This images shows the filtration zone where the ventilation occurs.
Question - is this helpful? Will need permission. This is from the second reference.
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DI = TO for Tobacco Product Identifier 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.
Steve H's suggestion of combining our previous product identifiers and product descriptors into a single dataset. This is a more traditional findings dataset structure. Advantages: it doesn't break any rules. SPTOBID is the Sponsor-defined Tobacco Product Identifier, and serves as the "subject" of all records since these are not (human) subject-level data.
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Rows 1-4: | Show the records for a tobacco product identifiers that were previously represented in a separate DI dataset | Rows 5-10: | Show the product descriptors which we would have originally put in a DO-like dataset. |
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Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOTESTCD | TOTEST | TOCAT | TOORRES | TOORRESU | TOSTRESC | TOSTRESN | TOSTRESU |
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1 | TOB07 | TO | CIG01a | | TBPRDCAT | Tobacco Product Category | PRODUCT IDENTIFIER | Cigarette |
| Cigarette |
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| 2 | TOB07 | TO | CIG01a | 2 | TBPRSCAT | Tobacco Product Subcategory | PRODUCT IDENTIFIER | Filtered, Combusted |
| Filtered, Combusted |
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| 3 | TOB07 | TO | CIG01a | 3 | MANUF | Manufacturer | PRODUCT IDENTIFIER | Joes Cigs USA |
| Joes Cigs USA |
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| 4 | TOB07 | TO | CIG01a | 4 | TRADENAM | Trade Name | PRODUCT IDENTIFIER | Treetop Menthol King Size |
| Treetop Menthol King Size |
|
| 5 | TOB07 | TO | CIG01a | 5 | PACKTYP | Package Type | PRODUCT DESCRIPTOR | HARD PACK |
| HARD PACK |
|
| 6 | TOB07 | TO | CIG01a | 6 | PRDQUAN | Product Quantity | PRODUCT DESCRIPTOR | 20 | CIGARETTE | 20 | 20 | CIGARETTE | 7 | TOB07 | TO | CIG01a | 7 | LENGTH | Length | PRODUCT DESCRIPTOR | 86.0 | mm | 86.0 | 86.0 | mm | 8 | TOB07 | TO | CIG01a | 8 | CIRCUMF | Circumference | PRODUCT DESCRIPTOR | 26.0 | mm | 26.0 | 26.0 | mm | 9 | TOB07 | TO | CIG01a | 9 | VENTLTN | Ventilation | PRODUCT DESCRIPTOR | 10.0 | % | 10.0 | 10.0 | % | 10 | TOB07 | TO | CIG01a | 10 | CHARFLAV | Characterizing Flavor | PRODUCT DESCRIPTOR | MENTHOL |
| MENTHOL |
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The Tobacco Product Design Parameters (DP) represents the manufacturing parameter specifications of the tobacco product as used. The example below shows the target, minimum, and maximum values associated with each of 19 separate design parameters. These parameters are defined as manufacturing guidelines, not determined experimentally.
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Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | DPSEQ | DPTESTCD | DPTEST | DPCAT | DPORRES | DPORRESU | DPSTRESC | DPSTRESN | DPSTRESU | DPCOLSRT |
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1 | | DP | CIG01a | | LENGTH | Length | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | TARGET | 2 | TOB07 | DP | CIG01a | 2 | LENGTH | Length | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | MINIMUM | 3 | TOB07 | DP | CIG01a | 3 | LENGTH | Length | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | MAXIMUM | 4 | TOB07 | DP | CIG01a | 4 | CIRCUMF | Circumference | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | TARGET | 5 | TOB07 | DP | CIG01a | 5 | CIRCUMF | Circumference | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | MINIMUM | 6 | TOB07 | DP | CIG01a | 6 | CIRCUMF | Circumference | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | MAXIMUM | 7 | TOB07 | DP | CIG01a | 7 | TBFLMASS | Tobacco Filler Mass | DESIGN PARAMETER SPECIFICATION |
| mg |
|
| mg | TARGET | 8 | TOB07 | DP | CIG01a | 8 | TBFLMASS | Tobacco Filler Mass | DESIGN PARAMETER SPECIFICATION |
| mg |
|
| mg | MINIMUM | 9 | TOB07 | DP | CIG01a | 9 | TBFLMASS | Tobacco Filler Mass | DESIGN PARAMETER SPECIFICATION |
| mg |
|
| mg | MAXIMUM | 10 | TOB07 | DP | CIG01a | 10 | MOISTURE | Moisture | DESIGN PARAMETER SPECIFICATION |
| % |
|
| % | TARGET | 11 | TOB07 | DP | CIG01a | 11 | MOISTURE | Moisture | DESIGN PARAMETER SPECIFICATION |
| % |
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| % | MINIMUM | 12 | TOB07 | DP | CIG01a | 12 | MOISTURE | Moisture | DESIGN PARAMETER SPECIFICATION |
| % |
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| % | MAXIMUM | 13 | TOB07 | DP | CIG01a | 13 | TOCUTSIZ | Tobacco Cut Size | DESIGN PARAMETER SPECIFICATION |
| mm or cuts per inch 2 |
|
| mm or cuts per inch 2 | TARGET | 14 | TOB07 | DP | CIG01a | 14 | TOCUTSIZ | Tobacco Cut Size | DESIGN PARAMETER SPECIFICATION |
| mm or cuts per inch 2 |
|
| mm or cuts per inch 2 | MINIMUM | 15 | TOB07 | DP | CIG01a | 15 | TOCUTSIZ | Tobacco Cut Size | DESIGN PARAMETER SPECIFICATION |
| mm or cuts per inch 2 |
|
| mm or cuts per inch 2 | MAXIMUM | 16 | TOB07 | DP | CIG01a | 16 | FLTRVENT | Filter Ventilation | DESIGN PARAMETER SPECIFICATION |
| % |
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| % | TARGET | 17 | TOB07 | DP | CIG01a | 17 | FLTRVENT | Filter Ventilation | DESIGN PARAMETER SPECIFICATION |
| % |
|
| % | MINIMUM | 18 | TOB07 | DP | CIG01a | 18 | FLTRVENT | Filter Ventilation | DESIGN PARAMETER SPECIFICATION |
| % |
|
| % | MAXIMUM | 19 | TOB07 | DP | CIG01a | 19 | TPNPLGTH | Tipping Paper Length | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | TARGET | 20 | TOB07 | DP | CIG01a | 20 | TPNPLGTH | Tipping Paper Length | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | MINIMUM | 21 | TOB07 | DP | CIG01a | 21 | TPNPLGTH | Tipping Paper Length | DESIGN PARAMETER SPECIFICATION |
| mm |
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| mm | MAXIMUM | 22 | TOB07 | DP | CIG01a | 22 | CIGBPPOR | Cigarette Base Paper Porosity or Permeability | DESIGN PARAMETER SPECIFICATION |
| CORESTA Unit (Cu) |
|
| CORESTA Unit (Cu) | TARGET | 23 | TOB07 | DP | CIG01a | 23 | CIGBPPOR | Cigarette Base Paper Porosity or Permeability | DESIGN PARAMETER SPECIFICATION |
| CORESTA Unit (Cu) |
|
| CORESTA Unit (Cu) | MINIMUM | 24 | TOB07 | DP | CIG01a | 24 | CIGBPPOR | Cigarette Base Paper Porosity or Permeability | DESIGN PARAMETER SPECIFICATION |
| CORESTA Unit (Cu) |
|
| CORESTA Unit (Cu) | MAXIMUM | 25 | TOB07 | DP | CIG01a | 25 | BNDDIF | Cigarette Paper Band Porosity or Permeability or Band Diffusivity | DESIGN PARAMETER SPECIFICATION |
| CORESTA Unit (Cu) or cm2/s |
|
| CORESTA Unit (Cu) or cm2/s | TARGET | 26 | TOB07 | DP | CIG01a | 26 | BNDDIF | Cigarette Paper Band Porosity or Permeability or Band Diffusivity | DESIGN PARAMETER SPECIFICATION |
| CORESTA Unit (Cu) or cm2/s |
|
| CORESTA Unit (Cu) or cm2/s | MINIMUM | 27 | TOB07 | DP | CIG01a | 27 | BNDDIF | Cigarette Paper Band Porosity or Permeability or Band Diffusivity | DESIGN PARAMETER SPECIFICATION |
| CORESTA Unit (Cu) or cm2/s |
|
| CORESTA Unit (Cu) or cm2/s | MAXIMUM | 28 | TOB07 | DP | CIG01a | 28 | CPBNDWID | Cigarette Paper Band Width | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | TARGET | 29 | TOB07 | DP | CIG01a | 29 | CPBNDWID | Cigarette Paper Band Width | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | MINIMUM | 30 | TOB07 | DP | CIG01a | 30 | CPBNDWID | Cigarette Paper Band Width | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | MAXIMUM | 31 | TOB07 | DP | CIG01a | 31 | CPBNDSPC | Cigarette Paper Band Space | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | TARGET | 32 | TOB07 | DP | CIG01a | 32 | CPBNDSPC | Cigarette Paper Band Space | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | MINIMUM | 33 | TOB07 | DP | CIG01a | 33 | CPBNDSPC | Cigarette Paper Band Space | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | MAXIMUM | 34 | TOB07 | DP | CIG01a | 34 | FLTREFF | Filter Efficiency | DESIGN PARAMETER SPECIFICATION |
| % |
|
| % | TARGET | 35 | TOB07 | DP | CIG01a | 35 | FLTREFF | Filter Efficiency | DESIGN PARAMETER SPECIFICATION |
| % |
|
| % | MINIMUM | 36 | TOB07 | DP | CIG01a | 36 | FLTREFF | Filter Efficiency | DESIGN PARAMETER SPECIFICATION |
| % |
|
| % | MAXIMUM | 37 | TOB07 | DP | CIG01a | 37 | DPF | Denier Per Filament | DESIGN PARAMETER SPECIFICATION |
| /filament |
|
| /filament | TARGET | 38 | TOB07 | DP | CIG01a | 38 | DPF | Denier Per Filament | DESIGN PARAMETER SPECIFICATION |
| /filament |
|
| /filament | MINIMUM | 39 | TOB07 | DP | CIG01a | 39 | DPF | Denier Per Filament | DESIGN PARAMETER SPECIFICATION |
| /filament |
|
| /filament | MAXIMUM | 40 | TOB07 | DP | CIG01a | 40 | TDENIER | Total Denier | DESIGN PARAMETER SPECIFICATION |
| g/9000 m |
|
| g/9000 m | TARGET | 41 | TOB07 | DP | CIG01a | 41 | TDENIER | Total Denier | DESIGN PARAMETER SPECIFICATION |
| g/9000 m |
|
| g/9000 m | MINIMUM | 42 | TOB07 | DP | CIG01a | 42 | TDENIER | Total Denier | DESIGN PARAMETER SPECIFICATION |
| g/9000 m |
|
| g/9000 m | MAXIMUM | 43 | TOB07 | DP | CIG01a | 43 | FLTRDEN | Filter Density | DESIGN PARAMETER SPECIFICATION |
| g/cm3 |
|
| g/cm3 | TARGET | 44 | TOB07 | DP | CIG01a | 44 | FLTRDEN | Filter Density | DESIGN PARAMETER SPECIFICATION |
| g/cm3 |
|
| g/cm3 | MINIMUM | 45 | TOB07 | DP | CIG01a | 45 | FLTRDEN | Filter Density | DESIGN PARAMETER SPECIFICATION |
| g/cm3 |
|
| g/cm3 | MAXIMUM | 46 | TOB07 | DP | CIG01a | 46 | FLTRLGTH | Filter Length | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | TARGET | 47 | TOB07 | DP | CIG01a | 47 | FLTRLGTH | Filter Length | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | MINIMUM | 48 | TOB07 | DP | CIG01a | 48 | FLTRLGTH | Filter Length | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | MAXIMUM | 49 | TOB07 | DP | CIG01a | 49 | FLTPRDRP | Filter Pressure Drop | DESIGN PARAMETER SPECIFICATION |
| mm H2O |
|
| mm H2O | TARGET | 50 | TOB07 | DP | CIG01a | 50 | FLTPRDRP | Filter Pressure Drop | DESIGN PARAMETER SPECIFICATION |
| mm H2O |
|
| mm H2O | MINIMUM | 51 | TOB07 | DP | CIG01a | 51 | FLTPRDRP | Filter Pressure Drop | DESIGN PARAMETER SPECIFICATION |
| mm H2O |
|
| mm H2O | MAXIMUM | 52 | TOB07 | DP | CIG01a | 52 | TORODDEN | Tobacco Rod Density | DESIGN PARAMETER SPECIFICATION |
| g/cm3 |
|
| g/cm3 | TARGET | 53 | TOB07 | DP | CIG01a | 53 | TORODDEN | Tobacco Rod Density | DESIGN PARAMETER SPECIFICATION |
| g/cm3 |
|
| g/cm3 | MINIMUM | 54 | TOB07 | DP | CIG01a | 54 | TORODDEN | Tobacco Rod Density | DESIGN PARAMETER SPECIFICATION |
| g/cm3 |
|
| g/cm3 | MAXIMUM | 55 | TOB07 | DP | CIG01a | 55 | Cigarette Paper Length | CIGPLGTH | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | TARGET | 56 | TOB07 | DP | CIG01a | 56 | Cigarette Paper Length | CIGPLGTH | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | MINIMUM | 57 | TOB07 | DP | CIG01a | 57 | Cigarette Paper Length | CIGPLGTH | DESIGN PARAMETER SPECIFICATION |
| mm |
|
| mm | MAXIMUM |
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The Tobacco Product Testing (TT) domain is used to represent the actual results of testing for conformance to the tobacco product design parameters shown in DP above.
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Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | TTSEQ | TTTESTCD | TTTEST | TTORRES | TTORRESU | TTSTRESC | TTSTRESN | TTSTRESU |
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1 | TOB07 | TT | CIG01a | | LENGTH | Length |
| mm |
|
| mm | 2 | TOB07 | TT | CIG01a | 2 | CIRCUMF | Circumference |
| mm |
|
| mm | 3 | TOB07 | TT | CIG01a | 3 | TBFLMASS | Tobacco Filler Mass |
| mg |
|
| mg | 4 | TOB07 | TT | CIG01a | 4 | MOISTURE | Moisture |
| % |
|
| % | 5 | TOB07 | TT | CIG01a | 5 | TOCUTSIZ | Tobacco Cut Size |
| mm or cuts per inch 2 |
|
| mm or cuts per inch 2 | 6 | TOB07 | TT | CIG01a | 6 | FLTRVENT | Filter Ventilation |
| % |
|
| % | 7 | TOB07 | TT | CIG01a | 7 | TPNPLGTH | Tipping Paper Length |
| mm |
|
| mm | 8 | TOB07 | TT | CIG01a | 8 | CIGBPPOR | Cigarette Base Paper Porosity or Permeability |
| CORESTA Unit (Cu) |
|
| CORESTA Unit (Cu) | 9 | TOB07 | TT | CIG01a | 9 | BNDDIF | Cigarette Paper Band Porosity or Permeability or Band Diffusivity |
| CORESTA Unit (Cu) or cm2/s |
|
| CORESTA Unit (Cu) or cm2/s | 10 | TOB07 | TT | CIG01a | 10 | CPBNDWID | Cigarette Paper Band Width |
| mm |
|
| mm | 11 | TOB07 | TT | CIG01a | 11 | CPBNDSPC | Cigarette Paper Band Space |
| mm |
|
| mm | 12 | TOB07 | TT | CIG01a | 12 | FLTREFF | Filter Efficiency |
| % |
|
| % | 13 | TOB07 | TT | CIG01a | 13 | DPF | Denier Per Filament |
| /filament |
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| /filament | 14 | TOB07 | TT | CIG01a | 14 | DENIER | Denier |
| g/9000 m |
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| g/9000 m | 15 | TOB07 | TT | CIG01a | 15 | FLTRDEN | Filter Density |
| g/cm3 |
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| g/cm3 | 16 | TOB07 | TT | CIG01a | 16 | FLTRLGTH | Filter Length |
| mm |
|
| mm | 17 | TOB07 | TT | CIG01a | 17 | FLTPRDRP | Filter Pressure Drop |
| mm H2O |
|
| mm H2O | 18 | TOB07 | TT | CIG01a | 18 | TORODDEN | Tobacco Rod Density |
| g/cm3 |
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| g/cm3 | 19 | TOB07 | TT | CIG01a | 19 | CIGPLGTH | Cigarette Paper Length |
| mm |
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| mm |
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The following tables illustrate the controlled terminology for the the --TESTCD and --TEST values that should be submitted for in datasets according to the examples above. for each tobacco product category. (We'll add more language as necessary to make this clearer)
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Sponsors should always verify controlled terminology using the published CDISC controlled terminology for the associated codelists below |
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title | Cigarettes Product Identifiers and Descriptors |
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| TOTESTCD | TOTEST | Alternative - which way? | TOSTRESC* | Description |
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TBPRDCAT | Tobacco Product Category |
| Cigarettes |
| TBPRSCAT | Tobacco Product Subcategory |
| Filtered |
| TBPRSCAT | Tobacco Product Subcategory |
| Non-Filtered |
| MANUF | Manufacturer |
| -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | TRADENAM | Trade Name |
| -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | PACKTYP | Package Type |
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| PRDQUAN | Product Quantity |
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| LENGTH | Length |
|
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| CIRCUMF | Circumference |
|
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| VENTLTN | Ventilation |
|
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| CHARFLAV | Characterizing Flavor |
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*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column. |
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title | Cigarettes Product Design Parameters and Conformance Testing |
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| Since the conformance testing of the design parameters and the design parameters themselves speak to the same concepts, they use the same terminology
DPTESTCD /TTESTCD | DPTEST/TTTEST | Description |
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LENGTH | Length |
| CIRCUMF | Circumference |
| TBFLMASS | Tobacco Filler Mass |
| MOISTURE | Moisture |
| TOCUTSIZ | Tobacco Cut Size |
| FLTRVENT | Filter Ventilation |
| TPNPLGTH | Tipping Paper Length |
| CIGBPPOR | Cigarette Base Paper Porosity or Permeability |
| BNDDIF | Cigarette Paper Band Porosity or Permeability or Band Diffusivity |
| CPBNDWID | Cigarette Paper Band Width |
| CPBNDSPC | Cigarette Paper Band Space |
| FLTREFF | Filter Efficiency |
| DPF | Denier Per Filament |
| TDENIER | Total Denier |
| FLTRDEN | Filter Density |
| FLTRLGTH | Filter Length |
| FLTPRDRP | Filter Pressure Drop |
| TORODDEN | Tobacco Rod Density |
| CIGPLGTH | Cigarette Paper Length |
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| Acrolein |
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| Acrylonitrile |
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| 4-Aminobiphenyl |
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| 1-Aminonaphthalene |
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| 2-Aminonaphthalene |
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| Ammonia |
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| Benzene |
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| Benzo[a]pyrene |
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| 1,3-Butadiene |
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| Carbon monoxide |
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| Crotonaldehyde |
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| Formaldehyde |
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| Isoprene |
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| Nicotine (total) |
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| NNK - 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone |
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| NNN - N-nitrosonornicotine |
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| Toluene |
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title | Roll-Your-Own Tobacco Products |
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title | Roll-Your-Own Tobacco Product Identifiers and Descriptors |
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| TOTESTCD | TOTEST | Alternative - which way? | TOSTRESC* | Description |
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TBPRDCAT | Tobacco Product Category |
| Roll-Your-Own Tobacco Products | Roll-your-own tobacco is defined in section 900(15) of the FD&C Act to mean “any tobacco product which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.” The term cigarette filler is not defined in the FD&C Act. For purposes of this draft guidance, we intend cigarette filler to mean the cut, ground, powdered, or leaf tobacco that is a component of a cigarette.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-under | TBPRSCAT | Tobacco Product Subcategory |
| Roll-Your-Own Tobacco Filler |
| TBPRSCAT | Tobacco Product Subcategory |
| Roll-Your-Own Tobacco Rolling Paper |
| TBPRSCAT | Tobacco Product Subcategory |
| Filtered Cigarette Tube |
| TBPRSCAT | Tobacco Product Subcategory |
| Non-Filtered Cigarette Tube |
| TBPRSCAT | Tobacco Product Subcategory |
| Non-Filtered Cigarette Tube Filter |
| TBPRSCAT | Tobacco Product Subcategory |
| Non-Filtered Cigarette Tube Paper-Tip |
| MANUF | Manufacturer |
| -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | TRADENAM | Trade Name |
| -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | PRDQUAN | Product Quantity |
|
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| CHTRFLAV | Characterizing Flavor |
|
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| PACKTYP | Package Type |
|
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| LENGTH | Length |
|
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| WIDTH | Width |
|
|
| DIAMETER | Diameter |
|
|
| VENTLTN | Ventilation |
|
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*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column. |
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title | Roll-Your-Own Tobacco Product Design Parameters and Conformance Testing |
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| Since the conformance testing of the design parameters and the design parameters themselves speak to the same concepts, they use the same terminology
DPTESTCD /TTESTCD | DPTEST/TTTEST | Description |
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| Tobacco Cut Size |
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| Tobacco Moisture |
|
| Ammonia |
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| Arsenic |
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| Cadmium |
|
| Nicotine (total) |
|
| NNK - 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone |
|
| NNN - N-nitrosonornicotine |
|
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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-under
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title | Cigars Product Identifiers and Descriptors |
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| TOTESTCD | TOTEST | TOSTRESC* | Description |
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TBPRDCAT | Tobacco Product Category | Cigars |
| TBPRSCAT | Tobacco Product Subcategory | |
| TBPRSCAT | Tobacco Product Subcategory | Unfiltered, Sheet-Wrapped |
| TBPRSCAT | Tobacco Product Subcategory | Unfiltered, Leaf-Wrapped |
| TBPRSCAT | Tobacco Product Subcategory | Cigar Component |
| TBPRSCAT | Tobacco Product Subcategory | Cigar Tobacco Filler |
| MANUF | Manufacturer | -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | TRADENAM | Trade Name | -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | PACKTYP | Package Type |
|
| PRDQUAN | Product Quantity |
|
| LENGTH | Length |
|
| DIAMETER | Diameter |
|
| TIP | Tip |
|
| VENTLTN | Ventilation |
|
| CHARFLAV | Characterizing Flavor |
|
| WRAPMTL | Wrapper Material |
|
|
|
|
|
|
*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.
|
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title | Cigars Product Design Parameters and Conformance Testing |
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| Since the conformance testing of the design parameters and the design parameters themselves speak to the same concepts, they use the same terminology
DPTESTCD /TTESTCD | DPTEST/TTTEST | Description |
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|
|
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title | Smokeless Tobacco Products |
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|
Expand |
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title | Smokeless Tobacco Product Identifiers and Descriptors |
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| TOTESTCD | TOTEST | TOSTRESC* | Description |
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TBPRDCAT | Tobacco Product Category | Smokeless Tobacco Products |
| TBPRSCAT | Tobacco Product Subcategory | |
| TBPRSCAT | Tobacco Product Subcategory | Portioned Moist Snuff |
| TBPRSCAT | Tobacco Product Subcategory | Loose Snus |
| TBPRSCAT | Tobacco Product Subcategory | Portioned Snus |
| TBPRSCAT | Tobacco Product Subcategory | Loose Dry Snuff |
| TBPRSCAT | Tobacco Product Subcategory | Dissolvable |
| TBPRSCAT | Tobacco Product Subcategory | Loose Chewing Tobacco |
| TBPRSCAT | Tobacco Product Subcategory | Portioned Chewing Tobacco |
| MANUF | Manufacturer | -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | TRADENAM | Trade Name | -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | PACKTYP | Package Type |
|
| PRDQUAN | Product Quantity |
|
| CHARFLAV | Characterizing Flavor |
|
| PRTNCT | |
|
| PRTNMS | Portion mass |
|
| PRTNLGTH | Portion length |
|
| PRTNWDTH | Portion width |
|
| PRTNTHCK | Portion thickness |
|
|
|
|
|
|
*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.
|
Expand |
---|
title | Smokeless Tobacco Product Design Parameters and Conformance Testing |
---|
| Since the conformance testing of the design parameters and the design parameters themselves speak to the same concepts, they use the same terminology
DPTESTCD /TTESTCD | DPTEST/TTTEST | Description |
---|
| |
|
| Arsenic |
|
| Benzo[a]pyrene |
|
| Cadmium |
|
| Crotonaldehyde |
|
| Formaldehyde |
|
| Nicotine (total and free) |
|
| NNK - 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone |
|
| NNN - N-nitrosonornicotine |
|
| pH |
|
| Temperature |
|
| Moisture Content |
|
| ?Method to stabilize or stop fermentation |
|
| Duration of fermentation |
|
| Type of heat treatment process |
|
| Conditions of heat treatment process - time, temperature, moisture |
|
|
|
|
|
|
|
|
|
Expand |
---|
title | Electronic Nicotine Delivery Systems (ENDS) (Vapes) |
---|
|
Expand |
---|
title | ENDS (Vapes) Product Identifiers and Descriptors |
---|
| TOTESTCD | TOTEST | TOSTRESC* | Description |
---|
TBPRDCAT | Tobacco Product Category | Electronic Nicotine Delivery System (ENDS) (Vapes) |
| TBPRSCAT | Tobacco Product Subcategory | |
| TBPRSCAT | Tobacco Product Subcategory | Closed E-Liquid |
| TBPRSCAT | Tobacco Product Subcategory | Closed E-Cigarette |
| TBPRSCAT | Tobacco Product Subcategory | Open E-Cigarette |
| TBPRSCAT | Tobacco Product Subcategory | Ends Component |
| MANUF | Manufacturer | -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | TRADENAM | Trade Name | -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | | Package Type |
|
| PRDQUAN | Product Quantity |
|
| LENGTH | Length |
|
| DIAMETER | Diameter |
|
| NICTNCNC | Nicotine Concentration |
|
| PGVGRT | PG/VG Ratio* |
|
| CHTRFLAV | Characterizing Flavor |
|
| VOLUMEE | Volume, E-liquid |
|
| WATT | Wattage |
|
| BATTCAP | Battery Capacity |
|
| DISPCRTG | Disposable Cartridge |
|
| CRTVOL | Cartridge volume |
|
| HTELNUM | Number of heating elements |
|
| BATCAPC | Battery capacity |
|
| BATNOMV | Battery nominal voltage |
|
| BTCRTRT | Battery Current Rating |
|
| VENTLTN | Ventilation |
|
| ELQDVISC | E-Liquid viscosity |
|
| ELQDVOL | E-liquid volume |
|
| PNUMCNC | Particle number concentration |
|
| CTMDDIAM | Count median diameter |
|
| PM | PM 2.5 |
|
|
*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.
|
Expand |
---|
title | ENDS (Vapes) Product Design Parameters and Conformance Testing |
---|
| Since the conformance testing of the design parameters and the design parameters themselves speak to the same concepts, they use the same terminology
DPTESTCD /TTESTCD | DPTEST/TTTEST | Description |
---|
| Draw Resistance |
| PUFCNT | Puff count (for full tank/cartridge) |
| CRTVOL | Cartridge volume |
| HTELNUM | Number of heating elements |
| HTELGTH | Heating element length |
| HTELRST | Heating element resistance |
| HTELRNG | Heating element range |
| HTELCFG | Heating element configuration |
| BTVLTORG | Battery voltage operating range |
| BTCRTORG | Battery current operating range |
| BATCAPC | Battery capacity |
| BATNOMV | Battery nominal voltage |
| BTCRTRT | Battery Current Rating |
| BTCHTPL | Battery Charging Temperature Limits |
| BTDCTMPL | Battery Discharge Temperature Limits |
| BTENDCV | Battery end of discharge voltage |
| BTMXCHC | Battery maximum charging current |
| BTMXDCC | Battery maximum discharging current |
| BTULCHV | Battery upper limits charging voltage |
| PDUVOR | Power Delivery Unit (PDU) voltage operating range |
| PDUCOR | PDU current operating range |
| PDUWTOR | PDU wattage operating range |
| PDUTCTOF | PDU temperature cut-off (if applicable) |
| AIRFLRT | Airflow rate |
| PDUCRCOF | PDU current cut-off (if applicable) |
| INHAERT | Inhaled aerosol temperature |
| VENTLTN | Ventilation |
| ELQDVISC | E-Liquid viscosity |
| ELQDVOL | E-liquid volume |
| PNUMCNC | Particle number concentration |
| CTMDDIAM | Count median diameter |
| PM | PM 2.5 |
|
|
|
Expand |
---|
title | Pipe Tobacco Products |
---|
|
Expand |
---|
title | Pipe Tobacco Product Identifiers and Descriptors |
---|
| TOTESTCD | TOTEST | TOSTRESC* | Description |
---|
TBPRDCAT | Tobacco Product Category | Pipe Tobacco Products |
| TBPRSCAT | Tobacco Product Subcategory | |
| TBPRSCAT | Tobacco Product Subcategory | Pipe Tobacco Filler |
| TBPRSCAT | Tobacco Product Subcategory | Pipe Tobacco Component |
| MANUF | Manufacturer | -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | TRADENAM | Trade Name | -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | PACKTYP | Package Type |
|
| PRDQUAN | Product Quantity |
|
| LENGTH | Length |
|
| DIAMETER | Diameter |
|
| CHARFLAV | Characterizing Flavor |
|
| TBCUTSTL | Tobacco Cut Style |
|
|
*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.
|
Expand |
---|
title | Pipe Tobacco Products Design Parameters and Conformance Testing |
---|
| Since the conformance testing of the design parameters and the design parameters themselves speak to the same concepts, they use the same terminology
DPTESTCD /TTESTCD | DPTEST/TTTEST | Description |
---|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expand |
---|
title | Waterpipe Tobacco Products |
---|
|
Expand |
---|
title | Waterpipe Tobacco Product Identifiers and Descriptors |
---|
| TOTESTCD | TOTEST | TOSTRESC* | Description |
---|
TBPRDCAT | Tobacco Product Category | Waterpipe Tobacco Product |
| TBPRSCAT | Tobacco Product Subcategory | |
| TBPRSCAT | Tobacco Product Subcategory | Waterpipe Filler |
| TBPRSCAT | Tobacco Product Subcategory | Waterpipe Heat Source |
| TBPRSCAT | Tobacco Product Subcategory | Waterpipe Component |
| MANUF | Manufacturer | -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | TRADENAM | Trade Name | -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | PACKTYP | Package Type |
|
| PRDQUAN | Product Quantity |
|
| PORTLGTH | Portion Length |
|
|
| Portion Width |
|
|
| Portion Mass |
|
|
| Portion Thickness |
|
|
| Number of Hoses |
|
|
| Source(s) of Energy |
|
| CHARFLAV | Characterizing Flavor |
|
|
*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column. |
Expand |
---|
title | Waterpipe Tobacco Product Design Parameters and Conformance Testing |
---|
| Since the conformance testing of the design parameters and the design parameters themselves speak to the same concepts, they use the same terminology
DPTESTCD /TTESTCD | DPTEST/TTTEST | Description |
---|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expand |
---|
title | Heated Tobacco Products |
---|
|
Expand |
---|
title | Heated Tobacco Product Identifiers and Descriptors |
---|
| TOTESTCD | TOTEST | TOSTRESC* | Description |
---|
TBPRDCAT | Tobacco Product Category | Heated Tobacco Products |
| TBPRSCAT | Tobacco Product Subcategory | |
| TBPRSCAT | Tobacco Product Subcategory | Open Htp |
| TBPRSCAT | Tobacco Product Subcategory | Htp Consumable |
| TBPRSCAT | Tobacco Product Subcategory | Htp Component |
| MANUF | Manufacturer | -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | TRADENAM | Trade Name | -- | TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name | PACKTYP | Package Type |
|
| PRDQUAN | Product Quantity |
|
| LENGTH | Length |
|
| DIAMETER | Diameter |
|
| WATT | Wattage |
|
| BATTCAP | Battery Capacity |
|
| CHARFLAV | Characterizing Flavor |
|
| VENTLTN | Ventilation |
|
|
*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.
|
Expand |
---|
title | Heated Tobacco Products Design Parameters and Conformance Testing |
---|
| Since the conformance testing of the design parameters and the design parameters themselves speak to the same concepts, they use the same terminology. The DPCAT variable provides the category or target of the Heated Tobacco Product the tests where the tests are administered.
DPTESTCD /TTESTCD | DPTEST/TTTEST | DPCAT | Description |
---|
MASS | Mass | Overall Product |
| LENGTH | Length | Overall Product |
| HEIGHT | Height | Overall Product |
| DIAMETER | Diameter | Overall Product |
| DRWRST | Draw Resistance | Overall Product |
| PUFCNT | Puff count (for full tank/cartridge) | Overall Product |
| PUFVOL | Puff volume | Overall Product |
| AIRFLRT | Airflow rate | Overall Product |
| VENTLTN | Ventilation | Overall Product |
| OPTEMP | Operational Temperature | Overall Product |
| TMPSENSR | Temperature sensor | Overall Product |
|
| Material wrapper length | Overall Product |
|
| Material wrapper width | Overall Product |
|
| Material basis weight | Overall Product |
|
| Material porosity | Overall Product |
|
| Heating element source/type/approach | Heating Element | Examples: electrical, carbon, aerosol, etc. |
| Heating element temperature range | Heating Element |
|
| Heating element operational temperature | Heating Element |
|
| Heating element maximum temperature | Heating Element |
|
| Heating element material | Heating Element |
|
| Heating element configuration | Heating Element |
|
| Heating element length | Heating Element |
|
| Heating element mass | Heating Element |
|
| Heating element location | Heating Element |
|
|
|
|
|
|
|
References:
- https://www.iso.org/obp/ui/#iso:std:iso:9512:ed-3:v1:en
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6059254/