This example illustrates The following examples illustrate how the list of ingredients of a tobacco product would be represented . The unique tobacco product substances interest would be assigned a STRFID identifier in the (IL) Ingredient List domain. The SPTOBID identifier is included in this IL domain to identify the tobacco product to which these ingredient data pertain. INCAT is used to differentiate the different categories of ingredient. INSCAT may be used to further differentiates sub categorize these ingredients. INCAT/INSCAT categories would be detemined by the sponosr and typically depend on the type of tobacco product being described. STRFID indicates the Reference ID assigned to the substance/ingredient by the sponosr. Each ingredient/substance record must be unique. Hence, the mu In this example the FDA UNII number was used. This was used since not all ingredients have a CAS Number, but usually have have UNII numbers. The information on what dictionary/code list was associated with STRID is provided in the define.xml that is submitted with the data. For example,. The same Iingredient from different manufacturers would be listed on separate lines. 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?)
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| | STUDYID | SPTOBID | STRFID | ILSPECIFITSPECIF | ILCATITCAT | ILCURMTHITCURMTH | ILSPFLITSPFL | RTOBMF |
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1 | IT | TOB07 | CIG01A | Burley Tobacco | NC 7LC |
| Air |
| MF5555555 |
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2 | IT | TOB07 | CIG01A | Bright Tobacco | CC 1063 |
| Flue |
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3 | IT | TOB07 | CIG01A | Oriental Tobacco | USDA Nicotiana Collection PI 552747 |
| Sun |
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4 | IT | TOB07 | CIG01A | Reconstituted Tobacco |
| COMPLEX PURCHASED INGREDIENT |
| No |
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Row | DOMAIN | STUDYID | SPTOBID | STRFID | IQCAT | IQPARENT | IQLEVEL | IQFUNCT | IQTARG | IGMIN | IQMAX | IQUNIT |
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1 | IQ | TOB07 | CIG01A | Tobacco Filler | TOBACCO INGREDIENT |
| 1 |
| 672.5 | 661.3 | 683.7 | mg/cigarette | 2 | IQ | TOB07 | CIG01A | Burley Tobacco | TOBACCO INGREDIENT | Tobacco Filler | 2 |
| 19 | 17 | 21 | mg/cigarette | 3 | IQ | TOB07 | CIG01A | Bright Tobacco | TOBACCO INGREDIENT | Tobacco Filler | 2 |
| 300 | 295 | 305 | mg/cigarette | 4 | IQ | TOB07 | CIG01A | Oriental Tobacco | TOBACCO INGREDIENT | Tobacco Filler | 2 |
| 115 | 113 | 117 | mg/cigarette | 5 | IQ | TOB07 | CIG01A | Reconstituted Tobacco | TOBACCO INGREDIENT | Tobacco Filler | 2 |
| 231 | 229 | 233 | mg/cigarette | 6 | IQ | TOB07 | CIG01A | Methylcellulose | NON-TOBACCO INGREDIENT | Reconstituted Tobacco | 3 | Binder | 20 | 19 | 21 | mg/cigarette | 7 | IQ | TOB07 | CIG01A | 1,3-Butanediol | NON-TOBACCO INGREDIENT | Reconstituted Tobacco | 3 | Humectant | 24 | 23 | 25 | mg/cigarette | 8 | IQ | TOB07 | CIG01A | Cocoa Extract | NON-TOBACCO INGREDIENT | Tobacco Filler | 2 | Flavor | 7 | 6.75 | 7.25 | mg/cigarette | 9 | IQ | TOB07 | CIG01A | Butyric Acid | NON-TOBACCO INGREDIENT | Tobacco Filler | 2 | Flavor | 0.5 | 0.55 | 0.45 | mg/cigarette | 10 | IQ | TOB07 | CIG01A | Cellulose Filter A | NON-TOBACCO INGREDIENT |
| 1 | Filter | 164 | 163 | 165 | mg/cigarette | 11 | IQ | TOB07 | CIG01A | Cellulose Acetate | NON-TOBACCO INGREDIENT | Cellulose Filter A | 2 | Filtration | 155 | 154 | 156 | mg/cigarette | 12 | IQ | TOB07 | CIG01A | Triacetin | NON-TOBACCO INGREDIENT | Cellulose Filter A | 2 | Plasticizer | 9 | 8 | 10 | mg/cigarette | 13 | IQ | TOB07 | CIG01A | FSC Paper B | NON-TOBACCO INGREDIENT |
| 1 | Cigarette Paper (Wrapper) | 50 | 49 | 51 | mg/cigarette | 14 | IQ | TOB07 | CIG01A | Cellulose Pulp | NON-TOBACCO INGREDIENT | FSC Paper B | 2 | Fiber | 30 | 29 | 31 | mg/cigarette | 15 | IQ | TOB07 | CIG01A | Calcium Carbonate | NON-TOBACCO INGREDIENT | FSC Paper B | 2 | Filler | 15 | 14 | 16 | mg/cigarette | 16 | IQ | TOB07 | CIG01A | Sodium Alginate | NON-TOBACCO INGREDIENT | FSC Paper B | 2 | Reduced ignition propensity | 2 | 1.75 | 2.25 | mg/cigarette | 17 | IQ | TOB07 | CIG01A | Trisodium Citrate | NON-TOBACCO INGREDIENT | FSC Paper B | 2 | Combustion Modifier | 0.5 | 0.45 | 0.55 | mg/cigarette | 18 | IQ | TOB07 | CIG01A | Cationic Starch | NON-TOBACCO INGREDIENT | FSC Paper B | 2 | Binder | 0.5 | 0.45 | 0.55 | mg/cigarette | 19 | IQ | TOB07 | CIG01A | Seam Adhesive | NON-TOBACCO INGREDIENT | FSC Paper B | 2 | Adhesive | 2 | 1.75 | 2.25 | mg/cigarette |
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