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.