What is food for special medical use?: A complete guide to FSMP

October 18, 2025 •

3 min read

Foods for special medical purposes (FSMP) are essential in managing the diets of patients whose nutritional needs cannot be met through conventional dietary modifications alone. This specialized category of nutrition, used under medical supervision, addresses a wide range of conditions, highlighting the critical question: what is food for special medical use?.

Quick Summary

Food for special medical purposes (FSMP) addresses the unique dietary needs of patients with specific medical conditions. These specially formulated foods, used under medical supervision, can provide exclusive or partial nutrition when a normal diet is insufficient.

Key Points

Definition: FSMP is a specially processed food for the dietary management of specific diseases or medical conditions under medical supervision.
Not a Supplement: FSMP is distinct from a food supplement; it addresses a diagnosed medical need, not just a dietary top-up.
Target Audience: It is for patients with impaired ability to digest or absorb normal food, or those with other medically-determined nutritional requirements.
Categorization: FSMP can be either nutritionally complete (sole source) or incomplete (supplemental), with formulations that are standard or disease-specific.
Administration: FSMP can be taken orally as a drink or powder, or via a feeding tube (enteral feeding).
Strict Regulation: The manufacturing, labeling, and marketing of FSMP are subject to stringent regulations to ensure safety and efficacy.

Understanding the definition of FSMP

Food for special medical purposes, or FSMP, is a category of specially formulated foods for the dietary management of patients with specific diseases, disorders, or medical conditions. These foods are designed to meet unique nutritional needs that cannot be fulfilled by modifying a regular diet alone. Unlike food supplements, which complement a normal diet, FSMP addresses a medical need. The use of FSMP is overseen by a healthcare professional.

The core purpose and types of FSMP

FSMP provides tailored nutritional support for individuals with impaired ability to consume, digest, absorb, metabolize, or excrete ordinary foods. Their formulations are based on scientific evidence to ensure safety and effectiveness. FSMPs come in various forms, including liquids, powders, and tube feeding solutions, and their purpose varies based on their nutritional completeness and the patient's needs.

Classification by nutritional completeness

FSMP products are generally classified as either nutritionally complete or incomplete.

Nutritionally Complete Foods: These provide all daily nutritional requirements and can serve as a patient's sole source of nourishment. They can have standard or disease-specific nutrient profiles.
Nutritionally Incomplete Foods: These are not suitable as the sole source of nutrition. They are used for partial feeding or as a supplement, with either standard or disease-specific formulations.

Common conditions supported by FSMP

FSMP is used to manage various medical conditions across all age groups. Some common applications include:

Malnutrition: Important for managing disease-related malnutrition when other methods are ineffective.
Metabolic Disorders: Specialized formulas, like those for phenylketonuria (PKU), restrict certain nutrients while providing others.
Cancer: High-protein, high-energy formulas can help manage weight loss and support patients undergoing treatment.
Neurological Disorders: Thickened liquids or textured foods help prevent aspiration in patients with swallowing difficulties.
Kidney Disease: Formulas with modified electrolyte levels are used to correct imbalances in patients with renal failure.
Gastrointestinal Disorders: Specialized formulas can provide complete or partial feeding for patients with malabsorption or severe diarrhea.

Administration methods for FSMP

FSMPs are available in formats suitable for different administration methods, determined by a healthcare professional.

Oral Nutritional Supplements (ONS): Liquids, powders, or semi-solids taken orally to supplement a regular diet.
Enteral Nutrition Formulas: Administered through a feeding tube for patients unable to consume enough food orally.

Regulatory oversight and key distinctions

FSMP differs from regular food in its intended use and regulatory framework. It is a regulated category used for medical purposes under supervision, unlike general foods for healthy individuals. The table below highlights key differences:


Feature	Food for Special Medical Use (FSMP)	Regular Food and Food Supplements
Purpose	To meet specific, medically-determined nutritional needs of patients.	To provide nutrition for healthy individuals and complement a normal diet.
Intended Use	For exclusive or partial dietary management when a normal diet is insufficient.	For general consumption; supplements complement a normal diet.
Medical Supervision	Mandatory.	Not required.
Regulation	Governed by strict regulations on formulation, composition, and labeling.	Governed by general food safety and labeling regulations.
Nutrient Claims	Claims relate to use in a specific medical condition.	Can make approved claims related to general health.

The critical role of FSMP in clinical nutrition

FSMPs are a cornerstone of clinical nutrition, offering a targeted approach for complex nutritional needs not met by conventional means, thereby improving patient outcomes. They are important in combating malnutrition, which affects a significant percentage of hospitalized patients.

Benefits of integrating FSMP into care plans

Supports Recovery: Provides nutrients for healing from surgery, burns, or wounds.
Prevents Complications: Helps manage nutrient deficiencies and fluid imbalances.
Improves Quality of Life: Makes eating easier and more pleasant for patients with difficulties like swallowing issues.
Supports Long-term Management: Helps individuals with chronic conditions maintain nutritional status.
Reduces Healthcare Costs: Optimizing nutritional status can potentially lead to shorter hospital stays.

Conclusion

Food for special medical use (FSMP) is a specialized and regulated category of nutritional products designed to meet the unique dietary needs of patients with specific medical conditions. Unlike regular foods or supplements, FSMPs are used under strict medical supervision to manage conditions like malnutrition, metabolic disorders, and chronic diseases when a modified normal diet is insufficient. They are an indispensable tool in clinical nutrition, with ongoing advancements leading to more personalized solutions for improving patient recovery and quality of life. For further reading, an excellent resource is available from the National Institutes of Health.

Frequently Asked Questions

A normal diet is for healthy individuals, while FSMP is specially formulated for patients with specific medical conditions whose dietary needs cannot be met by normal foods alone. FSMP is also used under medical supervision.

While regulations vary by region, FSMP products are intended to be used under medical supervision. In many areas, they are sold exclusively through pharmacies, medical practices, or specific distributors, often with a doctor or dietitian's recommendation.

Yes, FSMP includes specialized formulas for infants and young children with conditions like low birth weight, food allergies, or metabolic diseases. These must also be used under strict medical guidance.

FSMP is used widely across the healthcare spectrum, including in hospitals, care homes, and for home-based care. In hospitals, FSMP is vital for managing disease-related malnutrition.

Examples include specialized infant formulas, formulas for metabolic disorders, oral nutritional supplements for cancer patients, and enteral feeding formulas for individuals with neurological issues like dysphagia.

FSMP is a highly regulated category with specific standards for formulation, labeling, and claims. Regulatory bodies like the European Food Safety Authority (EFSA) and the U.S. Food and Drug Administration (FDA) oversee these products.

No. While both can supplement a diet, dietary supplements are for general health and wellbeing. FSMPs are for managing a specific, medically-diagnosed condition where a normal diet is insufficient.