|JOHNSON, ELIZABETH - Jean Mayer Human Nutrition Research Center On Aging At Tufts University|
|BARNETT, JUNAIDAH - Jean Mayer Human Nutrition Research Center On Aging At Tufts University|
|MEYDANI, SIMIN - Jean Mayer Human Nutrition Research Center On Aging At Tufts University|
Submitted to: Electronic Publication
Publication Type: Other
Publication Acceptance Date: 7/18/2016
Publication Date: 8/31/2016
Citation: Johnson, E.J., Barnett, J., Meydani, S.N. 2016. Medical foods: guidelines for development and usage. Electronic Publication. http://www.raps.org/Regulatory-Focus/Features/2016/09/01/25760/Medical-Foods-Guidlines-for-development-and-usage/.
Technical Abstract: Recognition and management of a change in nutritional requirements associated with disease is an integral part of the medical management. The nutritional needs associated with a disease reflect the amount needed in health to support life, adjusted for the distinctive changes in the nutritional needs resulting from the effects of the disease on inadequate nutrient intake, malabsorption, impaired metabolism, excessive loss of nutrients, increased nutrient turnover or drug-nutrient interactions. Medical food is a category of US Food and Drug Administration (FDA) regulated products that meet distinctive nutritional requirements or metabolic deficiencies of a particular disease that cannot be met by diet alone. Medical foods were first defined in the FDA's 1988 Orphan Drug Act Amendments, thereby creating a legal category for such foods. FDA regulates the claims that manufacturers can make about medical food nutrient content and effects on disease prevention, health or body function.