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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 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 device (tobacco) product. The primary purpose of this dataset is to provide a list of the devices (products) used in an application or study and to provide identifying information for each device (product), such as device (product category) type, manufacturer, properties, product name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Device Identifier (SPTOBID), a consistent variable, that is available for use in other domains where data pertaining to the device (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.
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Rows 1-4: | Show the records for a device given SPTOBID of the
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Rows 1-3: | Show the tobacco product is a Electronic Nicotine Delivery Systems (ENDS) Vape closed e-cigarette. | Rows 5-8: | Show the package type is a Box that contains 1 E-Cigarettes that is 107.2 mm long and 9.0 mm in diameter. | Rows 9-12: | Show the attributes or characteristics of the content of the e-liquid within the E-cigarette. | Rows 13-15: | Show the attributes or characteristics of the heating element for the E-cigarette . | Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOTESTCDTOPARMCD | TOTESTTOPARM | TOCAT | TOORRESTOSCAT | TOORRESUTOVAL | TOSTRESCTOVALU | TOSTRESN | TOSTRESU |
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1 | | 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 IDENTIFIER | Joes Smokeless | Joes Smokeless |
| 4 | TOB17 | TO | SNUS-77 | 4 | TRADENAM | Trade Name | NEW PRODUCT | PRODUCT IDENTIFIERHappy Dog Snus | Happy Dog Snus |
| 5 | TOB17 | TO | SNUS-77 | 5 | PACKTYP | Package Type | NEW PRODUCT | PRODUCT DESCRIPTOR | Plastic can and plastic lidPlastic can and plastic lidCan 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? |
| 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 | 13PRODUCT DESCRIPTOR | TOB17 | TO | SNUS-77 | 13 | Additional property | n/a |
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The Tobacco Design Parameters (DP) 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.
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.
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Rows 1-94: | Show the design parameter specification with target, minimum, and maximum value reflected in the DPCOLSRT variable. |
Rows 80-82: | Show the design parameter specification with the test condition of 20 degrees Celsius using the DPTSTCND variable. | Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | DPSEQPDSEQ | DPTESTCDPDPARMCD | DPTESTPDPARM | DPTSTCNDPDVALTRG | DPCATPDVALMIN | DPSCATPDVALMAX | DPORRES | DPORRESU | DPSTRESC | DPSTRESN | DPSTRESU | DPCOLSRT | PDVALU |
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1 | | DPPD | SNUS-77 | | TOCUTSIZ | Tobacco Cut Size or Tobacco Particle Size | DESIGN PARAMETER SPECIFICATION | mm or cuts per inch | | | | | TARGET | 2 | | DPPD | SNUS-77 | | 2TOPRTSIZ | Tobacco Cut Size or Tobacco Particle Size | DESIGN PARAMETER SPECIFICATION | mm or cuts per inch | MINIMUM | 3 | TOB17 | DP | SNUS-77 | 3 | Tobacco Cut Size or Tobacco Particle Size | DESIGN PARAMETER SPECIFICATION | mm or cuts per inch | MAXIMUM | | | | | 3 | TOB17 | PD | 4 | TOB17 | DP | SNUS-77 | 4 | Tobacco Moisture | DESIGN PARAMETER SPECIFICATION | % | TARGET | 5 | TOB17 | DP | SNUS-77 | 5 | Tobacco Moisture | DESIGN PARAMETER SPECIFICATION | % | MINIMUM | 6 | TOB17 | DP | SNUS-77 | 6 | Tobacco Moisture | DESIGN PARAMETER SPECIFICATION | % | MAXIMUM | 2 | TOMOISTR | Tobacco Moisture | 32.2 | 31 | 34 | % | 4 | TOB17 | PD | 7 | TOB17 | DP | SNUS-77 | 73 | Portion Length | DESIGN PARAMETER SPECIFICATION | mm | TARGET | 8 | TOB17 | DP | SNUS-77 | 8 | PRTLENG | Portion Length | DESIGN PARAMETER SPECIFICATION | mm | MINIMUM | 9 | TOB17 | DP | SNUS-77 | 9 | Portion Length | DESIGN PARAMETER SPECIFICATION | 38 | 36.5 | 39.5 | mm | 5 | TOB17 | PD | mm | MAXIMUM | 10 | TOB17 | DP | SNUS-77 | 10 | Portion Width | DESIGN PARAMETER SPECIFICATION | mm | TARGET | 11 | TOB17 | DP | SNUS-77 | 11 | 4 | PRTWDTH | Portion Width | DESIGN PARAMETER SPECIFICATION16 | mm | MINIMUM | 12 | TOB17 | DP | SNUS-77 | 12 | Portion Width | DESIGN PARAMETER SPECIFICATION | mm | 15 | 17 | mm | 6 | MAXIMUM | 13 | TOB17 | DPPD | SNUS-77 | 13 | Portion Mass | DESIGN PARAMETER SPECIFICATION | mg | TARGET | 14 | TOB17 | DP | SNUS-77 | 14 | 5 | PRTMASS | Portion Mass | DESIGN PARAMETER SPECIFICATION1000 | mg900 | MINIMUM | 15 | TOB17 | DP | SNUS-77 | 15 | Portion Mass | DESIGN PARAMETER SPECIFICATION | mg | MAXIMUM | MINIMUM | 1100 | mg | 716 | TOB17 | DPPD | SNUS-77 | 16 | Portion (pouch) material thickness (if applicable) | DESIGN PARAMETER SPECIFICATION | mm | TARGET | MAXIMUM | 17 | TOB17 | DP | SNUS-77 | 17 | Portion (pouch) material thickness (if applicable) | DESIGN PARAMETER SPECIFICATION | mm | MINIMUM | TARGET | 18 | TOB17 | DP | SNUS-77 | 18 | Portion (pouch) material thickness (if applicable) | DESIGN PARAMETER SPECIFICATION | mm | MAXIMUM | MINIMUM | 6 | PRTTHICK | Portion Material Thickness | 0.06 | 0.055 | 0.065 | mm | 8 | TOB17 | PD | 19 | TOB17 | DP | SNUS-77 | 19 | Pouch material basis weight (if applicable) | DESIGN PARAMETER SPECIFICATION | g/m^2 | TARGET | MAXIMUM | 20 | TOB17 | DP | SNUS-77 | 20 | Pouch material basis weight (if applicable) | DESIGN PARAMETER SPECIFICATION | g/m^2 | MINIMUM | TARGET | 21 | TOB17 | DP | SNUS-77 | 21 | Pouch material basis weight (if applicable) | DESIGN PARAMETER SPECIFICATION | g/m^2 | MAXIMUM | MINIMUM | 7 | PRTMWGT | Pouch Material Basis Weight | 16 | 15 | 17 | g/m2 | 9 | TOB17 | PD | 22 | TOB17 | DP | SNUS-77 | 22 | Pouch material porosity (permeability) (if applicable) | DESIGN PARAMETER SPECIFICATION | CORESTA Unit (Cu) or L/m^2/s | TARGET | MAXIMUM | 23 | TOB17 | DP | SNUS-77 | 23 | Pouch material porosity (permeability) (if applicable) | DESIGN PARAMETER SPECIFICATION | CORESTA Unit (Cu) or L/m^2/s | MINIMUM | TARGET | 24 | TOB17 | DP | SNUS-77 | 24 | Pouch material porosity (permeability) (if applicable) | DESIGN PARAMETER SPECIFICATION | CORESTA Unit (Cu) or L/m^2/s | MAXIMUM | MINIMUM | 8 | PRTMPOR | Pouch Material Porosity | 1850 | 1600 | 2200 | L/m2/s | 10 | TOB17 | PD | 25 | TOB17 | DP | SNUS-77 | 25 | Nicotine dissolution rate | DESIGN PARAMETER SPECIFICATION | %/min | TARGET | MAXIMUM | 26 | TOB17 | DP | SNUS-77 | 26 | Nicotine dissolution rate | DESIGN PARAMETER SPECIFICATION | %/min | MINIMUM | TARGET | 27 | TOB17 | DP | SNUS-77 | 27 | Nicotine dissolution rate | DESIGN PARAMETER SPECIFICATION | %/min | MAXIMUM | MINIMUM | 9 | NICTDSRT | Nicotine Dissolution Rate | 15 | 5 | 22 | %/min |
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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 rowsThe Tobacco Product Testing (TT) (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 (??? DP dataset).
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Rows 1-32: | Show the tobacco design parameter specification test and the result in ORRES (needs populated).
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Row 28: | Shows the design parameter specification test condition of 20 degrees Celsius using the TTTSTCND variable for the E-Liquid Viscosity test. | Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | TTSEQPTSEQ | TTREFIDPTTESTCD | TTTESTCDPTTEST | TTTESTPTCAT | TTTSTCNDPTORRES | TTCATPTORRESU | TTSCATPTSTRESC | TTORRESPTSTRESN | TTORRESU | TTSTRESC | TTSTRESN | TTSTRESUPTSTRESU | PTREPNUM |
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1 | TOB17 | TTPT | SNUS-77 | 1 | TOCUTSIZ | Tobacco Cut Size | DESIGN PARAMETER TESTING | | cuts per inch | | | cuts/in | 1 | 2 | TOB17 | PT | SNUS-77 | 1 | TOPRTSIZ | or Tobacco Particle Size | DESIGN PARAMETER SPECIFICATION TEST RESULT | mm or cuts per inch | TESTING | | mm | | | mm | 1 | 32 | TOB17 | TTPT | SNUS-77 | 2 | TOMOISTR | Tobacco Moisture | DESIGN PARAMETER SPECIFICATION TEST RESULT | % | TESTING | 31.8 | % | 31.8 | 31.8 | % | 1 | 43 | TOB17 | TTPT | SNUS-77 | 3 | PRTMASS | Portion Mass | DESIGN PARAMETER SPECIFICATION TEST RESULTTESTING | 998 | mg | 998 | 998 | mg | 1 | 54 | TOB17 | TTPT | SNUS-77 | 4 | Pouch material basis weight | DESIGN PARAMETER SPECIFICATION TEST RESULT | g/m^2 | 5 | PRTMWGT | Pouch Material Basis Weight | DESIGN PARAMETER TESTING | 15.3 | g/m2 | 15.3 | 15.3 | g/m2 | 1 | 6 | TOB17 | PT | TOB17 | TT | SNUS-77 | 5 | Pouch material porosity (permeability) | DESIGN PARAMETER SPECIFICATION TEST RESULT | CORESTA Unit (Cu) or L/m^2/s | PRTMPOR | Pouch Material Porosity | DESIGN PARAMETER TESTING | 1900 | L/m2/s | 1900 | 1900 | L/m2/s | 1 | 7 | TOB17 | PT | 6 | TOB17 | TT | SNUS-77 | 6 | NICTDSRT | Nicotine dissolution rateDissolution Rate | DESIGN PARAMETER SPECIFICATION TEST RESULTTESTING | 18 | %/min | 18 | 18 | %/min | 1 |
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