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This example illustrates 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. 

   The IT example shows tobacco filler and the types of tobacco of which it is composed, each listed as tobacco ingredients in the variable IGDCMPID (ingredient or component identifier) for the tobacco product CIG01A (SPTOBID). The variable ITSPECIF shows the specification/variety of the first 3 tobaccos. ITIGDPLX (Ingredient Complexity) is used to indicate that the tobacco filler and the reconstituted tobacco are complex ingredients (i.e., have 2 or more subcomponents). The details of which single tobacco ingredients compose these complex ingredients is made explicit in the IQ dataset example. ITCURMTH indicates the cure method. ITCIGIND (applicant-customized ingredient indicator) is used to indicate whether complex ingredients were made to the applicant's specification. TPMF indicates the Tobacco Product Master File name/number, which should be provided in the data if the component manufacturer has made it available.
Note that there are 2 varieties of burley tobacco in this tobacco product; each is given a unique IGDCMPID value (Burley Tobacco and Burley Tobacco 2).

Dataset wrap
NameILit
Dataset2
Row 

Row

DOMAIN

STUDYIDSPTOBID
STRFID
IGDCMPID
IUPACNAM
TPMF
TOBACCO TYPE
ITSPECIF
CASNO
ITIGDPLX
ILCAT
ITCURMTH
ILSPEC
ITCIGIND
ILGRADEILPURTYILMETHODILCMPLXILMANUFILMANUFNILSPFLTOBTMRFIL
1ITTOB07CIG01ATobacco
Blend
Filler
TOBACCO PRODUCTComplex SubstanceCIGAR MANU A Y1


COMPLEX INGREDIENT

2IT
IL
TOB07CIG01A
 Tobacco   
Burley Tobacco
Burle

8037-19-2

MF5555555NC 7LCSINGLE INGREDIENT
TOBACCO PRODUCT
Air
NC 7LCSingle Substance2IL

3ITTOB07CIG01ABright Tobacco
Bright

8037-19-2


CC 1063SINGLE INGREDIENT
TOBACCO PRODUCT
Flue
CC 1063Single Substance3IL

4ITTOB07CIG01AOriental Tobacco
Orienta
8037-19-2TOBACCO PRODUCTSun

USDA Nicotiana Collection PI 552747SINGLE INGREDIENT
Single Substance
Sun
4

5
IL
ITTOB07CIG01AReconstituted Tobacco
?????TOBACCO PRODUCTSingle Substance


COMPLEX INGREDIENT
N
6IT
5IL
TOB07CIG01A
Bright
Burley Tobacco
8037-19-
2
TOBACCO PRODUCT

KT215LC
Flue
SINGLE INGREDIENT
CC 1063Single Substance6ILTOB07CIG01AOriental Tobacco8037-19-2TOBACCO PRODUCTSunUSDA Nicotiana Collection PI 552747Single Substance7ILTOB07CIG01ABurley Tobacco8037-19-2TOBACCO PRODUCTAirNC 7LCSingle Substance8IL
Air

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 IGDCMPID. Where applicable, IUPAC name and CAS number are listed (IUPACNAM and CASNO variables, respectively). INIGDPLX is used to indicate whether an ingredient is a single ingredient or a complex ingredient. INCIGIND  indicates whether complex ingredients were made to the applicant's specification. Grade, purity, manufacturer name, ingredient unique item number, and the Tobacco Product Master File number complete the dataset.

Dataset wrap
NameIN
Complex Substance Purchased 
Dataset2
RowDOMAINSTUDYIDSPTOBIDIGDCMPIDINMANUFINMANUINTPMFIUPACNAMCASNOUNIIINIGDPLXINCIGINDINGRADEINPURTY
1INTOB07CIG01ACocoa Extract
NON TOBACCO PRODUCT
Flavor House AFLVR1234MF5555555


COMPLEX INGREDIENT
No
N
MF5555555
FOOD
9

2
IL
INTOB07CIG01AButyric Acid


butanoic acid107-92-6
NON TOBACCO PRODUCT

SINGLE INGREDIENT
USP≥99%
Single Substance10
3IN
IL
TOB07CIG01ACellulose Filter A
-NON TOBACCO PRODUCTComplex Substance Purchased MFR AFIL789No11
MFR AFIL789

-
COMPLEX INGREDIENTNUSP
4IN
IL
TOB07CIG01ACellulose Acetate


cellulose acetate9004-35-
7 NON TOBACCO PRODUCTSingle Substance
7
SINGLE INGREDIENT

99%
5IN
12IL
TOB07CIG01ATriacetin


1,3-diacetyloxypropan-2-yl acetate102-76-
1 
1
SINGLE INGREDIENT
USP
6IN
NON TOBACCO PRODUCTSingle Substance13IL
TOB07CIG01AFSC Paper B
NON TOBACCO PRODUCTComplex Substance Purchased 
MFR BFSC123MF5678910


COMPLEX INGREDIENT
No
N
14


7
IL
INTOB07CIG01ACellulose Pulp


cellulose pulp65996-61-
4 NON TOBACCO PRODUCTSingle Substance15
4
SINGLE INGREDIENT

≥99%
8IN
IL
TOB07CIG01ACalcium Carbonate


calcium carbonate471-34-
1 NON TOBACCO PRODUCTSingle Substance
1
SINGLE INGREDIENT
USP
9IN
16IL
TOB07CIG01ASodium Alginate


sodium;3,4,5,6-tetrahydroxyoxane-2-carboxylate9005-38-3
NON TOBACCO PRODUCTSingle Substance17

SINGLE INGREDIENT
FOOD
10IN
IL
TOB07CIG01ATrisodium Citrate


trisodium;2-hydroxypropane-1,2,3-tricarboxylate6132-04-3
NON TOBACCO PRODUCTSingle Substance18

SINGLE INGREDIENT

≥98%
11IN
IL
TOB07CIG01ACationic Starch


starch, 2-hydroxy-3-(trimethylammonio)propyl ether, chloride56780-58-
6 
6
SINGLE INGREDIENT
FOOD
12IN
NON TOBACCO PRODUCTSingle Substance19IL
TOB07CIG01ASeam Adhesive
-NON TOBACCO PRODUCT
Complex Substance Purchased 
MFR CADV123
NoMF234567820
MF2345678


COMPLEX INGREDIENTN

13IN
IL
TOB07CIG01AMethylcellulose
(5R)-2,3,4-trimethoxy-6-(methoxymethyl)-5-[(2S)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxyoxane




9004-67-5
NON TOBACCO PRODUCTSingle Substance

SINGLE INGREDIENT
FOOD
14IN
21IL
TOB07CIG01A1,3-Butanediol
4,4,4-trifluoro-2-methyl-1-phenyl-3-(trifluoromethyl)butane-1



Butane-1,3-diol34844-08-1
NON TOBACCO PRODUCTSingle Substance

. 

This example represents the target and max and minimum quanity of each unique ingredients in each compoment of  a tobacco product.  STRFID must be represented using the identical value defined by the sponosr in the Ingredient (IL) domain.  IQUNIT is the unot assoicated with the target, min, and max.      


SINGLE INGREDIENT
USP≥99%

Finally, the IQ domain is used to represent the quantity (target, minimum, and maximum) of each ingredient identified in IGDCMPID 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. Note: Ingredients that appear in more than 1 component of the tobacco product are quantified separately for each component. IQPARENT identifies a component or complex ingredient composed of the subcomponents/ingredients shown in IDGCMPID. IQLEVEL is used to identify at what level in the overall hierarchy that subcomponent/ingredient appears.

The following implementation rules apply, as described in more detail in Section 2.8.8.6, SDTM Ingredient Quantities by Component (IQ), Assumptions:

  • IQPARENT must correspond to a value of IGDCMPID in the same dataset. If parent is null, the ingredient is considered a top-level component and is assigned an IQLEVEL value of "1".
  • Records describing subcomponents/ingredients that compose a parent component listed in the dataset will have IQPARENT value equal to the IGDCMPID of that parent component. IQLEVEL will be set to n +1, where n = the parent record's value of IQLEVEL
  • Every value of IGDCMPID used in the IQ dataset must have a matching value of IGDCMPID:
    • In the IT dataset (when IQCAT=TOBACCO INGREDIENT), or
    • In the IN dataset (when IQCAT=NON-TOBACCO INGREDIENT)

Therefore, IQCAT is required to relate ingredient quantity records in IQ to the associated ingredient attributes described in either IT or IN.

The use of IQPARENT and IQLEVEL help make explicit the relationship between complex ingredients or components and the subcomponents/ingredients of which they are composed, and can assist when totaling the quantities of an ingredient that appears in multiple components of a tobacco product.
 
This concept map illustrates the representation of the hierarchical relationships between a component and its subcomponents/ingredients in the IQ domain structure. 

Excerpt Include
Concept Map. Relationships of Components, Subcomponents and Ingredients in IQ
Concept Map. Relationships of Components, Subcomponents and Ingredients in IQ

The IQ dataset example illustrates these principles, using a cigarette tobacco product:

Dataset wrap
NameIQ
Rowcaps
Rows 1, 13, 16:Show 3 top-level components of a cigarette product: tobacco filler, filter, and cigarette paper, respectively. Their target, minimum, and maximum quantities expressed in units of mg/cigarette are shown in IQVALTRG, IQVALMIN, IQVALMAX and IQUNIT. Because there is no parent component other than the finished product itself, IQPARENT is null, and IQLEVEL=1, indicating that these are top-level ingredients/components of the finished product.
Rows 2-5:Show the quantities of 4 types of tobacco used in the product. IQPARENT=Tobacco Filler and IQLEVEL=2, together indicating that these are subcomponents/ingredients in the tobacco filler, a top level-component of the cigarette product.
Rows 6-8:Show the 3 tobacco ingredients that compose reconstituted tobacco in row 5 (IQPARENT=Reconstituted Tobacco). The quantities of these tobaccos pertain to the quantity at which they appear in the reconstituted tobacco ONLY. IQLEVEL=3 to show that these ingredients are at the third level of the hierarchy (subcomponents/ingredients in Reconstituted Tobacco, which has IQLEVEL=2). Therefore, the total quantity of the individual tobaccos used in this tobacco product is the sum of these 3 rows plus the sum of the quantities shown in rows 2-4. 
Rows 9-10:Show the quantities of 2 non-tobacco ingredients, methylcellulose and 1,3-butanediol, which are further subcomponents/ingredients in Reconstituted Tobacco, as indicated by IQPARENT. IQFUNCT shows that methylcellulose functions as a binder and 1,3-butanediol functions as a humectant. IQLEVEL=3 to show that these ingredients are at the third level of the hierarchy.
Rows 11-12:Show the quantities of 2 subcomponents/ingredients that both function as a flavorant in the tobacco filler (as indicated by IQFUNCT= Flavor and IQPARENT=Tobacco Filler).
Rows 14-15:Show the quantities of 2 subcomponents/ingredients that function as filtration and plasticizer, respectively, in the filter portion of the cigarette (cellulose filter A, a top-level component shown in row 13).
Rows 17-22:Show the quantities and functions of 6 subcomponents/ingredients in the top-level component FSC paper B (the cigarette paper shown in row 16).
Dataset2
RowDOMAINSTUDYIDSPTOBIDIGDCMPID
Dataset wrap
NameIQ
STRFID 
Dataset2
RowDOMAINSTUDYID SPTOBID 
IQCATIQPARENTIQLEVELIQFUNCT
IQTARG
IQVALTRG
IGMIN
IQVALMIN
IQMAX 
IQVALMAX
IQUNIT 
IQUNIT
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
6IQTOB07CIG01ABurley Tobacco 2TOBACCO INGREDIENTReconstituted Tobacco3
191820mg/cigarette
7IQTOB07CIG01ABright TobaccoTOBACCO INGREDIENTReconstituted Tobacco3
103101105mg/cigarette
8IQTOB07CIG01AOriental TobaccoTOBACCO INGREDIENTReconstituted Tobacco3
656367mg/cigarette
9IQTOB07CIG01AMethylcelluloseNON-TOBACCO INGREDIENTReconstituted Tobacco3Binder
20 
201921mg/cigarette
7
10IQTOB07CIG01A1,3-ButanediolNON-TOBACCO INGREDIENTReconstituted Tobacco3Humectant
24 
242325mg/cigarette
8
11IQTOB07CIG01ACocoa ExtractNON-TOBACCO INGREDIENTTobacco Filler2Flavor
7 
76.757.25mg/cigarette
9
12IQTOB07CIG01AButyric AcidNON-TOBACCO INGREDIENTTobacco Filler2Flavor0.
5 
50.550.45mg/cigarette
10
13IQTOB07CIG01ACellulose Filter ANON-TOBACCO INGREDIENT
1Filter
164 
164163165mg/cigarette
11
14IQTOB07CIG01ACellulose AcetateNON-TOBACCO INGREDIENTCellulose Filter A2Filtration
155 
155154156
 mg
mg/cigarette
12
15IQTOB07CIG01ATriacetinNON-TOBACCO INGREDIENTCellulose Filter A2Plasticizer
9 
9810mg/cigarette
13
16IQTOB07CIG01AFSC Paper BNON-TOBACCO INGREDIENT
1Cigarette Paper (Wrapper)
50 
504951mg/cigarette
14
17IQTOB07CIG01ACellulose PulpNON-TOBACCO INGREDIENTFSC Paper B2Fiber
30 
302931mg/cigarette
15
18IQTOB07CIG01ACalcium CarbonateNON-TOBACCO INGREDIENTFSC Paper B2Filler
15 
151416mg/cigarette
16
19IQTOB07CIG01ASodium AlginateNON-TOBACCO INGREDIENTFSC Paper B2Reduced ignition
propensity 
propensity
2 
21.752.25mg/cigarette
17
20IQTOB07CIG01ATrisodium CitrateNON-TOBACCO INGREDIENTFSC Paper B2Combustion Modifier0.
5 
50.450.55
 mg
mg/cigarette
18
21IQTOB07CIG01ACationic StarchNON-TOBACCO INGREDIENTFSC Paper B2Binder0.
5 
50.450.55
 mg
mg/cigarette
19
22IQTOB07CIG01ASeam AdhesiveNON-TOBACCO INGREDIENTFSC Paper B2Adhesive
2 
21.752.25mg/cigarette