This is an example for the required tobacco product characterization, property description, and design parameter information in an FDA marketing application for one type of tobacco product SNUS. 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 product Premarket Authorization (PMTA) and Substantial Equivalence pathways. The applicant submitting for SE and PMTAs may include test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.
Tobacco Product Identifier (TO) (similar to Device Identifiers (DI)) is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. 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, properties, product name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID), a consistent variable, that is available for use in other domains where data pertaining to the product may be found.
Rows 1-4:
Show the records for a tobacco product given SPTOBID of the Smokeless Tobacco Product, portioned SNUS.
Rows 1-3:
Show the tobacco product is Joes Smokeless, Happy Dog Snus.
Rows 5-11:
Show the package type is a Plastic Can and Plastic Lid that is a package of 24 with a portion mass of 1g each. in 30 mm x 10 mm x 5 mm cans.
Rows 12-13:
Show the attributes or characteristics of the content of the SNUS.
to.xpt
to.xpt
Row
STUDYID
DOMAIN
SPTOBID
TOSEQ
TOTESTCD
TOTEST
TOCAT
TOORRES
TOORRESU
TOSTRESC
TOSTRESN
TOSTRESU
1
TOB17
TO
SNUS-77
1
TBPRDCAT
Tobacco Product Category
PRODUCT IDENTIFIER
Smokeless Tobacco Product
Smokeless Tobacco Product
2
TOB17
TO
SNUS-77
2
TBPRSCAT
Tobacco Product Subcategory
PRODUCT IDENTIFIER
Snus, portioned
Snus, portioned
3
TOB17
TO
SNUS-77
3
MANUF
Manufacturer
PRODUCT IDENTIFIER
Joes Smokeless
Joes Smokeless
4
TOB17
TO
SNUS-77
4
TRADENAM
Trade Name
PRODUCT IDENTIFIER
Happy Dog Snus
Happy Dog Snus
5
TOB17
TO
SNUS-77
5
PACKTYP
Package Type
PRODUCT DESCRIPTOR
Plastic can and plastic lid
Plastic can and plastic lid
6
TOB17
TO
SNUS-77
6
Package Quantity
PRODUCT DESCRIPTOR
24
g
7
TOB17
TO
SNUS-77
7
Portion Mass
PRODUCT DESCRIPTOR
1
g
8
TOB17
TO
SNUS-77
8
Portion count
PRODUCT DESCRIPTOR
24
eaches or blank? - EACH?
9
TOB17
TO
SNUS-77
9
Portion length
PRODUCT DESCRIPTOR
30
mm
10
TOB17
TO
SNUS-77
10
Portion width
PRODUCT DESCRIPTOR
10
mm
11
TOB17
TO
SNUS-77
11
Portion thickness
5
mm
12
TOB17
TO
SNUS-77
12
Characterizing Flavor
Mint
13
TOB17
TO
SNUS-77
13
Additional property
n/a
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The Tobacco Design Parameters (PD) is similar to the Device Properties (DO) domain represents properties of the tobacco product that do not vary over the life of the product. This is a findings domain and defines important characteristics of a product that the sponsor manufacturer 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 TPTESTCD/TPTEST.
Rows 1-27:
Show the design parameter specification with target, minimum, and maximum value reflected in the PDCOLSRT variable.
Rows 7-18:
Show the design parameter specification for portioned characteristics.
pd.xpt
pd.xpt
Row
STUDYID
DOMAIN
SPTOBID
PDSEQ
PDTESTCD
PDTEST
PDTSTCND
PDCAT
PDSCAT
PDORRES
PDORRESU
PDSTRESC
PDSTRESN
PDSTRESU
PDCOLSRT
1
TOB17
PD
SNUS-77
1
Tobacco Cut Size or Tobacco Particle Size
DESIGN PARAMETER SPECIFICATION
70
mm or cuts per inch
70
70
mm or cuts per inch
TARGET
2
TOB17
PD
SNUS-77
2
Tobacco Cut Size or Tobacco Particle Size
DESIGN PARAMETER SPECIFICATION
65
mm or cuts per inch
65
65
mm or cuts per inch
MINIMUM
3
TOB17
PD
SNUS-77
3
Tobacco Cut Size or Tobacco Particle Size
DESIGN PARAMETER SPECIFICATION
75
mm or cuts per inch
75
75
mm or cuts per inch
MAXIMUM
4
TOB17
PD
SNUS-77
4
Tobacco Moisture
DESIGN PARAMETER SPECIFICATION
32.2
%
32.2
32.2
%
TARGET
5
TOB17
PD
SNUS-77
5
Tobacco Moisture
DESIGN PARAMETER SPECIFICATION
31
%
31
31
%
MINIMUM
6
TOB17
PD
SNUS-77
6
Tobacco Moisture
DESIGN PARAMETER SPECIFICATION
34
%
34
34
%
MAXIMUM
7
TOB17
PD
SNUS-77
7
Portion Length
DESIGN PARAMETER SPECIFICATION
38
mm
38
38
mm
TARGET
8
TOB17
PD
SNUS-77
8
Portion Length
DESIGN PARAMETER SPECIFICATION
36.5
mm
36.5
36.5
mm
MINIMUM
9
TOB17
PD
SNUS-77
9
Portion Length
DESIGN PARAMETER SPECIFICATION
39.5
mm
39.5
39.5
mm
MAXIMUM
10
TOB17
PD
SNUS-77
10
Portion Width
DESIGN PARAMETER SPECIFICATION
16
mm
16
16
mm
TARGET
11
TOB17
PD
SNUS-77
11
Portion Width
DESIGN PARAMETER SPECIFICATION
15
mm
15
15
mm
MINIMUM
12
TOB17
PD
SNUS-77
12
Portion Width
DESIGN PARAMETER SPECIFICATION
17
mm
17
17
mm
MAXIMUM
13
TOB17
PD
SNUS-77
13
Portion Mass
DESIGN PARAMETER SPECIFICATION
1000
mg
1000
1000
mg
TARGET
14
TOB17
PD
SNUS-77
14
Portion Mass
DESIGN PARAMETER SPECIFICATION
900
mg
900
900
mg
MINIMUM
15
TOB17
PD
SNUS-77
15
Portion Mass
DESIGN PARAMETER SPECIFICATION
1100
mg
1100
1100
mg
MAXIMUM
16
TOB17
PD
SNUS-77
16
Portion (pouch) material thickness (if applicable)
DESIGN PARAMETER SPECIFICATION
0.06
mm
0.06
0.06
mm
TARGET
17
TOB17
PD
SNUS-77
17
Portion (pouch) material thickness (if applicable)
DESIGN PARAMETER SPECIFICATION
0.055
mm
0.055
0.055
mm
MINIMUM
18
TOB17
PD
SNUS-77
18
Portion (pouch) material thickness (if applicable)
DESIGN PARAMETER SPECIFICATION
0.065
mm
0.065
0.065
mm
MAXIMUM
19
TOB17
PD
SNUS-77
19
Pouch material basis weight (if applicable)
DESIGN PARAMETER SPECIFICATION
16
g/m^2
16
16
g/m^2
TARGET
20
TOB17
PD
SNUS-77
20
Pouch material basis weight (if applicable)
DESIGN PARAMETER SPECIFICATION
15
g/m^2
15
15
g/m^2
MINIMUM
21
TOB17
PD
SNUS-77
21
Pouch material basis weight (if applicable)
DESIGN PARAMETER SPECIFICATION
17
g/m^2
17
17
g/m^2
MAXIMUM
22
TOB17
PD
SNUS-77
22
Pouch material porosity (permeability) (if applicable)
DESIGN PARAMETER SPECIFICATION
1850
L/m^2/s
1850
1850
L/m^2/s
TARGET
23
TOB17
PD
SNUS-77
23
Pouch material porosity (permeability) (if applicable)
DESIGN PARAMETER SPECIFICATION
1600
L/m^2/s
1600
1600
L/m^2/s
MINIMUM
24
TOB17
PD
SNUS-77
24
Pouch material porosity (permeability) (if applicable)
DESIGN PARAMETER SPECIFICATION
2200
L/m^2/s
2200
2200
L/m^2/s
MAXIMUM
25
TOB17
PD
SNUS-77
25
Nicotine dissolution rate
DESIGN PARAMETER SPECIFICATION
%/min
%/min
TARGET
26
TOB17
PD
SNUS-77
26
Nicotine dissolution rate
DESIGN PARAMETER SPECIFICATION
%/min
%/min
MINIMUM
27
TOB17
PD
SNUS-77
27
Nicotine dissolution rate
DESIGN PARAMETER SPECIFICATION
%/min
%/min
MAXIMUM
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The Tobacco Product Testing (PT) (similar to the Laboratory Test Results (LB) domain) dataset shows the tobacco product test demonstrating the actual tests and test results for the specified Design Parameter Specification as noted in the DU dataset (??? PD dataset).
**For Pouch material porosity - which one should be the standard result?
Rows 1-6:
Show the tobacco design parameter specification test and the result in ORRES for the SNUS. (needs populated).
Row 3:
Shows the design parameter specification for the portion mass.