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Tobacco Product Identifiers and Descriptors (TO) is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. It is the origin of the sponsor-defined tobacco product identifier (SPTOBID). This identifier is additionally used in any dataset containing records that pertain to the product at all stages of the product development lifecycle, including nonclinical testing and testing in human subjects. See Tobacco Product Identifiers and Descriptors (TO) for a detailed description of this dataset.

The example below demonstrates how to identify both a new product and a predicate product. Subsequent examples in this guide focus only on NEW products in order to keep the tables concise and easier to review. In reality, many of the examples in this guide would contain data on both the new and predicate product, and the SPTOBID for both products would be used with every dataset on any record that pertains to the associated product.

This example illustrates TO concepts using a cigarette product and its predicate product for demonstration purposes. Section 3.1.2, Product Design Parameters and Conformance Testing, demonstrates this dataset for an ENDS product and a portioned snus product.

Rows 1-10:Show the identifying and descriptive parameters for a new product. Note that the category variable (TOCAT) is "NEW PRODUCT" for these records. The applicant chose to further subcategorize each parameter as either an identifying or descriptive parameter in the variable TOSCAT.
Rows 1-4:Show the records for the product identifiers for the tobacco product identified in SPTOBID.
Rows 11-21:Show the records for the product descriptors for a predicate tobacco product identified in SPTOBID. Note that the category variable (TOCAT) is "PREDICATE PRODUCT" for these records. The applicant chose to further subcategorize each parameter as either an identifying or descriptive parameter in the variable TOSCAT.
Row 13:

Shows the FDA submission tracking number (STN) associated with the predicate product. This parameter should be included for all products for which an FDA STN is available.

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RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOCATTOSCATTOVALTOVALU
1TOB07TOCIG01a

1

TBPRDCATTobacco Product CategoryNEW PRODUCTPRODUCT IDENTIFIERCigarettes
2TOB07TOCIG01a2TBPRSCATTobacco Product SubcategoryNEW PRODUCTPRODUCT IDENTIFIERFiltered
3TOB07TOCIG01a3MANUFManufacturerNEW PRODUCTPRODUCT IDENTIFIERJoes Cigs USA
4TOB07TOCIG01a4TRADENAMTrade NameNEW PRODUCTPRODUCT IDENTIFIERTreetop Menthol King Size
5TOB07TOCIG01a5PACKTYPPackage TypeNEW PRODUCTPRODUCT DESCRIPTORHARD PACK
6TOB07TOCIG01a6PRDQUANProduct QuantityNEW PRODUCTPRODUCT DESCRIPTOR20CIGARETTE
7TOB07TOCIG01a7LENGTHLengthNEW PRODUCTPRODUCT DESCRIPTOR86.0mm
8TOB07TOCIG01a8CIRCUMFCircumferenceNEW PRODUCTPRODUCT DESCRIPTOR26.0mm
9TOB07TOCIG01a9VENTLTOTTotal VentilationNEW PRODUCTPRODUCT DESCRIPTOR10.0%
10TOB07TOCIG01a10CHARFLAVCharacterizing FlavorNEW PRODUCTPRODUCT DESCRIPTORMENTHOL
11TOB07TOCIG064

1

TBPRDCATTobacco Product CategoryPREDICATE PRODUCTPRODUCT IDENTIFIERCigarette
12TOB07TOCIG0642TBPRSCATTobacco Product SubcategoryPREDICATE PRODUCTPRODUCT IDENTIFIERFiltered
13TOB07TOCIG0643FDASTNFDA Submission Tracking NumberPREDICATE PRODUCTPRODUCT IDENTIFIERSE0212345
14TOB07TOCIG0644MANUFManufacturerPREDICATE PRODUCTPRODUCT IDENTIFIERJoes Cigs USA
15TOB07TOCIG0645TRADENAMTrade NamePREDICATE PRODUCTPRODUCT IDENTIFIERTreetop Menthol King Size
16TOB07TOCIG0646PACKTYPPackage TypePREDICATE PRODUCTPRODUCT DESCRIPTORHARD PACK
17TOB07TOCIG0647PRDQUANProduct QuantityPREDICATE PRODUCTPRODUCT DESCRIPTOR20CIGARETTE
18TOB07TOCIG0648LENGTHLengthPREDICATE PRODUCTPRODUCT DESCRIPTOR86.5mm
19TOB07TOCIG0649CIRCUMFCircumferencePREDICATE PRODUCTPRODUCT DESCRIPTOR26.1mm
20TOB07TOCIG06410VENTLTOTTotal VentilationPREDICATE PRODUCTPRODUCT DESCRIPTOR12.0%
21TOB07TOCIG06411CHARFLAVCharacterizing FlavorPREDICATE PRODUCTPRODUCT DESCRIPTORMENTHOL
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