- IN is a special purpose domain for listing the non-tobacco ingredients (only) for a tobacco product. Tobacco ingredients, such as individual tobacco varieties would not be represented in this domain (see IT domain specification and assumptions for more information on handling tobacco ingredients).
- IN is one of two domains (along with IT) that serve as the origin of the consistent identifier variable IGDCMPID (Ingredient or Component Identifier).
- IGDCMPID must represent a non-tobacco ingredient that is unique with regard to the attributes listed in assumption 3 below. If two or more sources of the same non-tobacco ingredient differ on any of these attributes, they must each be assigned a different value for IGDCMPID (e.g., 1,3-Butanediol A, 1,3-Butanediol B)
- IGDCMPID is used with the same values in the IQ domain where the ingredients identified by those values are quantified by component (See IQ domain specification and assumptions for more information).
- Additionally, IN contains variables for representing the following attributes:
- Manufacturer's name and registration number (INMANUF)
- Manufacturer's unique identifying item number for the ingredient or component (INMANUIN).
- Tobacco Product Master File number (TPMF)
- IUPAC name (IUPACNAM), CAS registry number (CASNO), and FDA Unique Ingredient Identifier (UNII), with the following requirements for inclusion in the IN dataset:
- IUPACNAM is an expected variable, and should be populated with the preferred IUPAC name for all ingredients for which an IUPAC name is available
- At least one of the two permissible variables CASNO or UNII should also be provided if available.
- The complexity of the ingredient (INIGDPLX), to differentiate between single ingredients and complex ingredients, and a separate indicator (INCIGIND) as to whether a complex ingredient was made to the applicant's specifications
- Ingredient grade (INGRADE) and purity (INPURITY). According to the PMTA rule, at least one of these two attributes must be included. If the data are proprietary and only available via the TPMF, then TPMF should be populated.
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