Abstract
Medical foods in the United States and foods for special medical purposes (FSMPs) in Europe and many Gulf markets are designed for the dietary management of patients whose nutritional needs cannot be met by ordinary foods alone. They sit at a consequential boundary: they are foods used under medical supervision, yet they may be central to management of malnutrition, home enteral nutrition and rare metabolic disease. This narrative review synthesizes literature and primary regulatory materials published or available from 2020 through 5 August 2026, with emphasis on the United States, European Union (EU), and Arab countries. The three regions share a clinical logic—targeted nutrition for a defined patient group—but apply different regulatory architectures. The EU provides the most explicit harmonised FSMP framework, including categories, labelling, notification and a requirement for generally accepted scientific support. The US retains the statutory medical-food category, interpreted through FDA guidance. In Arab countries, the most directly documented current framework is Gulf-centred: GSO 1366:2021 defines handling requirements for FSMPs above 12 months of age, while Saudi Arabia has identifiable SFDA pathways for infant and special-medical formulas; available evidence does not support treating “Arab countries” as one harmonised market. Clinical evidence supports the use of specialised nutrition when it corrects a demonstrable nutritional problem, but does not justify treating the category as a uniform therapeutic class. Product selection, delivery technique, monitoring and access arrangements materially affect whether the intended nutrition is actually delivered.[1–5]
Keywords: medical foods; foods for special medical purposes; FSMP; enteral nutrition; disease-related malnutrition; regulatory science; European Union; United States; Gulf Cooperation Council; Arab countries.
1. Introduction
The phrase medical nutrition often obscures the regulatory and clinical distinctions that matter. A 2019 scoping review found inconsistent terminology across the literature and noted that regulations and economic evaluations were rarely addressed; that gap remains important because a product’s classification shapes its evidence expectations, labelling, reimbursement and distribution.[6]
In the United States, a medical food is understood in FDA-facing literature as a food used under medical supervision; FDA guidance addresses common questions about its definition and regulation, but the guidance itself describes current agency thinking rather than independently enforceable obligations.[3, 7] In the EU, FSMPs are foods for the exclusive or partial feeding of patients whose nutritional requirements cannot be met by normal foods and must be used under medical supervision.[1, 2]
This distinction should not be mistaken for a hierarchy of clinical value. A phenylalanine-free amino-acid mixture for phenylketonuria, for example, primarily circumvents a metabolic limitation by meeting nutritional needs; it differs conceptually from a nutrient product that exerts a studied pharmacological action and may be more appropriately regulated as a medicine.[8] The central question is therefore not whether an item is labelled “medical,” but whether its formulation, indication, delivery and monitoring credibly address a defined nutritional requirement.
2. Scope and approach
This article is a targeted narrative synthesis, not a systematic review. It draws on 2020–2026 publications retrieved using terms for medical foods, FSMPs, enteral nutrition, EU regulation, US FDA regulation, Gulf Cooperation Council (GCC), Saudi Arabia, United Arab Emirates (UAE), and Arab food-control systems, supplemented with primary regulatory pages and texts. “Arab countries” is used in its geographic and policy sense, not as a claim of a single legal regime. The directly retrievable FSMP-specific material was concentrated in GCC standards, Saudi sources and a Dubai access-and-reimbursement study; regulatory conclusions outside those settings should therefore be independently confirmed in the destination country.[4, 9, 10]
3. Regulatory architectures
3.1 United States: a distinct medical-food category, interpreted through guidance
The US category is clinically recognisable but frequently confused with dietary supplements, conventional foods and drugs. A 2020 review described this confusion as extending beyond the public to health professionals, reflecting overlapping food-system requirements and a changing regulatory environment.[3] A 2021 workshop similarly identified recurring issues: the meaning of “distinctive nutritional requirements,” whether a condition can be managed by modification of the normal diet alone, the role of clinical guidelines, medical supervision and the differentiation of medical foods from foods for special dietary use.[11]
For a developer or clinician, the practical implication is restraint in disease language. Medical supervision does not convert a food into a drug, and the FDA guidance page explicitly states that guidance is non-binding unless a statutory or regulatory requirement is cited.[7] The appropriate evidence package should therefore connect the product to a distinctive, disease-associated nutritional requirement, identify the population and use conditions, and avoid implying a general disease-treatment claim.
3.2 European Union: harmonised FSMP requirements with medical-supervision and notification controls
EU Regulation 609/2013 and Commission Delegated Regulation (EU) 2016/128 form the core framework. The delegated regulation is directly applicable, defines three categories—nutritionally complete standard, nutritionally complete nutrient-adapted, and nutritionally incomplete products—and requires a formulation grounded in sound medical and nutritional principles. Its use must be safe, beneficial and effective for the intended nutritional requirements on the basis of generally accepted scientific data.[2]
The EU framework is more prescriptive about information than the US guidance-led account presented above. Labels must state medical supervision, suitability as a sole source of nourishment where applicable, intended age group, relevant hazard warnings, the dietary-management indication, precautions, formulation characteristics and preparation/storage directions. Nutrition and health claims are prohibited.[2] Operators must notify the competent authority in each Member State where an FSMP is marketed, generally using a model label and any further information reasonably requested to establish compliance.[2]
EFSA’s 2021 guidance does not itself approve products; it provides a common dossier structure and identifies the evidence needed to assess whether a notified product falls within the FSMP category for its proposed use.[12] This is particularly important at the boundary between a disease-specific formulation and an ordinary food or supplement.
3.3 Arab countries: regional food-control systems, GCC standardisation and country-level implementation
Available 2020–2026 evidence supports a regional, not unitary, description. A 2022 review of Middle Eastern Arab food-control legislation describes systems adapting to evolving international food-safety requirements, but it does not establish a common FSMP approval pathway across all Arab states.[9] The strongest directly retrievable FSMP-specific instrument is GSO 1366:2021, published by the GCC Standardization Organization. It applies to special foods for medical purposes for people above 12 months of age and covers nutritionally complete foods, nutritionally incomplete/nutrient-adapted foods, formulas for metabolic genetic disorders and oral rehydration solutions.[4]
Saudi Arabia has a visible SFDA regulatory category for infant formula, follow-on formula and formulas for special medical purposes, indicating a dedicated food-authority pathway rather than a medicine-registration pathway.[13] In Dubai, a 2023 policy study found that medical-nutrition coverage was handled ad hoc in the absence of unified guidelines, with consideration depending on disease severity and perceived importance for recovery; product registration with the ministry was described as a prerequisite for consideration.[10] These data are policy-specific rather than representative of every Emirate or Arab country, but they illustrate the key commercial-access risk: regulatory status, reimbursement and clinical availability need separate assessment.
4. Clinical use: the product is not the intervention
FSMPs and medical foods are frequently delivered as oral nutritional supplements or enteral formulas. Their established role is to provide nutrition when oral intake, digestion, absorption, metabolism or excretion limits make an ordinary diet inadequate.[14] In practical terms, the clinical intervention includes patient assessment, prescription, route, volume, schedule, adherence, tolerance and follow-up—not merely selection of a branded formulation.
A 2022 multicentre observational study of 772 home-enteral-nutrition patients, predominantly with oncological or neurological disease, illustrates this point. Almost half of cancer and neurological patients received less than 1 g/kg/day protein, and more than half received less than 25 kcal/kg/day, despite FSMP use.[5] Continuous gastric feeding was associated with higher delivered protein, energy and volume than bolus feeding in that dataset, but the authors appropriately note that its retrospective, observational design cannot establish a causal advantage.[5]
This evidence supports careful monitoring of delivery rather than a generic claim that any FSMP solves malnutrition. Standard formulas may be appropriate for many patients, while hypercaloric or protein-enriched products may be useful when volume, protein requirements or tolerance constrain delivery. The choice remains individualised; the same study found both shortfalls and occasional micronutrient intakes above tolerable upper levels.[5]
5. Disease-specific formulations: plausible design does not equal universal benefit
A 2022 analysis of 118 adult enteral formulas marketed in Europe found wide heterogeneity in macronutrient composition, fatty-acid profiles and immunomodulatory substrates. Disease-specific products comprised 46.6% of the sample, but their composition varied substantially across metabolic stress, renal, cancer, pulmonary, diabetes, malabsorption and surgical indications.[14] Such variation can be clinically rational—for example, volume restriction, glycaemic control or malabsorption—but it makes category-level efficacy claims unreliable.
The same analysis found that only a minority of disease-specific formulas contained arginine and nucleotides, and it cautioned that immunomodulatory formulas had a routine guideline-supported role principally in selected upper gastrointestinal cancer surgery and major cancer surgery rather than across all cancer or critical-care settings.[14] A 2025 single-centre, double-blind randomised study in 36 cancer outpatients (25 completers) reported better nutritional-risk status and some physical-performance measures after eight weeks of an FSMP, but no significant reduction in sarcopenia prevalence. It is encouraging but too small and condition-specific to support broad claims for FSMPs in oncology.[15]
The strongest clinical principle is therefore narrower than the marketing category: select the formulation only when its nutrient profile addresses a documented requirement, and judge success using patient-level endpoints—intake delivered, tolerance, nutritional status, functional outcomes and, where relevant, disease-specific biochemical markers.[5]
6. Safety, quality and the food–medicine boundary
FSMP regulation includes important safeguards, but it does not reproduce medicinal-product oversight. In an EU review of nutritional therapy for inborn errors of metabolism, authors argued that the lower level of third-party oversight for food-grade products may leave gaps in dose accuracy, post-market safety monitoring, supply continuity and reimbursement.[8] This concern is most acute where a product is indispensable and a small compositional error can have serious metabolic consequences; it should not be generalized to imply that FSMPs are inherently unsafe.
The appropriate response is risk-proportionate governance. For a complete formula used as sole nutrition, quality specifications, stability, microbiological safety, nutrient verification and supply continuity deserve particular scrutiny. For disease-specific or metabolic products, the dossier should also show why ordinary diet modification cannot meet the patient’s requirement and why the proposed nutrient modifications are appropriate. EU law explicitly requires generally accepted scientific data for suitability, safety, benefit and effectiveness in meeting the target nutritional requirements.[2]
7. Implications for clinicians, developers and payers
For clinicians.
Treat the prescription as a monitored nutrition plan. Confirm the indication; specify whether the product is supplementary or sole-source; calculate delivered energy, protein, fluid and key micronutrients; assess gastrointestinal tolerance and adherence; and reassess rather than assuming the label’s theoretical provision equals intake.[5]
For developers.
Build the classification strategy before developing claims. In the EU, design the dossier around the defined patient population, the inability to meet needs through ordinary foods, the formulation rationale and scientific support; ensure labels meet the additional FSMP particulars and country notification requirements.[2, 12] In the US, keep the medical-supervision and distinctive-nutritional-requirement rationale distinct from drug-like disease-treatment claims.[7, 11]
For market-access teams in Arab countries.
Do not use “MENA” or “Arab” as a regulatory shortcut. Start with the product’s population (especially infant versus older-child/adult), route, disease indication, product composition and intended claims; then map the applicable national food authority, GCC/GSO standard where relevant, local registration steps, language/label requirements and reimbursement route. The Dubai experience shows that registration alone does not guarantee organised coverage.[4, 10, 13]
8. Conclusion
Medical foods and FSMPs should be understood as specialised nutrition products, not as a diluted version of pharmaceuticals or an upgraded version of ordinary supplements. The EU offers the clearest harmonised FSMP rule set, including explicit product categories, medical-supervision labelling, notification and scientific substantiation. The US maintains a distinctive medical-food category interpreted through FDA guidance. In Arab countries, the evidence retrieved supports GCC standards and country-level implementation—especially Saudi and Dubai examples—rather than a single pan-Arab pathway.[2, 4, 7, 10]
The clinical literature supports targeted medical nutrition when it closes a real nutritional gap, but it also shows that formulation alone does not assure adequate delivery or patient benefit. The decision standard should remain patient-specific: a defined nutritional problem, a formulation that directly addresses it, evidence proportionate to the intended use, and follow-up that verifies the intended nutrition is reaching the patient.[5, 14]
Selected references
- Markowitz J, Gurley PC, Gurley B. Medical Foods—A Closer Look at the Menu: A Brief Review and Commentary. 2020.[3]
- Holmes JL, Biella A, Morck T, et al. Medical Foods: Science, Regulation, and Practical Aspects. Summary of a Workshop. 2021.[11]
- European Commission. Commission Delegated Regulation (EU) 2016/128 (current consolidated version identified by EUR-Lex).[2]
- EFSA. Scientific and technical guidance on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013. 2021.[12]
- Folwarski M, Kłęk S, Zoubek-Wójcik A, et al. Foods for Special Medical Purposes in Home Enteral Nutrition—Clinical Practice Experience. 2022.[5]
- Ruperto M, Montero-Bravo A, Partearroyo T, et al. A Descriptive Analysis of Macronutrient, Fatty Acid Profile, and Some Immunomodulatory Nutrients in Standard and Disease-Specific Enteral Formulae in Europe. 2022.[14]
- Stolwijk N, Bosch AM, Bouwhuis A, et al. Food or medicine? A European regulatory perspective on nutritional therapy products to treat inborn errors of metabolism. 2023.[8]
- Faour-Klingbeil D, Al-Busaidi MA, Todd E. Legislation for food control in the Arab countries of the Middle East. 2022.[9]
- Ayesh WH, Mahagaonkar S, Hassan KI, et al. Assessment of burden of disease related malnutrition and reimbursement policies of the Dubai health authority for medical nutrition. 2023.[10]
