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Comment: Adapted and added from Steve's document CDISC TIG Product Description - potential considerations "Any changes of a product over time may affect the health risks of product use." Also added the "Measures of stability..."

Tobacco product stability is assessed to ensure products are as expected with regard to their properties, characteristics and constituents over the course of the product's shelf-life after manufacture.  Any changes of a product over time may affect the health risks of product use.

  • Finished product stability studies - most common. This may include aspects of:
    • raw materials stability studies - mention, but not focus
    • bulk e-liquid stability studies - mention,  but not focus


Measures of stability may include:

  • microbial stability
  • chemical stability
  • product component stability (i.e. battery)
  • container closure stability (i.e. leachability)
  • shelf life and storage