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• Tobacco Ingredients (IT) is used for listing the tobacco ingredients and their attributes within the tobacco product under study.
• Non-tobacco Ingredients (IN) is used for listing other ingredients and additives and their attributes as used in the tobacco product under study.
• Ingredients Quantified (IQ) is used for representing the quantity of each ingredient (both tobacco and non-tobacco) by component of the tobacco product in which they are included. These values represent the design/formulation specification of the product, not experimentally determined values (as the latter would be represented in the Product Testing (PT) dataset, not shown here). (see note 1 – need to confirm this is true)

All three datasets make use of the SPTOBID variable to represent the tobacco product under study, and the STRFID (Substance Reference Identifier) variable to represent the ingredient name. STRFID must be assigned by study sponsors to be unique with regard to the attributes that describe it. If, for instance, the same ingredient varies on one or more attribute (e.g., a different manufacturer supplied a compound that is used in one component of the product than the same ingredient used in another component), STRFID must be unique for each use to reflect this difference, even if they share the same IUPAC name and CAS number. 

The IT example below shows 4 types of tobacco listed as tobacco ingredients (STRFID) for the Tobacco Product CIG01A (SPTOBID). The variable ITSPECIF shows the specification (variety) of the first three tobaccos. ITCAT is used to indicate that Reconstituted Tobacco is a complex, purchased ingredient. ITCURMTH indicates the cure method. ITSPFL is used to indicate whether complex purchased ingredients were made to the applicants specification. RTOBMF indicates the reference tobacco master file (See note 12)

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Finally, the IQ domain is used to represent the quantity (target, minimum and maximum) of each ingredient identified in STRFID that the product (SPTOBID) is designed to contain, with the units for these values represented in IQUNIT. The function of each ingredient is described in IQFUNCT. Ingredients that appear in more than one component of the tobacco product are quantified separately for each component. (see note 23) IQPARENT and IQLEVEL are used to identify the component to which the record applies and and at which level in the overall hierarchy the ingredient appears, with the following implementation rules:

• IQPARENT must correspond to a value of STRFID in the same dataset. If parent is null, the ingredient is considered a top-level component and is assigned a value of "1" in IQLEVEL.
• Records describing ingredients that are constituent ingredients of another ingredient/component listed in the dataset will have IQPARENT set equal to the STRFID of that ingredient/component. IQLEVEL will be set to n +1, where n=the parent record's value of IQLEVEL.
• Every value of STRFID used in this dataset that has an IQLEVEL >1 (See note 34) must have a matching value of STRFID in either:
  • The IT dataset (when IQCAT=TOBACCO INGREDIENT) or,
  • The IN dataset (when IQCAT=NON-TOBACCO INGREDIENT)

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