The 2025 report from the Carabinieri NAS recorded 45,762 inspections, 6,255 criminal sanctions, 23,397 administrative sanctions, and total seizures of EUR 197 million, with 100 websites blocked during the year for illicit therapeutic claims on supplements and notified products. In the Padua territory in 2024, 320,000 non-compliant supplement packages had already been seized for a value of EUR 6 million. The Italian Competition Authority (AGCM) adopted in November 2024, effective November 19, a new investigative regulation that sets sanctions up to EUR 5 million, doubled to EUR 10 million for companies with turnover above EUR 50 million. The 2026 picture for Italian nutraceutical players is clear: claim compliance is no longer an optional practice, it is structural risk management.
The regulatory constraint is articulated on two overlapping levels. At the European level, EC Regulation 1924/2006 governs nutrition and health claims, and EU Regulation 432/2012 establishes the list of authorized claims with periodic updates via article 13.5. EU Regulation 1169/2011 governs food labeling, transposed in Italy by Legislative Decree 231/2017 with administrative sanctions between EUR 1,000 and 40,000. At the Italian national level, the notification procedure to the Ministry of Health, through the NSIS system and the Supplements Register, is mandatory for marketing, and in case of remarks the producer has thirty days to respond and modify the label. The framework is solid on paper. Its effective application, until 2024, has left margins of interpretation on which an entire area of the sector — botanicals — has built a precarious equilibrium for fifteen years.
The botanicals labyrinth: 2,000 claims pending since 2010
Approximately 2,000 claims relating to botanical substances — plant extracts, phytocomplexes, traditional herbal medicine ingredients — have been "on hold" at EFSA since 2010-2012, awaiting a formal scientific assessment that has never arrived. The picture was substantially unchanged as of May 2026. The European Parliament approved in January 2024 a resolution criticizing the block of EFSA assessments on botanicals and asking the Commission to unblock the pending list, coordinating with Member States to define an applicable framework. The structural block has allowed companies in the sector to operate for years in a grey area: "on hold" claims were not formally authorized but neither were they formally prohibited, and the national practice of individual EU countries allowed more or less permissive uses in advertising.
The 2024 ruling of the Court of Justice of the European Union and subsequent rulings of the Italian Council of State closed the grey area. The principle affirmed is clear: inclusion in the "on hold" list does not legitimize the advertising use of the claim. For Italian nutraceutical companies, which hold 26% of the European market precisely on plant-based products, the operational change is significant. Advertising strategies and packaging narratives based on "on hold" botanicals claims have become legal exposure, and mapping the risk of one's own portfolio is the first step that every Italian producer must take in 2026.
The operational chokepoint: notification to the Ministry
The Italian notification procedure to the Ministry of Health is the point where regulatory theory becomes operational practice. The producer — the OSA, Food Sector Operator — is responsible for the conformity of the product and the label. Notification passes through the NSIS system on the Ministry portal. In case of remarks, the producer has thirty days to respond and modify the label. The notified product flows into the Supplements Register, publicly accessible, and officially enters the authorized sales channel. The fluidity of this process determines the time-to-market of every new product and the speed with which a brand can iterate on its formulations and claims.
The constraint not always visible is the Ministry's remark rate. The most structured producers report multiple notification cycles — the first submission rarely passes without requests for modification — with cumulative approval times that can exceed six months. For a brand planning a seasonal launch or a range refresh, the constraint is critical. AI tools for pre-notification label audit are the most recent and dynamic segment of this domain: the system analyzes the proposed packaging, compares it with the EFSA authorized claims, with ministerial guidelines and with its own history of remarks, and signals in the pre-submission phase the points that will produce a modification request. The cumulative gain across a series of launches is not marginal.
AI compliance tools: what they do and what they don't
The segment of AI tools for nutraceutical claim compliance is in rapid expansion between 2024 and 2026. SGS Digicomply combines over 250 regulatory guides with a conversational chatbot for rapid consultation. Sieve/Taama operates on multi-jurisdiction frameworks FDA, EFSA, SFA, CFIA, FSANZ, useful for brands operating in multiple markets. Food Chain ID Supplements Compliance performs recipe and claim checks on EU and national frameworks. Food Label Maker, FDA AI-driven, covers the U.S. market with a similar approach. Apex Compliance was finalist at the Vitafoods Europe Startup Innovation Challenge 2024 in the regulatory innovation category for nutraceuticals.
The real capabilities of these tools in 2026 are concrete but must be qualified. The automatic audit of packaging against EFSA lists of authorized claims is operational and reliable; the recognition of borderline claims — formulations that allude to therapeutic effects without explicitly declaring them — still requires expert human assessment; integration with the Italian NSIS notification procedure is fragmentary and for now still requires the manual passage of the compliance officer. The added value of AI tools in 2026 is not the replacement of the compliance officer but the acceleration of the first screening: 70% of foreseeable remarks are intercepted in the pre-submission phase, leaving the human team with the 30% that requires qualitative assessment.
Pharma vs nutra: five years behind
The regulatory framework for medicinal products has been the subject of a structured digital transformation over the past fifteen years: eCTD for submission, IDMP for product identification, enterprise-grade document management systems, formalized change control, batch traceability integrated with MES systems. The regulatory framework for nutraceuticals is five to seven years behind on this trajectory. Notification to the Italian Ministry of Health is still a digital procedure, but SMEs in the sector — the majority of Italian producers — manage their regulatory dossiers with tools ranging from Excel to generic document management systems, rarely with the level of structured authoring required in pharma.
For Italian nutraceutical companies in 2026 the convergence of pharma standards toward nutra is a competitive opportunity. Implementing label audit, change control and document management structures that take up pharma practices reduces NAS and AGCM risk, lowers the notification time to the Ministry, accelerates the iteration speed of the portfolio. The cost of these capabilities is today accessible even to the mid-market thanks to AI: tools that five years ago required enterprise deployment of hundreds of thousands of euros are today available in SaaS at costs compatible with players from EUR 20-50 million in turnover. The remaining constraint is process design: compliance is not bought as a license, it is built as a practice. The EUR 197 million of NAS seizures in 2025 are the measure of the cost of not having built it in time.
