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titleTobacco domains

DI = TO for Tobacco Product Identifier

SPDEVID = SPTOBID for Sponsor Tobacco Device Identifier

DO/DU = Tobacco Design Parameters (DP)

LB = Tobacco Product Testing (TT)

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.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 5-10:
Dataset wrap
Nameto
Rowcaps
Rows 1-4:Show the records for a tobacco product identifiers that were previously represented in a separate DI dataset
TOSTRESN
Show the product descriptors which we would have originally put in a DO-like dataset. 
Dataset2
RowSTUDYIDDOMAINSPTOBIDTOSEQ
TOTESTCD
TOPARMCD
TOTEST
TOPARMTOCAT
TOORRES
TOSCAT
TOORRESU
TOVAL
TOSTRESC
TOVALU
TOSTRESU
1TOB07TOCIG01a

1

TBPRDCATTobacco Product CategoryNEW PRODUCTPRODUCT IDENTIFIER
CigaretteCigarette
Cigarettes
2TOB07TOCIG01a2TBPRSCATTobacco Product SubcategoryNEW PRODUCTPRODUCT IDENTIFIERFiltered
, CombustedFiltered, 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 DESCRIPTOR20CIGARETTE
20
20CIGARETTE
7TOB07TOCIG01a7LENGTHLengthNEW PRODUCTPRODUCT DESCRIPTOR
86.0mm86.0
86.0mm
8TOB07TOCIG01a8CIRCUMFCircumferenceNEW PRODUCTPRODUCT DESCRIPTOR26.0mm
26.0
26.0mm
9TOB07TOCIG01a9
VENTLTN
VENTLTOTTotal VentilationNEW PRODUCTPRODUCT DESCRIPTOR10.0%
10.0
10
.0
%10
TOB07TOCIG01a10CHARFLAVCharacterizing FlavorNEW PRODUCTPRODUCT DESCRIPTORMENTHOL
MENTHOL

The Tobacco Product Design Parameters (DP) 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
Namedppd
DPSTRESU
Dataset2
RowSTUDYIDDOMAINSPTOBID
DPSEQ
IGDCMPID
DPTESTCD
PDSEQ
DPTEST
PDPARMCD
DPCAT
PDPARM
DPORRES
PDVALTRG
DPORRESU
PDVALMIN
DPSTRESC
PDVALMAX
DPSTRESN
PDVALU
DPCOLSRT
1

TOB07

DP
PDCIG01a


1

LENGTHLength
DESIGN PARAMETER SPECIFICATION

84

83.5

84.5
mm

mm

TARGET
2TOB07
DP
PDCIG01a
2CIRCUMF
LENGTH
Circumference
LengthDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM
24.824.625mm
3TOB07
DP
PDCIG01a
3
LENGTH
TBFLMASS
LengthDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM
Tobacco Filler Mass783753814mg
4TOB07
DP
PDCIG01a
4
CIRCUMF
MOISTURE
Circumference
Moisture
DESIGN PARAMETER SPECIFICATION
13
mm
12
mm
14
TARGET
%
5TOB07
DP
PDCIG01a

Burley tobacco

5
CIRCUMF
TOCUTSIZ
CircumferenceDESIGN PARAMETER SPECIFICATIONmmmm
Tobacco Cut Size

22

20

24

cuts/in

MINIMUM

6TOB07
DP
PDCIG01a

Reconstituted tobacco

6TOCUTSIZ
CIRCUMF
Tobacco Cut Size
Circumference

27

DESIGN PARAMETER SPECIFICATION

25

mm
29

mm

MAXIMUM
7TOB07
DP
PDCIG01a


7
TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATIONmgmg
VENTLFLTFilter Ventilation

30

23

37

%

TARGET

8TOB07
DP
PDCIG01a
8
TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATIONmgmg
TPNPLGTHTipping Paper Length313032mm
MINIMUM
9TOB07
DP
PDCIG01a
9
TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATIONmgmg
CBPPOR

Cigarette Base Paper Porosity

50

45

55Cu
MAXIMUM
10TOB07
DP
PDCIG01a


10
MOISTUREMoistureDESIGN PARAMETER SPECIFICATION%%
CBPPERMCigarette Base Paper Permeability

50

45

55

Cu

TARGET

11TOB07
DP
PDCIG01a
11
MOISTUREMoistureDESIGN PARAMETER SPECIFICATION%%
CPBPORCigarette Paper Band Porosity100.213Cu
MINIMUM
12TOB07
DP
PDCIG01a
12
MOISTUREMoistureDESIGN PARAMETER SPECIFICATION%%
CPBPERMCigarette Paper Band Permeability100.213Cu
MAXIMUM
13TOB07
DP
PDCIG01a
13
TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONmm or cuts per inch 2mm or cuts per inch 2

CPBDIFF

Cigarette Paper Band Diffusivity0.050.0010.100cm2/s
TARGET
14TOB07
DP
PDCIG01a


14
TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONmm or cuts per inch 2mm or cuts per inch 2
CPBWIDCigarette Paper Band Width

7

6.7

7.3

mm

MINIMUM

15TOB07
DP
PDCIG01a


15
TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONmm or cuts per inch 2mm or cuts per inch 2MAXIMUM
CPBSPCCigarette Paper Band Space20

19.8

20.2

mm

16TOB07
DP
PDCIG01a


16
FLTRVENT
FLTREFFFilter
VentilationDESIGN PARAMETER SPECIFICATION
Efficiency

30

25

35
%

%

TARGET
17TOB07
DP
PDCIG01a


17
FLTRVENTFilter VentilationDESIGN PARAMETER SPECIFICATION%%MINIMUM
DPFDenier Per Filament43.64.4


18TOB07
DP
PDCIG01a


18
FLTRVENT
TDENIER
Filter VentilationDESIGN PARAMETER SPECIFICATION%%
Total Denier

30000

29100

30900

g/9000m

MAXIMUM

19TOB07
DP
PDCIG01a
19
TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATIONmmmm
FLTRDENFilter Density0.12340.1050.1419g/cm3
TARGET
20TOB07
DP
PDCIG01a
20
TPNPLGTH
FLTRLGTH
Tipping Paper
Filter Length
DESIGN PARAMETER SPECIFICATION
2524.525.5
mm
mm
MINIMUM
21TOB07
DP
PDCIG01a
21FLTPRDRP
TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATIONmmmm
Filter Pressure Drop605169mm H2O
MAXIMUM
22TOB07
DP
PDCIG01a
22
CIGBPPORCigarette Base Paper Porosity or PermeabilityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu)CORESTA Unit (Cu)
TORODDENTobacco Rod Density0.26780.24370.2919g/cm3
TARGET
23TOB07
DP
PDCIG01a
23
CIGBPPOR
CIGPLGTHCigarette
Base
Paper
Porosity or PermeabilityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu)CORESTA Unit (Cu)MINIMUM24TOB07DPCIG01a24CIGBPPORCigarette Base Paper Porosity or PermeabilityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu)CORESTA Unit (Cu)MAXIMUM25TOB07DPCIG01a25BNDDIFCigarette Paper Band Porosity or Permeability or Band DiffusivityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm2/sCORESTA Unit (Cu) or cm2/sTARGET26TOB07DPCIG01a26BNDDIFCigarette Paper Band Porosity or Permeability or Band DiffusivityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm2/sCORESTA Unit (Cu) or cm2/sMINIMUM27TOB07DPCIG01a27BNDDIFCigarette Paper Band Porosity or Permeability or Band DiffusivityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm2/sCORESTA Unit (Cu) or cm2/sMAXIMUM28TOB07DPCIG01a28CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATIONmmmmTARGET29TOB07DPCIG01a29CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM30TOB07DPCIG01a30CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM31TOB07DPCIG01a31CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATIONmmmmTARGET32TOB07DPCIG01a32CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM33TOB07DPCIG01a33CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM34TOB07DPCIG01a34FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION%%TARGET35TOB07DPCIG01a35FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION%%MINIMUM36TOB07DPCIG01a36FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION%%MAXIMUM37TOB07DPCIG01a37DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION/filament/filamentTARGET38TOB07DPCIG01a38DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION/filament/filamentMINIMUM39TOB07DPCIG01a39DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION/filament/filamentMAXIMUM40TOB07DPCIG01a40TDENIERTotal DenierDESIGN PARAMETER SPECIFICATIONg/9000 mg/9000 mTARGET41TOB07DPCIG01a41TDENIERTotal DenierDESIGN PARAMETER SPECIFICATIONg/9000 mg/9000 mMINIMUM42TOB07DPCIG01a42TDENIERTotal Denier DESIGN PARAMETER SPECIFICATIONg/9000 mg/9000 mMAXIMUM43TOB07DPCIG01a43FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATIONg/cm3g/cm3TARGET44TOB07DPCIG01a44FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATIONg/cm3g/cm3MINIMUM45TOB07DPCIG01a45FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATIONg/cm3g/cm3MAXIMUM46TOB07DPCIG01a46FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATIONmmmmTARGET47TOB07DPCIG01a47FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM48TOB07DPCIG01a48FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM49TOB07DPCIG01a49FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATIONmm H2Omm H2OTARGET50TOB07DPCIG01a50FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATIONmm H2Omm H2OMINIMUM51TOB07DPCIG01a51FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATIONmm H2Omm H2OMAXIMUM52TOB07DPCIG01a52TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATIONg/cm3g/cm3TARGET53TOB07DPCIG01a53TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATIONg/cm3g/cm3MINIMUM54TOB07DPCIG01a54TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATIONg/cm3g/cm3MAXIMUM55TOB07DPCIG01a55Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATIONmmmmTARGET56TOB07DPCIG01a56Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM57TOB07DPCIG01a57Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM

The Tobacco Product Testing (TT) domain is used to represent the actual results of testing for conformance to the tobacco product design parameters shown in DP above. 

...

Namett

...

1

...

Length535254mm

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
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

5TOCUTSIZTobacco Cut SizeDESIGN PARAMETER TESTING22cuts/in2222cuts/in
1
6TOB07PTCIG01a

Reconstituted tobacco

6TOCUTSIZTobacco Cut SizeDESIGN PARAMETER TESTING27mm2727mm
1
7TOB07PTCIG01a
7VENTLFLTFilter VentilationDESIGN PARAMETER TESTING35%3535%
1
8TOB07PTCIG01a
8TPNPLGTHTipping Paper LengthDESIGN PARAMETER TESTING30mm3030mm
1
9TOB07PTCIG01a
9CBPPORCigarette Base Paper PorosityDESIGN PARAMETER TESTING48Cu4848Cu
1
10TOB07PTCIG01a
10CBPPERMCigarette Base Paper PermeabilityDESIGN PARAMETER TESTING50Cu5050Cu
1
11TOB07PTCIG01a
11CPBPORCigarette Paper Band PorosityDESIGN PARAMETER TESTING9.8Cu9.89.8Cu
1
12TOB07PTCIG01a
12CPBPERMCigarette Paper Band PermeabilityDESIGN PARAMETER TESTING10Cu1010Cu
1
13TOB07PTCIG01a
13CPBDIFFCigarette Paper Band DiffusivityDESIGN PARAMETER TESTING0.06cm2/s0.060.06cm2/s
1
14TOB07PTCIG01a
14CPBWIDCigarette Paper Band WidthDESIGN PARAMETER TESTING7.1mm7.17.1mm
1
15TOB07PTCIG01a
15CPBSPCCigarette Paper Band SpaceDESIGN PARAMETER TESTING19.9mm19.919.9mm
1
16TOB07PTCIG01a
16FLTREFFFilter EfficiencyDESIGN PARAMETER TESTING28%2828%
1
17TOB07PTCIG01a
17DPFDenier Per FilamentDESIGN PARAMETER TESTING4.1
4.14.1

1
18TOB07PTCIG01a
18TDENIERTotal DenierDESIGN PARAMETER TESTING29900g/9000m2990029900g/9000m
1
19TOB07PTCIG01a
19FLTRDENFilter DensityDESIGN PARAMETER TESTING0.1112g/cm30.11120.1112g/cm3
1
20TOB07PTCIG01a
20FLTRLGTHFilter LengthDESIGN PARAMETER TESTING25mm2525mm
1
21TOB07PTCIG01a
21FLTPRDRPFilter Pressure DropDESIGN PARAMETER TESTING62mm H2O6262mm H2O
1
22TOB07PTCIG01a
22TORODDENTobacco Rod DensityDESIGN PARAMETER TESTING0.2701g/cm30.27010.2701g/cm3
1
23TOB07PTCIG01a
23CIGPLGTHCigarette Paper LengthDESIGN PARAMETER TESTING53mm5353mm
1

References:

...

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.

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.
  1. 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