How do you develop FSMPs?

With growth of 1.9% compared with 2020, the clinical nutrition market continues to expand. It posted substantial revenue of €369m in 2021, i.e. 61,394 tons of FSMPs (Foods for Special Medical Purposes) sold in France that year.1

FSMPs are included in the Foods for Specific Groups (FSGs), the claimed nutritional purpose of which distinguishes them from foodstuffs for normal consumption. They therefore meet the specific nutritional requirements of different populations. Each category of FSGs has a controlled composition, that complies with specific regulatory requirements, as well as basic rules that ensure the quality and safety of the product.

Laïta Nutrition – the nutrition division of the Laïta dairy cooperative – has highly-specialized know-how in developing foods with a complex nutritional formulation and is involved in clinical nutrition.

I. What do you need to know before developing FSMPs2,3?

Regulation (EU) No 609/2013 of 12 June 2013 defines FSMPs as “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, metabolise 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”.

FSMPs are therefore nutritional solutions that are used if changing the normal diet does not make it possible to meet the patient’s nutritional requirements. FSMPs can be consumed orally or administered enterally, and exist in solid, liquid or powder form. This type of food may be refundable by the social security if the manufacturer has included it on the list of refundable products and services (LPP).

According to the definition given in the regulation, “specially processed” means that the initial product has been greatly modified to make it suitable for the patient’s nutritional requirements. “Specially formulated” means that specific ingredients were chosen to create the recipe, to make the FSMPs suitable for the patient’s nutritional requirements.

There are three categories of FSMPs:

  • Nutritionally complete foods with a normal nutritional composition;
  • Nutritionally complete foods with an adapted nutritional composition;
  • And nutritionally incomplete foods with a composition that is normal or adapted to the patient’s nutritional requirements;

“Complete” FSMPs represent the target patient’s only source of food, whereas “incomplete” FSMPs cannot be the target patient’s only source of food.

The definition of FSMPs therefore already includes numerous elements to be taken into account when developing FSMPs.

II. Which regulations apply when developing FSMPs3?

FSMPs lie midway between food and medicines, but still have the status of food. They must therefore comply with all of the basic regulations applicable to foodstuffs:

  • Regulation (EC) No 178/2002 which guarantees the placing on the market of food that is safe for human consumption;
  • Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs;
  • Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs;
  • Regulation (EU) No 231/2012 which defines purity criteria for food additives;
  • FIC Regulation No 1169/2011 which defines the compulsory information to be included on food labels;

More specifically for FSMPs, Regulation (EU) No 609/2013 and Commission Delegated Regulation (EU) 2016/128 define the rules for the composition and labelling of FSMPs. Consequently, FSMPs must meet the specific nutritional requirements that result from a specific medical condition, but must not treat the medical condition of the target patient. The product must therefore not have a pharmacological, immunological or metabolic action, and the packaging must not promote or indicate properties to cure or prevent a disease. Nutrition and health claims are therefore prohibited.

Finally, the EU list from Regulation (EU) No 609/2013 sets out the substances authorized to develop FSMPs (and more generally to develop all categories of FSGs). The FSMPs marketed must be sold prepacked and ready-to-use/reconstitute.

The regulatory framework for developing FSMPs therefore makes it possible to guarantee the safety and quality of the products, while allowing innovation.

III. Markets in which you can develop FSMPs

The markets for FSMPs are all those involving patients who are unable to meet their nutritional requirements and are liable to be undernourished or malnourished.

The FSMPs market therefore comprises patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete a nutrient or its metabolites, or who have any other disorder or medical condition requiring nutritional adaptation.2 It therefore mainly concerns the elderly and infants.

Product marketing authorization for FSMPs is finally granted by the competent authorities at national level. The manufacturer must therefore notify the Directorate General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) before it is marketed, and must also be able to provide a supporting scientific dossier.4

Developing FSMPs therefore requires a wide range of knowledge, ranging from market trends to marketing procedures, regulations, and technical, budgetary and organoleptic constraints.

IV. Laïta Nutrition can help you develop suitable FSMPs

Laïta Nutrition’s expertise enables us to take all of the regulatory and technical constraints into account in order to develop effective, high-quality and safe FSMPs.

Via a personalized development methodology and thanks to our reinforced R&D team, our expertise in complex nutritional formulations enables us to formulate effective FSMPs, in powder or liquid form, suited to your specifications.

Our great technological expertise then enables us to produce product models and prototypes, and to provide reliable and regular monitoring throughout the development phases.

Finally, our command of highly specific processes enables us to guarantee the optimum quality of the FSMPs developed, in compliance with international food safety standards. Our plants are FSSC 22000 and ISO 9001 certified, which also makes it possible to guarantee the compliance, traceability and food safety of the FSMPs that we develop.

The adaptability and high standards of Laïta Nutrition make us an ideal partner to develop customized FSMPs at your request.

Laïta Nutrition has managed to apply its expertise to the clinical nutrition market where there is great demand, and can therefore meet the highly technical requirements for developing FSMPs. We are able to develop and offer FSMPs that meet both patients’ needs and regulatory requirements, while providing our expertise in the organoleptic qualities and the form of the product (liquid or powder). Laïta Nutrition therefore already has all of the know-how required to develop customized FSMPs, according to your request.

1. Syndicat Français de la Nutrition Spécialisée, 2021 figures

2. RNI Consulting, Les DADFMS: à la frontière entre aliments et médicaments

3. Official Journal of the European Union, Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013

4. EFSA, Newsroom, FAQ: foods for special medical purposes, November 2015