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Tobacco 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.

Rows 1-4:Show the records for a tobacco product identifiers that were previously represented in a separate DI dataset
Rows 5-10:Show the product descriptors which we would have originally put in a DO-like dataset.

to.xpt

to.xpt

RowSTUDYIDDOMAINSPTOBIDTOSEQTOTESTCDTOTESTTOCATTOORRESTOORRESUTOSTRESCTOSTRESNTOSTRESU
1TOB07TOCIG01a

1

TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERCigarette
Cigarette

2TOB07TOCIG01a2TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERFiltered, Combusted
Filtered, Combusted

3TOB07TOCIG01a3MANUFManufacturerPRODUCT IDENTIFIERJoes Cigs USA
Joes Cigs USA

4TOB07TOCIG01a4TRADENAMTrade NamePRODUCT IDENTIFIERTreetop Menthol King Size
Treetop Menthol King Size

5TOB07TOCIG01a5PACKTYPPackage TypePRODUCT DESCRIPTORHARD PACK
HARD PACK

6TOB07TOCIG01a6PRDQUANProduct QuantityPRODUCT DESCRIPTOR20CIGARETTE2020CIGARETTE
7TOB07TOCIG01a7LENGTHLengthPRODUCT DESCRIPTOR86.0mm86.086.0mm
8TOB07TOCIG01a8CIRCUMFCircumferencePRODUCT DESCRIPTOR26.0mm26.026.0mm
9TOB07TOCIG01a9VENTLTNVentilationPRODUCT DESCRIPTOR10.0%10.010.0%
10TOB07TOCIG01a10CHARFLAVCharacterizing FlavorPRODUCT DESCRIPTORMENTHOL
MENTHOL

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The Tobacco Product Design Parameters (DP) represents the manufacturing parameter specifications of the tobacco product as used. The example below shows the target, minimum, and maximum values associated with each of 19 separate design parameters. These parameters are defined as manufacturing guidelines, not determined experimentally.


dp.xpt

dp.xpt

RowSTUDYIDDOMAINSPTOBIDDPSEQDPTESTCDDPTESTDPCATDPORRESDPORRESUDPSTRESCDPSTRESNDPSTRESUDPCOLSRT
1

TOB07

DPCIG01a

1

LENGTHLengthDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
2TOB07DPCIG01a2LENGTHLengthDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
3TOB07DPCIG01a3LENGTHLengthDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM
4TOB07DPCIG01a4CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
5TOB07DPCIG01a5CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
6TOB07DPCIG01a6CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM
7TOB07DPCIG01a7TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATION
mg

mgTARGET
8TOB07DPCIG01a8TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATION
mg

mgMINIMUM
9TOB07DPCIG01a9TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATION
mg

mgMAXIMUM
10TOB07DPCIG01a10MOISTUREMoistureDESIGN PARAMETER SPECIFICATION
%

%TARGET
11TOB07DPCIG01a11MOISTUREMoistureDESIGN PARAMETER SPECIFICATION
%

%MINIMUM
12TOB07DPCIG01a12MOISTUREMoistureDESIGN PARAMETER SPECIFICATION
%

%MAXIMUM
13TOB07DPCIG01a13TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION
mm or cuts per inch 2

mm or cuts per inch 2TARGET
14TOB07DPCIG01a14TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION
mm or cuts per inch 2

mm or cuts per inch 2MINIMUM
15TOB07DPCIG01a15TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION
mm or cuts per inch 2

mm or cuts per inch 2MAXIMUM
16TOB07DPCIG01a16FLTRVENTFilter VentilationDESIGN PARAMETER SPECIFICATION
%

%TARGET
17TOB07DPCIG01a17FLTRVENTFilter VentilationDESIGN PARAMETER SPECIFICATION
%

%MINIMUM
18TOB07DPCIG01a18FLTRVENTFilter VentilationDESIGN PARAMETER SPECIFICATION
%

%MAXIMUM
19TOB07DPCIG01a19TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
20TOB07DPCIG01a20TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
21TOB07DPCIG01a21TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM
22TOB07DPCIG01a22CIGBPPORCigarette Base Paper Porosity or PermeabilityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu)

CORESTA Unit (Cu)TARGET
23TOB07DPCIG01a23CIGBPPORCigarette Base Paper Porosity or PermeabilityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu)

CORESTA Unit (Cu)MINIMUM
24TOB07DPCIG01a24CIGBPPORCigarette Base Paper Porosity or PermeabilityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu)

CORESTA Unit (Cu)MAXIMUM
25TOB07DPCIG01a25BNDDIFCigarette Paper Band Porosity or Permeability or Band DiffusivityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or cm2/s

CORESTA Unit (Cu) or cm2/sTARGET
26TOB07DPCIG01a26BNDDIFCigarette Paper Band Porosity or Permeability or Band DiffusivityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or cm2/s

CORESTA Unit (Cu) or cm2/sMINIMUM
27TOB07DPCIG01a27BNDDIFCigarette Paper Band Porosity or Permeability or Band DiffusivityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or cm2/s

CORESTA Unit (Cu) or cm2/sMAXIMUM
28TOB07DPCIG01a28CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
29TOB07DPCIG01a29CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
30TOB07DPCIG01a30CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM
31TOB07DPCIG01a31CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
32TOB07DPCIG01a32CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
33TOB07DPCIG01a33CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM
34TOB07DPCIG01a34FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION
%

%TARGET
35TOB07DPCIG01a35FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION
%

%MINIMUM
36TOB07DPCIG01a36FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION
%

%MAXIMUM
37TOB07DPCIG01a37DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION
/filament

/filamentTARGET
38TOB07DPCIG01a38DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION
/filament

/filamentMINIMUM
39TOB07DPCIG01a39DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION
/filament

/filamentMAXIMUM
40TOB07DPCIG01a40TDENIERTotal DenierDESIGN PARAMETER SPECIFICATION
g/9000 m

g/9000 mTARGET
41TOB07DPCIG01a41TDENIERTotal DenierDESIGN PARAMETER SPECIFICATION
g/9000 m

g/9000 mMINIMUM
42TOB07DPCIG01a42TDENIERTotal Denier DESIGN PARAMETER SPECIFICATION
g/9000 m

g/9000 mMAXIMUM
43TOB07DPCIG01a43FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATION
g/cm3

g/cm3TARGET
44TOB07DPCIG01a44FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATION
g/cm3

g/cm3MINIMUM
45TOB07DPCIG01a45FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATION
g/cm3

g/cm3MAXIMUM
46TOB07DPCIG01a46FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
47TOB07DPCIG01a47FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
48TOB07DPCIG01a48FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM
49TOB07DPCIG01a49FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATION
mm H2O

mm H2OTARGET
50TOB07DPCIG01a50FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATION
mm H2O

mm H2OMINIMUM
51TOB07DPCIG01a51FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATION
mm H2O

mm H2OMAXIMUM
52TOB07DPCIG01a52TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATION
g/cm3

g/cm3TARGET
53TOB07DPCIG01a53TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATION
g/cm3

g/cm3MINIMUM
54TOB07DPCIG01a54TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATION
g/cm3

g/cm3MAXIMUM
55TOB07DPCIG01a55Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
56TOB07DPCIG01a56Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
57TOB07DPCIG01a57Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM

Dataset Debug Messages

  • There is a leading, trailing, or non-breaking space in the dataset.
  • Please remove all formatting (see How to Clear Formatting).

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. 



dp.xpt

tt.xpt

RowSTUDYIDDOMAINSPTOBIDTTSEQTTTESTCDTTTESTTTORRESTTORRESUTTSTRESCTTSTRESNTTSTRESU
1TOB07DPCIG01a

1

LENGTHLength
mm

mm
2TOB07DPCIG01a2CIRCUMFCircumference
mm

mm
3TOB07DPCIG01a3TBFLMASSTobacco Filler Mass
mg

mg
4TOB07DPCIG01a4MOISTUREMoisture
%

%
5TOB07DPCIG01a5TOCUTSIZTobacco Cut Size
mm or cuts per inch 2

mm or cuts per inch 2
6TOB07DPCIG01a6FLTRVENTFilter Ventilation
%

%
7TOB07DPCIG01a7TPNPLGTHTipping Paper Length
mm

mm
8TOB07DPCIG01a8CIGBPPORCigarette Base Paper Porosity or Permeability
CORESTA Unit (Cu)

CORESTA Unit (Cu)
9TOB07DPCIG01a9BNDDIFCigarette Paper Band Porosity or Permeability or Band Diffusivity
CORESTA Unit (Cu) or cm2/s

CORESTA Unit (Cu) or cm2/s
10TOB07DPCIG01a10CPBNDWIDCigarette Paper Band Width
mm

mm
11TOB07DPCIG01a11CPBNDSPCCigarette Paper Band Space
mm

mm
12TOB07DPCIG01a12FLTREFFFilter Efficiency
%

%
13TOB07DPCIG01a13DPFDenier Per Filament
/filament

/filament
14TOB07DPCIG01a14DENIERDenier
g/9000 m

g/9000 m
15TOB07DPCIG01a15FLTRDENFilter Density
g/cm3

g/cm3
16TOB07DPCIG01a16FLTRLGTHFilter Length
mm

mm
17TOB07DPCIG01a17FLTPRDRPFilter Pressure Drop
mm H2O

mm H2O
18TOB07DPCIG01a18TORODDENTobacco Rod Density
g/cm3

g/cm3
19TOB07DPCIG01a19CIGPLGTHCigarette Paper Length
mm

mm

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

The following tables illustrate the controlled terminology for the the --TESTCD and --TEST values that should be submitted in datasets according to the examples above. (We'll add more language as necessary to make this clearer)

TOTESTCDTOTESTTOSTRESC*Description
TBPRDCATTobacco Product CategoryWaterpipe Tobacco Product
TBPRSCATTobacco Product Subcategoryx;y;z
MANUFManufacturer--TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
TRADENAMTrade Name--TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name




















*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.



Since the conformance testing of the design parameters and the design parameters themselves speak to the same concepts, they use the same terminology

DPTESTCD /TTESTCDDPTEST/TTTESTDescription




























This images shows the filtration zone where the ventilation occurs.

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



References:

  1. https://www.iso.org/obp/ui/#iso:std:iso:9512:ed-3:v1:en
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6059254/


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