A Comparison of the U.S., European & Japanese Nutraceutical Health and Medical Claim Rules

Proceedings of this conference were published in RegulatoryAffairs, Vol. 5, Summer 1993


Discussions and Recommendations for the U.S.

A nutraceutical is any substance that can be considereda food or part of a food and provides medical or health benefits,including the prevention and treatment of disease. Such productsrange from traditional foods, isolated nutrients, dietary supplementsand diets to genetically engineered “designer” foods,herbal products and processed foods such as cereals, soups andbeverages.

The Foundation coined the term nutraceutical to [a) give anidentiy to a new health sector that offers enormous health andmedical benefits to the consumer, and (b) to encourage the creationof a new regulatory category. This conference will address theU.S., European and Japanese nutraceutical systems and will considerrecommendations by both the panel and the audience regarding waysto encourage the establishment of a much needed vigorous researchand development oriented nutraceutical system in the United States.

The Foundation will present its own recommendations regardinga new nutraceutical regulatory category as an addition to existingones, where a sponsor can, at costs generally substantially lowerthan those associated with pharmaceuticals and food additives,obtain an exclusive health or medical claim. The rationale isbased on the economic principles which led to the highly successfulOrphan Drug Act.

As part of the program, the case method will be used regarding designer foods, plant and animal dietary supplements, processed foods – cereal and a food additive. Audience input will be emphasized. A summary of the conference, including the recommendations for a new regulatory approach, will be sent to appropriate parties including attendees.


Lyn CioccaThe Foundation for Innovation in Medicine, Cranford,NJ

William J. CurranJ.D., LL.M., S.M.HYG., Frances GlessnerLee Professor of Legal Medicine, Harvard Medical School, Boston,MA

Stephen L. DeFeliceM.D., Chairman, The Foundation forInnovation in Medicine, Cranford, NJ

Victor L. FulgoniIII, Ph.D., Vice President, Nutrition,Kellogg Company, Battle Creek, Ml

Tadayasu FurukawaPh.D., President, Nutri-Quest, Inc.,St. Louis, MO

Nicholas HallPresident, Nicholas Hall & Co., Essex,United Kingdom

Paul A. LachancePh.D., Professor & Chairman, RutgersUniversity, Food Science Department, New Brunswick, NJ

Louis LasagnaM.D., Dean, Sackler School of Graduate BiomedicalScience, Tufts University, Boston, MA

Stephen H. McNamaraEsq., partner, Hyman, Phelps &McNamara, P. C., Washington, DC

Abbey S. MeyersExecutive Director, National Organizationfor Rare Disorders, New Fairfield, CT

Herbert F. PiersonJr., M.S. Ph.D., Pharmacognocist/ChiefConsultant, Preventive Nutrition Consultants, Inc., Woodinville,WA

Gerard PilleyPh.D., Member of the French National Councilfor Pharmay, Paris, France

Richard S. RivlinM.D., Chief Nutrition Service, MemorialSloan-Kettering Cancer Center; Professor of Medicine and ChiefNutrition Division, Cornell Medical Center, New York, NY

Hercules ASegalas, Managing Director, Paine Webber Inc.,New York, NY

Michael D. YoungM.D., Ph.D., Corporate Director, Regulatoryand Clinical Development Worldwide, The Procter & Gamble Company,Cincinatti, OH