How Are Functional Ingredients and Bioactives Identified, Developed, and Marketed?

Consumers awareness of the link between food and health has increased greatly in the recent years.  There is considerable debate, however, as to what makes a food functional.  Japan was one of the first countries to define an official approval process for “Functional Foods” enabling health claims to be made.  In Japan such Functional Foods have been growing since the early 1980s and are defined as Foods for Specified Health Use (FOSHU).  In Japan, once a food has gained approval and is recognized as suitable for a specified health use, it may bear an approved statement and mark on its label indicating its specific health benefit. Approved claims appear to be modest and relate to health maintenance rather than disease prevention or treatment. In US, a Functional Food (by any name) is currently regulated under many statutory categories under the FD&C Act. The term “Dietary Supplement” is defined in the US under the Dietary Supplement Health & Education Act (DSHEA).  In Canada, which is in North America close to US, the regulations for Functional Foods and Nutraceuticals are totally different from US.  Within Europe, there is much debate regarding recent EFSA standards related to Functional Foods and it has been become increasingly difficult to make health related claims. New innovative Functional Foods or ingredients may fall under the scope of EU Novel Food Regulation and require approval via that route. Our in depth research into the science, technology and marketing strategies in the area of functional foods has enabled us to launch various innovative products globally, despite the various formidable regulations. Safe and effective health benefits are basic consumer requirements, however, for the ingredient supplier there is a great financial burden to clear safety and efficacy issues and launch new products meeting consumer demands in each region. In spite of our great regulatory clearances and international scientific awards, there are still many markets in which regulations continue to impede innovations. The diversity of regulations and safety policies continue to be bottlenecks. Harmonization of global regulations will provide a boost to new innovative products offering various health benefits. Various case studies of our functional ingredients, including Sunphenon®, Suntheanine®, Sunfiber®, SunActive®, and our Nutrition Delivery Systems will be discussed.