Medical Nutrition Terminology and Regulations in the United States and Europe

Published Jan 2019


Freijer K, Volger S, Pitter JG, et al. Medical nutrition terminology and regulations in the United States and Europe—a scoping review: report of the ISPOR Nutrition Economics Special Interest Group. Value Health. 2019; 22(1)1-12.


Background: The term medical nutrition (MN) refers to nutritional products used under medical supervision to manage disease- or condition-related dietary needs. Standardized MN definitions, aligned with regulatory definitions, are needed to facilitate outcomes research and economic evaluation of interventions with MN.

Objectives: Ascertain how MN terms are defined, relevant regulations are applied, and to what extent MN is valued.

Methods: ISPOR’s Nutrition Economics Special Interest Group conducted a scoping review of scientific literature on European and US MN terminology and regulations, published between January 2000 and August 2015, and pertinent professional and regulatory Web sites. Data were extracted, reviewed, and reconciled using two-person teams in a two-step process. The literature search was updated before manuscript completion.

Results: Of the initial 1687 literature abstracts and 222 Web sites identified, 459 records were included in the analysis, of which 308 used MN terms and 100 provided definitions. More than 13 primary disease groups as per International Classification of Disease, Revision 10 categories were included. The most frequently mentioned and defined terms were enteral nutrition and malnutrition. Less than 5% of the records referenced any MN regulation. The health economic impact of MN was rarely and insufficiently (n = 19 [4.1%]) assessed, although an increase in economic analyses was observed.

Conclusions: MN terminology is not consistently defined, relevant European and US regulations are rarely cited, and economic evaluations are infrequently conducted. We recommend adopting consensus MN terms and definitions, for example, the European Society for Clinical Nutrition and Metabolism consensus guideline 2017, as a foundation for developing reliable and standardized medical nutrition economic methodologies.

Keywords: enteral nutrition, foods intended for specific groups, malnutrition, medical food, medical nutrition, nutrition economics, nutritional support, oral nutritional supplement, parenteral nutrition

Copyright: Copyright © 2019, ISPOR The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc.

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