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

Feature Articles

| 31 August 2022 | By Manfred Ruthsatz, PhD, RAC, FRAPSJunshi Chen, MDChunzhu Wu, MScTimothy Morck, PhD 

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This two-part article covers the precise necessities for putting meals for particular medical functions (FSMPs) available on the market in main jurisdictions – EU, UK, US, China, and different areas of the world – to enhance the position of diet in help of optimum look after sufferers. Part 1 covers common rules governing FSMPs, use of FSMPs in group and hospital settings, frequent regulatory challenges, alternatives for class progress, and considers a multistakeholder initiative for optimum diet look after all. Part 2 presents a worldwide overview of the regulatory framework for medical meals/FSMPs within the aforementioned international locations and areas.
 
Keywords – FSMPs, world coverage, medical meals, diet, affected person care, regulatory synopsis
 

Introduction

Foods for particular medical functions, or FSMPs, are often known as medical meals in some non-EU international locations (e.g., US, Argentina) or as enteral diet (e.g., Brazil), can be generally utilized by healthcare professionals. FSMPs are specifically formulated and processed for the dietary administration of sufferers with a illness, dysfunction, or medical situation, that’s, meant to be used below medical supervision for sufferers. FSMPs have a longstanding historical past of sensible utilization over the past many years, laying a basis for dietary affected person care.1 FSMPs could represent a affected person’s sole supply of nourishment over quick or prolonged intervals or could complement his or her common weight-reduction plan, administered by way of tube feeding or as an oral dietary complement (ONS). Gaining traction because of their potential help in well being and illness administration, FSMPs are topic in precept to common meals laws, together with good manufacturing observe (GMP), and have to be secure as labeled for his or her meant use, make truthful, not deceptive claims and are topic to novel meals, contaminants, components, and packaging laws, to call only a few.
 
FSMPs, as they’re recognized within the EU, by Codex Alimentarius and most international locations on the planet, or medical meals within the US, are outlined broadly as a class of meals which are specifically processed or formulated and offered for sufferers’ dietary administration and used solely below medical supervision. Overall FSMP or medical meals rules, their definitions, constraints, and alternatives, present outstanding similarities throughout a number of international locations. This article presents an outline of the worldwide medical meals/FSMP regulatory framework, with a concentrate on Codex Alimentarius, the US, the EU (Table 1).
 

PART 1
General rules of medical diet and its regulatory setting

Originally, given the shortage of a sophisticated regulatory framework because the Nineteen Sixties, these specialised medical meals or FSMPs had been historically ruled by drug rules.2 Over the previous a number of many years; nonetheless, they’ve more and more been characterised below meals legal guidelines worldwide. An FSMP is meant for the unique or partial feeding of sufferers with restricted or impaired capability to take, digest, take up, or metabolize peculiar foodstuffs or sure vitamins contained therein; or produce other particular medically decided nutrient necessities and whose dietary administration can’t be achieved solely by modifying the traditional weight-reduction plan.
 
FSMPs are for enteral utilization, together with tube and sip feeding or oral dietary supplementation (ONS). They are regulated as meals, to not be confused with parenteral diet (i.e., infusion of vitamins immediately into the blood circulation), which is regulated below medicinal regulation.
 
Despite a rising physique of proof on the advantages of FSMPs, their utilization just isn’t reaching its full potential and dealing with challenges in areas worldwide. On the one hand, this can be because of the obvious “frontier state of affairs” for meals for medical functions with the necessity to construct consciousness and educate all vested stakeholders. On the opposite hand, regional variations in regulatory frameworks could contribute to this fundamental dilemma. US regulators and payers seem to use a intentionally slim interpretation to restrict medical meals utilization largely to enteral tube feeds and for inborn errors of metabolism, but seldom reimburse oral diet dietary supplements. The EU has developed a realistic method when revisiting the whole meals for particular group (FSG) framework for weak populations, abandoning the idea of meals for particular dietary makes use of (FSDU), but together with a patient-oriented interpretation relating to FSMPs. In Asia, a slowly evolving FSMP framework in key international locations faces points reminiscent of lack of expertise and wide-spread healthcare reimbursement techniques outdoors of hospitals, and a major prevalence of parenteral diet utilization over enteral diet.
 
The regulatory standards {that a} medical meals/FSMP be uniquely formulated to deal with distinctive dietary necessities of sufferers with a illness or situation, outdoors regular dietary modification, is gaining evidence-based help because the dietary science group reconsiders the which means of “requirement” past avoidance of historic nutrient deficiency syndromes. Technological advances in analytical checks allow extra delicate diagnostics to characterize nutrient adequacy or impairment on the organ, tissue, and even mobile degree. Accelerating innovation in medical meals analysis, with willingness of regulatory our bodies to adapt definitions as science advances, will allow healthcare professionals and funding businesses to manage and reimburse these secure, cost-effective, and needed merchandise which are more and more proven to enhance high quality of life for sufferers whereas contributing higher well being financial outcomes. Current challenges are given, together with sensible alternatives to enhance the position of diet in help of optimum look after sufferers.
 

FSMPs in group and hospital settings

FSMPs are used throughout varied healthcare settings, in group and care properties and hospitals. Enteral diet can present medical advantages and decrease healthcare prices by lowering hospital stays and sustaining sufferers’ independence longer. Similar outcomes had been proven for specialised ONS in varied settings.3-5
 
In the US, medical meals protection is state- and disease-dependent. Each state regulates merchandise and illnesses that will need to have protection below state legal guidelines in another way, together with federal plans. Medicare covers some medical meals merchandise for inpatients in acute care and in long-term care services for the primary 100 days. For outpatients, Medicare covers enteral diet for long-term use by way of tube feeding solely after the preliminary 100 days in a long-term care facility; but ONS aren’t lined. Commercial plans apply totally different protection insurance policies for medical meals within the US.
 
In the EU, reimbursement is predicated largely on various nationwide, regional, or native protection guidelines, which could embody particular compositional standards (e.g., protein, power degree, fiber). Beyond FSMPs for disease-related malnutrition (e.g., quick bowel syndrome), reimbursement additionally could also be attainable for FSMPs for dietary illness administration, reminiscent of toddler allergic reactions to cow’s milk protein, inborn errors of metabolism (e.g., phenylketonuria, maple syrup urine illness).
 

Common regulatory challenges

There are frequent components of medical meals/FSMP rules throughout the globe supporting the wants of a number of stakeholders. Healthcare professionals want clear, scientifically legitimate, detailed product data to help medical judgment on which sufferers would profit, and what medical situations are addressed by specifically formulated dietary merchandise. Manufacturers want well-defined rules setting out affected person/illness eligibility standards, requirements for GMP and any registration or approval processes to confidently produce and market the product. Regulatory our bodies rely upon analysis and medical scientists to characterize distinct dietary necessities of assorted illnesses requiring specifically formulated FSMPs to compensate for the lack of straightforward weight-reduction plan manipulation to realize. But, as already said, a extra built-in physiologic, metabolic, and mobile understanding is required of how dietary “bio-active substances” contribute to well being and even rebalance unhealthy conditions ensuing from illness. This ought to embody beforehand outlined vitamins, with every day necessities established for the final “wholesome inhabitants” however advancing analysis proof now means that dietary sources of enzymes, substrates, and metabolically energetic elements must also be thought of. Government or third-party healthcare payers should take into account FSMPs as a vital part of illness administration to justify reimbursement for the upper value of specialised substances in comparison with typical “meals.” Together, when all have the affected person’s final result as their major focus, mutual advantages to bigger built-in healthcare techniques could also be attainable. Benefits anticipated from focused dietary help embody decreased prices related to shorter hospital size of keep because of faster restoration from acute sickness or surgical procedure; simpler therapeutic interventions because of higher metabolic help from correctly nourished sufferers; ample monetary incentives to drive innovation for improved FSMPs addressing malnutrition or illness administration extra successfully, and finally, improved affected person high quality of life.6
 
Certain challenges exist that can require multistakeholder consideration in a coordinated option to overcome. A number of examples of those challenges limiting a extra speedy enlargement of applicable medical meals/FSMP use are proven under, although this record is on no account exhaustive:
 

  • Establishing with key opinion leaders, analysis scientists, clinicians, and affected person teams whether or not specifically formulated dietary merchandise are wanted in particular illnesses, when alteration of the traditional weight-reduction plan is inadequate, together with the popularity that the usage of an FSMP could be of medical profit past simply correcting a nutrient deficiency from insufficient dietary consumption. This additionally consists of attainable advantages for sufferers with power illnesses not historically thought of for dietary intervention (e.g., neurological issues).
  • Realigning priorities that take into account nontraditional analysis designs (e.g., unethical randomization to placebo management; small affected person populations with illnesses, reminiscent of inborn errors of metabolism (IEM); and complexity of metabolic interactions with medicine and/or the microbiome) and place better emphasis on medical dedication of affected person suitability for dietary administration of their illness. Evidence of affected person profit from secure FSMP administration ought to drive regulatory acceptance, not be restricted by it.
  • Recognizing that there are circumstances by which it might be inconceivable, impractical, or unsafe for sufferers to solely devour foodstuffs that aren’t an FSMP, emphasised in official EU tips.7
  • Redefining the position of the affected person as a client and more and more turning into an energetic participant in their very own healthcare choices that may affect compliance with FSMP medical suggestions.8
  • Characterizing what facet of dietary help must be overcome/corrected with the intention to meet a affected person’s dietary wants, reminiscent of larger nutrient ranges to compensate for decreased digestion/absorption; enteral tube feeding when oral consumption is contraindicated; hydrolyzed proteins or peptides when digestive enzymes are insufficient; decrease ranges of key vitamins if their metabolism is impaired, leading to buildup of poisonous wastes; or better nutrient density when quantity administered is of concern.
  • Speeding up the method of validating “omic” biomarkers offering perception into metabolic and physiologic processing of vitamins, precursors, and energetic metabolites to extra carefully handle FSMP effectiveness in sufferers. It finally additionally could require redefining what constitutes a affected person sooner or later, e.g., whether or not individuals recognized with a genetic pre-disposition to a illness are thought of (potential) sufferers.9
  • Increasing diet analysis funding to validate the significance of FSMPs in illness administration
  • Including influence on general “value of care” in potential research by capturing well being financial final result information in massive medical trials to show cost-effectiveness and justify larger reimbursement charges not tied to energy as presently seen in some international locations

 
These are a pattern of points limiting progress of the medical meals market, each in massive and smaller international locations. Importation of merchandise from main international locations into lesser-developed international locations is frequent however assembly the standards for registration with authoritative our bodies requires comparable information so the challenges are, primarily, world in nature.
 

Opportunities for class progress

New rising developments in science will have an effect on the observe of recent medication and the character of affected person care, with a possible influence on regulatory frameworks at a quicker tempo than ever earlier than. For occasion, new instruments utilizing “omics” platforms to discover the interrelationships between genes, proteins, metabolism, environmental elements, and the intimate relationship with the microbiome are advancing the understanding of hyperlinks between meals, well being, and illness.10 It emphasizes the complexity of this relationship, making the analysis of the influence on anybody dimension tougher. Further advances in diagnostics will affect how we outline the long run journey from well being (customers) to illness (affected person), resulting in a extra particular, personalised diet method. Linking a number of observations collectively is the sphere of bioinformatics, making use of huge information applied sciences, together with likelihood calculations and a few degree of uncertainty, that can affect our future approaches in find out how to launch new merchandise for the person, reminiscent of medical meals and FSMPs, with the good thing about science-based dietary illness administration formulated, and meant to learn every affected person and enhance general healthcare outcomes. If key scientific, medical, and policymaking stakeholders can align on a patient-centric healthcare mannequin, incentives to speed up progressive medical diet formulations focusing on dietary administration of sufferers with varied illnesses ought to observe.
 
While the challenges to reaching full potential of medical meals/FSMPs in superior affected person and illness administration could seem to hinge on both the pliability or constraints inside the regulatory framework, progress is being made with a multistakeholder method.
 
The dietary science group consists of analysis specialists working to ascertain and validate extra delicate biomarkers of nutrient adequacy, inadequacy, and even optimum ranges. Compared to previous practices of building nutrient necessities based mostly on epidemiologic fashions of wholesome folks, individualized diet, and personalised medication fields are advancing quickly. This is required to fulfill medical meals/FSMP standards that sufferers who aren’t wholesome do, certainly, have necessities for sure vitamins, that differ from regular people.
 
There is a rising willingness to just accept “n-of-1” research design, by which every analysis affected person serves as their very own management for a time period, then is given the therapeutic check product, and final result markers on the finish of every interval are in contrast. In this manner, particular person variation in metabolic, genetic, and dietary components are higher accounted for than when in comparison with others within the research, which can have very totally different physiologic baselines.11
 
Medical practitioners will rapidly undertake promising therapies when proof of efficacy is demonstrated by medical information. Together, and after amassing information on well being financial outcomes for sufferers receiving FSMPs along with different medical remedies, the cost-effectiveness of secure, acceptable, specialised dietary merchandise will turn out to be evident. Providing market incentives to stimulate extra progressive, food-based, specifically formulated merchandise that fall inside the expanded definition of individualized dietary help advantages all sectors. A present instance of how this could work is proven under.
 

Multistakeholder initiative to attempt for optimum diet look after all12

Disease associated malnutrition is a major, typically nonetheless unrecognized challenge in Europe in addition to different elements of the world. The European Nutrition for Health Alliance (ENHA) pushed Optimal Nutritional Care for All (ONCA) multistakeholder initiative is an ongoing concerted real-life instance to beat complexities in public well being to make sure that “each affected person who’s malnourished, or susceptible to undernutrition, is systematically screened and has entry to applicable, equitable, high-quality dietary care.”
 
Key to the ONCA marketing campaign’s progress is aligning various stakeholders, reminiscent of healthcare professionals, sufferers, trade associations, and public authorities in a number of focus international locations behind a standard purpose to kind a nationwide alliance and develop a dietary care plan to facilitate better malnutrition screening and dietary care implementation, which embody FSMPs, and actively promote public consciousness, applicable reimbursement insurance policies and medical training.

Conclusion for Part 1

A overview of medical meals and FSMP rules, their constraints however alternatives, exhibits outstanding similarities throughout a number of international locations. The alternative for stakeholder engagement with improved high quality of healthcare and patient-centered outcomes is rising. Each sector, be it medical, analysis, regulatory, affected person, trade, or payers, advantages when speaking about the advantages of improved affected person diet derived from specialised medical meals/FSMPs.

PART 2

Global regulatory frameworks for medical meals/FSMPs
This part presents an outline of the regulatory frameworks for medical meals/FSMPs within the EU, US, China, Codex Alimentarius, in addition to Brazil, Canada, South Africa, Australia/New Zealand, Japan, India, Turkey, the Middle East, and the Association of Southeast Asian Nations (ASEAN) member states.
 
It must be famous that the next sections present a glimpse – with no expectation of completeness or coherence – of FSMP rules (if current) in key international locations or areas worldwide. It demonstrates that FSMPs are based mostly on a meals regulatory framework with some outstanding similarities, however that additionally it is  advanced and various. All FSMPs are required for use below medical or healthcare supervision. That requirement isn’t a surprise on condition that their meant position is to handle the dietary features of illness, which has turn out to be a brand new frontier for enhancing the position of diet.
 
Where attainable within the References part of this text, hyperlinks are supplied to English paperwork. However, some rules can be found solely within the authentic, regional languages, and in these circumstances, the hyperlinks go to the unique language paperwork.
 

European Union

FSMPs have a long-standing historical past and sensible utilization within the EU. In 2013, the authorized framework for FSMPs was revisited inside the Foods for Specific Groups Regulation (EU) 609/2013,13 harmonized throughout EU member states. Well anchored inside meals regulation (Regulation (EC) 178/2002),14 the FSG regulation changed the idea of dietetic meals established by the meals for specific dietary makes use of (PARNUTs) framework directive in 1989. FSMPs aren’t topic to premarket approval. The laws permits flexibility in formulating such merchandise based mostly on sound medical and dietary rules (e.g., European Society for Clinical Nutrition and Metabolism [ESPEN] tips 15) to fulfill their meant use for the dietary administration of illnesses, issues, or medical situations. FSMPs are for use below medical supervision, meant for the unique or partial feeding of individuals whose dietary necessities can’t be met by regular meals. Regulation (EU) 2016/12816 has revised the precise compositional and data necessities for FSMPs. This framework permits the event and evaluation of merchandise positioned as FSMPs, recognizing the pliability required within the rules and their interpretations to accommodate the variety of medical situations for which FSMPs are presently used and must be used sooner or later.
 
Framework regulation of FSGs
Some people or inhabitants teams require particular dietary help because of their physiological situations or the precise illnesses from which they undergo. The FSG Regulation is meant to strengthen provisions on meals for outlined weak inhabitants teams needing specific safety (Article 1):
 

  • Infant and follow-on formulae,
  • Processed cereal-based meals and different child meals,
  • Food for particular medical functions, and
  • Total weight-reduction plan alternative for weight management.

 
Various FSG Regulation articles are particularly related to FSMPs:
 

  • Article 2(2)(g) comprises the authorized FSMP definition.
  • Article 3 permits the European Commission (EC) to make interpretation choices as as to if a product falls inside the FSG Regulation’s scope and, if that’s the case, by which class it belongs.
  • Article 9 units down common compositional and data necessities relevant to all FSG classes. It additionally clarifies the labeling, presentation, and promoting guidelines, significantly just about properties of stopping, treating, or curing a human illness and shall not forestall dissemination of helpful data and suggestions meant for HCPs (i.e., individuals with {qualifications} in medication, pharmacy, or diet, or these liable for maternal and little one care).
  • Article 11 units down the areas by which the EC ought to undertake particular guidelines for meals class composition and labeling inside the regulation’s scope.
  • Articles 15 and 16 embody the necessities for a Union record of gear that could be added to meals for particular teams. The annex comprises the Union record of permitted substances, which incorporates sources of nutritional vitamins, minerals, amino acids, carnitine and taurine, nucleotides, choline, and inositol.

 
EC discover on FSMP classification17
Although harmonized, it has been acknowledged that the FSMP definition could also be interpreted in another way throughout the EU member states, and interpretative variations would influence the EU inside market’s functioning and affected person care, respectively. The EC therefore issued a steering doc aimed toward meals enterprise operators (FBOs) and member state nationwide authorities, with the target of putting a stability between guaranteeing the boundaries of the FSMP class are interpreted narrowly inside the context of the full meals and meals complement market whereas recognizing that dietary science will proceed to develop to be used within the administration of different illness areas. During improvement of the steering and session with stakeholders, quite a few key rules had been established, vital to the idea of FSMPs:
 

  • All components of the FSMP definition have to be considered, and no single ingredient must be thought of in isolation to incorporate or exclude a product from the classes of particular processing and/or formulation.
  • Use in partial or unique feeding of sufferers and below medical supervision (i.e., advice of a professional HCP) for the dietary administration of sufferers, who because of their illness, dysfunction, or medical situation, have medically decided nutrient necessities, and people medically decided nutrient necessities can’t be met by modification of the traditional weight-reduction plan alone.
  • The measure of whether or not it’s attainable to realize the required dietary consumption by modification of the traditional weight-reduction plan have to be thought of within the context of the affected person and the challenges of their illness, dysfunction, or medical situation.
  • FSMPs may also provide dietary and medical benefits to sufferers over and above modification of regular weight-reduction plan and this too have to be thought of. It could be inconceivable for some sufferers to fulfill their necessities by way of regular meals, however it additionally could be unsafe, impractical, or disadvantageous to change sufferers’ diets to fulfill the dietary calls for of their illness or medical situation, and FSMPs present a realistic resolution.

 
EFSA steering on Article 3 interpretation choices7,13
A provision within the FSG Regulation (Article 3) permits the EC to find out whether or not a meals falls inside the scope of FSG or one in every of its classes. Article 3 is meant for distinctive use and isn’t meant to switch the final guidelines at nationwide degree, which allow FBOs to market meals on the premise of their very own dedication as to compliance with the FSMP definition and leaves nationwide authorities with the final accountability for implementing meals regulation.
 
When there’s uncertainty whether or not a product is taken into account an FSMP, a nationwide competent authority could request the EC to interpret and determine, by the use of implementing acts as outlined in Article 3, Regulation (EU) 609/2013, to which particular class a given product belongs to make sure uniform implementation throughout the EU. In this context, the European Food Safety Authority’s (EFSA’s) panel on dietetic merchandise, diet and allergic reactions supplied scientific and technical steering on FSMPs. It presents a standard format and descriptions the info in addition to the important thing points to be addressed within the file to evaluate the extent to which a meals product notified as an FSMP falls below the scope of the regulation, based mostly on its proposed use.
 
The EC could ask EFSA to deal with the extent to which the precise meals product and illness, dysfunction, or medical situation is characterised sufficiently for its classification as an FSMP. It considers the impossibility or issue of taking, digesting, absorbing, metabolizing, or excreting peculiar foodstuffs or sure vitamins, and particular medically decided nutrient necessities that can not be glad fairly or realistically by modifying the traditional weight-reduction plan, that’s, whether it is inconceivable, impractical, or unsafe for sufferers to devour solely foodstuffs (together with fortified meals and meals dietary supplements) that aren’t FSMPs or whether or not such sufferers would have dietary or medical disadvantages. The steering will probably be up to date, as applicable, within the mild of future expertise gained.
 
EFSA’s scientific and technical steering goals to deal with key questions, which the EC could must think about with the intention to take choices below Article 3. The questions deal with:
 

  • Whether the precise meals product is sufficiently characterised;
  • The extent to which the illness/dysfunction/medical situation for which the precise product is meant is sufficiently characterised;
  • The extent to which sufferers affected by the precise illness, dysfunction, or situation
  • Are unable to (or have issue) taking, digesting, absorbing, metabolizing, or excreting peculiar foodstuffs, or sure vitamins contained therein, or metabolites; or
  • Have particular medically decided nutrient necessities, typical to the illness, dysfunction, or situation that can not be fairly or realistically glad by modifying the traditional weight-reduction plan;
  • The product’s particular position within the dietary administration of the illness, dysfunction, or meant situation, significantly the extent to which the precise product is totally different from or extra appropriate than non-FSMP meals (i.e., together with meals dietary supplements and fortified meals), considering the product’s composition, manufacturing course of, bodily kind, mode of administration, sample of consumption, meant use, and the proposed directions of use;
  • The extent to which the usage of the precise meals product is critical or extra sensible or safer than the unique use of foodstuffs that aren’t FSMPs, and/or has a dietary or medical benefit for the affected person, and the the reason why it must be administered below medical supervision; and
  • Whether there are any potential restrictions of use.

 
Notification
An authorization just isn’t required earlier than putting the FSMP available on the market. The FBO should notify the competent authority of every member state the place the product is being marketed, by sending a mannequin of the label used and another data the Competent Authority fairly could request to ascertain compliance with this regulation, except a member state exempts the meals enterprise operator from that obligation below a nationwide system that ensures an environment friendly official monitoring of the product involved (Article 9).16
 
Labeling: Food and diet data, communication, claims
Nutrition data is necessary for FSMPs and will observe the final guidelines laid down in Regulation (EU) No. 1169/2011 on meals data to customers18 for all meals, but Article 6 of Regulation (EU) 2016/128 specifies that the necessary diet declaration for FSMPs should take into account further data for the healthcare skilled or affected person utilizing the product. The further data consists of:
 

  • A press release that the product have to be used below medical supervision;
  • A press release whether or not the product is appropriate to be used as the only real supply of nourishment;
  • A press release that the product is meant for a particular age group, as applicable;
  • Where applicable, a press release that the product poses a well being hazard when consumed by individuals who wouldn’t have the illness, dysfunction, or medical situation for which the product is meant;
  • The assertion “For the dietary administration of …” the place the clean must be crammed in with the illness, dysfunction, or medical situation for which the product is meant;
  • Where applicable, a press release regarding ample precautions and contraindications;
  • An outline of the properties and/or traits making the product helpful in relation to the illness, dysfunction, or medical situation, for the “dietary administration” of which the product is meant, significantly, because the case could also be, regarding the particular processing and formulation, the vitamins which were elevated, decreased, eradicated, or in any other case modified and the rationale for the product’s use;
  • Where applicable, a warning that the product just isn’t for parenteral use; and
  • Instructions for applicable product preparation, use, and storage after opening the container, as applicable.

 
Whereas (3) of Regulation (EU) No. 2016/128 clarifies “medical supervision” could also be with the help of different competent healthcare professionals (e.g., with {qualifications} in medication, dietetics, diet, nursing, pharmacy):
 
Nutrition and well being claims shall not be made on FSMP (Art. 7). ‘Whereas Art. 14’ requires that each one data on the properties and traits of the product (e.g., any particular processing and formulation, dietary composition and rationale of use of the product that make it helpful for its meant objective) is necessary data and due to this fact not thought of as diet and well being claims inside the which means of Regulation (EC) 1924/2006.19
 
The FSG Regulation introduces further provisions on pesticide ranges in addition to FSMP labeling, presentation, promoting and promotional, and industrial practices for infants (0-12 months), much like these relevant to toddler system and follow-on system. Regulation (EU) No. 2016/128 consists of these particular provisions on labeling, presentation, and promoting of FSMPs meant for infants (Article 8).
It states that any necessary data meant for the buyer should seem in a language that’s simply understood, and that it mustn’t embody footage of infants and be designed to allow customers to make a transparent distinction between FSMPs and toddler and follow-on system. However, the need to speak to healthcare professionals is acknowledged, permitting them to evaluate totally different merchandise’ suitability for his or her meant use in addition to present applicable details about the vital use and compositional data to sufferers and care suppliers (Article 8(4)).
 
FSMP classes and suppleness of compositional necessities
An FSMPs composition could differ considerably relying on its meant use, that’s, the precise illness, dysfunction, or medical situation it’s meant to handle; affected person age; and the place sufferers obtain healthcare help. Because of FSMPs’ broad range, the quickly evolving scientific data on which they’re based mostly, and the necessity to guarantee ample flexibility to develop progressive merchandise, it appeared not applicable to put down detailed compositional guidelines for such merchandise, relatively than setting rules and necessities particular to them. Article 2(2) states that FSMPs’ formulation must be based mostly on sound medical and dietary rules and must be secure, useful, and efficient in assembly the precise dietary necessities of the individuals for whom they’re meant. This means an FSMP’s composition/formulation must be supported by a powerful dietary and medical rationale, however particular medical trials could not at all times be required if there are ample information already accessible within the public area to help their composition and use.
 
Regulation (EU) 2016/128 classifies FSMPs in three classes (Article 2) as nutritionally full with a normal nutrient formulation, nutritionally full with a nutrient-adapted formulation, or nutritionally incomplete (Table 2). FSMPs developed to fulfill infants’ dietary necessities ought to adjust to the provisions regarding different vitamins relevant to toddler system and follow-on system (Regulation (EU) 2016/127),20 supplied they’re in keeping with the meant use.
 

Plastic merchandise
The EU directive on the discount of the influence of sure plastic merchandise on the setting 21 makes an attempt to stop and scale back the numerous unfavorable environmental, well being, and financial influence, respectively. Although, single-use plastic beverage containers for the administration of FSMPs in liquid kind are exempted from product recycling and assortment necessities.
 
Market entry, well being economics, and reimbursement
FSMPs are consumed throughout all healthcare settings, reminiscent of hospitals, clinics, and nursing properties and at dwelling. They have been proven to lead to decrease healthcare prices by lowering hospital stays and sustaining a affected person’s independence longer.22 While EU laws on FSMP composition and labeling is harmonized throughout the member states, there is no such thing as a harmonization of healthcare techniques. Hence, reimbursement is predicated on nationwide, regional, or native well being organizations and budgets. Even inside international locations, guidelines could possibly be utilized in another way by areas or provinces and public or personal healthcare suppliers. The standards for FSMP reimbursement approval range in line with native guidelines and could also be based mostly on composition or provision of scientific rationale and/or well being financial proof.
 
In most EU member states, many merchandise notified as FSMPs are reimbursable as a part of native healthcare techniques (public or personal payers). This sometimes consists of nutritionally full FSMPs which will function sole diet sources. Reimbursement ranges additionally could also be based mostly on particular compositional standards (e.g., protein, power degree [Kcal/KJ], fibre) per particular classes (e.g., infants/adults, hydrolyzed/nonhydrolyzed proteins) or in line with nationwide guidances.6 Apart from merchandise designed for disease-related malnutrition, reimbursement additionally could also be attainable for particular FSMPs that handle illnesses or medical issues reminiscent of:
 

  • Infant allergy to cow’s milk proteins or a number of meals allergic reactions;
  • Malabsorption syndromes (e.g., quick bowel syndrome) ;
  • Hereditary inborn errors of metabolism of carbohydrate, fats or protein (e.g., phenylketonuria); and
  • Epilepsy (ketogenic weight-reduction plan formulation).

 
EU abstract
Health and illness administration requires the event of applicable, performing healthcare options, utilizing all choices from medicinal therapy, way of life adjustments, and diet. Patient views on diet,8 developed by affected person associations the European Patients’ Forum and European Genetic Alliances Network and the ENHA, demonstrates diet as a significant a part of well being and illness administration. It examines the position of diet in relation to a wide range of totally different well being points, together with mind issues, most cancers, coeliac illness, diabetes, inflammatory bowel illness, and kidney illness.
 
This goes hand-in-hand with the principal notion of a regulatory framework that encourages innovation globally for the sake of figuring out probably the most appropriate pathways in well being and illness administration.23 The EU FSMP Regulation—a results of professional enter from all member states—supplies a well-defined framework, together with compositional standards, particular and related provisions on labeling, data, and monitoring of merchandise available on the market. FSMPs aren’t topic to premarket approval. This framework acknowledges the pliability required to accommodate the variety of medical situations for which FSMPs are and must be used, based mostly on sound medical and dietary rules and supported by usually accepted scientific information (e.g., ESPEN tips) to fulfill their meant use for the dietary administration of illnesses, issues, or medical situations.
 

United Kingdom24

Following the UK’s departure from the EU in 2020, known as “Brexit,” new regulation is an autonomous matter for each the UK and EU as two separate authorized and regulatory techniques. After contributing considerably to EU laws for round 40 years as an EU member state, the post-Brexit UK meals, together with medical meals/FSMP-related necessities, nonetheless resemble their EU previous. Processes are since solely depending on UK governmental establishments, together with the Department of Health and Social Care, the Advisory Committee on Borderline Substances, and National Health Service.24
 

United States

The US Food and Drug Administration (FDA) is charged with defending the general public well being by means of oversight of medication (human and veterinary), organic merchandise, medical units, cosmetics, and merchandise that emit radiation. In addition, it oversees the nation’s meals provide, guaranteeing security of substances and manufacturing processes, and serving to the general public get correct, science-based data wanted to make use of medicines and meals to take care of and enhance well being.25
 
Before 1972, any product labeled or promoted as an article meant for the prevention, mitigation, therapy, or remedy of a illness was thought of to be a drug, topic to pre-market approval by means of FDA’s new drug software course of. As a uncommon class of genetic illnesses grew to become acknowledged, so was it found that the one therapy for sufferers with IEM, reminiscent of phenylketonuria, was offering extremely specialised formulation with nutrient ratios inconceivable to acquire from weight-reduction plan modification of regular meals. The time period “medical meals” was first outlined by the Orphan Drug Act, amended in 1988, which instructed the FDA to develop rules allowing such specialised meals formulations for use below medical supervision for the dietary administration of a illness or situation with medically established distinctive dietary necessities.26
 
Further enlargement of this statutory mandate was integrated into rules for the meals trade when the Nutrition Labeling and Education Act of 1990 (NLEA) was finalized in 1993.27 The precise language is necessary to learn verbatim, as summaries at instances have created an imprecise image of how strict the definition truly is. The full textual content, from 21 CFR 101.9(j)(8),27 is as follows:
 
Medical meals as outlined in part 5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)). A medical meals is a meals which is formulated to be consumed or administered enterally below the supervision of a doctor and which is meant for the precise dietary administration of a illness or situation for which distinctive dietary necessities, based mostly on acknowledged scientific rules, are established by medical analysis. A meals is topic to this exemption provided that:
 
(i) It is a specifically formulated and processed product (versus a naturally occurring foodstuff utilized in its pure state) for the partial or unique feeding of a affected person by the use of oral consumption or enteral feeding by tube;
(ii) It is meant for the dietary administration of a affected person who, due to therapeutic or power medical wants, has restricted or impaired capability to ingest, digest, take up, or metabolize peculiar foodstuffs or sure vitamins, or who has different particular medically decided nutrient necessities, the dietary administration of which can’t be achieved by the modification of the traditional weight-reduction plan alone;
(iii) It supplies dietary help particularly modified for the administration of the distinctive nutrient wants that outcome from the precise illness or situation, as decided by medical analysis;
(iv) It is meant for use below medical supervision; and
(v) It is meant just for a affected person receiving energetic and ongoing medical supervision whereby the affected person requires medical care on a recurring foundation for, amongst different issues, directions on the usage of the medical meals.

 
The FDA selected to narrowly interpret the statute, stating that even a specifically formulated meals couldn’t be a medical meals if the illness/situation for which it was meant could possibly be managed “… by modification of the traditional weight-reduction plan alone.”27 The want for ongoing medical supervision for affected person appropriateness and progress was burdened; nonetheless, a definition of what constituted “particular medically decided nutrient necessities” was missing. While fundamental meals data was required (producer, web contents, ingredient assertion), medical meals had been exempt from different claims and diet information format outlined within the NLEA.
 
In an try to make clear phrases reminiscent of “distinctive dietary necessities” that have to be related to a illness, and “modification of the peculiar weight-reduction plan alone,” FDA revealed an advance discover of proposed rulemaking (ANPR) in 1996, requesting public feedback in regards to the company’s expanded rationale on the time.28 However, because of larger priorities for inadequately resourced workers, the ANPR was withdrawn from energetic consideration in 2004, after eight years of no regulatory motion. To at the present time, nonetheless, it’s known as “directional pondering” of the company and is usually quoted in warning letters to firms accused of promoting “unapproved medicine” below the false pretense as a medical meals, when claims are made about its impact on the illness course of.
 
Two approaches to find out if distinctive dietary necessities exist for a illness had been proposed within the ANPR. A “Physiological Interpretation” for when dietary administration of sufferers with particular illnesses could require vitamins that differ considerably from the wants of wholesome individuals was in comparison with a second “Alternative Interpretation” for sufferers unable to ingest, digest, or metabolize typical meals because of their illness or situation, outlined in a extra in-depth evaluation of those approaches.29
 
FDA issued draft, then ultimate variations of nonbinding steering to trade, giving solutions to ceaselessly requested questions on medical meals. Extensive feedback to the 2013 draft had been submitted by firms, medical and affected person societies, scientific and commerce associations, congressional workers, and people, all of which challenged the company’s place that diabetes was not a illness appropriate as a goal for medical meals. The rationale that sufferers are in a position to modify their weight-reduction plan to fulfill dietary wants remained within the ultimate model, ignoring the extraordinarily low compliance of sufferers requested to considerably change their weight-reduction plan.30
 
Another nonbinding steering doc that referenced medical meals was issued by the FDA in 2013, in ultimate kind with out alternative for public remark. Its objective was to assist investigators, sponsors, and institutional overview boards (IRBs) decide whether or not human analysis research could possibly be carried out with out submitting an investigational new drug software (IND), sometimes required when finding out a brand new drug or biologic. However, this steering said that even when the compound being studied was a meals, medical meals, or dietary complement, if illness endpoints had been being evaluated, it could be thought of to be an investigational new drug. This dramatically impacts the tutorial analysis group, including complexity, value, and ambiguity when dietary merchandise had been studied as probably useful in stopping power illness (subject of well being claims) or in correcting nutrient imbalance associated to illness. Some of those provisions had been placed on maintain or “stayed” in a 2016 discover that reversed the IND requirement when research had been designed to find out the impact of construction or operate of the physique, and never expressly for illness administration.31
 
There are encouraging indicators that personalised diet, contemplating genetic, metabolic, environmental, way of life, and behavioral elements of every particular person, represents the best, and sensible, method to selling well being and wellness. After years of neglect, this facet of diet is now gaining analysis precedence inside the National Institutes of Health (NIH), with the 2022 Budget allocating $170 million for analysis grants over 5 years,
 
The Nutrition for Precision Health powered by the All of Us Research Program (NPH) will recruit a various pool of 10,000 members who’re a part of the NIH’s All of Us Research Program to tell extra personalised diet suggestions.32
 
This builds upon progress made because the 2015 creation of the Precision Medicine Initiative, which states:

The Precision Medicine Initiative (PMI), launched in 2015, is a nationwide initiative to maneuver away from the “one-size-fits-all” method to well being care supply and to as an alternative tailor therapy and prevention methods to folks’s distinctive traits, together with setting, way of life, and biology.33
 
Enforcement actions within the US 34
The goal of FDA regulatory applications is to guarantee compliance with the Federal Food, Drug, and Cosmetic (FD&C) Act. Adulteration or misbranding is often the results of a person failing to take steps to guarantee compliance with the regulation. Such a person could also be answerable for a violation of FD&C Act and, if discovered responsible, be topic to the penalties specified by the regulation.
 
Although there is no such thing as a pre-market approval required to introduce a medical meals into the US market, FDA does train postmarket surveillance to insure that marketed merchandise adjust to all federal rules, and that they don’t pose a security danger. With jurisdiction over meals and drug labeling, FDA could study product labels on the time of a producing plant inspection, by amassing merchandise by means of commerce channels, or by reviewing gross sales/advertising supplies posted on web sites (that are thought of to be “labeling”). The sort of enforcement exercise relies on the diploma of violation. Specific enforcement actions embody actions to right and stop violations, take away violative merchandise or items from the market, and punish offenders. These actions could vary from issuing a letter notifying the person or firm of a violation and requesting correction, to legal prosecution of the person or firm.
 
The Federal Trade Commission (FTC) has jurisdiction over promoting and verifying the reality in substantiation of any product claims made to customers. Medical meals are meant for use below medical supervision, not bought direct to customers. However, if they’re, FTC could coordinate with FDA if any violation in rules governing labeling, or inappropriate well being or illness claims, could also be suspected.
 
US abstract
The historical past of building a class of medical meals, separate from medicine however for the precise dietary administration of sufferers with a illness or situation has been troublesome. Both regulators and trade have struggled to carry progressive, secure, cost-effective dietary merchandise with proof of medical profit to sufferers with altered capability to take care of a standard weight-reduction plan. The alternative to extend the worth of this class will rely upon bringing collectively stakeholders representing dietary science, medical observe, regulatory science, and medical diet researchers in addition to healthcare funding entities with the intention to leverage the potential medical advantages of medical meals within the individualized dietary administration of sufferers with a various vary of illnesses and situations. This would then should be accommodated inside a regulatory framework that adequately protects the buyer, whereas additionally permitting the well timed scientific analysis and progress of dietary interventions. Globally, it’s the identical problem, with some minor variations on the theme of meals meant for use for particular and distinctive medical functions.
 

China

The promulgation of the FSMP requirements (Figure 1), as a part of the nationwide meals security requirements, ended the lengthy debate and confusion in China on whether or not FSMPs must be regulated as meals or as medication. FSMPs had been now outlined as specifically formulated meals that had been produced to fulfill the particular necessities for nutrient or meals of people that suffered from consuming limitation, dysfunction of digestion and absorption, metabolic issues or particular illness state and these merchandise must be eaten individually or with different meals below the steering of medical doctors or dietitians. FSMPs had been categorized as meals for particular dietary makes use of, or FSDU. It can be stipulated within the Food Safety Law that FSDU merchandise must be authorised and registered below the precise rules of State Administration for Market Regulation (SAMR).35

Figure 1. National Food Safety Standards System of China35

 
FSDU, meals for particular dietary makes use of
Compiled by Chen & Wu

FSMPs and associated meals security requirements
Currently, the FSMP requirements included the FSMP normal for Infants (GB 25596-2010), General FSMP Standard for kids older than 1 yr (GB 29922-2013), and good manufacturing observe for FSMPs (GB 29923-2013). In common, they’re in keeping with the Codex FSMP requirements and rules and requirements in developed international locations. The Chinese FSMP requirements have extra element provisions, such because the subcategories of the FSMP merchandise and vary of vitamins contents. The FSMP merchandise are additional divided into three courses and 5 subcategories below the GB 25596 and 15 subcategories below the GB 29922 (Figure 2).
 
 Figure 2. Categorization of FSMP merchandise in China35

FSMP, meals for particular medical functions
Compiled by Chen & Wu

To facilitate enforcement and inspection by the SAMR in addition to product registration by the trade, an ongoing main revision of GB 29922 has been carried out, together with the event of separate requirements for particular person subcategories of FSMPs for two.1 to 2.8 and a pair of.10. In that case, there could be particular person requirements for every illness (e.g., most cancers, diabetes, and many others.) within the class of nutritionally full system for particular illnesses. An overview of FSMPs and associated relevant meals security requirements is proven in Table 3.36
 
 
Product registration
Corresponding rules on the FSMP registration necessities had been promulgated by the SAMR since 2016, which had been relevant to each home and imported FSMP merchandise. The primary rules had been the SAMR administrative regulation for registration of FSMPs. Its accompanied implementation rules supplied required data on the file content material, the labeling, the steadiness testing, the medical trial high quality administration observe, the on-site audit process, and the important thing necessities. Accordingly, the candidates are required to conduct three batches of manufacturing trials on the industrial manufacturing line, and to offer a complete registration file together with the product system, the manufacturing methods, the labeling, and the proof of product security, dietary adequacy and medical results, and the steadiness check report. Mandatory on-site audits could be carried out if thought of as needed throughout software overview by SAMR. For full diet system for particular illnesses merchandise, medical trial report is required as a part of registration file. The medical trial must be carried out in China in line with the SAMR’s regulation on FSMP medical trial high quality administration observe. For home FSMP merchandise, along with product registration, the producer wants to use for a manufacturing license, which has been licensed by native administration for market regulation. The importation of FSMP merchandise was supervised by the General Administration of Customs of the People’s Republic of China (GACC). Before importing any FSMP merchandise into the Chinese market, the overseas producer wanted to register its manufacturing facility facility with the GACC and acquire product registration approval from the SAMR.
 
The time for the completion of a FSMP product registration is a minimum of 2-3 years and could possibly be for much longer. As of February 2022, a complete of 81 FSMP merchandise had been authorised and registered below the SAMR. A abstract of authorised FSMP merchandise by class is confirmed in Figure 3.37 It must be famous that no single full diet FSMP product for particular illnesses had been authorised but. A flowchart of FSMP regulatory management all through the FSMP lifecycle is proven in Figure 4.
 

 Figure 3. Registered FSMP merchandise in China by class to February 202235

 FSMP, meals for particular medical functions
Compiled by Chen & Wu; Source, SAMR

Figure 4. A flowchart of FSMP regulatory management in China35


AMR, Administration for Market Regulation; FSMP, meals for particular medical functions; GACC, General Administration of Customs; MARA, Ministry of Agriculture and Rural Affairs; NHC, National Health Commission; SAMR, State Administration of Market Regulation.
Source: Chen & Wu
 

Challenges within the regulatory management of FSMP

The determination to manage FSMP merchandise as meals below the Food Safety Law was a major progress, which was in keeping with Codex and most different international locations on the planet. The set of three FSMP requirements had been common and had thought of the broad divergence of the FSMP merchandise. However, the registration necessities for particular person FSMP merchandise had been complete in China.
 
Because the registration rules are new, there are uncertainties within the necessities which presents challenges for the trade candidates. This was one of many main elements of the lengthy software and overview course of (2-3 years or extra). Clinical trials are necessary for disease-specific full diet system software. It is pricey and time consuming, and a number of the necessities aren’t possible. Some nutritionists have questioned the rationale of a fixed-design medical trial technique and never permitting use of knowledge from the real-world research from the FSMP trade.
 
On-site audit of FSMP services is one other main problem for worldwide firms which have abroad manufacturing services. With journey restrictions because of the COVID-19 pandemic, no abroad audit was carried out since early 2020. The overview course of for these functions was not in a position to transfer ahead with out on-site audit when SAMR considers on-site audit is critical. Another problem is that FSMP merchandise can’t be positioned in most hospital pharmacies as a result of they’re thought of to be meals and never medicine. Recently, the SAMR has been exploring methods to enhance the registration of FSMPs, system for toddler and well being practical meals for younger youngsters. Given the divergent opinions amongst directors, regulators, trade, and academia, the precise reformation could be a protracted course of.
 

Codex Alimentarius requirements framework

Codex Alimentarius is a world physique whose mandate is to develop internationally harmonized meals security and high quality requirements to guard the well being of customers and guarantee truthful practices within the meals commerce. Although Codex Alimentarius requirements and tips are, in precept, voluntary to observe, they’ve a major influence on worldwide processes for setting and decoding rules, significantly in growing international locations.38
 
The Codex Alimentarius Standard 180-199139 defines FSMPs as a class of meals for particular dietary makes use of (FSDU; Codex Standard 146-1985),40 which is specifically processed or formulated and offered for the dietary administration of sufferers and could also be used solely below medical supervision. It is meant for the unique or partial feeding of sufferers with restricted or impaired capability to take, digest, take up, or metabolize peculiar foodstuffs or sure vitamins contained therein; or who produce other particular medically decided nutrient necessities whose dietary administration can’t be achieved solely by modification of the traditional weight-reduction plan, by different FSDUs, or by a mix of the 2.
 
Under the usual, the formulation of FSMPs must be based mostly on sound medical and dietary rules. Their use ought to have been demonstrated, by scientific proof, to be secure and useful in assembly the dietary necessities of the individuals for whom they’re meant. The labels, accompanying leaflets, and/or different labeling and promoting of all sorts of meals for particular medical functions ought to present ample data on the character and objective of the meals in addition to detailed directions and precautions for his or her use. In addition, the promoting of those merchandise to most of the people is prohibited. The format of the knowledge given must be applicable for the particular person for whom it’s meant.
 
The FSMP definition is, in precept, equal to these within the US and EU. However, the usual – apart from FSMPs meant for infants (Codex Standard 72-1981)41 – describes solely particular labeling and claims features, and never compositional standards, for sufferers older than 1 yr.
 
Codex Alimentarius has additionally been instrumental in offering a platform for establishing a world guideline for the secure and efficacious use of ready-to-use therapeutic meals (RUTF), as a part of the dietary administration of extreme acute malnutrition. The Codex Committee on Nutrition and Foods for Special Dietary Uses has established an digital working group – chaired by South Africa and cochaired by Senegal and Uganda – which resulted within the finalization of the RUTF guideline in 2021, which is predicted to be endorsed by the CODEX Alimentarius fee. It could also be used as an applicable reference for imported or domestically produced merchandise, to facilitate native regulation and encourage allocation of nationwide budgets to those merchandise.42
 

Brazil

Foods for managed vitamins consumption, reminiscent of formulation for enteral diet (RDC 21-2015),43 are an outlined class in Regulation for Food for Special Purpose (Portaria 29/1998),44 which requires pre-market approval from the Brazilian Health Regulatory Agency, often known as ANVISA. Enteral diet is classed into 4 subcategories:

  • Standard system for enteral diet,
  • Modified system for enteral diet,
  • Pediatric Formula for Enteral Nutrition (for kids youthful than 10 years), and
  • Modules of Nutrients for Enteral Nutrition.

 
ANVISA additionally determines compositional, stability research, sanitary registration, and labeling necessities. Nutrient compounds and different substances that may be added to formulation for enteral diet are outlined in laws (RDC 22-2015) that requires adoption of the necessities.45 Regulation for particular meals components for formulation for enteral diet was revealed in 2017 (RDC 160-2017).46 Nevertheless, ANVISA will overview all laws, which is predicted to be revealed in 2024.
 

Canada

Health Canada is the first federal authorities company that units the well being and diet necessities for FSDUs, whereas the Canadian Food Inspection Agency is liable for the enforcement of Division 24 and different related meals rules that shield sufferers and customers.
There aren’t any regulatory provisions in Canada for medical meals or FSMPs. However, some meals regulated as such elsewhere are recognized in Canada as “meals for particular dietary use,” or FSDU. These meals are outlined as,
 
… meals that has been specifically processed or formulated to fulfill the actual necessities of an individual (a) in whom a bodily or physiological situation exists because of a illness, dysfunction or damage; or (b) for whom a specific impact, together with however not restricted to weight reduction, is to be obtained by a managed consumption of meals.47
 
FSDUs are regulated inside Division 24 of the Food and Drug Regulations, which strictly prescribes the compositional necessities for the power, macronutrient, and micronutrient profiles, in addition to the necessities for labeling and any promoting or promoting prohibitions. The meals included below the regulatory definition of FSDUs are formulated liquid diets, meal replacements for particular dietary use, dietary dietary supplements, gluten-free meals, meals represented for protein-restricted diets, meals represented for low-[name of amino acid] diets, and meals represented to be used in very low-energy diets. There isn’t any notification course of to carry an FSDU to market in Canada, apart from meals represented to be used in very low-energy diets, by which case a 90-day premarket notification is required.
 
The present Canadian FSDU regulatory framework had its origins within the Nineteen Seventies, with the publication in 1978 of the definition for FSDU. The most up-to-date substantial adjustments to the framework had been in 1995, with solely minor adjustments since then.47 With its early origins, the Canadian system influenced the event of the definition for FSDUs at Codex assembly in 1985.40 However, the Canadian framework didn’t proceed to evolve because the Codex normal for FSMPs was outlined in 1991,39 and worldwide FSMP frameworks have since emerged.
 
From these origins, the Canadian FSDU framework is characterised by its closed categorical definitions, slim and rigid compositional necessities that don’t align to present diet suggestions, and a divergence from worldwide harmonization with different FSMP frameworks.48 Canada has a major alternative to modernize its stringent and outdated FSDU rules to carry them in keeping with probably the most present worldwide FSMP techniques48 based mostly on modernization objectives and subsequent steps proposed from a tripartite workshop.49
 
One space by which Health Canada is growing new FSDU rules pertains to medical trials that research the usage of noncompliant meals meant as the only real or major supply of diet for infants, youngsters, or adults. This modernization effort will cowl beforehand nonpermitted toddler system, human milk fortifier, or formulated liquid weight-reduction plan FSDU to be thought of for medical research in Canada.50
 

South Africa

Currently, Codex Alimentarius is used as a reference for compositional necessities, claims, and labeling for all FSMPs in South Africa. In addition to this, the rules associated to the labeling and promoting of foodstuffs (No. R. 146-2010),51 should even be adopted comparable to what’s required for all foodstuffs. Infant or follow-up formulation for particular dietary administration for infants with particular medical situations are additionally lined by the native toddler rules regarding foodstuffs for infants and younger youngsters (No. R. 991-2012).52 This regulation covers all formulation from start as much as 36 months. FSMPs for younger youngsters and adults will probably be lined by the newly drafted common labeling rules regarding the labeling and promoting of meals: modification (No. R. 429).53 This regulation has been in draft since 2014.
 
The trade is awaiting suggestions from the Department of Health. However, it has been confirmed that the regulation won’t be promulgated as is. It stays to be seen what influence the rules can have on enteral meals as there’s presently no certainty round whether or not the usage of enteral meals for particular medical functions have to be supported by information from medical trials. Currently, FSMPs for adults could be launched with out registering the product supplied that it meets all related laws.
 

Australia and New Zealand54

Standard 2.9.5 of the Food Standards Australia New Zealand (FSANZ) Code defines meals for particular medical functions. Since most FSMPs are imported from abroad, compatibility with worldwide rules and requirements is necessary to reduce the chance of imposing commerce obstacles on merchandise imported into Australia and New Zealand. The objective of the FSMP normal is to guard the well being and security of customers, achieved by means of three main necessities:
 

  • It requires that FSMPs, that are represented as being appropriate to be used as a person’s sole supply for diet, complies with a set of compositional necessities of nutritional vitamins, minerals, and electrolytes. The normal permits for these necessities to be diversified, relying on a specific medical situation.
  • It comprises necessary labeling data, statements, and declarations (cf. Sections 2.9.5-9 and a pair of.9.5-10), 54 meant to make sure that healthcare professionals are supplied with sufficient data to make applicable choices relating to affected person use of the product. There is a few flexibility in labeling of substances to undertake both Standard 1.2.4 of the Food Standard Code, or EU or US rules.
  • It imposes restrictions on the place, and by whom, FSMPs could also be bought on to customers. The restriction on sale is meant to advertise customers’ incentive to hunt medical and healthcare skilled recommendation on appropriateness of the product for his or her situation, whereas proscribing sale to distributors extra within the industrial features of FSMP sale direct to customers.

 
FSMPs don’t embody meals formulated and represented as being for the dietary administration of weight problems or obese; or an toddler system product as outlined in Standard 2.9.1.
 

Japan

The FSMP normal inside the Japanese meals regulation was established earlier than the Codex Alimentarius normal 180-1991, and due to this fact takes priority over the worldwide normal. FSMP merchandise fall right into a class of meals for particular dietary makes use of (FOSDU). To register a product as FOSDU, authority approval is required, a course of that takes round 2-3 years requiring scientific proof to help the meant use. The registration charge varies in line with the aim of use. The FOSDU regulation comprises illness particular standards, reminiscent of rheological requirement of texture-modified merchandise appropriate for dysphagia.
 

India55

Codex Alimentarius Standard 180-1991 could be thought of a pivotal supply of reference for FSMPs. The Food Safety Authority of India has issued a course for the operationalization of Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Foods for Special Medical objective and Probiotic and Prebiotic Food) Regulation, 2022, to be known as FSS (Nutra) Regulation, 2022. This is a revised overhaul regulation and would supersede the FSS (Nutra) Regulations, 2016.
 

Turkey

The Turkish Ministry of Health (MoH) is the accountable physique for approving FSMPs and water. The Ministry of Agriculture and Forestry is liable for different meals. The Turkish Food Codex Communiqué on Special Dietary Foods for Medical Purposes 2001/4256,57 determines the composition and labeling situations to make sure hygienic manufacturing, preparation, processing, preservation, storage, transportation and advertising. The communiqué provisions are executed by the MoH and the Ministry of Agriculture and Forestry.
 
The Communiqué on the Production Sites of Special Dietary Foods for Medical Purposes 13.09.2015/29474,58 issued by the MoH, regulates the procedures and rules relating to the appliance, inspection and permission processes of manufacturing websites. Within the scope of the Draft Regulation on Licensing of Foods for Special Medical Purposes, the legislative research, that are ongoing, and two draft tips have been circulated for suggestions from third events. The tips are:

  • Draft Guideline on Application for Special Medical Purpose Foods License Application. This addresses the procedures and rules to be utilized within the issuance of permission certificates and authorizing merchandise to make sure the specified effectiveness and security and required high quality.
  • Draft Guideline on the Stability Studies of Foods for Special Medical Purposes. This addresses the aim of figuring out the necessities for stability research to be included within the authorization software file.

 
The preliminary import allow software and import allow renewal software for particular dietary meals for medical functions are made to the MoH and Medical Devices Agency. For current merchandise, import permits, named management certificates, need to be renewed yearly. For merchandise registered for the primary time, pricing and reimbursement are further steps to the import allow approval course of, which takes about 24 months from submission to approval. FSMPs could also be bought solely in pharmacies.
 

Middle East

The Gulf Cooperation Council (GCC) international locations, together with United Arab Emirates (UAE), Oman, Kuwait, Qatar, Kingdom of Saudi Arabia, and Bahrain, have just lately revealed an FSMP normal (GSO 1366-2021)59 and a brand new normal for meals dietary supplements (GSO 2571-2021).60
 
For toddler system, follow-up system, and system for particular medical functions for infants, the GCC issued a brand new normal (GSO 2106-2021),61 based mostly on the EU regulation and never CODEX, as beforehand. GCC international locations have till the top of 2022 to place this normal into impact. FSMPs and toddler system are actually required to be registered in all GCC international locations and different Middle East international locations. Registration is finished by means of the next authorities in every nation:

  • The respective Food and Drug Authorities in Saudi Arabia, Kuwait, and Jordan; and
  • The respective MoHs in Bahrain, UAE, Qatar, Oman, Iran, and Lebanon.

 
Iraq doesn’t require registration.
 
In common, the next paperwork are required:

  • Certificates of free sale, manufacturing facility GMP, well being, and analyses;
  • Copies of the artworks of the product;
  • Samples of the product (not required by all international locations); and
  • Product specs.

 

ASEAN member states

The ASEAN includes the founding members Indonesia, Malaysia, the Philippines, Singapore, Thailand, and the newer members, Vietnam, Brunei Darussalam, Cambodia, Laos, and Myanmar. The FSMP class just isn’t clearly outlined but in lots of them, though some regulatory efforts have began in a number of. The Codex Alimentarius normal 180-1991 is a vital and revered reference for all. 39
 
Indonesia defines processed FSMPs, abbreviated as PKMK, as “processed meals that’s specifically processed or formulated for dietary administration for folks with sure illnesses/issues” (Article 1 of Regulation 1-2018).62 Infant system for particular medical wants is outlined as “meals for infants that’s specifically processed or formulated and serves as a dietary administration of toddler sufferers in order that they’ll individually meet the dietary wants of infants with issues, illnesses, or particular medical situations throughout the first few months of life, till the introduction of breast milk, and will solely be used below medical supervision” (Article 1, Regulation HK.03.1.52.08.11.07235-2011).63
 
Examples of FSMPs/PKMK for infants and kids, as stipulated in Amendment Regulation 24-2020,64  embody sufferers with metabolic issues (inborn errors of metabolism); little one diet help danger of failure to thrive, malnutrition or malnutrition unhealthy; untimely infants; PKMK to enrich breast milk diet (human milk); sufferers allergic to take advantage of protein; ketogenic weight-reduction plan; malabsorption sufferers; sufferers with power liver illness; inflammatory bowel sufferers illnesses; and lactose illiberal infants.
 
Examples of FSMPs/PKMK for adults embody folks with diabetes; sufferers with power kidney illness; sufferers with power liver illness; dietary help for grownup sufferers with malnutrition; sufferers with metabolic issues (inborn errors of metabolism); and people on a ketogenic weight-reduction plan.
 
FSMP/PKMK distribution is restricted to pharmacies, hospital pharmacies, and different public well being facilities (Article 16 of Regulation 1-2018). 62 FSMPs have to be manufactured in line with GMP and hazard evaluation and significant management factors, or HACCP. Regulations additionally present steering on composition and labeling for every sort of PKMK.
 
Vietnam usually follows Codex requirements and defines meals for particular medical functions or medical meals as “meals administered orally or with feeding tubes that are designated to manage the affected person’s weight-reduction plan and are solely used below the supervision of well being staff” (Article 2 of Circular No 43-2014).65 It describes formulation with particular medical functions for infants as “merchandise with liquid or powdered kind processed from artificial or pure substances with origin from animals or vegetation are produced to fulfill the particular dietary wants for infants as much as 12 months affected by sickness, issues, or in want of medical care. Formulas with particular medical functions for infants as much as 12 months outdated can be utilized as a meals supply to switch breast milk” (Article 3 of Circular No 21-2012).66
 
FSMPs require premarketing approval. Human efficacy medical research are wanted for FSMPs that haven’t been authorised by competent authorities within the nation of origin (Article 4 of Circular No 43-2014).65
 
Thailand refers to particular objective meals as these meals which are processed or formulated or to particular ingredient meals for particular functions, appropriate – because of their traits, appearances or classes and portions of substances, clearly totally different from regular meals – for sufferers or individuals who’ve a particular objective in meals consumption, reminiscent of weight management or being aged or pregnant (Thai Notification No. 238 and 357).67,68
 
Malaysia’s particular objective meals regulated by the MoH refers to meals significantly appropriate for consumption by individuals with particular diet wants, together with requirements for toddler system; follow-up system; canned meals for infants and kids; processed cereal-based meals for infants and younger youngsters; low-energy meals; particular dietary meals with low-sodium content material, together with salt substitute; and system dietary meals. The latter is appropriate as an entire weight-reduction plan when consumed in accordance with its meant use (Regulation 388).69
 
Singapore’s particular objective meals is appropriate for consumption by individuals requiring a particular weight-reduction plan. It consists of meals substances modified or ready to own meant dietary properties. It consists of meals for diabetics, low-sodium meals, gluten-free meals, low-protein meals, carbohydrate-modified meals, low-calorie meals, power meals, toddler formulation and formulated meals (Regulation 247).70
 
Brunei Darussalam’s meals rules are aligned with these of Malaysia and Singapore. Special objective meals ought to embody diabetic meals, low-sodium meals, gluten-free meals, low-protein meals, carbohydrate-modified meals, low-calorie meals, power meals, low-protein meals, toddler system meals, and formulated meals (Regulation 318).71
 
Cambodia, Laos, and Myanmar wouldn’t have particular regulation on FSMPs, however observe Codex requirements.
 
The Philippines has no particular rules for, or a definition of, FSMPs. It usually follows the Codex Alimentarius Standard 180-1991.  is regulated as “high-risk meals.”72
  
FSMPs ought to adjust to the composition and high quality normal and labeling said within the reference information to stakeholders to evaluate compliance of submitted paperwork as full necessities for product registration (cf. Annex D of the regulation).
 

Summary of Part 2

A synopsis of the worldwide regulatory frameworks for medical meals/FSMPs demonstrates the similarities in addition to divergence amongst chosen international locations and areas worldwide. Ultimately, after many years of regulatory evolution regarding the dietary features of affected person care, extra harmonized, pragmatic approaches relatively have prevailed for FSMPs, and though FSMPs are regulated below meals regulation, they’re  required for use below medical or healthcare supervision. This patient-focused pragmatism is gaining traction. Examples of this embody the EU, the place non-disease particular FSMP rules are an possibility and there’s recognition that there could also be circumstances by which it’s inconceivable, impractical, or unsafe for sufferers to solely devour foodstuffs that aren’t an FSMP; or Australia and New Zealand’s place on importing FSMPs.sss
 
FSMPs are consumed throughout all healthcare settings, reminiscent of hospitals, clinics, nursing properties, and in sufferers’ properties. To additional profit affected person and market entry, it’s prudent to acknowledge the important worth FSMPs carry to make healthcare techniques sustainable, that’s, the hyperlink between regulatory and reimbursement and well being economics. FSMPs decrease healthcare prices by lowering hospital stays and sustaining sufferers’ independence longer. Hence harmonizing affordable reimbursement standards by public or personal healthcare suppliers throughout international locations or areas will profit FSMP product improvement to deal with the precise dietary wants for big an specifically typically very small affected person populations.
 
Acronyms and abbreviations
ANPR, advance discover of proposed rulemaking; ASEAN, Association of Southeast Asian Nations; ANVISA, Agência Nacional de Vigilância Sanitária [Brazilian Health Regulatory Agency]; EC, European Commission; EFSA, European Food Safety Authority; ENHA, European Nutrition for Health Alliance; ESPEN, European Society for Clinical Nutrition and Metabolism; EU, European Union; FBO, meals enterprise operator; FDA, [US] Food and Drug Administration; FSANZ, Food Standards Australia New Zealand; FSDU, meals for particular dietary use; FSG, meals for particular group; FSMPs, meals for particular medical functions; FTC, Federal Trade Commission; GACC, General Administration of Customs of the People’s Republic of China; GCC, Gulf Cooperation Council; GMP, good manufacturing observe; HACCP, hazard evaluation and significant management factors; HCP, healthcare supplier; MoH, Ministry of Health; NLEA, Nutrition Labeling and Education Act; IND, investigational new drug; IRB, institutional overview board; NIH, National Institutes of Health; ONCA, optimum dietary look after all; ONS, oral dietary complement; PARNUT, [food for] specific dietary [uses]; RUTF, ready-to-use therapeutic meals; SAMR, State Administration for Market Regulation; UAE, United Arab Emirates; UK, United Kingdom; US, United States.
 

About the authors

Manfred Ruthsatz, PhD, RPh, DABT, RAC, FRAPS, is the chief director of Nutrition+HealthCARE, Switzerland, which focuses on specialised and personalised diet, the intestine microbiome, and wholesome longevity. His healthcare regulatory expertise, rounded out by high quality, security, vigilance, well being economics, and reimbursement, spans greater than 30 years in various healthcare trade and public well being service settings, together with US FDA’s CDER and NIH. His publishing and talking actions in Europe, US, Asia, and LATAM embody a big selection of regulatory- and policy-related healthcare subjects, with a concentrate on the well being and illness continuum and world convergence. He is an energetic member of RAPS and its Editorial Advisory Committee, in addition to a number of different regulatory, scientific, and dietary establishments and advisory boards. He could be contacted at [email protected]
 
Junshi Chen, MD, has been working in diet and meals security analysis for greater than 60 years. Since 2011, he has been the senior analysis professor and chief adviser for China’s National Centre for Food Safety Risk Assessment. He presently chairs the advisory board of the Chinese National Expert Committee for Food Safety Risk Assessment and serves because the chief scientist of the National Food Safety Standard Reviewing Committee. Internationally, Chen serves because the honorary chairperson of the Codex Committee on Food Additives and is member of the WHO Food Safety Expert Panel. He has performed key roles in growing nationwide meals security rules and requirements in China, together with FSMP requirements. Chen is a graduate of Beijing Medical College. He could be reached at [email protected]
 
Chunzhu Wu, MSc, is regional regulatory and scientific affairs director APAC at Tate & Lyle Trading (Shanghai) Company. She has greater than 27 years’ expertise in meals and diet trade, together with nationwide and worldwide regulatory affairs, high quality administration, and product improvement. Wu has a grasp’s diploma in meals engineering. She could be reached at [email protected]
 
Timothy Morck, PhD, is president of Spectrum Nutrition LLC, a US-based consultancy, offering experience in scientific and regulatory areas within the meals, pharmaceutical, and medical fields. Drawing on greater than 40 years of expertise in medical, tutorial, affiliation, and world trade govt positions, he brings a multidisciplinary perspective that integrates science and enterprise aims with a ardour for personalised approaches to enhancing well being. He is an energetic member of American Society for Nutrition, Institute of Food Technologists, and The Obesity Society. He could be contacted at [email protected]
 
Acknowledgment The authors specific their honest gratitude to colleagues worldwide for sharing their regional- and country-specific expertise and insights: Wai Mun Poon, Louise Göttsche, Sam Jennings, Müge Çakir, Eliana Miyazaki, Orin Crisholm, Eyad Attari, and David Oosterveld.
 
Disclaimer This chapter displays the private opinion and expertise of the authors and specialists. It can on no account be construed as an official place by any group with which the authors are affiliated.
 
Citation Ruthsatz M, Chen J, Wu C, Morck T. Foods for particular medical functions/medical meals: A world regulatory synopsis. Regulatory Focus. 31 August 2022.

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