NUTRITIONAL PRODUCTS AS DRUGS OR FOOD IMPLICATIONS FOR DEVELOPMENT

It is currently recognized that food, other than supplying calories, produces profound effects on bodily function. Consumers and patients receive information regarding whole foods, individual ingredients, and diets from many sources, most of which are unverified for efficacy and safety. No satisfactory mechanism exists for the production of this data, and its regulatory oversight is made more difficult, since many of the products are in everyday commerce and readily available to the consumer The differences between the methods by which consumer-patient behavior is modified, are discussed. A framework is suggested by which research and development investment over time could be created and maintained, so as to provide well-documented data on safety and medical benefits. Patent and regulatory issues are important elements of the proprietary position essential to sustain an intensive, extended research and development effort in this area.