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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?)

Dataset wrap
Nameit
Dataset2

Row

DOMAIN

STUDYIDSPTOBIDSTRFIDILSPECIFITSPECIFILCATITCATILCURMTHITCURMTHILSPFLITSPFLRTOBMF
1ITTOB07CIG01ABurley TobaccoNC 7LC
Air
MF5555555
2ITTOB07CIG01ABright TobaccoCC 1063
Flue

3ITTOB07CIG01AOriental TobaccoUSDA Nicotiana Collection PI 552747
Sun

4ITTOB07CIG01AReconstituted Tobacco
COMPLEX PURCHASED INGREDIENT
No

...

Dataset wrap
NameIQ
Dataset2
RowDOMAINSTUDYIDSPTOBIDSTRFIDIQCATIQPARENTIQLEVELIQFUNCTIQTARGIGMINIQMAXIQUNIT
1IQTOB07CIG01ATobacco FillerTOBACCO INGREDIENT
1
672.5661.3683.7mg/cigarette
2IQTOB07CIG01ABurley TobaccoTOBACCO INGREDIENTTobacco Filler2
191721mg/cigarette
3IQTOB07CIG01ABright TobaccoTOBACCO INGREDIENTTobacco Filler2
300295305mg/cigarette
4IQTOB07CIG01AOriental TobaccoTOBACCO INGREDIENTTobacco Filler2
115113117mg/cigarette
5IQTOB07CIG01AReconstituted TobaccoTOBACCO INGREDIENTTobacco Filler2
231229233mg/cigarette
6IQTOB07CIG01AMethylcelluloseNON-TOBACCO INGREDIENTReconstituted Tobacco3Binder201921mg/cigarette
7IQTOB07CIG01A1,3-ButanediolNON-TOBACCO INGREDIENTReconstituted Tobacco3Humectant242325mg/cigarette
8IQTOB07CIG01ACocoa ExtractNON-TOBACCO INGREDIENTTobacco Filler2Flavor76.757.25mg/cigarette
9IQTOB07CIG01AButyric AcidNON-TOBACCO INGREDIENTTobacco Filler2Flavor0.50.550.45mg/cigarette
10IQTOB07CIG01ACellulose Filter ANON-TOBACCO INGREDIENT
1Filter164163165mg/cigarette
11IQTOB07CIG01ACellulose AcetateNON-TOBACCO INGREDIENTCellulose Filter A2Filtration155154156mg/cigarette
12IQTOB07CIG01ATriacetinNON-TOBACCO INGREDIENTCellulose Filter A2Plasticizer9810mg/cigarette
13IQTOB07CIG01AFSC Paper BNON-TOBACCO INGREDIENT
1Cigarette Paper (Wrapper)504951mg/cigarette
14IQTOB07CIG01ACellulose PulpNON-TOBACCO INGREDIENTFSC Paper B2Fiber302931mg/cigarette
15IQTOB07CIG01ACalcium CarbonateNON-TOBACCO INGREDIENTFSC Paper B2Filler151416mg/cigarette
16IQTOB07CIG01ASodium AlginateNON-TOBACCO INGREDIENTFSC Paper B2Reduced ignition propensity21.752.25mg/cigarette
17IQTOB07CIG01ATrisodium CitrateNON-TOBACCO INGREDIENTFSC Paper B2Combustion Modifier0.50.450.55mg/cigarette
18IQTOB07CIG01ACationic StarchNON-TOBACCO INGREDIENTFSC Paper B2Binder0.50.450.55mg/cigarette
19IQTOB07CIG01ASeam AdhesiveNON-TOBACCO INGREDIENTFSC Paper B2Adhesive21.752.25mg/cigarette