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The examples in this section illustrate how to use CDISC standards to represent various aspects of the identification, descriptive characteristics, product design, and testing of tobacco products that occur separately from product testing in human subjects.  These examples include:

• How to represent identifying and descriptive characteristics using the Tobacco Product Identifiers and Descriptors (TO) dataset
• How to represent product design parameter specifications and testing for conformance to those specifications using the Product Design Parameters (PD) and Product Testing (PT) domains.
• How to represent and quantify tobacco ingredients, non-tobacco ingredients, and additives using the Tobacco Ingredients (IT), Non-Tobacco Ingredients (IN) and Ingredients Quantified by Component (IQ) domains.
• How to represent tobacco product testing for HPHCs in the PT domain
• How to represent stability study data data in the PT domain
• How to represent...

Discuss SPTOBID, PTCAT? term “tobacco product” means any product made or derived from tobacco that is intended for human consumption. (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1140.3). As of April 14, 2022, products containing non-tobacco nicotine (NTN)—that is, nicotine not made or derived from tobacco, such as synthetic nicotine must ensure compliance with applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). (https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14)Descriptions of tobacco products are key aspects of tobacco research which is used to as it is necessary to assess how the product will affect individual and public health. Tobacco products may be characterized by their ingredients, additives, and constituents, design, and stability. 

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