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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.


 SPTOBID... ?SPTOBID - should it be SPTOBID for Sponsor Tobacco Product Identifier???

Rows 1-4:Show the records for a tobacco product given SPTOBID of CIG01a.
Rows 3-4:Show the tobacco product is a filtered, combusted type of cigarette.

to.xpt

to.xpt

RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOVAL
1TOB07TOCIG01a1TBPRDCATTobacco Product CategoryCigarette
2TOB07TOCIG01a2TBPRSCATTobacco Product SubcategoryFiltered, Combusted
3TOB07TOCIG01a3MANUFManufacturerJoes Cigs USA
4TOB07TOCIG01a4TRADENAMTrade NameTreetop Methol King Size
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The Tobacco Product Design Parameters (TP)  is (similar to the Device Properties (DO) domain) represents properties of the tobacco product as used. This is a findings domain and defines important characteristics of a product that the sponsor manufacturer (tobacco researcher) wishes to include in the submission but do not form part of the unique sponsor-defined identification of the product. Each property is identified using controlled terminology and is stored in TTTESTCD/TTTEST.

Rows 1-4:Show the package type is a hard pack that each contain 20 cigarettes that are 86.0 mm long and 26.0 mm in circumference.
Row 5:Shows the ventilation flow expressed as a percentage. Ventilation is the aspiration of atmospheric air in an unlit cigarette. (ISO 9512:2019) - 1
Row 6:Shows the characterizing flavor is menthol for this package of cigarettes.
Row 7:Shows the heat source is xxx.

tt.xpt

tp.xpt

RowSTUDYIDDOMAINSPTOBIDTTSEQTTTESTCDTTTESTTTCATTTSCATTTORRESTTORRESUTTSTRESCTTSTRESNTTSTRESU
1TOB07TTCIG01a1PACKTYPPackage TypeCIGARETTEFILTERED, COMBUSTEDHARD PACK
HARD PACK

2TOB07TTCIG01a2PRDQUANProduct QuantityCIGARETTEFILTERED, COMBUSTED20CIGARETTE2020CIGARETTE
3TOB07TTCIG01a3LENGTHLengthCIGARETTEFILTERED, COMBUSTED86.0mm86.086.0mm
4TOB07TTCIG01a4CIRCUMCircumferenceCIGARETTEFILTERED, COMBUSTED26.0mm26.026.0mm
5TOB07TTCIG01a5VENTLTNVentilationCIGARETTEFILTERED, COMBUSTED10.0%10.010.0%
6TOB07TTCIG01a6CHARFLAVCharacterizing FlavorCIGARETTEFILTERED, COMBUSTEDMENTHOL
MENTHOL

7TOB07TTCIG01a7HTSOURCEHeat SourceCIGARETTEFILTERED, COMBUSTEDxxx
xxx

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Rows 1-4: 
Row 5:S
Row 6: 
Row 7: 

Row Captions Debug Message

Please provide a caption for every row caption label.

$titleHtml

tt.xpt

RowSTUDYIDDOMAINSPTOBIDTTSEQTTGRPIDTTTESTCDTTTESTTTCATTTORRESTTORRESUTTSTRESCTTSTRESNTTSTRESUTTCOLSRT
1TOB07TTCIG01a1

Tobacco Filler mass

mg

mg


1TOB07TTCIG01a1

Tobacco Filler mass

mg

mg


1TOB07TTCIG01a1

Tobacco Filler mass

mg

mg
































2TOB07TTCIG01a2

Tobacco moisture or Oven Volatiles

%

%
3TOB07TTCIG01a3

Tobacco cut size

mm or cuts per inch 2

mm or cuts per inch 2
4TOB07TTCIG01a4

Tobacco Rod density

g/cm3

g/cm3
5TOB07TTCIG01a5

Filter Ventilation

%

%
6TOB07TTCIG01a6

Cigarette base paper Porosity or Permeability

CORESTA Unit (Cu)

CORESTA Unit (Cu)
7TOB07TTCIG01a7

Cigarette Paper band porosity or permeability or band diffusivity

CORESTA Unit (Cu) or cm2/s

CORESTA Unit (Cu) or cm2/s
8TOB07TTCIG01a8

Filter efficiency 1

%

%
9TOB07TTCIG01a9

Denier per Filament

DPF

DPF
10TOB07TTCIG01a10

Total Denier

g/9000 m

g/9000 m
11TOB07TTCIG01a11

Filter Density

g/cm3

g/cm3
12TOB07TTCIG01a12

Filter Pressure Drop

mm H2O

mm H2O


$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.



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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