Dr Stephen DeFelice, renowned for coining the term ‘nutraceutical’ back in 1989, will deliver the keynote speech at the 15th Vitafoods Europe Conference from 22-24 May 2012 where he will discuss the past, present and future of the nutraceutical revolution. Here he gives Nutraceuticals Now a sneak preview of his presentation at the show, along with his thoughts on the concept of the NREA, nutraceutical research and Education Act.
The Concept of the NREA: 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.
I coined the term “nutraceutical” as a regulatory umbrella which encompasses all types of foods, special diets and dietary supplements (including herbal remedies) in order to make it easier for Congress to both understand and act on a single nutraceutical law. All other terms such as functional foods, pharma foods, herbal foods, designer foods and others are marketing terms which are understandably necessary for product promotion.
The definition of a nutraceutical is: ‘A food or parts of foods that have a health or medical benefit including the prevention and treatment of disease.’ Though the term is now in many
dictionaries, including the prestigious Oxford English Dictionary which credits me with coining the term, this and other published definitions are not correct.
A food or dietary supplement becomes a nutraceutical only when its activity is confirmed by one or more clinical studies! About three years ago I again attempted to persuade Congress to enact the NREA. Once more, history repeated itself. There was no support.
There is, however, some good news. Largely due to FIM’s conferences and public relations efforts, many companies did conduct clinical studies but lacked a sufficient proprietary position and capital to market properly. Also, they are understandably inexperienced in clinical protocol design, and many results were not optimum.
What dealt a major blow to the clinical trials movement and to the image of dietary supplements were the negative clinical results of vitamin E’s effect on cardiovascular disease. Vitamin E was the number one accepted nutraceutical by the medical profession, academic communities, consumers and the media. These studies were conceptually faulty being designed with a pharmaceutical mentality instead of a nutraceutical one. Unfortunately, there were no objections to be heard anywhere and the negative impact continues to this day, unopposed.
Then other negative news followed. Clinical studies on dietary supplements such as vitamins and minerals taken chronically were reported to have no health or medical benefits, and were heavily covered by media. These studies were highly faulty in design but, once more, no one objected and the negative impact remains.
I’d like to emphasise that I’m not addressing the current, traditional United States dietary supplement and food markets which are doing well. From a nutraceutical point of view, however, what I have said sounds pessimistic but need not be.
At the Vitafoods Europe Conference I will discuss some strategies on how to develop proprietary, high profit margin nutraceuticals including establishing brand names. There
is reason to believe that in the United States the current traditional food and dietary supplement industries and potential nutraceutical one can co-exist and dramatically complement each other.
To view the full conference programme and register, visit http://www.vitafoods.eu.com/confpr/