ABSTRACT
This review offers a comprehensive analysis of food for special medical purposes (FSMPs)—specially formulated foods designed to support the dietary management of individuals with specific medical conditions. The regulatory frameworks governing FSMP differ significantly across key regions, including the European Union, North America (with a focus on the United States), and Asia (primarily China and India). FSMP is critical in addressing malnutrition, metabolic disorders (including inborn errors of metabolism), and chronic diseases, such as cancer, diabetes, and neurological conditions. Recent advancements, such as the application of three-dimensional printing technology and the growing emphasis on personalized nutrition, are poised to revolutionize the FSMP industry. The global market for FSMP is experiencing rapid growth, particularly in China, driven by factors like aging populations and the increasing prevalence of chronic diseases. Future trends suggest a shift toward more personalized, technologically advanced FSMP formulations. However, challenges such as high costs, limited accessibility, unclear regulations, and poor palatability must be addressed to maximize the potential of FSMP in enhancing patient care.
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Keywords: Malnutrition; Trends; Metabolic diseases; Formulated food
INTRODUCTION
Food for special medical purposes (FSMP) refers to a distinct category of food products designed for individuals with medically diagnosed conditions that impair their ability to ingest, digest, absorb, metabolize, or excrete regular food. These products are also intended for patients with specific nutrient needs that cannot be met through conventional dietary modifications alone [
1]. The increasing prevalence of conditions necessitating specialized nutritional support, such as chronic diseases, metabolic disorders, and malnutrition, underscores the growing significance of FSMP in modern healthcare [
2]. For instance, increasing rates of cancer, particularly head and neck cancer and malignancies of the upper gastrointestinal tract, have intensified the demand for targeted nutritional interventions [
3]. Moreover, the aging global population faces unique dietary challenges due to reduced metabolic efficiency and age-related health conditions [
4]. Strategic integration of FSMP has shown potential in improving nutritional status, facilitating rehabilitation processes, shortening hospital stays, and ultimately lowering healthcare costs [
5]. This review provides a comprehensive overview of the global use of FSMP, examining current applications, regional regulatory frameworks, recent advancements and innovations, emerging market trends, and projected future directions.
DEFINING FSMP
European Union (EU)
In the EU, Regulation (EU) No. 609/2013 defines FSMP as food specially processed or formulated for the dietary management of patients, including infants, under medical supervision. It is designed for the exclusive or partial feeding of patients with limited or impaired ability to ingest, digest, absorb, metabolize, or excrete regular food or specific nutrients or those with other medically determined nutritional needs that cannot be addressed through dietary modifications alone [
1]. This broad definition covers a wide range of patient groups, including infants, and addresses diverse nutritional needs resulting from various medical conditions. The EU further classifies FSMP into 3 categories as follows: (1) nutritionally complete food with a standard nutrient formulation, which can serve as the sole source of nutrition; (2) nutritionally complete food with a disease-specific nutrient-adapted formulation that can serve as the sole source of nutrition; and (3) nutritionally incomplete food with either a standard or disease-specific nutrient-adapted formulation intended for partial feeding or use as a dietary supplement [
1]. A central tenet of FSMP regulation in the EU is that these products must be used under medical supervision, emphasizing the critical role of healthcare professionals in ensuring their appropriate and safe application [
1]. The EU has established a well-defined regulatory framework for FSMP, emphasizing the necessity of medical supervision and clear labeling practices to guarantee their appropriate application [
1].
In North America, specifically the US, the Food and Drug Administration (FDA) defines medical foods, a term often used interchangeably with FSMP in non-EU countries, under the Orphan Drug Amendments of 1988. The FDA defines medical foods as foods formulated to be consumed or administered enterally under the supervision of a physician intended for the specific dietary management of a disease or condition with distinctive nutritional needs, established through medical evaluation based on recognized scientific principles [
6]. This definition differs from that provided by the EU in terms of the following: (1) specific emphasis on enteral administration and disease-specific nutritional requirements; (2) clear differentiation from general foods and special dietary supplements [
7]; and (3) mandatory medical supervision [
6]. This narrow framework underscores the therapeutic purpose of medical foods in managing conditions with distinct nutritional needs, requiring both physician oversight and evidence of distinct dietary needs that cannot be met through regular diet modifications [
6].
In Asia, particularly in China, the Food Safety Law defines FSMP as specially formulated nutritional products designed to meet the unique dietary needs of individuals with dietary restrictions, digestive and absorption disorders, metabolic disorders, or specific diseases [
6], with a regulatory framework that categorizes FSMP into 2 groups: those intended for infants (0–12 months) and those for individuals above 1 year of age, each containing further subclassifications based on specific patient populations and nutritional requirements [
8]. China mandates physician or clinical nutritionist supervision for FSMP use [
9]. The registration process requires clinical trial data for disease-specific formulations, indicating a strong regulatory emphasis on premarket safety and efficacy validation [
10].
The Food Safety and Standards Authority of India (FSSAI) regulates FSMP as products designed to provide disease-specific nutritional support to individuals under a medical practitioner’s supervision [
11,
12]. These products are typically available in various formulations (powders and liquids) for oral or enteral administration [
12]. Similar to that in the EU, FSMP in India is categorized based on nutritional completeness, including nutritionally complete foods with standard or nutrient-adapted formulations and nutritionally incomplete foods with standard or nutrient-adapted formulations [
12]. The Indian definition underscores the supportive role of FSMP in managing medical conditions under medical supervision, emphasizing the provision of nutritional support tailored to specific needs [
12].
While the fundamental concept of FSMP revolves around providing specialized nutrition for individuals with specific medical needs across different regions, the nuances in their definitions and categorization reflect varying regulatory philosophies and healthcare priorities (
Table 1). For instance, the US definition emphasizes enteral administration and distinctive disease-specific nutritional requirements, whereas the EU adopts a broader scope covering exclusive and partial feeding for diverse conditions under medical supervision. Meanwhile, China enforces strict registration protocols with clinical trial mandates to validate “unique” nutritional needs, and India aligns more closely with the EU model in terms of categorization based on nutritional completeness. These differences highlight the complexity of the global regulatory landscape for FSMP [
11].
Table 1Comparison of definitions for food for special medical purpose across key regions
Table 1
|
Region |
Defining authority |
Key definition points |
Requirement for medical supervision |
|
EU |
Regulation (EU) No. 609/2013 |
Intended for the dietary management of individuals, including infants with limited or impaired ability to ingest, digest, absorb, metabolize, or excrete regular food; also includes other medically determined nutritional needs and may be used as the sole or partial source of nutrition. |
Yes |
|
North America (US) |
Orphan Drug Amendments of 1988 |
Formulated for enteral use in the dietary management of specific diseases or conditions; addresses unique nutritional requirements based on scientific principles and clinical evaluation. |
Yes, under the supervision of a physician |
|
Asia (China) |
Food Safety Law |
Specially processed and formulated to meet the unique nutritional or dietary needs of individuals with dietary restrictions, digestive or absorption disorders, metabolic disorders, or diagnosed diseases. |
Yes, under the guidance of a physician or clinical nutritionist |
|
Asia (India) |
FSSAI |
Designed to support the nutritional needs of individuals with specific diseases, disorders, or medical conditions; used as part of dietary management through oral or enteral administration. |
Yes, under the directions of a medical practitioner |
GLOBAL REGULATORY FRAMEWORKS
EU
In the EU, the regulatory framework for FSMP is primarily governed by Regulation (EU) No. 609/2013 on foods for specific groups (FSG regulation) and further specified by the Commission Delegated Regulation (EU) 2016/128, which outlines the specific compositional and information requirements for FSMP [
1]. This framework is comprehensive and specifically addresses the unique nutritional characteristics of these products while mandating market notification procedures to inform national authorities of new product introductions [
13]. The EU enforces strict labeling standards, mandating the inclusion of specific warnings and usage guidance for consumers and healthcare professionals [
1]. Notably, regulatory changes, such as the implementation of the Commission Delegated Regulation (EU) 2016/128, have influenced notification trends. For example, data from Ireland showed a decrease in the total number of notified FSMP between 2018–2020 and 2021–2023, likely due to stricter requirements introduced by the regulation, particularly those related to FSMP intended for infants [
14]. The EU has established a detailed and specific regulatory system for FSMP within the broader context of the FSG regulation, incorporating notification protocols and stringent labeling standards to ensure their safe and appropriate use [
1].
In the US, the FDA regulates medical foods under 21 CFR 101.9(j)(8) [
7], establishing specific definitional criteria and granting conditional exemptions from standard nutrition labeling requirements that apply to other food products [
7]. This exemption acknowledges the specialized nature of medical foods and their intended use under medical supervision. The FDA clearly distinguishes medical foods from drugs and dietary supplements, ensuring that each category falls under the appropriate regulatory framework [
7]. A key aspect of the US regulatory framework is the requirement that medical foods be used under medical supervision and be intended for the specific dietary management of a disease or condition [
6]. The FDA also offers detailed criteria for defining and regulating medical foods, including exemptions from specific labeling requirements and explicit separation from drugs and supplements [
7].
China employs a premarket registration system for FSMP, which is overseen by the State Administration for Market Regulation [
9], indicating a high degree of regulatory oversight. The registration process in China requires comprehensive documentation, including the submission of detailed information on product formulation, production techniques, labeling, and clinical trial data for specific FSMP categories [
10]. The mandatory requirement for clinical trial data for certain products underscores the strong regulatory emphasis on scientific validation and therapeutic efficacy. Notably, the regulatory framework for FSMP in China has recently been updated to streamline approval processes, including the introduction of priority review pathways for products targeting rare diseases and other urgent clinical needs [
9]. These changes reflect a proactive approach by the Chinese government to support the FSMP industry and ensure timely access to essential medical nutrition products [
9]. China’s regulatory approach to FSMP involves a rigorous registration system, including clinical trials for specific categories, and recent efforts to expedite approvals, particularly for products needed for rare diseases [
10].
In India, FSSAI serves as the primary regulatory body for FSMP [
11]. Its guidance note on FSMP outlines specific regulatory requirements, emphasizing that FSMP should be used under medical supervision to support individuals with defined medical conditions [
11,
12]. While the regulatory framework for FSMP in India is still evolving, FSSAI plays a central role in establishing standards and regulatory guidelines for these specialized products [
11].
Regulatory frameworks for FSMP vary considerably across regions (
Table 2). China enforces the most stringent premarket approval process, often requiring clinical trials. Conversely, the EU and the US focus on well-defined standards for composition, labeling, and notification. Meanwhile, the regulatory framework of India is under development. These regulatory differences significantly impact global market access strategies and product development pathways [
11].
Table 2Key regulatory bodies and requirements for FSMP
Table 2
|
Region |
Regulatory body |
Key regulations/guidance |
Key requirements |
|
EU |
European Commission; European Food Safety Authority |
Regulation (EU) No. 609/2013 (FSG regulation); Commission Delegated Regulation (EU) 2016/128 |
Premarket notification; compliance with specific compositional and labeling standards; medical supervision required. |
|
North America (US) |
FDA |
21 CFR 101.9(j)(8) |
Compliance with food labeling standards (with specific exemptions); medical supervision; designed for the dietary management of diseases with distinctive nutritional needs. |
|
Asia (China) |
State Administration for Market Regulation |
Food Safety Law; Registration management measures for FSMP |
Premarket registration; submission of product formula, production methods, labels, and clinical trial data (for specific categories); use under the guidance of a physician or clinical nutritionist. |
|
Asia (India) |
FSSAI |
Guidance note on FSMP |
Provide nutritional support for specific diseases or disorders; use under the medical practitioner’s directions; categorized based on nutritional completeness. |
CURRENT USAGE OF FSMP IN MANAGING MEDICAL CONDITIONS
While the usage patterns of FSMP vary across countries, they are primarily used in the dietary management of malnutrition, metabolic disorders, and chronic diseases (
Table 3).
Table 3 Examples of FSMP usage in different medical conditions
Table 3
|
Medical condition |
Examples of FSMP types and formulations |
Key nutritional considerations |
|
Malnutrition |
Nutritionally complete formulas (standard and nutrient-adapted), oral nutritional supplements, and enteral feeding formulas. |
Ensuring adequate energy and protein intake, correcting micronutrient deficiencies, and supporting specific nutritional needs. |
|
Inborn errors of metabolism |
Protein substitutes (amino acid-based formulas with specific amino acid restrictions) and specialized formulas for specific metabolic pathways. |
Restricting harmful metabolites, providing essential nutrients, and maintaining metabolic balance. |
|
Cancer |
High-energy and high-protein formulas, oral nutritional supplements, and formulas with omega-3 fatty acids or other specific nutrients. |
Supporting increased energy and protein needs, enhancing immune function, and managing treatment-related side effects. |
|
Diabetes |
Formulas with modified carbohydrate content, low glycemic index formulas, and fiber-enriched formulas. |
Managing blood glucose levels, maintaining steady energy, and promoting satiety. |
|
Neurological disorders (e.g., dysphagia, Parkinson’s disease) |
Texture-modified foods, thickened liquids, oral nutritional supplements, and enteral feeding formulas. |
Ensuring safe swallowing, meeting specific nutrient needs, and preventing micronutrient deficiencies. |
Malnutrition
FSMP plays a vital role in managing malnutrition, particularly when it results from limited dietary intake or disease-specific causes (disease-related malnutrition) [
14]. When conventional strategies, such as dietary fortification and supplementation, fail to meet nutritional needs, FSMP becomes essential [
14]. In home enteral nutrition (HEN), FSMP provides essential nutritional support to patients, particularly those with oncological and neurological diseases who require long-term tube feeding at home [
3]. However, the usage rates of FSMP for malnutrition in China remain significantly lower than those in developed countries such as the US, highlighting a considerable potential for market expansion [
9]. Studies on patients receiving HEN have revealed a potential gap between their nutritional needs, especially for protein, energy, and certain micronutrients, and standard FSMP formulations provided, highlighting the need for more tailored nutritional solutions [
3].
FSMP is indispensable in the dietary management of inborn errors of metabolism, including various aminoacidopathies [
6]. In many cases, treatment relies heavily on specialized protein substitutes that limit specific amino acid intake while providing essential nutrients. This dietary control is essential for preventing severe, often irreversible, health complications [
15]. Although the FSMP market in China is growing, there remains a scarcity of domestically produced products for amino acid metabolic disorders. Most available options are imported, indicating a significant unmet need and potential market opportunity [
9]. The development of these specialized formulas faces technical challenges, including limited access to protein-free ingredients and complications related to solubility and nutrient interactions [
15].
The role of FSMP in managing various chronic diseases, including cancer, diabetes, and neurological disorders, is gaining increased recognition [
6]. For instance, in patients with dysphagia following a stroke, FSMP ensures adequate nutrition despite swallowing difficulties [
16]. Beyond providing basic nutritional support, FSMP can complement medical treatments and improve the overall quality of life of individuals with chronic conditions [
5]. Research has indicated that specific food proteins can aid in the management of chronic diseases, such as regulating blood glucose in diabetes, improving cardiovascular risk factors, and preserving muscle mass in conditions such as kidney disease [
17]. Growing awareness among healthcare professionals about the potential benefits of nutrition in disease management is driving greater interest in the use of FSMP as a complementary therapy across a wide range of chronic illnesses [
16].
CATEGORIES AND FORMULATIONS OF FSMP
Classification by nutritional completeness
FSMP can be broadly categorized based on their nutritional completeness. Nutritionally complete foods with standard formulations are designed to meet the total daily nutritional requirements of individuals and can be used as the sole source of nutrition [
1]. Conversely, nutritionally complete foods with disease-specific nutrient-adapted formulations are formulated to meet the unique nutritional requirements associated with specific medical conditions and can also be used as the sole source of nutrition [
1]. Nutritionally incomplete foods with either standard or nutrient-adapted formulations are not suitable for use as the sole source of nutrition and are instead used for partial feeding or as a supplement to the diet [
1].
FSMP are available in a wide array of formulations to suit different patient needs and methods of administration. These include reconstitutable powders, ready-to-drink liquids, semisolid preparations, and solid forms, such as tablets and capsules, for specific nutrient supplementation [
6]. Common FSMP formulations include enteral nutrition formulas administered through feeding tubes, oral nutritional supplements designed to augment dietary intake, and highly specialized products tailored for specific medical conditions, such as metabolic disorders and organ failure [
11]. Recent innovations have introduced three-dimensional (3D)-printable food inks that enable the creation of FSMP with customized nutritional profiles and textures, offering enhanced palatability and ease of consumption for patients with specific needs, such as dysphagia [
2].
The FSMP market encompasses a diverse range of products tailored to various medical and nutritional needs. For instance, specialized formulas are available for premature and low birth weight infants to support their rapid growth and development [
8]. Protein-based formulas, including amino acid blends, are used for individuals with specific protein requirements or metabolic disorders [
18]. Carbohydrate-specific formulations are designed for patients with conditions such as diabetes and carbohydrate malabsorption [
18]. Electrolyte-rich formulas are crucial for maintaining fluid and electrolyte balance, particularly in conditions involving dehydration or electrolyte imbalances [
9]. Liquid formulations are widely used for patients with dysphagia or those requiring tube feeding [
18]. Furthermore, comprehensive nutritional formulas are designed for managing chronic conditions, such as diabetes, respiratory diseases, kidney disease, cancer, and liver diseases, each tailored to the unique nutritional challenges of these conditions [
8].
RECENT APPLICABLE ADVANCEMENTS AND INNOVATIONS IN FSMP
Advances in food technology have opened new possibilities for FSMP development, enabling the adoption of innovative methods in production (
Table 4).
Table 4 Recent advancements and innovations in FSMP
Table 4
|
Advancement/innovation |
Description |
Potential impact |
|
3D printing applications |
Technology to create FSMP with tailored nutrition, appearance, and texture; enables personalized products and assistive devices. |
Enhanced customization, improved palatability, increased patient compliance, precision nutrition, and support for autonomous feeding. |
|
Personalized nutrition |
Tailoring FSMP composition to individual patient needs based on medical evaluation and potentially genetic/metabolic profiling. |
More precise nutritional therapy, enhanced efficacy, and better clinical outcomes. |
|
Novel ingredients |
Development of printing formulations using alternative proteins and plant-based products; exploration of bioactive peptides and amino acids for therapeutic benefits. |
Broader dietary inclusivity, enhanced nutritional profiles, and potential disease-modifying benefits. |
|
Regulatory developments (e.g., in China) |
Implementation of streamlined registration procedures, prioritized reviews for urgent medical needs, and updated clinical trial guidelines. |
Accelerated innovation, faster market access for innovative FSMP, and sustained regulatory standards for safety and efficacy. |
Application of 3D printing
A significant recent advancement in FSMP is the application of 3D printing technology [
2]. This technique allows for the precise customization of nutritional content, appearance, and texture to meet the specific needs of individual patients [
2]. By enabling the creation of personalized FSMP, 3D printing supports targeted dietary interventions across various medical conditions and age groups [
2]. The benefits of 3D printing in FSMP extend beyond meeting physiological needs, offering enhanced sensory and psychological eating experiences, which are particularly important for patients with reduced appetite or sensory sensitivities [
2]. This technology supports the advancement of precision medicine in nutrition and enables personalized home-based preparation of FSMP [
2]. Recent advancements include the development of customized food products, such as nutrient-dense noodles and personalized nutrition stacks formulated using biometric data from skin scanners [
2]. Furthermore, 3D printing is being explored to develop adaptive tools, such as custom holders and feeding devices, enhancing mealtime independence for individuals with disabilities [
2].
There is a growing focus on customizing FSMP formulations based on a patient’s specific medical and nutritional profile following comprehensive clinical evaluation [
3]. This trend toward personalized nutrition reflects a deeper understanding of individual metabolic and physiological differences and aims to provide more targeted and effective nutritional interventions. The integration of food science and nutrition with emerging technologies, such as 3D printing, is facilitating the development of FSMP tailored to individual needs [
2]. This approach allows for the precise adjustment of nutrient composition and the inclusion of targeted bioactive compounds, offering the potential to improve treatment efficacy and clinical outcomes.
Innovation in the FSMP industry includes the development of novel ingredients, such as alternative protein sources and plant-based products, to meet the growing demand for nonanimal-based nutritional options and address specific dietary restrictions [
2]. Furthermore, research is increasingly focused on the therapeutic potential of bioactive peptides and amino acids derived from various food sources. These ingredients are being explored with the aim of incorporating these into FSMP to provide specific health benefits, particularly in managing chronic diseases [
17]. These advancements indicate a shift toward not only meeting basic nutritional needs but also enhancing the functional properties of specific food components.
Regulatory bodies are evolving to facilitate innovation in the FSMP industry. In China, for example, the registration process has been streamlined with the introduction of priority review pathways for FSMP products addressing urgent clinical needs, such as those for rare diseases [
9]. In addition, the standards for clinical trials for FSMP in China have been updated to enhance their scientific rigor and applicability [
9]. These regulatory changes are designed to expedite the development and availability of innovative and essential FSMP products while maintaining high standards of safety and efficacy.
MARKET TRENDS AND GROWTH DRIVERS
Global market trends
The global market for FSMP is expanding and is projected to reach approximately $19.41 billion by 2030 [
16]. This expansion reflects an increasing global demand for specialized nutritional products. A notable trend is the rising prevalence of HEN, where patients receive nutritional support through feeding tubes at home, which is driving the demand for FSMP designed for home administration [
3]. Furthermore, the demand for FSMP is increasing across various healthcare settings, including hospitals, long-term care facilities, and home care environments, indicating a broader integration of these products into comprehensive nutritional management strategies [
3].
Several key factors drive the growth of the FSMP market globally. The increasing prevalence of chronic diseases, such as cancer, diabetes, and neurological disorders, underscores the need for specialized nutritional interventions to support treatment and improve patient outcomes [
4]. The growing global aging population, which faces unique nutritional challenges due to age-related health issues and reduced metabolic efficiency, is another major factor driving the growth of the FSMP market [
4]. Growing awareness among healthcare professionals and the general public about the critical role of clinical nutrition in disease management is leading to greater acceptance and use of FSMP [
2]. In addition, the increasing awareness about digestive disorders that require specialized nutrition is further boosting the demand for FSMP products tailored to these conditions [
4].
The FSMP market in China has been expanding rapidly, especially since 2023, marked by a significant increase in registered products [
9]. Domestic manufacturers now dominate the Chinese market, accounting for over 80% of approvals since 2020, indicating robust strengthening of the local industry [
9]. This growth is further supported by the proactive efforts of the Chinese government, including streamlining of regulatory processes and prioritization of approvals for FSMP products addressing urgent needs, such as those for rare diseases [
9]. However, despite this rapid growth, the use of FSMP among malnourished patients in China remains significantly lower than that in developed countries, indicating a substantial unmet need and potential for further market growth, particularly for products targeting specific diseases and rare conditions [
9].
DISCUSSION
The global landscape of FSMP highlights a critical category of food products designed to manage diverse medical conditions across various age groups. While the fundamental purpose of FSMP—providing tailored nutrition for individuals with specific medical needs—remains consistent, regulatory frameworks, definitions, and market dynamics vary significantly across regions such as the EU, the US, China, and India. These regional differences impact market access, product development, and patient care.
Several challenges are associated with the development and use of FSMP. The high cost of these specialized products can impose a significant financial burden on patients, potentially limiting their access [
6]. In certain regions or through particular distribution channels, the availability of specific FSMP products may be limited, hindering optimal nutritional management [
6]. Regulatory complexities and vague definitions and classifications of FSMP often pose challenges for manufacturers and regulators [
19]. Moreover, there is a recognized need for greater product diversity to meet the varied nutritional needs of different medical conditions, especially rare diseases [
2]. With the increasing FSMP availability through online platforms, maintaining strict quality control and ensuring the accuracy of product information are crucial [
20]. Furthermore, the limited taste options and variety of FSMP can hinder patient adherence, underscoring the need for improved palatability [
6]. Finally, while advancements such as 3D printing hold great promise, technological challenges must be addressed for their widespread application in the FSMP industry [
2].
Despite these challenges, the future of FSMP presents significant promise for growth and application. Advances in personalized nutrition, including genetic and metabolic profiling, could lead to highly individualized FSMP that precisely meet patient needs. Expanding FSMP applications to cover a wider range of diseases and medical conditions has the potential to improve patient outcomes. Furthermore, technological innovations such as 3D printing can be refined to create highly customized, appealing FSMP products that address concerns related to palatability and texture. The development of novel ingredients with specific therapeutic benefits could expand the role of FSMP beyond basic nutritional support. Improving the taste, texture, and overall palatability of FSMP is crucial for enhancing patient adherence and maximizing effectiveness. Streamlining regulatory processes can facilitate the development and market access of innovative FSMP products, ensuring timely access to valuable nutritional solutions. Raising awareness and educating healthcare professionals and patients about the benefits and proper use of FSMP is essential for optimal utilization. Addressing unmet needs in specific populations, such as those with rare diseases, offers a significant opportunity to improve the lives of affected individuals. The potential for home-based preparation of personalized FSMP using emerging technologies could revolutionize nutritional management, offering patients greater convenience and control. The FSMP market is projected to grow significantly, driven by demographic shifts and an increasing awareness of clinical nutrition, indicating a promising future. However, clear regulations and distinct differentiation from other food categories are essential to fully realize their potential [
16]. Ambiguities in regulatory definitions by the EU often lead manufacturers to reclassify products as food supplements, highlighting the need for clearer regulatory boundaries [
19]. The growing availability of FSMP online improves access but presents challenges related to cost, information accuracy, and the continued need for professional guidance in selecting and using these products [
20].
5120200313836
Ministry of Agriculture, Food and Rural Affairshttps://doi.org/10.13039/501100003624
322010-5
NOTES
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Funding: This study was supported by grants from the BK21 plus program “AgeTech-Service Convergence Major” through the National Research Foundation (NRF) funded by the Ministry of Education of Korea (Grant No. 5120200313836). Additional support was provided by Korea Institute of Planning and Evaluation for Technology in Food, Agriculture and Forestry (IPET) through High Value-added Food Technology Development Program funded by the Ministry of Agriculture, Food and Rural Affairs (MAFRA) (grant number 322010-5).
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Conflict of Interest: The authors declare that they have no competing interests.
-
Author Contributions:
Conceptualization: Kang HJ, Park YK.
Data curation: Kang HJ, Park YK.
Funding acquisition: Park YK.
Investigation: Kang HJ.
Methodology: Park YK.
Supervision: Park YK.
Writing - original draft: Kang HJ.
Writing - review & editing: Park YK.
ACKNOWLEDGEMENTS
The authors would like to thank the BK21 program “Age Tech-Service Convergence Major” through the National Research Foundation by the Ministry of Education of Korea, and Korea Institute of Planning and Evaluation for Technology in Food, Agriculture and Forestry (IPET).
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