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Foods for special medical purposes/medical foods: A global regulatory synopsis

Updated: Jul 4, 2023

This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions – EU, UK, US, China, and other regions of the world – to improve the role of nutrition in support of optimal care for patients. Part 1 covers general principles governing FSMPs, use of FSMPs in community and hospital settings, common regulatory challenges, opportunities for category growth, and considers a multistakeholder initiative for optimal nutrition care for all. Part 2 presents a global overview of the regulatory framework for medical foods/FSMPs in the aforementioned countries and regions.

EU summary

Health and disease management requires the development of appropriate, performing healthcare solutions, using all options from medicinal treatment, lifestyle changes, and nutrition. Patient perspectives on nutrition, developed by patient associations the European Patients’ Forum and European Genetic Alliances Network and the ENHA, demonstrates nutrition as a vital part of health and disease management. It examines the role of nutrition in relation to a variety of different health issues, including brain disorders, cancer, coeliac disease, diabetes, inflammatory bowel disease, and kidney disease.

This goes hand-in-hand with the principal notion of a regulatory framework that encourages innovation globally for the sake of determining the most suitable pathways in health and disease management. The EU FSMP Regulation—a result of expert input from all member states—provides a well-defined framework, including compositional criteria, specific and relevant provisions on labeling, information, and monitoring of products on the market. FSMPs are not subject to premarket approval. This framework recognizes the flexibility required to accommodate the diversity of medical conditions for which FSMPs are and should be used, based on sound medical and nutritional principles and supported by generally accepted scientific data (e.g., ESPEN guidelines) to meet their intended use for the dietary management of diseases, disorders, or medical conditions.

United Kingdom

Following the UK’s departure from the EU in 2020, referred to as “Brexit,” new regulation is an autonomous matter for both the UK and EU as two separate legal and regulatory systems. After contributing significantly to EU legislation for around 40 years as an EU member state, the post-Brexit UK food, including medical food/FSMP-related requirements, still resemble their EU past. Processes are since solely dependent on UK governmental institutions, including the Department of Health and Social Care, the Advisory Committee on Borderline Substances, and National Health Service.

United States

The US Food and Drug Administration (FDA) is charged with protecting the public health through oversight of drugs (human and veterinary), biological products, medical devices, cosmetics, and products that emit radiation. In addition, it oversees the nation’s food supply, ensuring safety of ingredients and manufacturing processes, and helping the public get accurate, science-based information needed to use medicines and foods to maintain and improve health.

Information from RAPS!

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