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.
SPTOBID... ?SPTOBID - should it be SPTOBID for Sponsor Tobacco Product Identifier???
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OPtion 2:
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Option 1 of Steve H's suggestion of combining our previous product identifiers and product descriptors into a single dataset:
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.
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Row
STUDYID
DOMAIN
SPTOBID
TOSEQ
TOPARMCD
TOPARM
TOVAL
TOVALU
1
TOB07
TO
CIG01a
1
TBPRDCAT
Tobacco Product Category
Cigarette
2
TOB07
TO
CIG01a
2
TBPRSCAT
Tobacco Product Subcategory
Filtered, Combusted
3
TOB07
TO
CIG01a
3
MANUF
Manufacturer
Joes Cigs USA
4
TOB07
TO
CIG01a
4
TRADENAM
Trade Name
Treetop Menthol King Size
5
TOB07
TO
CIG01a
5
PACKTYP
Package Type
HARD PACK
6
TOB07
TO
CIG01a
6
PRDQUAN
Product Quantity
20
CIGARETTE
7
TOB07
TO
CIG01a
7
LENGTH
Length
86.0
mm
8
TOB07
TO
CIG01a
8
CIRCUMF
Circumference
26.0
mm
9
TOB07
TO
CIG01a
9
VENTLTN
Ventilation
10.0
%
10
TOB07
TO
CIG01a
10
CHARFLAV
Characterizing Flavor
MENTHOL
11
TOB07
TO
CIG01a
11
HTSOURCE
Heat Source
xxx
Row
STUDYID
DOMAIN
SPTOBID
DPSEQ
DPTESTCD
DPTEST
DPCAT
DPSCAT
DPORRES
DPORRESU
DPSTRESC
DPSTRESN
DPSTRESU
DPCOLSRT
1
TOB07
DP
CIG01a
1
TBPRDCAT
Tobacco Product Category
Cigarette
Cigarette
2
TOB07
DP
CIG01a
2
TBPRSCAT
Tobacco Product Subcategory
Filtered, Combusted
Filtered, Combusted
3
TOB07
DP
CIG01a
3
MANUF
Manufacturer
Joes Cigs USA
Joes Cigs USA
4
TOB07
DP
CIG01a
4
TRADENAM
Trade Name
Treetop Methol King Size
Treetop Methol King Size
5
TOB07
DP
CIG01a
5
PACKTYP
Package Type
HARD PACK
HARD PACK
6
TOB07
DP
CIG01a
6
PRDQUAN
Product Quantity
20
CIGARETTE
20
20
CIGARETTE
7
TOB07
DP
CIG01a
7
LENGTH
Length
86.0
mm
86.0
86.0
mm
8
TOB07
DP
CIG01a
8
CIRCUMF
Circumference
26.0
mm
26.0
26.0
mm
9
TOB07
DP
CIG01a
9
VENTLTN
Ventilation
10.0
%
10.0
10.0
%
10
TOB07
DP
CIG01a
10
CHARFLAV
Characterizing Flavor
MENTHOL
MENTHOL
11
TOB07
DP
CIG01a
11
HTSOURCE
Heat Source
xxx
xxx
The Tobacco Product Design Parameters (DP) 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.
dp.xpt
dp.xpt
Row
STUDYID
DOMAIN
SPTOBID
DPSEQ
DPTESTCD
DPTEST
DPCAT
DPSCAT
DPORRES
DPORRESU
DPSTRESC
DPSTRESN
DPSTRESU
DPCOLSRT
1
TOB07
DP
CIG01a
1
TBPRDCAT
Tobacco Product Category
Cigarette
Cigarette
2
TOB07
DP
CIG01a
2
TBPRSCAT
Tobacco Product Subcategory
Filtered, Combusted
Filtered, Combusted
3
TOB07
DP
CIG01a
3
MANUF
Manufacturer
Joes Cigs USA
Joes Cigs USA
4
TOB07
DP
CIG01a
4
TRADENAM
Trade Name
Treetop Methol King Size
Treetop Methol King Size
5
TOB07
DP
CIG01a
5
PACKTYP
Package Type
HARD PACK
HARD PACK
6
TOB07
DP
CIG01a
6
PRDQUAN
Product Quantity
20
CIGARETTE
20
20
CIGARETTE
7
TOB07
DP
CIG01a
7
LENGTH
Length
86.0
mm
86.0
86.0
mm
8
TOB07
DP
CIG01a
8
CIRCUMF
Circumference
26.0
mm
26.0
26.0
mm
9
TOB07
DP
CIG01a
9
VENTLTN
Ventilation
10.0
%
10.0
10.0
%
10
TOB07
DP
CIG01a
10
CHARFLAV
Characterizing Flavor
MENTHOL
MENTHOL
11
TOB07
DP
CIG01a
11
HTSOURCE
Heat Source
xxx
xxx
12
TOB07
DP
CIG01a
12
LENGTH
Length
DESIGN PARAMETER SPECIFICATION
mm
TARGET
13
TOB07
DP
CIG01a
13
LENGTH
Length
DESIGN PARAMETER SPECIFICATION
mm
MINIMUM
14
TOB07
DP
CIG01a
14
LENGTH
Length
DESIGN PARAMETER SPECIFICATION
mm
MAXIMUM
15
TOB07
DP
CIG01a
15
Cigarette circumference or diameter 2
DESIGN PARAMETER SPECIFICATION
mm
TARGET
16
TOB07
DP
CIG01a
16
Cigarette circumference or diameter 2
DESIGN PARAMETER SPECIFICATION
mm
MINIMUM
17
TOB07
DP
CIG01a
17
Cigarette circumference or diameter 2
DESIGN PARAMETER SPECIFICATION
mm
MAXIMUM
18
TOB07
DP
CIG01a
18
Tobacco Filler mass
DESIGN PARAMETER SPECIFICATION
mg
TARGET
19
TOB07
DP
CIG01a
19
Tobacco Filler mass
DESIGN PARAMETER SPECIFICATION
mg
MINIMUM
20
TOB07
DP
CIG01a
20
Tobacco Filler mass
DESIGN PARAMETER SPECIFICATION
mg
MAXIMUM
21
TOB07
DP
CIG01a
21
Tobacco moisture or Oven Volatiles
DESIGN PARAMETER SPECIFICATION
%
TARGET
22
TOB07
DP
CIG01a
22
Tobacco moisture or Oven Volatiles
DESIGN PARAMETER SPECIFICATION
%
MINIMUM
23
TOB07
DP
CIG01a
23
Tobacco moisture or Oven Volatiles
DESIGN PARAMETER SPECIFICATION
%
MAXIMUM
24
TOB07
DP
CIG01a
24
Tobacco cut size
mm or cuts per inch 2
TARGET
25
TOB07
DP
CIG01a
25
Tobacco cut size
mm or cuts per inch 2
MINIMUM
26
TOB07
DP
CIG01a
26
Tobacco cut size
mm or cuts per inch 2
MAXIMUM
27
TOB07
DP
CIG01a
27
Filter Ventilation
%
TARGET
28
TOB07
DP
CIG01a
28
Filter Ventilation
%
MINIMUM
29
TOB07
DP
CIG01a
29
Filter Ventilation
%
MAXIMUM
30
TOB07
DP
CIG01a
30
Tipping Paper Length
mm
TARGET
31
TOB07
DP
CIG01a
31
Tipping Paper Length
mm
MINIMUM
32
TOB07
DP
CIG01a
32
Tipping Paper Length
mm
MAXIMUM
33
TOB07
DP
CIG01a
33
Cigarette base paper Porosity or Permeability
CORESTA Unit (Cu)
TARGET
34
TOB07
DP
CIG01a
34
Cigarette base paper Porosity or Permeability
CORESTA Unit (Cu)
MINIMUM
35
TOB07
DP
CIG01a
35
Cigarette base paper Porosity or Permeability
CORESTA Unit (Cu)
MAXIMUM
36
TOB07
DP
CIG01a
36
Cigarette Paper band porosity or permeability or band diffusivity
CORESTA Unit (Cu) or cm2/s
TARGET
37
TOB07
DP
CIG01a
37
Cigarette Paper band porosity or permeability or band diffusivity
CORESTA Unit (Cu) or cm2/s
MINIMUM
38
TOB07
DP
CIG01a
38
Cigarette Paper band porosity or permeability or band diffusivity