What is a “Distinctive Nutritional Requirement”? A Position Paper of the Healthcare Nutrition Council()

The Healthcare Nutrition Council (HNC) represents manufacturers of enteral nutrition formulas and oral nutrition supplements, including those categorized as medical foods and parenteral nutrition. HNC member companies, Abbott’s Nutrition Division, Nestlé Health Science, and Nutricia North America, a subsidiary of Danone S.A., manufacture a majority of the medical foods consumed in the United States. HNC is proposing a modernized interpretation of the medical food framework to reflect the evolution of nutrition science and health care. The medical food category was first defined in 1988 as part of the Orphan Drug Act. Since then, the scientific community's understanding of nutrition and the role it can play in disease management has progressed. HNC believes that a patient-centric approach is needed to foster research and innovation and to position medical foods as a viable solution in the dietary management of disease. HNC proposes that distinctive nutritional requirements refer to the clinical need for a specific nutritional intake (compared with the intake of healthy populations), which may exist by reason of abnormal physiologic manifestation or physical impairment associated with a disease or condition. The dietary management of these diseases and conditions results in clinically meaningful improvements, including but not limited to nutritional status, health outcomes, or quality of life. HNC believes that abnormal physiologic manifestation or physical impairment would include a limited, impaired, or disturbed capacity to ingest, digest, absorb, metabolize, or excrete ordinary food or certain nutrients or metabolites or other medically determined requirements for nutrients or other food substances of biological value. HNC recommends our position be considered as we build consensus across the industry. We request that the Food and Drug Administration modify and codify the current definition to reflect this. Patients and the health care system will benefit from a strong regulatory interpretation of the medical foods framework.