NZ Marine Biotech ($20M MC - High Growth Prospect), page-7

The issue is, IF the company wants the benefits of "pharmaceutical" margins etc...it WILL need hard clinical trials and therefore the likes of FDA clearance to sell such products in major markets. Sooner or later [sooner] even the likes of China will pull the plug and the likes of the USA and other first world economies will never open the doors...sure short-term they might get away with it, but as soon as people start making health claims....the FDA will do its job and it's lights out, til hard clinical trial results are available.