Page History

Info

title	Tobacco domains

DI = TO for Tobacco Product Identifiers and Descriptors

SPDEVID = SPTOBID for Sponsor Tobacco Product Identifier

DO/DU = ~~Tobacco~~ Product Design Parameters (PD)

LB = Tobacco Product Testing (PT) - [Would Findings be better?]

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 foundThe following example illustrates the representation of a smokeless tobacco product's (portioned snus) identifiers and descriptors using the TO domain. Note that this example uses TOSCAT to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

Dataset wrap

Name	to

Rowcaps

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.

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOTESTCDTOPARMCD	TOTESTTOPARM	TOCAT	TOORRESTOSCAT	TOORRESU	TOSTRESC	TOSTRESN	TOVAL	TOVALUTOSTRESU
1	TOB17	TO	SNUS-77	1	TBPRDCAT	Tobacco Product Category	NEW PRODUCT	PRODUCT IDENTIFIER	Smokeless Tobacco ProductSmokeless Tobacco ProductProducts
2	TOB17	TO	SNUS-77	2	TBPRSCAT	Tobacco Product Subcategory	NEW PRODUCT	PRODUCT IDENTIFIER	Portioned Snus, portionedSnus, portioned
3	TOB17	TO	SNUS-77	3	MANUF	Manufacturer	NEW PRODUCT	PRODUCT IDENTIFIERJoes Smokeless	Joes Smokeless
4	TOB17	TO	SNUS-77	4	TRADENAM	Trade Name	NEW PRODUCT	PRODUCT IDENTIFIER	Happy Dog Snus	Happy Dog Snus
5	TOB17	TO	SNUS-77	5	PACKTYP	Package Type	NEW PRODUCT	PRODUCT DESCRIPTOR	Plastic can and plastic lid	Plastic can and plastic lid	Can with Lid
6	TOB17	TO	SNUS-77	6	PACKQUAN	Package Quantity	NEW PRODUCT	PRODUCT DESCRIPTOR	24	g
7	TOB17	TO	SNUS-77	7	PRTMASS	Portion Mass	NEW PRODUCT	PRODUCT DESCRIPTOR	1	g
8	TOB17	TO	SNUS-77	8	PORTCONT	Portion count	NEW PRODUCT	PRODUCT DESCRIPTOR	24	eaches or blank? - EACH?
9	TOB17	TO	SNUS-77	9	PRTLENG	Portion length	NEW PRODUCT	PRODUCT DESCRIPTOR	30	mm
10	TOB17	TO	SNUS-77	10	PRTWDTH	Portion width	NEW PRODUCT	PRODUCT DESCRIPTOR	10	mm
11	TOB17	TO	SNUS-77	11	PRTTHICK	Portion thickness	NEW PRODUCT	PRODUCT DESCRIPTOR	5	mm
12	TOB17	TO	SNUS-77	12	CHARFLAV	Characterizing FlavorMint	NEW PRODUCT	13	TOB17	TO	SNUS-77	13	Additional property	n/a	PRODUCT DESCRIPTOR	Flavored

The manufacturing parameter specifications of the portioned snus tobacco product as intended for use are represented in the PD domain. The following example shows the target, minimum, and maximum values associated with each of 10 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally. 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.

rowcaps

Dataset wrap

Name	pd

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.

Dataset2

MAXIMUM

Row	STUDYID	DOMAIN	SPTOBID	PDSEQ	PDTESTCDPDPARMCD	PDTESTPDPARM	PDTSTCNDPDVALTRG	PDCATPDVALMIN	PDSCAT	PDORRES	PDORRESU	PDSTRESC	PDSTRESN	PDSTRESU	PDCOLSRT	PDVALMAX	PDVALU
1	TOB17	PD	SNUS-77	1	TOCUTSIZ	Tobacco Cut Size or Tobacco Particle Size	DESIGN PARAMETER SPECIFICATION	70	mm or cuts per inch	70	70	mm or cuts per inch	65	75	cuts/in TARGET
2	TOB17	PD	SNUS-77	1	2TOPRTSIZ	Tobacco Cut Size or Tobacco Particle Size	DESIGN PARAMETER SPECIFICATION 70	65	mm or cuts per inch	65	65 75	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	%	2	TOMOISTR	Tobacco Moisture	32.2	31	34	%
4	MINIMUM	6	TOB17	PD	SNUS-77	6	Tobacco Moisture	DESIGN PARAMETER SPECIFICATION	34	%	34	34	%	MAXIMUM	3	PRTLENG	Portion Length	38	36.5	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	mm39.539.
5	mm		10	TOB17	PD	SNUS-77	4	10PRTWDTH	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	1517	mm	MINIMUM
126	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	5	PRTMASS	Portion Mass	1000	900	1100	mg
7	TOB17	PD	SNUS-77	15	Portion Mass	DESIGN PARAMETER SPECIFICATION	1100	mg	1100	1100	mg	MAXIMUM	6	PRTTHICK	Portion Material Thickness	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	0.0550.055065	mm	MINIMUM
188	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	7	PRTMWGT	Pouch Material Basis Weight	16	15	17	g/m2
9	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	8	PRTMPOR	Pouch Material Porosity	1850	1600	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^2m2/s	2200	2200	L/m^2/s	MAXIMUM
2510	TOB17	PD	SNUS-77	259	Nicotine dissolution rate	DESIGN PARAMETER SPECIFICATION	%/min	%/min	TARGET	26	TOB17	PD	SNUS-77	26	Nicotine dissolution rate	DESIGN PARAMETER SPECIFICATION	%/min	%/min	MINIMUM	NICTDSRT	Nicotine Dissolution Rate	15	5	22	27	TOB17	PD	SNUS-77	27	Nicotine dissolution rate	DESIGN PARAMETER SPECIFICATION	%/min	%/min	MAXIMUM

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?Finally, the PT domain is used to represent the actual results of testing the manufactured portioned snus product for conformance to the tobacco product design parameters shown in PD. PTCAT is a Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. 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.

Show the tobacco design parameter specification test and the result in ORRES for the SNUS. (needs populated).

Dataset wrap

Name	pt

Rowcaps

Rows 1-6:

Row 3:

Shows the design parameter specification for the portion mass.

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	PTSEQ	PTREFID	PTTESTCD	PTTESTPTTSTCND	PTCAT	PTSCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTREPNUM	PTTPT	PTTPTNUM
1	TOB17	PT	SNUS-77	1	TOCUTSIZ	Tobacco Cut Size or Tobacco Particle Size	DESIGN PARAMETER SPECIFICATION TEST RESULTTESTING	70	mm or cuts per inch	70	70	mm or cuts per inch	1	Week 0	1	cuts/in	1
2	TOB17	PT	SNUS-77	1	TOPRTSIZ	Tobacco Particle Size	DESIGN PARAMETER TESTING	70	mm	70	70	mm	1
32	TOB17	PT	SNUS-77	2	TOMOISTR	Tobacco Moisture	DESIGN PARAMETER SPECIFICATION TEST RESULTTESTING	31.8	%	31.8	31.8	%	1	Week 0	1
4	3	TOB17	PT	SNUS-77	3	PRTMASS	Portion Mass	DESIGN PARAMETER SPECIFICATION TEST RESULTTESTING	998	mg	998	998	mg	1	Week 0	1
45	TOB17	PT	SNUS-77	4	PRTMWGT	Pouch Material Basis WeightPouch material basis weight	DESIGN PARAMETER SPECIFICATION TEST RESULTTESTING	15.3	g/m^2m2	15.3	15.3	g/m^2m2	1	Week 0	1
56	TOB17	PT	SNUS-77	5	PRTMPOR	Pouch material porosity (permeability)Material Porosity	DESIGN PARAMETER SPECIFICATION TEST RESULTTESTING	1900	CORESTA Unit (Cu) or L/m^2m2/s	1900	1900	CORESTA Unit (Cu) or L/m^2m2/s	1	Week 0	1
67	TOB17	PT	SNUS-77	6	NICTDSRT	Nicotine dissolution rateDissolution Rate	DESIGN PARAMETER SPECIFICATION TEST RESULTTESTING	18	%/min	18	18	%/min	1	Week 0	1

Page tree

Versions Compared

Old Version 10

New Version Current

Key