I think the FDA approval is being taken a bit too seriously, it's not drug approval and it's voluntary to undergo it for cosmetics, but it does mean that the FDA are accepting all the components aren't harmful essentially, which means once the formulation is right they won't get into any trouble.
I think the more important part is the upfront payments from the distributor and the fact they have distribution in California which in itself is the 7th or 8th Largest economy in the world (by GDP)!
Ann: Chairman's Update to Shareholders-MXC.AX, page-31
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