Toxicological risk assessment

The flavourings typically used in therapeutic vaping products are food-suitable extracts deemed ‘Generally Recognised As Safe’ (GRAS) by a relevant regulatory authority, such as the US FDA or the European Food Safety Authority. In Australia, food additives are regulated by the Australia New Zealand Food Standards Code.

It is critical to note that compounds recognised as GRAS have been assessed for ingestion, not inhalation.

To increase the quality of inhaled ingredients, these flavour ingredients should meet European Pharmacopoeia (Ph. Eur.) or United States Pharmacopoeia (USP) standards when available. Where those standards have not been established, the ingredients should meet Australian, European, or US food-grade standards.

In addition to meeting these Pharmacopeia quality standards, flavours can be formulated using molecularly defined ingredients – individual chemical constituents that are compounded into flavour concentrates. This approach allows each compound to be characterised at the molecular level for its physicochemical characteristics and potential toxicological hazards. These ingredients can then undergo a TRA to evaluate the potential health risks associated with inhalation exposure.

A TRA is a systematic process for identifying potential health hazards, determining the levels at which those hazards might occur (dose-response), and comparing those levels with the anticipated user exposure to quantify the health risk for critical health endpoints. TRAs must be carried out by suitably qualified professionals capable of evaluating an exposure’s potential local and systemic effects.

When seeking the current gold standard for aerosol safety, prescribed NVPs should be limited to those manufactured from molecularly defined ingredients and validated via a TRA.