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Can FSMP Salt Substitutes Support Antihypertensive Therapy in Mild-to-Moderate Hypertension? A Narrative Review of Rationale, Evidence, Safety, and Regulatory Implications

  • Andrea Zovi 1,*,   
  • Sauro Vittori 2

Received: 22 Jan 2026 | Revised: 03 Jun 2026 | Accepted: 04 Jun 2026 | Published: 15 Jun 2026

Abstract

Aims. Arterial hypertension remains one of the leading modifiable cardiovascular risk factors worldwide, and its management requires the integration of pharmacological treatment with evidence-based lifestyle and dietary measures. Among non-pharmacological approaches, sodium reduction is strongly recommended, although long-term adherence to a low-salt diet is often limited by reduced palatability. In this context, low-sodium, potassium-enriched salt substitutes, including products classifiable in specific settings as foods for special medical purposes (FSMP), have emerged as a potentially relevant adjunctive strategy for the dietary management of selected hypertensive patients. Data Synthesis. This narrative review specifically examines low-sodium, potassium-enriched salt substitutes intended for the dietary management of arterial hypertension, with emphasis on their compositional rationale, mechanisms of blood pressure reduction, regulatory framework, clinical efficacy, safety profile, and practical applicability. Available evidence from randomized trials and meta-analyses indicates that these products can reduce systolic and diastolic blood pressure and, in some settings, improve cardiovascular outcomes and all-cause mortality. However, the strength of the evidence is tempered by heterogeneity in study populations, formulations, background diets, and healthcare settings. In addition, the risk of hyperkalaemia remains a clinically relevant concern, especially in patients with chronic kidney disease, diabetes mellitus, adrenal insufficiency. Conclusions. Low-sodium, potassium-enriched salt substitutes should be regarded not as a replacement for standard antihypertensive therapy in most patients, but as a potentially effective adjunct, and in selected mild-to-moderate cases a possible supportive alternative within a medically supervised care pathway. Future research should better define which patient groups derive the greatest net clinical benefit and how these products can be integrated into different regulatory and healthcare contexts.

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How to Cite
Zovi, A.; Vittori, S. Can FSMP Salt Substitutes Support Antihypertensive Therapy in Mild-to-Moderate Hypertension? A Narrative Review of Rationale, Evidence, Safety, and Regulatory Implications. Food as Medicine 2026, 2 (2), 5. https://doi.org/10.53941/fm.2026.100005.
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