Yes, I understand the issue of tainted product, of substituted product and of toxicity, and the need to regulate dietary, or food supplements. But sweeping dietary and food ingredients with a long history of known use, in the same legislative framework as these technologies:
new chemical entity – Compound never regulated or approved (not an active moiety).
new molecular entity - active moieties (biologically active) not previously approved
new active substance – new substance, or mixture of isomers which differ from previously authorised.
new biological entity – contains human or non-human cells, bacteria, viruses, and material derived from those cells or viruses. Can be modified or engineered (including gene-edited).
...is wrong. And from the start, Andrew Little’s Bill downplays the degree to which the safety and risk from new drugs & biologics remain profoundly uncertain. Iatrogenic injury from medical inventions and drugs is far more extensively documented than dietary and food supplements.
The Bill is so messy, so complex that there is not a clear line of sight to understand how and who is responsible, when something goes wrong.
Long read, but to be expected as this is not a simple topic.