Redefining 'Medical Food': An Evaluation of the Definition Proposed by the International Society for Medical Food and Nutrition (ISMN)

Redefining 'Medical Food': An Evaluation of the Definition Proposed by the International Society for Medical Food and Nutrition (ISMN)

Volume 3 Issue 1 – June 2025, Page 32-36,doi: 10.63238/JMN.000.03.01.07

Kshitij Bhardwaj1, Narsingh Verma2, Shipra Bhardwaj3,4, Kamlakar Tripathi5, Anuj Maheshwari6, Amit Gupta7, Abhishek Arun8, Poonam Tiwari9, Smita Singh10

1 Chairman of the Nutrition Council of India and Head, Department of Food Science and Technology, IFNH.

2 Former Professor and Head of Department at King George's Medical University, Lucknow.

3 Chief Scientist, Food and Biosciences Research Lab

4 Faculty, Dr. Giri Lal Gupta Institute of Public Health & Public Affairs, University of Lucknow

5 Ex Prof & Head, Department of Nephrology, Banaras Hindu University

6 Professor & Head, Department of Medicine, Hind Institute of Medical Sciences, President Elect, RSSDI, India

7 Chief Consultant and RSSDI National Executive member

8 Professor, Department of Medicine, Hind Institute of Medical Sciences, Lucknow

9 Chief Clinical Dietitian, Dr. RMLIMS, Lucknow

10 Chief Clinical Dietician, Midland Hospital, Lucknow

Received:  April 15,  2025 | Published: June 15, 2025

Abstract

The term "Medical Food" has long been a subject of debate in academic and policy-making spheres, particularly in regions like India, where its use has often been misinterpreted or inconsistently applied. To address this, the International Society for Medical Food and Nutrition (ISMN) has proposed a new, globally harmonized definition grounded in both classical medical science and modern advancements. This study aims to critically evaluate the ISMN's proposed definition, focusing on its conceptual clarity, scientific foundation, regulatory implications, and practical relevance. A thorough content analysis of existing definitions and regulatory frameworks from multiple countries—including the United States, European Union, Japan, and India—was conducted. The ISMN’s definition was then assessed for its potential to bridge gaps between regulatory and scientific interpretations. Expert reviews from clinical nutritionists, food technologists, regulatory experts, and medical professionals were used to validate the definition.

The ISMN defines a Medical Food as:

"A scientifically formulated product intended for the dietary management of a disease or medical condition, administered under medical supervision. It possesses disease-specific efficacy, supported by clinical or epidemiological evidence, and does not function merely as a dietary supplement or conventional food derived from ethical, natural, or functional sources to ensure bioavailability, safety, and efficacy."

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