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Tobacco products contain ingredients, additives, and constituents. Constituents may be inherent to the product or may be generated by product use. A subset of constituents are This sub-section illustrates how to create CDISC-conformant datasets on lists on testing for harmful and potentially harmful constituents (HPHC) which may cause direct and indirect harm to product users, listing of tobacco and non-tobacco ingredients, and quantifying tobacco and non-tobacco ingredients by component.

Ingredients refer to the components of parts of a tobacco product made or derived from tobacco, or are burned, aerosolized or ingested during tobacco product use. Additives refer to substances where intended use results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product Constituents refer to chemicals in the tobacco product or its smoke or aerosol. Other basic components of tobacco products, such as a cigarette filter, or ENDS battery, are characterized in the product design and performance sections.