Q- How long have you been involved in the nutrition field?A- I’ve been in the nutritional field for about 35 years. I worked for 14 years for Pillsbury which became General Mills then I left that job and worked another 20 years for a pharmaceutical food Company called Novartis, a large food corporation. Q- What did you do for these companies?A- Well I was in a lowly position with Pillsbury where I was working as a technician and I was a non-professional. I had a 2 years degree and then I worked my way up the ladder there and then I became a food scientist and finally ended up getting a 4-year degree from the University of Minnesota.Then when I went to work for Novartis, I ended up working with a scientist title and I continued to work my way up and I did a lot of work formulating products, looking at the nutrition of different products and really following the development of food all the way up from the research state to full scale manufacturing. Basically a product development food scientist does everything; they work with the marketing people of the Company. They help conceive the ideas for food products like analog products, like a cereal or whatever it may happen to be. It could also be a fabricated product like a take off of a baked item. You come up with the idea working with the marketing people. You would then put together a prototype of the product idea so that the marketing group would have something they could look at and actually sit around the conference table and talk about.Then as a team you would decide which of these products you’d like to develop then one of those products would be picked and taken to the next stage and the product development scientist would begin to refine that product. It might be improvement in flavor or taste or texture. The product would be refined and presented again to the marketing group. There would be another round table discussion about that particular product and the marketing group would point to food scientist in the direction he needs to go.So I would go back to the bench so to speak in the lab and then make further refinements and then you end up at the first stage of product development, which would be product approval. Then once the product is approved by research and marketing then you begin to pull manufacturing into the picture. Is it possible to manufacture the product you have been working on, then at that point you have three groups involved, you have the research and marketing and manufacturing people then you would all work on development. Q- At what point do you have to present that to the FDA? A- Generally it is the responsibility of the product development people to be aware of the Food and Drug Administrations requirements. So when I used to work in the lab I had a library of different regulations called the Federal Code of Regulations. I would be aware of all the guidelines and I would either take that back to marketing or present that to whomever I needed to inform.We would talk about that regulation and whether it would be a problem in the development of this new product we are working on and if we agreed it was a problem then we would have to submit something to the FDA and if it wasn’t a problem we would just proceed on. Q- What was the average time limit until the first step until the product hit the shelf?A- It’s hard to tell but with the company like one of those mentioned, we would manufacture products. There were several different groups and one was a food product service and those would be the products you are most familiar with. They would be the products you would see of the shelf in the grocery stores. Then another group would research what was called the clinical group products and that particular group would work on developing products that would be intended for use in clinics and for people that required special feedings.The development time and the rules and regulations applied to the different kinds of products, whether they are food service items or clinic products. There were regulations that govern the formulation of and development of and the marketing of all of those different products. They were all different.For example, Novartis had a line of weight loss products that were very popular. It was the Optifast Line. Within that product line I’m just going to guess there were at least 75 different products. There were different categories of products, liquid, supplements and there would be formulas of products intended to be administered through hospital tube feedings. There were solid foods as opposed to liquid.It kept getting divided even in the categories because the nutrition and they had very strict federal guidelines intended for hospital feeding situations. The products would be tested extensively then we could be talking years of clinical trials. Q- Some of the commercials that have been on TV recently have been very enlightening, I’m not sure if it’s Glaxco, but you’ve see

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