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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???illustrates the representation of a cigarette product's identifiers and descriptors using the TO domain. Note that this example uses TOSCAT (Subcategory of Tobacco Prod ID Element, a permissible variable) to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

Show the tobacco product is a filtered, combusted type of cigarette.

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Name	to

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Rows 1-4:

Show the records for a tobacco product given SPTOBID of CIG01a.

Rows 3-4:

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOPARMCD	TOPARM	TOCAT	TOSCAT	TOVAL
1	TOB07	TO	CIG01a	1	TBPRDCAT	Tobacco Product Category	NEW PRODUCT	PRODUCT IDENTIFIER	CigarettesCigarette
2	TOB07	TO	CIG01a	2	TBPRSCAT	Tobacco Product Subcategory	NEW PRODUCT	PRODUCT IDENTIFIER	FilteredFiltered, Combusted
3	TOB07	TO	CIG01a	3	MANUF	Manufacturer	NEW PRODUCT	PRODUCT IDENTIFIER	Joes Cigs USA
4	TOB07	TO	CIG01a	4	TRADENAM	Trade Name	NEW PRODUCT	PRODUCT IDENTIFIER	Treetop Methol Menthol King Size

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.


5	TOB07	TO	CIG01a	5	PACKTYP	Package Type	NEW PRODUCT	PRODUCT DESCRIPTOR	HARD PACK
6	TOB07	TO	CIG01a	6	PRDQUAN	Product Quantity	NEW PRODUCT	PRODUCT DESCRIPTOR	20	CIGARETTE
7	TOB07	TO	CIG01a	7	LENGTH	Length	NEW PRODUCT	PRODUCT DESCRIPTOR	86.0	mm
8	TOB07	TO	CIG01a	8	CIRCUMF	Circumference	NEW PRODUCT	PRODUCT DESCRIPTOR	26.0	mm
9	TOB07	TO	CIG01a	9	VENTLTOT	Total Ventilation	NEW PRODUCT	PRODUCT DESCRIPTOR	10.0	%
10	TOB07	TO	CIG01a	10	CHARFLAV	Characterizing Flavor	NEW PRODUCT	PRODUCT DESCRIPTOR	MENTHOL

The manufacturing parameter specifications of the cigarette 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 23 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.

Note the use of the variable IGDCMPID (Ingredient or Component Identifier) in rows 5-6. This tobacco product had 2 tobacco ingredients with 2 different tobacco cut sizes. IGDCMPID identifies to which tobacco ingredient the cut size applies. IGDCMPID originates in the IT (Tobacco Ingredients) and IN (Non-Tobacco Ingredients) domains. See Section 3.1.3.1, Ingredients and Additives, for more information.

Shows the heat source is xxx.

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Name	pd

Dataset wrap

Name	dp

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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:

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	DPSEQIGDCMPID	DPTESTCDPDSEQ	DPTESTPDPARMCD	DPCATPDPARM	DPSCATPDVALTRG	DPORRESPDVALMIN	DPORRESUPDVALMAX	DPSTRESC	DPSTRESN	DPSTRESU	DPCOLSRT	PDVALU
1	TOB07	DPPD	CIG01a		1	PACKTYPLENGTH	Package TypeLength	CIGARETTE	FILTERED, COMBUSTED	HARD PACK	84	83.5	84.5	mm HARD PACK
2	TOB07	DPPD	CIG01a		2	PRDQUANCIRCUMF	Product Quantity	CIGARETTE	FILTERED, COMBUSTED	20	CIGARETTE	20	20	CIGARETTE	Circumference	24.8	24.6	25	mm
3	TOB07	DPPD	CIG01a		3	LENGTHTBFLMASSLength	Tobacco Filler Mass	CIGARETTE783	FILTERED, COMBUSTED	86.0	mm	86.0	86.0	mm	753	814	mg
4	TOB07	DPPD	CIG01a		4	CIRCUMMOISTURE	CircumferenceMoisture	CIGARETTE13	FILTERED, COMBUSTED	26.0	mm	26.0	26.0	12	14	%mm
5	TOB07	DPPD	CIG01a	Burley tobacco	5	VENTLTNTOCUTSIZVentilation	Tobacco Cut Size	CIGARETTE 22	FILTERED, COMBUSTED	10.0	%	10.0	10.0	%	20	24	cuts/in
6	TOB07	DPPD	CIG01a	Reconstituted tobacco	6	CHARFLAV	Characterizing Flavor	CIGARETTE	FILTERED, COMBUSTED	MENTHOL	TOCUTSIZ	Tobacco Cut Size	27	25	29	mm MENTHOL
7	TOB07	DPPD	CIG01a		7	HTSOURCEVENTLFLT	Heat SourceFilter Ventilation	CIGARETTE 30	FILTERED, COMBUSTED 23	xxx37xxx	%
8	TOB07	DP	Cigarette length	DESIGN PARAMETER SPECIFICATION	mm		PD	CIG01a		8	TPNPLGTH	Tipping Paper Length	31	30	32	mmTARGET
9	TOB07	DP	Cigarette length	DESIGN PARAMETER SPECIFICATION	mm		PD	CIG01a		9	CBPPOR	Cigarette Base Paper Porosity	50	45	55	CuMINIMUM
10	TOB07	DP	Cigarette length	DESIGN PARAMETER SPECIFICATION	mm		PD	CIG01a		10	CBPPERM	Cigarette Base Paper Permeability	50	45	55	Cu MAXIMUM
11	TOB07	PD	CIG01a		11	CPBPOR	Cigarette Paper Band Porosity	10	0.2	13	Cu
12	TOB07	PD	CIG01a		12	CPBPERM	Cigarette Paper Band Permeability	10	0.2	13	Cu	DP	Cigarette circumference or diameter ²	DESIGN PARAMETER SPECIFICATION	mm	TARGET	12	TOB07	DP	Cigarette circumference or diameter ²	DESIGN PARAMETER SPECIFICATION	mm	MINIMUM
13	TOB07	DP	Cigarette circumference or diameter ²	DESIGN PARAMETER SPECIFICATION	mm	PD	CIG01a		13	CPBDIFF	Cigarette Paper Band Diffusivity	0.05	0.001	0.100	cm2/sMAXIMUM
14	TOB07	DP	Tobacco Filler mass	DESIGN PARAMETER SPECIFICATION	mg	TARGET	15	TOB07	DP	Tobacco Filler mass	DESIGN PARAMETER SPECIFICATION	mg	MINIMUM	16	TOB07	DP	Tobacco Filler mass	DESIGN PARAMETER SPECIFICATION	mg	MAXIMUM	17	TOB07	DP	Tobacco moisture or Oven Volatiles	DESIGN PARAMETER SPECIFICATION	%	TARGET	18	TOB07	DP	Tobacco moisture or Oven Volatiles	DESIGN PARAMETER SPECIFICATION	%	MINIMUM	19	TOB07	DP	Tobacco moisture or Oven Volatiles	DESIGN PARAMETER SPECIFICATION	%	MAXIMUM	20	TOB07	DP	Tobacco cut size	mm or cuts per inch ²	TARGET	21	TOB07	DP	Tobacco cut size	mm or cuts per inch ²	MINIMUM	22	TOB07	DP	Tobacco cut size	mm or cuts per inch ²	MAXIMUM	23	TOB07	DP	Filter Ventilation	%	TARGET	24	TOB07	DP	Filter Ventilation	%	MINIMUM	25	TOB07	DP	Filter Ventilation	%	MAXIMUM	26	TOB07	DP	Tipping Paper Length	mm	TARGET	27	TOB07	DP	Tipping Paper Length	mm	MINIMUM	28	TOB07	DP	Tipping Paper Length	mm	MAXIMUM	29	TOB07	DP	Cigarette base paper Porosity or Permeability	CORESTA Unit (Cu)	TARGET	30	TOB07	DP	Cigarette base paper Porosity or Permeability	CORESTA Unit (Cu)	MINIMUM	31	TOB07	DP	Cigarette base paper Porosity or Permeability	CORESTA Unit (Cu)	MAXIMUM	32	TOB07	DP	Cigarette Paper band porosity or permeability or band diffusivity	CORESTA Unit (Cu) or cm²/s	TARGET	33	TOB07	DP	Cigarette Paper band porosity or permeability or band diffusivity	CORESTA Unit (Cu) or cm²/s	MINIMUM	34	TOB07	DP	Cigarette Paper band porosity or permeability or band diffusivity	CORESTA Unit (Cu) or cm²/s	MAXIMUM	35	TOB07	DP	Cigarette Paper band width	mm	TARGET	36	TOB07	DP	Cigarette Paper band width	mm	MINIMUM	37	TOB07	DP	Cigarette Paper band width	mm	MAXIMUM	38	TOB07	DP	Cigarette Paper band space	mm	TARGET	39	TOB07	DP	Cigarette Paper band space	mm	MINIMUM	40	TOB07	DP	Cigarette Paper band space	mm	MAXIMUM	41	TOB07	DP	Filter efficiency¹	%	TARGET	42	TOB07	DP	Filter efficiency ¹	%	MINIMUM	43	TOB07	DP	Filter efficiency¹	%	MAXIMUM	44	TOB07	DP	Denier per Filament	DPF	TARGET	45	TOB07	DP	Denier per Filament	DPF	MINIMUM	46	TOB07	DP	Denier per Filament	DPF	MAXIMUM	47	TOB07	DP	Total Denier	g/9000 m	TARGET	48	TOB07	DP	Total Denier	g/9000 m	MINIMUM	49	TOB07	DP	Total Denier	g/9000 m	MAXIMUM	50	TOB07	DP	Filter Density	g/cm³	TARGET	51	TOB07	DP	Filter Density	g/cm³	MINIMUM	52	TOB07	DP	Filter Density	g/cm³	MAXIMUM	53	TOB07	DP	Filter Length	mm	TARGET	54	TOB07	DP	Filter Length	mm	MINIMUM	55	TOB07	DP	Filter Length	mm	MAXIMUM	56	TOB07	DP	Filter Pressure Drop	mm H2O	TARGET	57	TOB07	DP	Filter Pressure Drop	mm H2O	MINIMUM	58	TOB07	DP	Filter Pressure Drop	mm H2O	MAXIMUM	59	TOB07	DP	Tobacco Rod Density	g/cm³	TARGET	60	TOB07	DP	Tobacco Rod Density	g/cm³	MINIMUM	61	TOB07	DP	Tobacco Rod Density	g/cm³	MAXIMUM	62	TOB07	DP	Cigarette Paper Length	mm	TARGET	63	TOB07	DP	Cigarette Paper Length	mm	MINIMUM	64	TOB07	DP	Cigarette Paper Length	mm	MAXIMUM

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Name	tt

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Rows 1-4:

Row 5:

S

Row 6:

Row 7:

Dataset2

Row

STUDYID

DOMAIN

SPTOBID

TTSEQ

TTGRPID

TTTESTCD

TTTEST

TTCAT

TTORRES

TTORRESU

TTSTRESC

TTSTRESN

TTSTRESU

TTCOLSRT

1

TOB07

TT

CIG01a

1

Tobacco Filler mass

mg

2

TOB07

TT

CIG01a

2

Tobacco moisture or Oven Volatiles

%

3

TOB07

TT

CIG01a

3

Tobacco cut size

mm or cuts per inch ²

4

TOB07

TT

CIG01a

4

Tobacco Rod density

g/cm³

5

TOB07

TT

CIG01a

5

Filter Ventilation

%

6

TOB07

TT

CIG01a

6

Cigarette base paper Porosity or Permeability

CORESTA Unit (Cu)

7

TOB07

TT

CIG01a

7

Cigarette Paper band porosity or permeability or band diffusivity

CORESTA Unit (Cu) or cm²/s

8

TOB07

TT

CIG01a

8

Filter efficiency¹

%

9

TOB07

TT

CIG01a

9

Denier per Filament

DPF

10

TOB07

TT

CIG01a

10

Total Denier

g/9000 m

11

TOB07

TT

CIG01a

11

Filter Density

g/cm³

12

TOB07

TT

CIG01a

12

Filter Pressure Drop

mm H2O

This images shows the filtration zone where the ventilation occurs.

Image Removed

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

References:

PD	CIG01a		14	CPBWID	Cigarette Paper Band Width	7	6.7	7.3	mm
15	TOB07	PD	CIG01a		15	CPBSPC	Cigarette Paper Band Space	20	19.8	20.2	mm
16	TOB07	PD	CIG01a		16	FLTREFF	Filter Efficiency	30	25	35	%
17	TOB07	PD	CIG01a		17	DPF	Denier Per Filament	4	3.6	4.4
18	TOB07	PD	CIG01a		18	TDENIER	Total Denier	30000	29100	30900	g/9000m
19	TOB07	PD	CIG01a		19	FLTRDEN	Filter Density	0.1234	0.105	0.1419	g/cm3
20	TOB07	PD	CIG01a		20	FLTRLGTH	Filter Length	25	24.5	25.5	mm
21	TOB07	PD	CIG01a		21	FLTPRDRP	Filter Pressure Drop	60	51	69	mm H2O
22	TOB07	PD	CIG01a		22	TORODDEN	Tobacco Rod Density	0.2678	0.2437	0.2919	g/cm3
23	TOB07	PD	CIG01a		23	CIGPLGTH	Cigarette Paper Length	53	52	54	mm

Finally, the PT domain is used to represent the actual results of testing the manufactured cigarette product for conformance to the tobacco product design parameters shown in PD above. PTCAT is a Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. As described in the PD example, IGDCMPID is also used here to differentiate 2 records of the same test performed on each of 2 different types of tobacco that are ingredients of the tobacco product. 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.

Dataset wrap

Name	pt

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	IGDCMPID	PTSEQ	PTTESTCD	PTTEST	PTCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTREPNUM
1	TOB07	PT	CIG01a		1	LENGTH	Length	DESIGN PARAMETER TESTING	83.9	mm	83.9	83.9	mm	1
2	TOB07	PT	CIG01a		2	CIRCUMF	Circumference	DESIGN PARAMETER TESTING	24.9	mm	24.9	24.9	mm	1
3	TOB07	PT	CIG01a		3	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER TESTING	779	mg	779	779	mg	1
4	TOB07	PT	CIG01a		4	MOISTURE	Moisture	DESIGN PARAMETER TESTING	13.1	%	13.1	13.1	%	1
5	TOB07	PT	CIG01a	Burley tobacco	5	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER TESTING	22	cuts/in	22	22	cuts/in	1
6	TOB07	PT	CIG01a	Reconstituted tobacco	6	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER TESTING	27	mm	27	27	mm	1
7	TOB07	PT	CIG01a		7	VENTLFLT	Filter Ventilation	DESIGN PARAMETER TESTING	35	%	35	35	%	1
8	TOB07	PT	CIG01a		8	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER TESTING	30	mm	30	30	mm	1
9	TOB07	PT	CIG01a		9	CBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER TESTING	48	Cu	48	48	Cu	1
10	TOB07	PT	CIG01a		10	CBPPERM	Cigarette Base Paper Permeability	DESIGN PARAMETER TESTING	50	Cu	50	50	Cu	1
11	TOB07	PT	CIG01a		11	CPBPOR	Cigarette Paper Band Porosity	DESIGN PARAMETER TESTING	9.8	Cu	9.8	9.8	Cu	1
12	TOB07	PT	CIG01a		12	CPBPERM	Cigarette Paper Band Permeability	DESIGN PARAMETER TESTING	10	Cu	10	10	Cu	1
13	TOB07	PT	CIG01a		13	CPBDIFF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER TESTING	0.06	cm2/s	0.06	0.06	cm2/s	1
14	TOB07	PT	CIG01a		14	CPBWID	Cigarette Paper Band Width	DESIGN PARAMETER TESTING	7.1	mm	7.1	7.1	mm	1
15	TOB07	PT	CIG01a		15	CPBSPC	Cigarette Paper Band Space	DESIGN PARAMETER TESTING	19.9	mm	19.9	19.9	mm	1
16	TOB07	PT	CIG01a		16	FLTREFF	Filter Efficiency	DESIGN PARAMETER TESTING	28	%	28	28	%	1
17	TOB07	PT	CIG01a		17	DPF	Denier Per Filament	DESIGN PARAMETER TESTING	4.1		4.1	4.1		1
18	TOB07	PT	CIG01a		18	TDENIER	Total Denier	DESIGN PARAMETER TESTING	29900	g/9000m	29900	29900	g/9000m	1
19	TOB07	PT	CIG01a		19	FLTRDEN	Filter Density	DESIGN PARAMETER TESTING	0.1112	g/cm3	0.1112	0.1112	g/cm3	1
20	TOB07	PT	CIG01a		20	FLTRLGTH	Filter Length	DESIGN PARAMETER TESTING	25	mm	25	25	mm	1
21	TOB07	PT	CIG01a		21	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER TESTING	62	mm H2O	62	62	mm H2O	1
22	TOB07	PT	CIG01a		22	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER TESTING	0.2701	g/cm3	0.2701	0.2701	g/cm3	1
23	TOB07	PT	CIG01a		23	CIGPLGTH	Cigarette Paper Length	DESIGN PARAMETER TESTING	53	mm	53	53	mm	1

References:

International Organization for Standardization. ISO 9512:2019(en) - Cigarettes — Determination of ventilation — Definitions and measurement principles. ISO; June 2019. Accessed October 15, 2023. https://www.iso.org/obp/ui/#iso:std:iso:9512:ed-3:v1:en
Song M-A, Benowitz NL, Berman M, et al. Cigarette filter ventilation and its relationship to increasing rates of lung adenocarcinoma. J Natl Cancer Inst. 2017;109(12):djx075. https://wwwdoi.ncbi.nlm.nih.gov/pmc/articles/PMC6059254/org/10.1093/jnci/djx075

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