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Posted 16 July 2018 | By Cathy Bushell, Manfred Ruthsatz, PhD, RPh, DABT, RAC, FRAPS
This article addresses the 2010-2017 full revision of the regulatory framework in the European Union (EU) for Food for Special Medical Purposes (FSMP) and summarizes key advocacy messages critical to the pragmatic and successful regulation of this special category of foods to ensure their availability to patients and healthcare professionals.
Over the last several decades, there has been a long history for the practical use of Food for Special Medical Purposes (FSMPs) in the EU. Subject to framework legislation in the EU since 1979,1 subsequent, specific harmonized legislation for FSMPs generally reflects the principles laid down in the relevant CODEX standards for food for special dietary use2 and food for special medical purposes.3 Between 2010 and 2017, the EU legislative framework for FSMP has been through a process of in-depth discussion and review, culminating in the publication of two regulations4-6 as well as two guidance documents 7,8 aimed at providing clarification on the FSMP category. Stakeholders involved in the process included the EU Commission, Parliament, Council and Member States, European Food Safety Authority (EFSA), consumer groups, industry associations, healthcare professional and scientific societies.
There were several motivations behind the changes made to the regulatory framework. The introduction of claims legislation in the EU meant there was a new means of communicating the potential nutritional and health benefits of foods for different populations. With the introduction of the food supplement category, there also was some blurring of the boundary between supplements with benefits for “healthy” populations or to combat the normal health effects of aging and the FSMP category intended for dietary management of diseases, disorders or medical conditions.
FSMPs are a food category specially formulated or processed to meet the medically determined nutrient requirements of patients with a disease, disorder or medical condition. Used under the supervision of a healthcare professional, FSMPs form an integral part of patient management across all healthcare settings, including the community, care homes and hospitals.9,10 FSMPs can be either the only source of nourishment or part of the diet for both acute or chronic conditions, from short-term to longer-term use.
FSMPs are for enteral usage (i.e., tube feeds oral nutrition supplements) and regulated as foods, unlike “parenteral nutrition” (i.e., infusion of nutrients directly into the blood circulation), regulated under medicinal law worldwide. Several overviews have demonstrated enteral nutrition can provide clinical benefits and lower healthcare costs by reducing the length of hospital stays and maintaining patients’ independence longer.11-15
Some individuals or population groups require specific nutritional support due to their physiological conditions or the specific diseases from which they suffer. For such individuals, the EU established a harmonized, legal dietetic foods framework in the 1980s, covering the so-called Foods for Particular Nutritional Uses (PARNUTs). This framework was revised in 2013 with the introduction of Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control, known as the Foods for Specific Groups (FSG) Regulation.16 The new FSG Regulation was intended to strengthen provisions on foods for vulnerable populations needing particular protection, such as infants and children up to the age of three, overweight or obese people, people with specific medical conditions and to ensure clear categorization, harmonization and free movement across the EU. The revision took effect 20 July 2016 and the new FSG Regulation repealed and replaced Directive 2009/39/EC (PARNUTs),17 abolishing the concept of “dietetic foods.”
When the FSG Regulation was drafted, there were a number of important elements of the original PARNUTs legislation critical to maintaining a regulatory environment, which could continue to protect vulnerable consumers and at the same time, support innovation and progress in the development of nutrition in healthcare.
Within the FSG Regulation, there is a delegation of powers to the EU Commission to develop the specific technical provisions for each of the categories. In February 2016, the European Commission adopted a new legislative text via a delegated act (i.e., legislative process not involving comitology), covering the specific compositional and information requirements for FSMP. This Regulation (EU) No 2016/128,18 closely reflects the rules previously included in FSMP Directive 1999/21/EC,19 with some additional provisions and some adaptations to reflect the change in the FSG framework legislation.
The EU FSMP Regulation—a result of expert input from 28 Member States—provides a well-defined framework, including compositional criteria, specific and relevant provisions on labelling, information and monitoring for products on the market. This framework allows the development and assessment of products positioned as FSMPs, recognizing the flexibility required to accommodate the diversity of medical conditions for which FSMPs are and should be used in the future. The legislation allows flexibility in formulating such products based on sound medical and nutritional principles, supported by generally accepted scientific data (e.g., European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines),20 to meet their intended use for the dietary management of diseases, disorders or medical conditions.
The following sections describe in greater detail the important advocacy messages and discussion that took place on the FSMP category during all stages of development of the revised legislation.
FSMP is recognized as a specialized category of foods intended for use by vulnerable populations where specific legislation is critical to ensure FSMPs are appropriately labelled and placed on the market. Without this specific category of foods, it is very difficult to provide necessary nutritional support to patients in a healthcare setting. However, FSMPs require appropriate indications for use, an appropriate level of information for healthcare professionals and patients, and a route of access to specific targeted nutritional interventions appropriate to a specific disease or medical condition.
In Europe, the existence of robust legislation for FSMP provides a framework and regulatory category can form the basis for national reimbursement laws and ensure access to nutritional interventions for patients, interventions that both improve their nutritional status and their disease outcomes, adding value within the healthcare systems.21
FSMPs are defined in Article 2(2)(g) of framework Regulation (EU) 609/2013.
“FSMP means food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolize or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone.”
This definition is broad enough to encompass the wide variety of FSMP necessary to meet the needs of the many diseases, disorders and medical conditions and benefit patients by allowing innovation in areas where nutrition will play a future role in disease management.
The definition is further supported by describing three categories of FSMP—nutritionally complete standard, nutritionally complete nutrient adapted and nutritionally incomplete. The existence of the “nutritionally incomplete” category is essential as it includes valuable products for the dietary management of rare, inherited metabolic disorders, dysphagia and other complex nutritional interventions, such as intractable epilepsy.22
However, it has been recognized that, although harmonized, interpretative differences in the FSMP definition across the EU Member States would impact the EU internal market’s functioning and potentially the integrity of the category. Accordingly, the European Commission, in consultation with multiple stakeholders, such as national experts, regulators, policy makers, EU parliamentarians, industry associations, scientific societies, European Food Safety Authority and consumer representatives have implemented several safeguards to ensure robust regulation and monitoring of FSMPs.
This notice is a guidance document aimed at Food Business Operators (FBO) and member state national authorities with the objective of striking a balance between ensuring the boundaries of the FSMP category are interpreted narrowly within the context of the total food and food supplement market while recognizing that nutritional science will continue to develop for use in the management of other disease areas.23
During development of the guidance and consultation with stakeholders, a number of key principles were established, critical to the concept of FSMP:
A new provision in the FSG Regulation, Article 3 permits the Commission, at its own discretion, to make a determination and implement a decision as to whether a food falls within the scope of the FSG Regulation and if so, in which category. However, the Commission clarifies in its notice on classification24 that this Article 3 process is not intended to replace the current regime, which permits food business operators to market foods on the basis of their own determination as to compliance with the FSMP definition, and leaves national authorities with the general responsibility for enforcing food law.
The Commission notice also states that, taking into account considerations of subsidiarity and proportionality of EU action and the role of the Commission as guardian of the application of EU law, Article 3 should be considered as a complementary solution for making decisions on cases in which Member States' divergent approaches on the same product might hinder the free circulation of goods in the internal market. It is not a tool to systematically classify all FSMP at EU level. Article 3 is therefore intended for exceptional use and not used to replace the normal notification process and decision-making at national level.
In the context of introduction of Article 3, following a request from the European Commission in 2015, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) issued a scientific and technical guidance on FSMPs.25 It presents a common format and outlines the data potentially included in a dossier as well as the key issues the dossier should address to assess whether a food product notified as an FSMP falls under the regulation’s scope based on its proposed use.
Exceptionally, the Commission may request the EFSA’s opinion as to whether there is sufficient evidence to support the positioning of a specific product as being qualified to be classified as FSMP. The scientific and technical dossier aims to address key issues listed below that may need to be considered by the EU Commission in implementing a decision under Article 3:
There are a number of important elements considered within the guidance critical to the concept of FSMP. These elements are also addressed in the EU Commission Notice26 outlined above and used, for example, to characterization of the disease, the patient, their related nutritional requirements and the role of the FSMP product in meeting those requirements. These elements can be considered as part of the Distinct Nutritional Requirements (DNRs) of the disease and also included within the US Food and Drug Administration’s (FDA) definition of a medical food.27,28
Another important element is the need for the FSMP to be “used under medical supervision,” which may be for the initial prescription of the regime, the ongoing monitoring of the use of the FSMP, ongoing evaluation of outcome such as body weight/composition and/or monitoring of biomarkers, such as blood biochemistry, related to the adequacy of the nutritional intervention. The term “medical supervision” is clarified in the FSMP Regulation (Whereas 3)29 to mean ‘with the assistance of other competent health professionals.’
The final and critical element of the definition is that the patient’s requirement cannot be met by modification of the normal diet alone. However, clarification is given that a theoretical ability to modify food intake to achieve the required nutritional intervention is not pragmatic. Too, the judgement as to whether it is possible to achieve the desired intake using normal foods or food supplements also needs to consider the safety and practicality of feeding the sick individual along with the clinical advantage to the patient of being able to achieve an appropriate level of intake using an FSMP that is specially designed to meet their needs. A good, practicable example of this is the use of FSMP in the ketogenic diet for the dietary management of epilepsy.30 While it is theoretically possible to modify the diet using normal foods, in practice, it is extremely difficult, especially where patients are disabled or have behavioural challenges. The use of FSMP offers opportunities to achieve compliance with a difficult dietary regime and therefore, provides a positive clinical advantage to the patient.
The composition of FSMP may differ substantially depending on its intended use, among other things, such as the specific disease, disorder or medical condition it is intended to manage as well as patient age and where patients receive healthcare support. Because of the wide diversity of FSMPs, the rapidly evolving scientific knowledge on which they are based, and the need to ensure adequate flexibility to develop innovative products, it is not appropriate to lay down detailed compositional rules for such products. However, it is important to set principles and specific requirements to ensure they are safe, beneficial and effective for the patients for whom they are intended, based on generally accepted scientific data.
Article 2(2) of the FSMP Regulation31 states that FSMPs’ formulation shall be based on sound medical and nutritional principles and shall be safe, beneficial and effective in meeting the specific nutritional requirements of the persons for whom they are intended, as demonstrated by generally accepted scientific data. This means an FSMP’s composition/formulation should be supported by a strong nutritional and medical rationale and substantiated in the scientific literature. Specific clinical trials may not be required for FSMPs if there are adequate data available in the public domain to support their composition and use.
FSMPs can be classified in a variety of categories depending on whether their composition is standard or adapted specifically for a disease, disorder or medical condition and whether they constitute the patient’s sole nourishment source. The FSMP Regulation (EU) 2016/128 differentiates FSMPs into three categories, depending on their intended use as:
Minimum and maximum values are set for micronutrients (vitamins and minerals) in Annex 1 of Regulation (EU) No 2016/128. Part A includes compositional criteria for FSMPs intended for infants up to 12 months of age, with Part B criteria for 1–10 years of age and adults. These criteria are set primarily to ensure FSMP used as the sole source of nutrition for a patient over a period of time contain sufficient and safe levels of essential nutrients. However, for both categories (b) and (c), there is flexibility, based on the product’s specific intended use, to deviate from the compositional criteria laid down in Annex I. The need for deviation may be related to the specific nutritional requirements of the disease, disorder or medical condition for which the product is formulated or how it will be used with the patient’s diet.
Based on a sound medical and nutritional rationale, this principle of deviation from the nutrient ranges in the Annex, is critical for providing the level of compositional flexibility required to accommodate the many types and uses of FSMP for patients requiring a variety of nutritional interventions. A justification for any nutrient deviations may be required as part of the notification process, but there is no requirement for a specific approval for products deviating from compositional norms.
One key provision within the European regulations is a specific recognition for the need to communicate information to Healthcare Professionals (HCP).
Article 9 of the FSG Regulation states although FSMP products cannot make claims around the treatment, prevention or cure of disease, there is a requirement to provide information useful for HCPs to evaluate suitability for patients. To ensure appropriate recommendation and use of FSMP products, it is necessary to communicate information that would not be acceptable for or understood by an audience of patients or the general public.
FSMPs are an important tool for HCPs to support their patients. They are often developed alongside HCPs to cover an identified unmet need in the patient population. It is important that HCPs can be fully informed about the product composition, the clinical rationale and supporting evidence, the appropriate use, preparation, and intended target population, without the restrictions generally placed on communication to the general public. Similar to specifying the use under “medical supervision” (FSMP Regulation), a “healthcare professional” is defined in the FSG Regulation (Article 9),32 as referring to “useful information or recommendations exclusively intended for persons having qualifications in medicine, nutrition, pharmacy or for other healthcare professionals responsible for maternal care and childcare.”
Unless otherwise specified by a specific derogation within Regulation (EU) 2016/128, an FSMP shall comply with all mandatory aspects of the general food labelling Regulation (EU) 1169/2011 on food information to consumers.33 Given the specific intended use, there are distinct additional mandatory labelling particulars for FSMP, the most important of which:
Nutrition information is mandatory for FSMP and should follow the general rules laid down in Regulation (EU) No 1169/2011 for all foods. There are, however, some additional provisions within Article 6 of the FSMP Regulation taking into account the need for relevant information for the healthcare professional and/or the patient using the product.
Both patients who consume FSMP products and HCPs who recommend them to ensure their safe and efficacious use, require appropriate, factual information on the FSMP. The recent legislative revision introduced a prohibition for FSMP on the use of nutrition and health claims to consumers (Article 7 of Regulation (EU) No 2016/128). In principle, nutrition and health claims are intended to inform healthy consumers regarding the potential nutritional and health benefits of general foods. However, it is essential that the regulation of FSMP allows a description of key elements in the formulation and about nutritional content that make it suitable for the patient, but without this information being considered nutrient-content claims.
Article 5(g) of the FSMP Regulation34 requires mandatory indication of the product’s properties and characteristics, such as any special processing and formulation, nutritional composition and rationale of the product’s use that make it useful for its intended purpose. Whereas Article 14 clarifies that information on the product’s properties and characteristics is not considered as nutrition and health claims within the meaning of Regulation (EC) 1924/2006.35 This provision allows appropriate communication of product content to all stakeholders, especially for products whose intended use requires a composition containing fiber, no fiber or which are high in protein.
The FSG Regulation introduces a new provision for rules regarding labelling, presentation, advertising and promotional and commercial practices for FSMPs intended for infants, age 0–12 months, similar to those applicable to infant formula and follow-on formula. However, there is recognition that it is not appropriate to restrict factual information on FSMP intended for infants and the rules need some adaptations to take into account the specificities of use (Whereas 18).36
Labelling, presentation and advertising of FSMPs intended for infants shall not include pictures of infants and it is important for the consumer to be able to make a clear distinction between FSMPs and infant versus follow on formula. Since FSMPs are intended to be used under medical supervision, the necessity to communicate with healthcare professionals is recognized, allowing them to assess different products’ suitability for their intended use as well as provide appropriate information about the critical use and compositional information to patients and care providers. This is clarified in Article 8(4) on advertising37 where it states that restrictions shall not prevent the dissemination of information exclusively intended for healthcare professionals. It is also recognized (Whereas 18)38 that product provided for professional evaluation with patients is a necessary part of healthcare practice in assessing the suitability for a particular infant.
Because of the wide diversity of food for special medical purposes, the rapidly evolving scientific knowledge on which it is based, and the need to ensure adequate flexibility to develop innovative products, it is not appropriate to lay down detailed compositional rules’ for FSMPs (Whereas 5).39 This flexibility in composition ensures availability of innovative products for patients to ensure improved nutritional status and outcomes in disease.
However, where legislation needs amendment to encompass an innovation, the process can be very lengthy, even when the scientific or safety evaluation has been completed. It is important to ensure that innovation is not hampered by subsequent extended administrative processes. Within the previous PARNUTs legislation40 the so called “innovation clause” (Article 4(2)) permitted the placing on the market of a FSMP for a period of two years during which time the legislation was amended to incorporate an innovation, such as a new ingredient or composition.
In the FSG Regulation (EU No 609/2013), power to amend technical aspects of the legislation is delegated to the European Commission as the key stakeholder. In order to enable consumers to benefit rapidly from technical and scientific progress, especially in relation to innovative products, and thus to stimulate innovation, the power to regularly update the specific requirements on compositional and informational requirements for FSMP is delegated to the EU Commission, who take into account all relevant data. (Whereas 39)41
The FSG Regulation maintains the requirement for notification with a model of the label when placing a FSMP on the market. The purpose of notification is to inform the competent authority that the product has been placed on the market in their country so that official monitoring activities can take place. This also allows the authority to make a determination of whether they agree with the FBO that the product falls within the FSMP category.
There is no premarket notification or authorization required for FSMP as it is the responsibility of the FBO in the EU to determine that a food product is safe and appropriate for its intended use.42
The regulated labelling requirements ensure that both the HCP and the patient are well informed about the product and its appropriate use. Compositional criteria included in the annex of the FSMP Regulation ensure that FSMP that may be used as a sole source of nutrition contain safe and adequate levels of nutrients. Sources of nutritional substances, permitted technical additives and non-intentional contaminants are regulated within both the FSG and the general food legislation. These robust regulatory measures ensure that FSMP products are safe and fit for their intended use and preclude the requirement for a prior authorization.
FSMPs have been shown to lower healthcare costs by reducing hospital stays and maintaining patients’ independence longer.43 While legislation on FSMP composition and labelling is harmonized across the EU Member States, there is no harmonization of healthcare systems. Thus, reimbursement is based on national, regional or local health organizations and budgets. The criteria for FSMP reimbursement approval can vary by region or by province and may be based on composition or provision of scientific rationale and/or health economic evidence.
In most EU Member States, many products notified as FSMPs are reimbursable as part of local healthcare systems and public or private payers. This provision typically includes nutritionally complete FSMPs serving as sole nutrition sources. Reimbursement levels also may be based on specific compositional criteria, such as protein, energy level, or fibre per specific categories (e.g., infants/adults, hydrolysed/non-hydrolysed proteins), or according to national guidances.44,45 Apart from products designed for disease-related malnutrition, reimbursement also may be available for specific FSMPs aimed at managing a range of diseases or medical disorders such as:
The existence of a specific category for FSMP provides a robust framework for the national regulation of reimbursement and for the evaluation of products that will be funded by the healthcare system to support and improve patient outcomes.
FSMP is a specialized and relatively small food category, particularly in the dietary management of rare disease. FSMPs provide a high value to patients, typically serve as a prerequisite to reimbursement and given their cost-efficiency, set a strong signal for a holistic approach to reducing costs in disease management. There is significant European expertise in R&D and manufacturing within the FSMP category. However, the feasibility of manufacture and supply of these specialized products is dependent on harmonization or convergence of rules. Global alignment on the categorization and definition of FSMP and its regulatory context can optimize access to nutritional care for patients, both inside and outside of the EU.
The full revision of the regulatory framework in the EU for Food for Special Medical Purposes with the consultation of all vested stakeholders, resulted in an improved, more practical interpretation of the existent EU FSMP regulation. During the seven-year revision period, key messages and interpretations were maintained or newly introduced in regulations or guidance documents (EFSA; EU Commission) were critical to the pragmatic and successful regulation of this special category of foods to ensure their availability to patients and healthcare professionals. It may serve as a positive benchmark of how multiple stakeholders can work together to benefit the concerned targeted patients.
Cathy Bushell is the head of regulatory affairs at Vitaflo International, UK. Coming from a dietetic background and having practiced as a clinical dietitian in the NHS, she has worked in the medical nutrition industry for more than 20 years, in both R&D and regulatory affairs/advocacy. With a leading role in European industry groups, over the last 10 years she has focused on development of the European regulatory framework for FSMP. She may be contacted at firstname.lastname@example.org.
Manfred Ruthsatz, PhD, RAC, FRAPS, is the global head regulatory advocacy at Nestlé Health Science, Switzerland. His healthcare regulatory experience, rounded out by quality, safety, vigilance, health economics and reimbursement, spans more than 25 years in diverse healthcare industry settings, in the US FDA’s CDER and NIH. His publishing and speaking activities in Europe, US, Asia and Latin America include a wide range of regulatory and policy-related healthcare topics with a focus on the health and disease continuum and global convergence. He may be contacted at email@example.com.
Disclaimer: this article reflects the personal opinion and experience of the authors. By no means can it be construed as an official position by any organization with which the authors are affiliated.
Cite as: Bushell C and Ruthsatz M. “Revising the EU FSMP Regulatory Framework: Laying the Foundation for Future Nutritional Patient Care". Regulatory Focus. July 2018. Regulatory Affairs Professionals Society.
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