTHCigarette Paper LengthDESIGN PARAMETER TESTING53mm5353mm
1
Week 01

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