This is a nutraceutical, like most vitamins and supplements that are sold over the counter. Marketing a substance as nutraceutical eliminates most of the pre-marketing  development costs, eliminates a need to meet FDA-regulatory requirements and opens the door to a much wider market than would be available for an FDA-approved drug. However, a nutraceutical must be essentially identical to a natural biological substance, cannot be substantially modified, and cannot be marketed with health benefit claims. With regard to the latter, some of the statements quoted by Cardax execs in this article appear to be alluding to health benefits and disease treatment.