REGULATORY PROCESS
According to the consulting firm Bain and Company, the average cost of developing a single new drug is $1.7 billion. The development and the FDA approval process can easily take up to 12 years, without certainty that the synthetic drug is ever going to be approved.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements are regulated like food. Unlike new drugs, dietary supplements don't generally have to go through review by the Food and Drug Administration for safety and efficacy or be "approved" before they can he marketed. But manufacturers must provide pre-market notice and evidence of safety for any supplements they plan to sell that contain dietary ingredients that were not on the market before DSHEA was passed. The company believes that its all-natural and non-synthetic products and its proprietary method of growing such natural drugs has the potential of revolutionizing the pharmaceutical industry by being able to partner with mother nature to formulate such natural drugs and bringing them to market faster and at a lower cost.
In addition to selling its products as nutraceuticals, the company intends to explore the pharmaceutical development and FDA clinical trials as well.