Recommendations

1. Novel formulations and their associated active agents should be assessed for their toxicokinetics on a case-by-case basis.

2. The model systems used to assess alterations in toxicokinetics should consider species differences with respect to metabolism.

3. The effect of the feeding state (fed vs. fasted) is a key determinant of bioavailability and must be critically considered when comparing across different formulations.

4. The suitability of acceptable daily intakes (ADIs) and other health-based guidance values (HBGVs) for an unformulated supplement for characterising the risk from that supplement formulated to increase its bioavailability should always be considered.

5. There are a number of approaches that can be used to consider how HBGVs relate to differences in bioavailability, and these should be assessed and utilised on a case-by-case basis.