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This sub-section illustrates how to create CDISC-conformant datasets on:

  • testing for harmful and potentially harmful constituents (HPHC),
  • listing of tobacco and non-tobacco ingredients, and
  • quantifying tobacco and non-tobacco ingredients by component and stating their function within the product.

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.

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