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In the tapestry of our lives, food weaves a thread of sustenance, joy, and communal connection. Yet, for some navigating the labyrinth of specific medical conditions, more than conventional food might be required. Enter Foods for Special Medical Purposes (FSMPs) – a lifeline of specialized nutrition tailored to meet unique health needs.

Foods for Special Medical Purposes (FSMPs) are alternatively referred to as medical foods or enteral nutrition. This nomenclature, adopted by healthcare professionals, underscores their crucial role in the dietary management of patients with specific medical conditions. This article provides a global regulatory synopsis of FSMPs, shedding light on their formulation, historical significance, and pivotal role in nutritional patient care.

Food for Special Medical Purposes (FSMP)

Food for Special Medical Purposes (FSMP) refers to specially formulated foods designed to meet the nutritional requirements of individuals facing challenges in obtaining adequate nutrition from regular foods due to specific diseases, disorders, or medical conditions. FSMPs, encompassing Oral Nutritional Supplements (ONS) and Enteral Tube Feeding (EFT), play a crucial role in providing partial or complete nutrient support under medical supervision.

Formulation and Purpose

FSMPs are meticulously formulated and processed to meet the dietary needs of patients suffering from diseases, disorders, or specific medical conditions. These formulations are explicitly intended for use under medical supervision. With a rich history of practical application spanning decades, FSMPs have emerged as foundational elements in nutritional patient care.

Ingredients in FSMPs

The composition of FSMPs varies based on the specific medical condition and regional formulations. Common ingredients include proteins (e.g., whey and soy), fats, carbohydrates (lactose, glucose polymers), vitamins, minerals, and optional components like caseinate. For infants, some FSMPs may incorporate probiotics to support gut health and immune function.

Modes of Administration

FSMPs offer a versatile approach to patient nutrition, serving as a comprehensive source of nourishment for both short and extended periods. Their flexibility allows for adaptation as either the sole source of sustenance or as supplemental support to a regular diet, making them a valuable asset in healthcare practices worldwide.

Enteral Tube Feeding (EFT) – Precise Nutrient Delivery through Tubes

Another crucial mode of administration for FSMPs is Enteral Tube Feeding (EFT). This method involves delivering a liquid formula directly into the digestive tract through a tube. EFT is particularly valuable for individuals who experience difficulties in oral food intake. It ensures precise and controlled nutrient delivery, making it an essential component in managing the nutritional needs of patients, especially those with specific medical conditions.

 Specifications and Requirements

FSMPs must adhere to specific criteria, including a balanced nutrient composition tailored to individual needs. Strict labeling rules, encompassing front-of-pack nutrition labeling (FOPNL), ensure clear information on nutritional content and usage instructions. These products should be used exclusively or partially under medical supervision, meeting stringent quality standards outlined in the EU Regulation on Foods for Specific Groups.

Development Process and Scientific Insights

FSMPs are developed based on scientific and clinical insights, often in collaboration with healthcare professionals. The formulation process relies on sound medical and scientific data, aligning with national, international, or professional guidelines.

Regulatory Framework

Subject to general food legislation, FSMPs adhere to principles such as good manufacturing practice (GMP). Ensuring safety as labeled for their intended use, truthfulness in claims, and compliance with various regulations, including those related to novel foods, contaminants, additives, and packaging, underscores the meticulous scrutiny these products undergo.

Medical Foods in Inborn Errors of Metabolism (IEM)

Medical foods play a pivotal role in the dietary management of individuals with Inborn Errors of Metabolism (IEM). This group of conditions arises from deficiencies in specific metabolic enzymes, disrupting the normal metabolism of protein, fat, or carbohydrates. The accompanying table provides insights into categories of IEMs where medical foods find application.

Disorders of Protein Metabolism

Amino acidopathies

Organic acidaemias

  • Methylmalonic acidaemia
  • Propionic acidaemia
  • Isovaleric acidaemia
  • Glutaric acidaemia type 1

Urea cycle disorders

  • Carbamoyl phosphate synthetase 1 deficiency
  • Ornithine transcarbamylase deficiency
  • Argininosuccinate synthetase deficiency
  • Arginase 1 deficiency
  • Argininosuccinate lyase deficiency
  • N-acetyl glutamate synthetase deficiency

Disorders of Fat Metabolism

  • Disorders of carnitine metabolism
  • Very long-chain acyl-CoA dehydrogenase deficiency
  • Long-chain hydroxyl acyl-CoA dehydrogenase deficiency
  • Medium chain acyl-CoA dehydrogenase deficiency
  • Mitochondrial trifunctional protein deficiencies
  • Multiple acyl-CoA dehydrogenase deficiency

Disorders of Carbohydrate Metabolism

  • Galactosemia
  • Glycogen Storage Diseases (GSD)

Newborn Screening and Dietary Management

Newborn screening (NBS) plays a pivotal role in identifying IEMs early, enabling the initiation of specific dietary modifications. Through NBS, healthcare professionals can prevent adverse outcomes associated with IEMs. Early identification and dietary management, often relying on specialized medical foods, contribute significantly to mitigating the consequences of these conditions.

Global Product VS FSMP India

The Food for Special Medical Purposes (FSMP) market is a global industry that provides specialized nutritional products for individuals with specific medical conditions. The global FSMP market is estimated to be worth USD 13,100 million in 2021 due to the COVID-19 pandemic. The market is segmented by region (country), company, type, and application. The largest application areas include adults, the elderly, infants, and young children. North America holds the largest market share, with a 45% share, followed by the Asia-Pacific region, with a 30% share.

In India, the FSMP market is experiencing growth due to factors like rising healthcare expenditure, especially in low and middle-income countries. Organizations such as the National Organization for Rare Diseases are actively promoting research into FSMP to address the prevalent issue of malnutrition in developing nations within the Asia-Pacific region.

Compared to the global FSMP market, the Indian market is still in its early stages but offers significant potential for growth. The involvement of major players, diverse application areas, and a focus on specialized nutritional products characterize the global market. The Indian market, on the other hand, is just beginning to adopt these products and is likely to see an increase in the number of players and product offerings in the coming years.

The Future Trajectory of FSMP Market – 2030

The Food for Special Medical Purposes (FSMP) market is poised for substantial growth by 2030, driven by factors such as the increasing demand for personalized nutrition, a growing aging population with specific dietary needs, advancements in food science and biotechnology, and rising disposable incomes, particularly in developing nations. Enteral nutrition, addressing those unable to consume adequate nutrients orally, is projected to grow at a CAGR of over 6%, while parenteral nutrition, delivering nutrients intravenously, is expected to maintain a steady growth of around 5%. 

FSMPs tailored for metabolic disorders are anticipated to experience the fastest growth, with a Compound Annual Growth Rate (CAGR) exceeding 7%. Despite these positive projections, challenges like regulatory complexities, reimbursement uncertainties, and consumer price sensitivity could pose obstacles to market expansion. Nevertheless, ongoing innovation, increasing demand, and favorable regulatory environments position the FSMP market for sustained growth in the years leading up to 2030. 


In conclusion, Foods for Special Medical Purposes (FSMPs) play a pivotal role in global healthcare, offering indispensable dietary solutions for individuals confronting challenges in obtaining adequate nutrition from regular foods. The tailored formulation, precise selection of ingredients, and adherence to rigorous specifications highlight the commitment to meeting diverse nutritional needs, ensuring both safety and efficacy while complying with regulatory standards. In the broader context of patient care, FSMPs emerge as versatile tools, addressing specific medical conditions with a focus on Inborn Errors of Metabolism (IEM). Their significance extends beyond mere dietary management, encompassing early identification and preventive measures, thereby emphasizing their essential role in shaping the evolving landscape of nutritional healthcare. 



Written By

Aswini PriyaMedical Content Writer

Reviewed By

Dr. AnchalMedico Expert

Last Updated
06 Feb 2024 | 12:15 PM (IST)

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