Nutraceuticals Now Previews Presentation for Vitafoods Europe Conference
Nutraceuticals Now wrote a great piece about the upcoming Vitafoods Europe Conference. Check out the whole article here. Here is an excerpt that focuses on the presentation I will give on the Nutraceutical Research and Education Act.
We obtained two FDA approvals under the Orphan Drug Act. The purpose of the successful Orphan Drug Act is to promote economic incentives to companies to develop drugs, including unpatented ones, for rare or orphan diseases by granting exclusive rights to the company to make a medical claim based on clinical studies as well as reduce development costs. Later on and much to my surprise, carnitine also became available as a dietary supplement. I then learned that the dietary supplement industry is a commodity, a low profit margin one instead, just like the pharmaceutical industry which is a proprietary, high profit one.
In order to transform a segment of the industry into the pharmaceutical clinical studies model, FIM, the Foundation for Innovation in Medicine held a series of nutraceutical conferences. I proposed the NREA or Nutraceutical Research and Education Act which was introduced in Congress in 1989 by Representative Frank Pallone but not enacted. There was virtually no support from any segment of the food and dietary supplement industries nor nutritional professionals and organisations. For certain reasons, I was surprised that the formulation- manufacturing industries did not step forward with their support.
The NREA is based on the Orphan Drug Act but deals primarily with foods and dietary supplements. If, for example, a company conducts even a single clinical study that demonstrates that vitamin E or a generic herbal remedy reduces acne, FDA will grant the exclusive right to that company to make the medical claim. This would, along with formulation and manufacturing know-how, convert a product from a commodity to a proprietary one. There are lots of ways to do this.