On October 28, 2025, the Italian Ministry of Health released updated guidelines regarding Foods for Special Medical Purposes (FSMP; Italian: AFMS – “Alimenti a Fini Medici Speciali”), following the revision dated July 15, 2025, by the Section for Dietetics and Nutrition of the competent Technical Committee.

The guidelines provide a clear interpretative framework for food operators (FBOs), defining criteria for correct classification, formulation and labeling of FSMPs, ensuring consistent application of national standards aligned with the EU regulatory reference such as Regulation (EU) 609/2013 and Regulation (EU) 2016/128.

In line with the recent orientation of the Court of Justice of the European Union, the Ministry emphasizes that FSMP labeling must remain strictly technical; marketing or promotional language is prohibited. This reinforces the role of FSMPs as clinical nutrition tools, distinct from standard foods and food supplements.

What is an FSMP?

FSMPs are specifically formulated for patients whose medical conditions create nutritional vulnerabilities that cannot be managed through ordinary foods or food supplements.

To be classified as an FSMP, a product must meet three criteria:

• It must be expressly formulated for patients under strict medical supervision, as part of a structured clinical nutrition strategy.
• It is intended for the total or partial feeding of patients (oral or enteral) with impaired capacity to take, digest, absorb, metabolize, or eliminate ordinary foods or nutrients.
• The patient’s clinical dietary management cannot be achieved solely by modifying the normal diet, including the use of food supplements.

The guidelines clarify that the term “dietary management” (“gestione dietetica”) should be interpreted as “nutritional management” (“gestione nutrizionale”), particularly for patients receiving enteral nutrition (e.g. via tube feeding or PEG), in order to prevent malnutrition and optimizing metabolic balance.

Regulatory context: why the update?

The Italian Ministry of Health reiterates that FSMPs must be understood and regulated as medical nutrition products, not as consumer or wellness goods. This distinction is essential to:

• safeguard patient safety;
• preserve the integrity of the National Register of FSMPs, which governs products eligible for reimbursement by the Italian National Health Service (SSN);
• prevent borderline classifications that undermine regulatory consistency.

Key clarifications

1. Absolute ban on nutrition and health claims [Section 4]

Labels must remain strictly technical and clinical. Use of health claims, e.g. “immune support” (“supporto immunitario”) is excluded in favor of clinical statements describing “dietary management” (“gestione dietetica”) of the patient’s condition.

2. FSMPs for dysphagia [Section 7]

The guidelines clarify that freeze-dried and homogenized meals do not qualify as FSMPs. For ready-to-use meals targeting dysphagia and malnutrition, FBOs must now:

• Specify dilution proposals according to the IDDSI scale.
• Clearly indicate the target population (adults and/or children).

Additionally, certain products, such as 24% sucrose solutions, are now restricted to exclusive hospital use.

3. New mandatory warning for inherited metabolic diseases (MMC) [Section 7]

For products (MMC – 7.3.9), where vitamin or mineral levels exceed the thresholds set in Tables I and II of Regulation 2016/128, the label must state exactly:

“A causa dei livelli elevati di vitamine e minerali del prodotto, il medico valuterà, quando opportuno, l’esecuzione di un follow-up nutrizionale (incluso il monitoraggio nutrizionale antropometrico) e di esami specifici.”

(“Due to the high levels of vitamins and minerals in the product, the physician will assess, when appropriate, the performance of a nutritional follow-up (including anthropometric nutritional monitoring) and specific tests.”).

4. Additional examples for low-protein products [Section 7]

New practical examples (7.2.7) distinguish medical substitutes from ordinary “low-protein” consumer goods. The guide reaffirms established thresholds for these substitutes:​

• “Aproteic”(“Aproteici”): protein residue ≤ 1%.
• “Low protein” (“Ipoproteici”): protein residue between 1% and 2%.

Compliance with these examples is required for inclusion in the National Register and SSN reimbursement.

What food business operators need to consider

FBOs should proactively review their product portfolios for full compliance with the guidelines.

• Classification: focus on clinical needs, rather than general wellness.

• Formulation: align nutrient compositions with the intended clinical purpose, with particular attention to new standards for metabolic disorders, dysphagia, and low-protein food categories.
• Dossier: ensure complete adherence to all guideline requirements.
• Labeling: maintain clinical, non-promotional labels in line with current restrictive interpretations.

>>> Complife Group provides specialized regulatory and technical consultancy in the nutraceutical and clinical nutrition field. We support companies in:

• correctly classifying their products as FSMPs;
• assessing formulation compliance;
• reviewing labels and draft technical documentation;
• preparing and submitting compliant notifications to the competent authorities.

Our integrated approach helps FBO navigate the regulatory framework and ensure full compliance, minimizing regulatory risk and supporting market access.

SOURCE:
https://www.salute.gov.it/new/sites/default/files/2025-10/linee%20guida%20afms%202025%20luglio.pdf