The following examples illustrate how the list of ingredients of a tobacco product would be represented and quantified using three datasets:
- Tobacco Ingredients (IT) is used for listing the tobacco types 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,
- Quantified Ingredients (IQ) is used for representing the quantity of each ingredient by component of the tobacco product in which they are included. These values represent the design/formulation of the product, not experimentally determined values (as the latter would be represented in the Product Testing (TP) dataset, not shown here).
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 (what is this? why does only one row have this info?)
The IN dataset example shows the list of non-tobacco ingredients used in the tobacco product identified as CIG01A. Each unique ingredient is listed in STRFID. Where applicable, IUPAC name and CAS number are listed (IUPACNAM and CASNO, respectively). INCAT is used to indicate whether an ingredient is a single chemical substance or a complex purchased ingredient. INSPFL indicates whether complex purchased ingredients were made to the applicant's specification. Grade, purity, manufacturer name and ID number, and the reference tobacco master file number complete the dataset.
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Finally, the IQ dataset example shows the quantity (target, minimum and maximum) of each ingredient listed in STRFID that the product (SPTOBID) is designed to contain, with the units for each of 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. (we need examples of this to illustrate. I created one but not sure how valid it is) 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:
- IQPARENT must correspond to a value of STRFID in the same table. 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 sub-components of another ingredient listed will have IQPARENT set to equal the STRFID of that ingredient. IQLEVEL will be set to n +1, where n=the parent record's value of IQLEVEL.
The concept map below illustrates the representation of the hierarchical relationships between a complex ingredient and its subcomponents in the IQ domain structure. The hypothetical parent ingredient has two constituent components, A and B. Additionally, B consists of two constituent components, B1 and B2. Therefore, there are a total of 5 ingredient records to be represented in the IQ domain: the parent ingredient, its two constituent components A and B, and B's two constituent components, B1 and B2.
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