I. Introduction

The longevity economy is commonly estimated at several hundred billion dollars worldwide and continues to grow rapidly.[1] Venture capital flows into biotechnology companies that promise to slow, halt, or reverse aging. Clinics from Zurich to Seoul to Miami sell “longevity programmes.” Supplement brands attach the word “longevity” to products ranging from NAD precursors to collagen powders. And yet the word “longevity” does not exist as a legal category in European Union law. There is no definition, no register, no certification scheme, and no authority empowered to decide what may or may not describe itself as a longevity product, a longevity clinic, or a longevity company.

The gap between an enormous market and a non-existent legal definition is precisely where legal risk accumulates. Where there is no definition, there is classification risk, claims risk, and enforcement risk. There is also a phenomenon that this article, borrowing from the vocabulary of environmental marketing, calls “longevity washing.”

This article examines the longevity industry through the lens of EU regulatory law. The EU framework governs a market of some 450 million consumers and, because it is horizontal, sector-specific, and increasingly enforcement-oriented, it offers a useful point of comparison for practitioners in the United States, Asia, and Latin America. Part II explains why “longevity” is not a legal category and introduces the borderline-product problem that follows from that fact. Part III develops the concept of longevity washing and its consumer-facing, unfair-commercial-practice, and investor-facing dimensions. Part IV addresses the regulation of artificial intelligence in longevity research and diagnostics, including the revised timeline of the AI Act, the position of the European Medicines Agency on AI in the medicinal-product lifecycle, and the data-protection architecture formed by the GDPR and the European Health Data Space. Part V maps the sectoral “hot spots” across pharmaceuticals, medical devices, cosmetics, and food supplements. Part VI draws conclusions for practitioners.

II. “Longevity” in the Eyes of the Law: The Borderline-Product Problem

In EU regulatory law, aging is not a disease. The European Medicines Agency has never approved a medicinal product with “aging” as a therapeutic indication, and under Directive 2001/83/EC a medicinal product is defined by reference to the treatment or prevention of disease or the restoration, correction, or modification of physiological functions.[2] The position in the United States is comparable. The long-running debate around the Targeting Aging with Metformin (TAME) trial illustrates the point: its designers had to negotiate a trial protocol with the Food and Drug Administration that targets aging indirectly, through a composite of age-related diseases, precisely because “aging” itself is not an approvable indication.[3]

The consequence is profound. A company cannot lawfully market a product “to treat aging.” The entire longevity industry therefore operates in the space of indirect claims: “supports healthy aging,” “promotes cellular health,” “extends healthspan.” Each of those phrases pushes the product toward one of several very different regulatory regimes.

This is the borderline-product problem, and it is the single most important legal concept in the sector. The same molecule – an NAD precursor, for example – may be: a medicinal product, if it is presented as treating or preventing disease or exerts a significant pharmacological, immunological, or metabolic effect; a food supplement under Directive 2002/46/EC;[4] a novel food requiring pre-market authorisation under Regulation (EU) 2015/2283;[5] a cosmetic under Regulation (EC) No 1223/2009, if applied to the skin with a claim limited to appearance;[6] or a medical device. The last category is broader than it may appear: since the Medical Device Regulation (MDR) came into application, products listed in its Annex XVI – dermal fillers, certain energy-based aesthetic equipment – are regulated as devices even where they have no medical purpose at all.[7]

Classification does not follow the label a company chooses. It follows presentation, composition, and route of administration. The Court of Justice of the European Union has held for four decades that a product is a medicinal product “by presentation” where it is described or recommended as having properties for treating or preventing disease, irrespective of whether it actually has those properties; and that classification “by function” turns on a case-by-case scientific assessment of the product’s actual pharmacological, immunological, or metabolic action, not on the manufacturer’s intention.[8] Marketing language alone can therefore reclassify a product and, with it, the entire compliance burden: marketing authorisation, good manufacturing practice, pharmacovigilance, and advertising restrictions.

When a client says “we are a longevity company,” the first question counsel should ask is: which regime are you actually in? “Longevity” is a marketing word. The law knows only medicines, devices, foods, and cosmetics.

III. Longevity Washing: When the Claim Outruns the Science

Greenwashing – claiming environmental virtue one does not have – is a familiar concept. Longevity washing is its younger sibling: labelling a product, a clinic, a research programme, or an entire company as “longevity-focused” when the science, the indication, or the business model does not support that description. The practice matters legally for three reasons.

A. Consumer-Facing Claims

Under the Health Claims Regulation, any health claim made on a food – and food supplements are foods – must be specifically authorised and listed in the EU register.[9] Claims such as “slows aging,” “supports cellular repair,” or “extends lifespan” are not authorised health claims. National authorities in the EU and the United Kingdom have treated phrases such as “cellular repair” and even “healthy aging” as impermissible where they imply a physiological mechanism or a reduction of disease risk. A substantial part of the longevity supplement market is thus operating with claims that would not survive enforcement scrutiny.

B. Unfair Commercial Practices and the Greenwashing Template

The second layer is the general prohibition of misleading commercial practices under the Unfair Commercial Practices Directive (UCPD).[10] Here the EU has recently built an entire enforcement architecture against greenwashing that repays close study by anyone advising on health claims. The Empowering Consumers for the Green Transition Directive amends the UCPD to prohibit generic environmental claims – “eco-friendly,” “climate-neutral” – unless the trader can demonstrate recognised excellent environmental performance, and it adds a series of specific greenwashing practices to the UCPD’s blacklist. Its provisions apply across the Union from 27 September 2026.[11]

The Directive should be read as a template. If “climate-neutral” now requires substantiation, it is a very short doctrinal step for regulators and courts to demand the same of “clinically proven to slow biological aging.” The methodology of anti-greenwashing enforcement – generic claim, absence of substantiation, misleading omission – maps directly onto longevity claims. The UCPD’s general clauses on misleading actions and omissions already provide the legal basis; what the green-claims reform supplies is a worked example of how those clauses can be operationalised against vague virtue-signalling.

C. Investor-Facing Washing

The third dimension is of particular relevance to transactional lawyers. Start-ups increasingly brand themselves as “longevity biotech” because that is where the capital is, even when the underlying asset is a conventional dermatology product or a wellness application. For investors, this creates due-diligence risk: is the “longevity platform” in fact a regulated medicinal pipeline, with all the timeline and cost that implies, or a supplement business one enforcement letter away from relabelling? Misclassification discovered after investment is a valuation event. For the company, aggressive longevity framing in fundraising materials can generate liability under securities and misrepresentation rules in multiple jurisdictions. In due diligence on a longevity start-up, the regulatory classification memorandum is not an annex to the deal; it is the deal.

IV. Artificial Intelligence in Longevity Research and Diagnostics

The longevity field is arguably the most AI-dependent sector in the life sciences, for a simple reason: aging is not one target but thousands of interacting biological processes. A geroprotective drug cannot be designed the way an antibiotic is designed. The entire aging phenotype must be modelled, and that means machine learning on large multi-omic datasets. AI is not an add-on in longevity; it is the core methodology. That raises three distinct regulatory questions under EU law.

A. The AI Act

Regulation (EU) 2024/1689, the AI Act, is the most comprehensive horizontal AI regulation in force anywhere and applies to almost every AI system used in the longevity value chain.[12] It adopts a risk-based structure – prohibited practices, high-risk systems, transparency obligations, and minimal-risk systems – and the critical category for this sector is high-risk. An AI system that is itself a medical device, or a safety component of one, under the MDR or the In Vitro Diagnostic Regulation, and that is subject to third-party conformity assessment under those instruments, is high-risk under Article 6(1) and Annex I of the AI Act.[13] This captures, for example, an AI tool that estimates a patient’s “biological age” from a blood panel and uses that estimate to guide a clinical intervention; an AI-driven diagnostic that predicts age-related disease risk; and the software layer of many longevity-clinic platforms once it makes a diagnostic or prognostic claim.

High-risk status is not a prohibition; it is a compliance regime. It requires a risk-management system, data governance with representative and bias-tested training data, technical documentation, logging, human oversight, transparency to deployers, accuracy, robustness and cybersecurity, a conformity assessment, and post-market monitoring.[14] For most longevity start-ups this is a wholly new compliance layer on top of MDR conformity assessment, and the two must be coordinated.

The timeline has recently changed, and practitioners should update their advice accordingly. The original AI Act applied the high-risk obligations from 2 August 2026 for stand-alone systems listed in Annex III and from 2 August 2027 for AI embedded in products covered by Annex I, including medical devices. The Digital Omnibus on AI, adopted as Regulation (EU) 2026/1744 and in force since 27 July 2026, defers those dates to 2 December 2027 and 2 August 2028 respectively.[15] The deferral does not lighten the substantive regime; the prohibitions in Article 5, the obligations of providers of general-purpose AI models, and the transparency obligations of Article 50 (which apply from 2 August 2026) are unaffected. For longevity companies whose AI is a medical device, the practical effect is a compliance window of roughly two years, during which harmonised standards and notified-body capacity are expected to mature. The window is an opportunity to design AI Act compliance into the MDR technical file from the outset rather than to defer the exercise.

B. AI in Drug Discovery and the European Medicines Agency

The position for drug discovery is more nuanced. An AI model used purely internally to identify candidate molecules – the classic “AI for drug discovery” use case that dominates longevity-biotech pitch decks – is generally not, in itself, a high-risk AI system under the AI Act, because it does not make or materially influence decisions about individual patients. The regulatory question shifts instead to the European Medicines Agency. The EMA’s Reflection Paper on the use of AI in the medicinal product lifecycle sets out the Agency’s expectations from discovery through pharmacovigilance.[16] Its core message is that the burden of proof rests on the sponsor to demonstrate that the AI model is fit for its regulatory purpose. That entails documented data provenance, model validation, a degree of explainability appropriate to the stage of development, and lifecycle management of the model itself.

If a longevity company tells its investors that “our AI discovered this molecule,” the regulator will eventually ask to see the model, the training data, and the validation. Vague AI claims in fundraising materials do not survive regulatory scrutiny and, increasingly, do not survive investor due diligence either.

C. Data: The GDPR and the European Health Data Space

The third question concerns data, and it is here that longevity becomes uniquely difficult. Aging research is inherently longitudinal and multi-omic: genomic, epigenetic, and proteomic data, wearable data, and medical records, ideally across decades. Under the General Data Protection Regulation this is special-category data – health, genetic, and biometric data – and the available lawful bases are narrow.[17] The scientific-research provisions of Article 9(2)(j) and Article 89 assist, but they are implemented differently in each Member State, which produces real fragmentation for pan-European longevity cohorts.

The European Health Data Space Regulation adds a second layer.[18] It creates, for the first time, a mandatory EU-wide framework for the secondary use of electronic health data, administered by health-data-access bodies in each Member State. For longevity research the EHDS is potentially transformative, because it opens access to population-scale health data for research purposes. It also imposes strict conditions: purpose limitation, processing only within secure processing environments, a prohibition on re-identification, and specific prohibitions on using the data for advertising or marketing, for decisions detrimental to individuals such as insurance or employment decisions, or for developing products harmful to health.[19] The secondary-use chapter applies from March 2029 for most data categories, but the lead time is short in the context of longitudinal cohorts. Longevity companies that intend to monetise health data – and many do – should be mapping their data flows against the EHDS regime now.

V. Sector-by-Sector Regulatory Hot Spots

Four sectoral silos together make up the longevity industry, and the same start-up frequently straddles two or three of them without realising it. In each silo, specific “hot spots” – advertising, manufacturing standards, registration, and market withdrawal – recur in practice.

A. Pharmaceuticals

True longevity drugs – rapamycin analogues, senolytics, geroprotectors – sit squarely within Directive 2001/83/EC and its implementing rules, and will continue to do so under the new pharmaceutical package once it applies. Three practical hot spots stand out. First, off-label prescribing of rapamycin and metformin for longevity indications is widespread in private clinics across Europe. Off-label prescribing as such is a matter of clinical freedom, but off-label promotion by or on behalf of the marketing-authorisation holder is prohibited: advertising must conform to the summary of product characteristics, and advertising of unauthorised products or indications is not permitted.[20] Longevity clinics are increasingly the vehicle through which promotional messaging reaches patients, and enforcement authorities have begun to take notice. Second, good manufacturing practice: anything presented as a medicine must be manufactured under an EU manufacturing authorisation and EU GMP, with qualified persons and full traceability; compounding pharmacies producing “longevity peptides” have become a significant enforcement target. Third, unlicensed importation: a large part of the longevity-peptide market operates through personal importation and grey channels, and customs enforcement across the EU has visibly tightened.

B. Medical Devices

The MDR has fundamentally reshaped this space. Aesthetic devices – dermal fillers, energy-based devices used in longevity clinics, at-home devices marketed for “cellular rejuvenation” – are caught by Annex XVI even without a medical purpose. Three hot spots follow. Classification: many longevity wearables and applications become software as a medical device once they make a diagnostic or prognostic claim. Advertising: Article 7 of the MDR prohibits misleading claims and specifically prohibits ascribing to a device functions and properties it does not have, which operates in practice as a codified anti-washing rule for devices.[21] Registration and vigilance: the first four modules of the EUDAMED database – actor registration, UDI/device registration, notified bodies and certificates, and market surveillance – have been mandatory since 28 May 2026, with legacy devices to be registered by 28 November 2026; the vigilance module is not yet mandatory, so serious incidents and field safety corrective actions continue to be reported to national competent authorities.[22] Market withdrawals happen: a device sold as a “cellular biomarker analyser” without valid clinical evidence can be removed from the market by any national competent authority, and the MDR’s market-surveillance coordination means that one withdrawal can cascade across the Union.

C. Cosmetics and Aesthetic Products

The Cosmetics Regulation governs anti-aging creams, serums, and topical actives. Two hot spots dominate. The first is the Product Information File: the responsible person must hold a complete file including a safety assessment and substantiation of every claim. The second is the Claims Regulation, Commission Regulation (EU) No 655/2013, with its six common criteria: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making.[23] A claim such as “reverses skin aging at the cellular level” fails the evidential-support criterion unless a robust dossier stands behind it. Enforcement is largely national, but the Cosmetic Products Notification Portal is EU-wide, and non-compliant products are routinely notified through the Safety Gate rapid-alert system.

D. Food Supplements and Novel Foods

It is in the food and supplement space that the longevity industry is most creative and most exposed. Directive 2002/46/EC governs vitamins and minerals in supplements; everything else falls under the general food law of Regulation (EC) No 178/2002[24] and, critically, the Novel Food Regulation. Nicotinamide mononucleotide (NMN), one of the most heavily marketed longevity molecules, is the paradigmatic case. NMN is treated as a novel food in the EU, which means it cannot lawfully be placed on the market as a supplement without pre-market authorisation by the Commission following an EFSA safety assessment. Nicotinamide riboside received such an authorisation in 2020.[25] NMN has not – although the picture is now moving. In March 2026 EFSA’s NDA Panel adopted a positive opinion on the safety of β-NMN in food supplements at up to 300 mg per day for adults, and the opinion was published in May 2026.[26] An EFSA opinion is a scientific assessment, not an authorisation; the Commission must still adopt an implementing act adding NMN to the Union list, and where the applicant has requested data protection the authorisation will initially be proprietary to that applicant’s specification. Until that act is adopted, NMN products on the shelves of European longevity clinics remain unauthorised novel foods. That is not a grey area; it is a non-compliant market operating in plain sight, and it is the kind of enforcement pipeline that eventually produces high-profile withdrawal actions. Once the Health Claims Regulation is added to the picture, the conclusion is unavoidable: the food and supplement leg of the longevity industry is the most legally exposed part of the entire sector.

VI. Conclusions

The longevity industry is a genuine scientific and commercial phenomenon, and much of the underlying research is serious. But lawyers advising companies, investors, clinicians, and, increasingly, regulators in this space must see it clearly: “longevity” is not a legal category. It is a marketing frame layered on top of four very different regulatory regimes. Three practical conclusions follow for anyone whose product touches European consumers.

First, always begin with classification. The word “longevity” conveys nothing about the applicable regime. Ask what the product is, how it is presented, and what it does, and let the regulatory regime follow from those answers.

Second, treat longevity claims the way green claims are now treated. The direction of enforcement is unmistakable. The Empowering Consumers for the Green Transition Directive, applicable from 27 September 2026, gives regulators a sharpened toolkit that will, sooner or later, be pointed at health and wellness claims. Substantiation is no longer optional.

Third, integrate AI Act compliance with sectoral compliance from the outset. For any longevity venture using AI in diagnostics or patient-facing decision support, the AI Act, the MDR, and the GDPR, soon joined by the European Health Data Space, form a single interlocking compliance architecture. The deferral of the AI Act’s high-risk obligations to 2027 and 2028 is a design window, not a reprieve. Retrofitting is expensive; designing for compliance is not.

The longevity industry will keep growing, and regulators will keep catching up. The lawyers who understand both the science and the sectoral map will be the ones clients call first.

[1] Longevity economy estimates vary widely by definition; see, e.g., the periodic longevity-market reports of Bank of America Global Research and McKinsey Health Institute. The figure is offered here as an order of magnitude, not a precise valuation.

[2] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use, art. 1(2), 2001 O.J. (L 311) 67 [hereinafter Directive 2001/83]. At the time of writing, the new EU pharmaceutical package (a new directive on the Union code for medicinal products for human use and a new regulation on Union authorisation procedures) has been politically agreed and is in the final stage of formal adoption; the substantive rules discussed here are carried over into the new framework, which will apply after a transitional period of approximately two years from entry into force.

[3] See Nir Barzilai et al., Metformin as a Tool to Target Aging, 23 Cell Metabolism 1060 (2016) (describing the design of the Targeting Aging with Metformin (TAME) trial around a composite of age-related diseases).

[4] Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the Approximation of the Laws of the Member States Relating to Food Supplements, 2002 O.J. (L 183) 51.

[5] Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on Novel Foods, 2015 O.J. (L 327) 1 [hereinafter Novel Food Regulation].

[6] Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products, 2009 O.J. (L 342) 59 [hereinafter Cosmetics Regulation].

[7] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices, Annex XVI, 2017 O.J. (L 117) 1 [hereinafter MDR]; Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 Laying Down Common Specifications for the Groups of Products Without an Intended Medical Purpose Listed in Annex XVI, 2022 O.J. (L 311) 60.

[8] Case 227/82, Van Bennekom, ECLI:EU:C:1983:354 (establishing that a product is a medicinal product “by presentation” where it is described or recommended as having therapeutic or prophylactic properties, irrespective of its actual efficacy); Case C-319/05, Comm’n v. Germany, ECLI:EU:C:2007:678 (garlic capsules); Case C-140/07, Hecht-Pharma GmbH v. Staatliches Gewerbeaufsichtsamt Luneburg, ECLI:EU:C:2009:5 (classification “by function” requires a case-by-case assessment of pharmacological, immunological or metabolic properties). See also Directive 2001/83, supra note 2, art. 2(2) (in cases of doubt, the medicinal-products regime prevails).

[9] Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on Nutrition and Health Claims Made on Foods, arts. 10, 13, 14, 2006 O.J. (L 404) 9 [hereinafter Health Claims Regulation]. The EU Register of nutrition and health claims is maintained by the European Commission.

[10] Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 Concerning Unfair Business-to-Consumer Commercial Practices in the Internal Market, 2005 O.J. (L 149) 22 [hereinafter UCPD].

[11] Directive (EU) 2024/825 of the European Parliament and of the Council of 28 February 2024 Amending Directives 2005/29/EC and 2011/83/EU as Regards Empowering Consumers for the Green Transition, OJ L, 2024/825, 6.3.2024 [hereinafter ECGT Directive]. Member States were required to transpose the Directive by 27 March 2026; its provisions apply from 27 September 2026. The separate Green Claims Directive proposal, which would have introduced ex ante verification of explicit environmental claims, was withdrawn by the Commission in 2025 and is not discussed here.

[12] Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 Laying Down Harmonised Rules on Artificial Intelligence, OJ L, 2024/1689, 12.7.2024 [hereinafter AI Act].

[13] AI Act, supra note 12, art. 6(1) & Annex I, § A (listing the MDR and Regulation (EU) 2017/746 on in vitro diagnostic medical devices). The Annex I route applies where the AI system is a product, or a safety component of a product, that is itself subject to third-party conformity assessment under the listed Union harmonisation legislation.

[14] AI Act, supra note 12, arts. 9–15, 17, 43, 72.

[15] Regulation (EU) 2026/1744 of the European Parliament and of the Council Amending Regulation (EU) 2024/1689 as Regards the Simplification of Certain Obligations (“Digital Omnibus on AI”), OJ L, 2026/1744, 24.7.2026 (in force 27 July 2026). The Regulation defers the high-risk obligations for stand-alone (Annex III) systems to 2 December 2027 and for AI embedded in products covered by Annex I, including medical devices, to 2 August 2028; the Article 50 transparency obligations continue to apply from 2 August 2026.

[16] Eur. Medicines Agency, Reflection Paper on the Use of Artificial Intelligence (AI) in the Medicinal Product Lifecycle, EMA/CHMP/CVMP/83833/2023 (adopted Sept. 2024).

[17] Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural Persons with Regard to the Processing of Personal Data, arts. 9(2)(j), 89, 2016 O.J. (L 119) 1 [hereinafter GDPR].

[18] Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space, OJ L, 2025/327, 5.3.2025 [hereinafter EHDS Regulation]. The Regulation entered into force on 26 March 2025 and applies in stages: most provisions from 26 March 2027, and the core secondary-use chapter from 26 March 2029 (2031 for certain data categories). See id. art. 105.

[19] EHDS Regulation, supra note 18, arts. 50–54 (secure processing environments; permitted and prohibited purposes of secondary use).

[20] Directive 2001/83, supra note 2, art. 87(2) (all parts of advertising must comply with the particulars listed in the summary of product characteristics), arts. 40–53 (manufacturing authorisation and good manufacturing practice) and art. 87(1) (prohibition of advertising of medicinal products without a marketing authorisation).

[21] MDR, supra note 7, art. 7.

[22] Commission Decision (EU) 2025/2371 of 26 November 2025 (declaring the first four EUDAMED modules functional), OJ L, 2025/2371, 27.11.2025; Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024, OJ L, 2024/1860, 9.7.2024 (gradual roll-out of EUDAMED). The four modules (actor registration, UDI/device registration, notified bodies and certificates, market surveillance) are mandatory from 28 May 2026; legacy devices remaining on the market must be registered by 28 November 2026. The vigilance and clinical-investigation modules are not yet mandatory, and serious incidents continue to be reported to national competent authorities.

[23] Cosmetics Regulation, supra note 6, arts. 11, 13, 20; Commission Regulation (EU) No 655/2013 of 10 July 2013 Laying Down Common Criteria for the Justification of Claims Used in Relation to Cosmetic Products, Annex, 2013 O.J. (L 190) 31.

[24] Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 Laying Down the General Principles and Requirements of Food Law, 2002 O.J. (L 31) 1.

[25] Commission Implementing Regulation (EU) 2020/16 of 10 January 2020 Authorising the Placing on the Market of Nicotinamide Riboside Chloride as a Novel Food, 2020 O.J. (L 7) 6.

[26] EFSA Panel on Nutrition, Novel Foods and Food Allergens, Safety of Beta-Nicotinamide Mononucleotide (β-NMN) Pursuant to Regulation (EU) 2015/2283 and the Bioavailability of Nicotinamide from This Source in the Context of Directive 2002/46/EC, 24 EFSA J. e10007 (2026) (opinion adopted 4 March 2026, published 11 May 2026). Authorisation requires a Commission implementing act amending the Union list established by Commission Implementing Regulation (EU) 2017/2470; at the time of writing no such act has been published, and any authorisation granted on the basis of proprietary data will initially benefit only the applicant. See Novel Food Regulation, supra note 5, arts. 12, 26.

Artykuł Longevity Washing, AI and the Regulatory Fault Lines of the Longevity Industry: A European Perspective pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

ABA ILS, Life Sciences and Healthcare Committee, September 2026Prepared by KIELTYKA GLADKOWSKI KG LEGAL

I. Introduction

The longevity economy is commonly estimated at several hundred billion dollars worldwide and continues to grow rapidly.[1] Venture capital flows into biotechnology companies that promise to slow, halt, or reverse aging. Clinics from Zurich to Seoul to Miami sell “longevity programmes.” Supplement brands attach the word “longevity” to products ranging from NAD precursors to collagen powders. And yet the word “longevity” does not exist as a legal category in European Union law. There is no definition, no register, no certification scheme, and no authority empowered to decide what may or may not describe itself as a longevity product, a longevity clinic, or a longevity company.

The gap between an enormous market and a non-existent legal definition is precisely where legal risk accumulates. Where there is no definition, there is classification risk, claims risk, and enforcement risk. There is also a phenomenon that this article, borrowing from the vocabulary of environmental marketing, calls “longevity washing.”

This article examines the longevity industry through the lens of EU regulatory law. The EU framework governs a market of some 450 million consumers and, because it is horizontal, sector-specific, and increasingly enforcement-oriented, it offers a useful point of comparison for practitioners in the United States, Asia, and Latin America. Part II explains why “longevity” is not a legal category and introduces the borderline-product problem that follows from that fact. Part III develops the concept of longevity washing and its consumer-facing, unfair-commercial-practice, and investor-facing dimensions. Part IV addresses the regulation of artificial intelligence in longevity research and diagnostics, including the revised timeline of the AI Act, the position of the European Medicines Agency on AI in the medicinal-product lifecycle, and the data-protection architecture formed by the GDPR and the European Health Data Space. Part V maps the sectoral “hot spots” across pharmaceuticals, medical devices, cosmetics, and food supplements. Part VI draws conclusions for practitioners.

II. “Longevity” in the Eyes of the Law: The Borderline-Product Problem

In EU regulatory law, aging is not a disease. The European Medicines Agency has never approved a medicinal product with “aging” as a therapeutic indication, and under Directive 2001/83/EC a medicinal product is defined by reference to the treatment or prevention of disease or the restoration, correction, or modification of physiological functions.[2] The position in the United States is comparable. The long-running debate around the Targeting Aging with Metformin (TAME) trial illustrates the point: its designers had to negotiate a trial protocol with the Food and Drug Administration that targets aging indirectly, through a composite of age-related diseases, precisely because “aging” itself is not an approvable indication.[3]

The consequence is profound. A company cannot lawfully market a product “to treat aging.” The entire longevity industry therefore operates in the space of indirect claims: “supports healthy aging,” “promotes cellular health,” “extends healthspan.” Each of those phrases pushes the product toward one of several very different regulatory regimes.

This is the borderline-product problem, and it is the single most important legal concept in the sector. The same molecule – an NAD precursor, for example – may be: a medicinal product, if it is presented as treating or preventing disease or exerts a significant pharmacological, immunological, or metabolic effect; a food supplement under Directive 2002/46/EC;[4] a novel food requiring pre-market authorisation under Regulation (EU) 2015/2283;[5] a cosmetic under Regulation (EC) No 1223/2009, if applied to the skin with a claim limited to appearance;[6] or a medical device. The last category is broader than it may appear: since the Medical Device Regulation (MDR) came into application, products listed in its Annex XVI – dermal fillers, certain energy-based aesthetic equipment – are regulated as devices even where they have no medical purpose at all.[7]

Classification does not follow the label a company chooses. It follows presentation, composition, and route of administration. The Court of Justice of the European Union has held for four decades that a product is a medicinal product “by presentation” where it is described or recommended as having properties for treating or preventing disease, irrespective of whether it actually has those properties; and that classification “by function” turns on a case-by-case scientific assessment of the product’s actual pharmacological, immunological, or metabolic action, not on the manufacturer’s intention.[8] Marketing language alone can therefore reclassify a product and, with it, the entire compliance burden: marketing authorisation, good manufacturing practice, pharmacovigilance, and advertising restrictions.

When a client says “we are a longevity company,” the first question counsel should ask is: which regime are you actually in? “Longevity” is a marketing word. The law knows only medicines, devices, foods, and cosmetics.

III. Longevity Washing: When the Claim Outruns the Science

Greenwashing – claiming environmental virtue one does not have – is a familiar concept. Longevity washing is its younger sibling: labelling a product, a clinic, a research programme, or an entire company as “longevity-focused” when the science, the indication, or the business model does not support that description. The practice matters legally for three reasons.

A. Consumer-Facing Claims

Under the Health Claims Regulation, any health claim made on a food – and food supplements are foods – must be specifically authorised and listed in the EU register.[9] Claims such as “slows aging,” “supports cellular repair,” or “extends lifespan” are not authorised health claims. National authorities in the EU and the United Kingdom have treated phrases such as “cellular repair” and even “healthy aging” as impermissible where they imply a physiological mechanism or a reduction of disease risk. A substantial part of the longevity supplement market is thus operating with claims that would not survive enforcement scrutiny.

B. Unfair Commercial Practices and the Greenwashing Template

The second layer is the general prohibition of misleading commercial practices under the Unfair Commercial Practices Directive (UCPD).[10] Here the EU has recently built an entire enforcement architecture against greenwashing that repays close study by anyone advising on health claims. The Empowering Consumers for the Green Transition Directive amends the UCPD to prohibit generic environmental claims – “eco-friendly,” “climate-neutral” – unless the trader can demonstrate recognised excellent environmental performance, and it adds a series of specific greenwashing practices to the UCPD’s blacklist. Its provisions apply across the Union from 27 September 2026.[11]

The Directive should be read as a template. If “climate-neutral” now requires substantiation, it is a very short doctrinal step for regulators and courts to demand the same of “clinically proven to slow biological aging.” The methodology of anti-greenwashing enforcement – generic claim, absence of substantiation, misleading omission – maps directly onto longevity claims. The UCPD’s general clauses on misleading actions and omissions already provide the legal basis; what the green-claims reform supplies is a worked example of how those clauses can be operationalised against vague virtue-signalling.

C. Investor-Facing Washing

The third dimension is of particular relevance to transactional lawyers. Start-ups increasingly brand themselves as “longevity biotech” because that is where the capital is, even when the underlying asset is a conventional dermatology product or a wellness application. For investors, this creates due-diligence risk: is the “longevity platform” in fact a regulated medicinal pipeline, with all the timeline and cost that implies, or a supplement business one enforcement letter away from relabelling? Misclassification discovered after investment is a valuation event. For the company, aggressive longevity framing in fundraising materials can generate liability under securities and misrepresentation rules in multiple jurisdictions. In due diligence on a longevity start-up, the regulatory classification memorandum is not an annex to the deal; it is the deal.

IV. Artificial Intelligence in Longevity Research and Diagnostics

The longevity field is arguably the most AI-dependent sector in the life sciences, for a simple reason: aging is not one target but thousands of interacting biological processes. A geroprotective drug cannot be designed the way an antibiotic is designed. The entire aging phenotype must be modelled, and that means machine learning on large multi-omic datasets. AI is not an add-on in longevity; it is the core methodology. That raises three distinct regulatory questions under EU law.

A. The AI Act

Regulation (EU) 2024/1689, the AI Act, is the most comprehensive horizontal AI regulation in force anywhere and applies to almost every AI system used in the longevity value chain.[12] It adopts a risk-based structure – prohibited practices, high-risk systems, transparency obligations, and minimal-risk systems – and the critical category for this sector is high-risk. An AI system that is itself a medical device, or a safety component of one, under the MDR or the In Vitro Diagnostic Regulation, and that is subject to third-party conformity assessment under those instruments, is high-risk under Article 6(1) and Annex I of the AI Act.[13] This captures, for example, an AI tool that estimates a patient’s “biological age” from a blood panel and uses that estimate to guide a clinical intervention; an AI-driven diagnostic that predicts age-related disease risk; and the software layer of many longevity-clinic platforms once it makes a diagnostic or prognostic claim.

High-risk status is not a prohibition; it is a compliance regime. It requires a risk-management system, data governance with representative and bias-tested training data, technical documentation, logging, human oversight, transparency to deployers, accuracy, robustness and cybersecurity, a conformity assessment, and post-market monitoring.[14] For most longevity start-ups this is a wholly new compliance layer on top of MDR conformity assessment, and the two must be coordinated.

The timeline has recently changed, and practitioners should update their advice accordingly. The original AI Act applied the high-risk obligations from 2 August 2026 for stand-alone systems listed in Annex III and from 2 August 2027 for AI embedded in products covered by Annex I, including medical devices. The Digital Omnibus on AI, adopted as Regulation (EU) 2026/1744 and in force since 27 July 2026, defers those dates to 2 December 2027 and 2 August 2028 respectively.[15] The deferral does not lighten the substantive regime; the prohibitions in Article 5, the obligations of providers of general-purpose AI models, and the transparency obligations of Article 50 (which apply from 2 August 2026) are unaffected. For longevity companies whose AI is a medical device, the practical effect is a compliance window of roughly two years, during which harmonised standards and notified-body capacity are expected to mature. The window is an opportunity to design AI Act compliance into the MDR technical file from the outset rather than to defer the exercise.

B. AI in Drug Discovery and the European Medicines Agency

The position for drug discovery is more nuanced. An AI model used purely internally to identify candidate molecules – the classic “AI for drug discovery” use case that dominates longevity-biotech pitch decks – is generally not, in itself, a high-risk AI system under the AI Act, because it does not make or materially influence decisions about individual patients. The regulatory question shifts instead to the European Medicines Agency. The EMA’s Reflection Paper on the use of AI in the medicinal product lifecycle sets out the Agency’s expectations from discovery through pharmacovigilance.[16] Its core message is that the burden of proof rests on the sponsor to demonstrate that the AI model is fit for its regulatory purpose. That entails documented data provenance, model validation, a degree of explainability appropriate to the stage of development, and lifecycle management of the model itself.

If a longevity company tells its investors that “our AI discovered this molecule,” the regulator will eventually ask to see the model, the training data, and the validation. Vague AI claims in fundraising materials do not survive regulatory scrutiny and, increasingly, do not survive investor due diligence either.

C. Data: The GDPR and the European Health Data Space

The third question concerns data, and it is here that longevity becomes uniquely difficult. Aging research is inherently longitudinal and multi-omic: genomic, epigenetic, and proteomic data, wearable data, and medical records, ideally across decades. Under the General Data Protection Regulation this is special-category data – health, genetic, and biometric data – and the available lawful bases are narrow.[17] The scientific-research provisions of Article 9(2)(j) and Article 89 assist, but they are implemented differently in each Member State, which produces real fragmentation for pan-European longevity cohorts.

The European Health Data Space Regulation adds a second layer.[18] It creates, for the first time, a mandatory EU-wide framework for the secondary use of electronic health data, administered by health-data-access bodies in each Member State. For longevity research the EHDS is potentially transformative, because it opens access to population-scale health data for research purposes. It also imposes strict conditions: purpose limitation, processing only within secure processing environments, a prohibition on re-identification, and specific prohibitions on using the data for advertising or marketing, for decisions detrimental to individuals such as insurance or employment decisions, or for developing products harmful to health.[19] The secondary-use chapter applies from March 2029 for most data categories, but the lead time is short in the context of longitudinal cohorts. Longevity companies that intend to monetise health data – and many do – should be mapping their data flows against the EHDS regime now.

V. Sector-by-Sector Regulatory Hot Spots

Four sectoral silos together make up the longevity industry, and the same start-up frequently straddles two or three of them without realising it. In each silo, specific “hot spots” – advertising, manufacturing standards, registration, and market withdrawal – recur in practice.

A. Pharmaceuticals

True longevity drugs – rapamycin analogues, senolytics, geroprotectors – sit squarely within Directive 2001/83/EC and its implementing rules, and will continue to do so under the new pharmaceutical package once it applies. Three practical hot spots stand out. First, off-label prescribing of rapamycin and metformin for longevity indications is widespread in private clinics across Europe. Off-label prescribing as such is a matter of clinical freedom, but off-label promotion by or on behalf of the marketing-authorisation holder is prohibited: advertising must conform to the summary of product characteristics, and advertising of unauthorised products or indications is not permitted.[20] Longevity clinics are increasingly the vehicle through which promotional messaging reaches patients, and enforcement authorities have begun to take notice. Second, good manufacturing practice: anything presented as a medicine must be manufactured under an EU manufacturing authorisation and EU GMP, with qualified persons and full traceability; compounding pharmacies producing “longevity peptides” have become a significant enforcement target. Third, unlicensed importation: a large part of the longevity-peptide market operates through personal importation and grey channels, and customs enforcement across the EU has visibly tightened.

B. Medical Devices

The MDR has fundamentally reshaped this space. Aesthetic devices – dermal fillers, energy-based devices used in longevity clinics, at-home devices marketed for “cellular rejuvenation” – are caught by Annex XVI even without a medical purpose. Three hot spots follow. Classification: many longevity wearables and applications become software as a medical device once they make a diagnostic or prognostic claim. Advertising: Article 7 of the MDR prohibits misleading claims and specifically prohibits ascribing to a device functions and properties it does not have, which operates in practice as a codified anti-washing rule for devices.[21] Registration and vigilance: the first four modules of the EUDAMED database – actor registration, UDI/device registration, notified bodies and certificates, and market surveillance – have been mandatory since 28 May 2026, with legacy devices to be registered by 28 November 2026; the vigilance module is not yet mandatory, so serious incidents and field safety corrective actions continue to be reported to national competent authorities.[22] Market withdrawals happen: a device sold as a “cellular biomarker analyser” without valid clinical evidence can be removed from the market by any national competent authority, and the MDR’s market-surveillance coordination means that one withdrawal can cascade across the Union.

C. Cosmetics and Aesthetic Products

The Cosmetics Regulation governs anti-aging creams, serums, and topical actives. Two hot spots dominate. The first is the Product Information File: the responsible person must hold a complete file including a safety assessment and substantiation of every claim. The second is the Claims Regulation, Commission Regulation (EU) No 655/2013, with its six common criteria: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making.[23] A claim such as “reverses skin aging at the cellular level” fails the evidential-support criterion unless a robust dossier stands behind it. Enforcement is largely national, but the Cosmetic Products Notification Portal is EU-wide, and non-compliant products are routinely notified through the Safety Gate rapid-alert system.

D. Food Supplements and Novel Foods

It is in the food and supplement space that the longevity industry is most creative and most exposed. Directive 2002/46/EC governs vitamins and minerals in supplements; everything else falls under the general food law of Regulation (EC) No 178/2002[24] and, critically, the Novel Food Regulation. Nicotinamide mononucleotide (NMN), one of the most heavily marketed longevity molecules, is the paradigmatic case. NMN is treated as a novel food in the EU, which means it cannot lawfully be placed on the market as a supplement without pre-market authorisation by the Commission following an EFSA safety assessment. Nicotinamide riboside received such an authorisation in 2020.[25] NMN has not – although the picture is now moving. In March 2026 EFSA’s NDA Panel adopted a positive opinion on the safety of β-NMN in food supplements at up to 300 mg per day for adults, and the opinion was published in May 2026.[26] An EFSA opinion is a scientific assessment, not an authorisation; the Commission must still adopt an implementing act adding NMN to the Union list, and where the applicant has requested data protection the authorisation will initially be proprietary to that applicant’s specification. Until that act is adopted, NMN products on the shelves of European longevity clinics remain unauthorised novel foods. That is not a grey area; it is a non-compliant market operating in plain sight, and it is the kind of enforcement pipeline that eventually produces high-profile withdrawal actions. Once the Health Claims Regulation is added to the picture, the conclusion is unavoidable: the food and supplement leg of the longevity industry is the most legally exposed part of the entire sector.

VI. Conclusions

The longevity industry is a genuine scientific and commercial phenomenon, and much of the underlying research is serious. But lawyers advising companies, investors, clinicians, and, increasingly, regulators in this space must see it clearly: “longevity” is not a legal category. It is a marketing frame layered on top of four very different regulatory regimes. Three practical conclusions follow for anyone whose product touches European consumers.

First, always begin with classification. The word “longevity” conveys nothing about the applicable regime. Ask what the product is, how it is presented, and what it does, and let the regulatory regime follow from those answers.

Second, treat longevity claims the way green claims are now treated. The direction of enforcement is unmistakable. The Empowering Consumers for the Green Transition Directive, applicable from 27 September 2026, gives regulators a sharpened toolkit that will, sooner or later, be pointed at health and wellness claims. Substantiation is no longer optional.

Third, integrate AI Act compliance with sectoral compliance from the outset. For any longevity venture using AI in diagnostics or patient-facing decision support, the AI Act, the MDR, and the GDPR, soon joined by the European Health Data Space, form a single interlocking compliance architecture. The deferral of the AI Act’s high-risk obligations to 2027 and 2028 is a design window, not a reprieve. Retrofitting is expensive; designing for compliance is not.

The longevity industry will keep growing, and regulators will keep catching up. The lawyers who understand both the science and the sectoral map will be the ones clients call first.

[1] Longevity economy estimates vary widely by definition; see, e.g., the periodic longevity-market reports of Bank of America Global Research and McKinsey Health Institute. The figure is offered here as an order of magnitude, not a precise valuation.

[2] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use, art. 1(2), 2001 O.J. (L 311) 67 [hereinafter Directive 2001/83]. At the time of writing, the new EU pharmaceutical package (a new directive on the Union code for medicinal products for human use and a new regulation on Union authorisation procedures) has been politically agreed and is in the final stage of formal adoption; the substantive rules discussed here are carried over into the new framework, which will apply after a transitional period of approximately two years from entry into force.

[3] See Nir Barzilai et al., Metformin as a Tool to Target Aging, 23 Cell Metabolism 1060 (2016) (describing the design of the Targeting Aging with Metformin (TAME) trial around a composite of age-related diseases).

[4] Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the Approximation of the Laws of the Member States Relating to Food Supplements, 2002 O.J. (L 183) 51.

[5] Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on Novel Foods, 2015 O.J. (L 327) 1 [hereinafter Novel Food Regulation].

[6] Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products, 2009 O.J. (L 342) 59 [hereinafter Cosmetics Regulation].

[7] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices, Annex XVI, 2017 O.J. (L 117) 1 [hereinafter MDR]; Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 Laying Down Common Specifications for the Groups of Products Without an Intended Medical Purpose Listed in Annex XVI, 2022 O.J. (L 311) 60.

[8] Case 227/82, Van Bennekom, ECLI:EU:C:1983:354 (establishing that a product is a medicinal product “by presentation” where it is described or recommended as having therapeutic or prophylactic properties, irrespective of its actual efficacy); Case C-319/05, Comm’n v. Germany, ECLI:EU:C:2007:678 (garlic capsules); Case C-140/07, Hecht-Pharma GmbH v. Staatliches Gewerbeaufsichtsamt Luneburg, ECLI:EU:C:2009:5 (classification “by function” requires a case-by-case assessment of pharmacological, immunological or metabolic properties). See also Directive 2001/83, supra note 2, art. 2(2) (in cases of doubt, the medicinal-products regime prevails).

[9] Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on Nutrition and Health Claims Made on Foods, arts. 10, 13, 14, 2006 O.J. (L 404) 9 [hereinafter Health Claims Regulation]. The EU Register of nutrition and health claims is maintained by the European Commission.

[10] Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 Concerning Unfair Business-to-Consumer Commercial Practices in the Internal Market, 2005 O.J. (L 149) 22 [hereinafter UCPD].

[11] Directive (EU) 2024/825 of the European Parliament and of the Council of 28 February 2024 Amending Directives 2005/29/EC and 2011/83/EU as Regards Empowering Consumers for the Green Transition, OJ L, 2024/825, 6.3.2024 [hereinafter ECGT Directive]. Member States were required to transpose the Directive by 27 March 2026; its provisions apply from 27 September 2026. The separate Green Claims Directive proposal, which would have introduced ex ante verification of explicit environmental claims, was withdrawn by the Commission in 2025 and is not discussed here.

[12] Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 Laying Down Harmonised Rules on Artificial Intelligence, OJ L, 2024/1689, 12.7.2024 [hereinafter AI Act].

[13] AI Act, supra note 12, art. 6(1) & Annex I, § A (listing the MDR and Regulation (EU) 2017/746 on in vitro diagnostic medical devices). The Annex I route applies where the AI system is a product, or a safety component of a product, that is itself subject to third-party conformity assessment under the listed Union harmonisation legislation.

[14] AI Act, supra note 12, arts. 9–15, 17, 43, 72.

[15] Regulation (EU) 2026/1744 of the European Parliament and of the Council Amending Regulation (EU) 2024/1689 as Regards the Simplification of Certain Obligations (“Digital Omnibus on AI”), OJ L, 2026/1744, 24.7.2026 (in force 27 July 2026). The Regulation defers the high-risk obligations for stand-alone (Annex III) systems to 2 December 2027 and for AI embedded in products covered by Annex I, including medical devices, to 2 August 2028; the Article 50 transparency obligations continue to apply from 2 August 2026.

[16] Eur. Medicines Agency, Reflection Paper on the Use of Artificial Intelligence (AI) in the Medicinal Product Lifecycle, EMA/CHMP/CVMP/83833/2023 (adopted Sept. 2024).

[17] Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural Persons with Regard to the Processing of Personal Data, arts. 9(2)(j), 89, 2016 O.J. (L 119) 1 [hereinafter GDPR].

[18] Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space, OJ L, 2025/327, 5.3.2025 [hereinafter EHDS Regulation]. The Regulation entered into force on 26 March 2025 and applies in stages: most provisions from 26 March 2027, and the core secondary-use chapter from 26 March 2029 (2031 for certain data categories). See id. art. 105.

[19] EHDS Regulation, supra note 18, arts. 50–54 (secure processing environments; permitted and prohibited purposes of secondary use).

[20] Directive 2001/83, supra note 2, art. 87(2) (all parts of advertising must comply with the particulars listed in the summary of product characteristics), arts. 40–53 (manufacturing authorisation and good manufacturing practice) and art. 87(1) (prohibition of advertising of medicinal products without a marketing authorisation).

[21] MDR, supra note 7, art. 7.

[22] Commission Decision (EU) 2025/2371 of 26 November 2025 (declaring the first four EUDAMED modules functional), OJ L, 2025/2371, 27.11.2025; Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024, OJ L, 2024/1860, 9.7.2024 (gradual roll-out of EUDAMED). The four modules (actor registration, UDI/device registration, notified bodies and certificates, market surveillance) are mandatory from 28 May 2026; legacy devices remaining on the market must be registered by 28 November 2026. The vigilance and clinical-investigation modules are not yet mandatory, and serious incidents continue to be reported to national competent authorities.

[23] Cosmetics Regulation, supra note 6, arts. 11, 13, 20; Commission Regulation (EU) No 655/2013 of 10 July 2013 Laying Down Common Criteria for the Justification of Claims Used in Relation to Cosmetic Products, Annex, 2013 O.J. (L 190) 31.

[24] Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 Laying Down the General Principles and Requirements of Food Law, 2002 O.J. (L 31) 1.

[25] Commission Implementing Regulation (EU) 2020/16 of 10 January 2020 Authorising the Placing on the Market of Nicotinamide Riboside Chloride as a Novel Food, 2020 O.J. (L 7) 6.

[26] EFSA Panel on Nutrition, Novel Foods and Food Allergens, Safety of Beta-Nicotinamide Mononucleotide (β-NMN) Pursuant to Regulation (EU) 2015/2283 and the Bioavailability of Nicotinamide from This Source in the Context of Directive 2002/46/EC, 24 EFSA J. e10007 (2026) (opinion adopted 4 March 2026, published 11 May 2026). Authorisation requires a Commission implementing act amending the Union list established by Commission Implementing Regulation (EU) 2017/2470; at the time of writing no such act has been published, and any authorisation granted on the basis of proprietary data will initially benefit only the applicant. See Novel Food Regulation, supra note 5, arts. 12, 26.

#LongevityIndustry #LongevityWashing #EURegulatoryLaw #ArtificialIntelligence #AIAct #HealthcareLaw #LifeSciencesLaw #HealthTech #MedicalDevices #PharmaceuticalLaw #GDPR #EuropeanHealthDataSpace #EUlaw #HealthClaims #NovelFoods

Artykuł Longevity Washing, AI and the Regulatory Fault Lines of the Longevity Industry: A European Perspective pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

1. Reports only via e-Sanepid

Every dietary supplement introduced to the market for the first time must be reported to the Chief Sanitary Inspector (GIS). Until now, various forms were acceptable – paper or electronic, with a handwritten or electronic signature. After the amendment comes into effect, the only acceptable method will be the e-Sanepid platform.

What does this mean in practice?

• It is necessary for each person submitting notifications to have a qualified electronic signature or a trusted profile.
• All communication with sanitary inspection bodies – letters, decisions, and confirmations – will be handled through the platform account. The moment of notification submission will be clearly confirmed with an official receipt, eliminating disputes over the deadline.
• Companies that have previously used paper forms or traditional correspondence must immediately switch to the new channel and ensure appropriate employee training.

The change also concerns the timing of the notification obligation: the previous option to notify the Chief Sanitary Inspectorate (GIS) at the stage of intended product introduction is no longer available. The obligation now arises at the time of actual introduction to the market.

2. Strict deadlines and automatic presumption of irregularities

The amendment introduces a completely new mechanism for conducting investigations. This change has the greatest potential to surprise companies without effective internal compliance procedures.

How does the new mechanism work?

If the Chief Sanitary Inspectorate initiates an investigation and requests the entity to submit a scientific opinion, the company has exactly 14 days to submit an application to an accredited scientific unit – at the same time forwarding a copy of it to the Chief Sanitary Inspectorate.

The mechanism for presuming irregularities is a significant innovation. Previously, a company’s inaction during the proceedings did not automatically result in any legal consequences – the proceedings could drag on for years. Following the amendment, any failure to meet the 14-day deadline will lead to direct negative consequences, regardless of whether the product is safe.

3. Advertising without reporting? A fine of nearly one million zlotys

This change directly impacts brands engaging in active digital marketing. Previously, advertising or presenting a dietary supplement without prior notification to the Chief Sanitary Inspectorate (GIS) was punishable by a fine (a misdemeanor). Following the amendment, this becomes grounds for imposing an administrative fine – with new, significantly higher penalties.

What exactly is prohibited?

The amendment penalizes not only the sale of a supplement without reporting it to the Chief Sanitary Inspectorate (GIS), but also the mere advertising or presentation of it if the notification has not been effectively submitted. In other words:

• Sponsored post on Instagram or Facebook promoting a new supplement before notification = grounds for an administrative penalty.
• Product page in the online store visible to the public before successful reporting to GIS = risk of infringement.
• Promotional materials sent to wholesalers or distributors before GIS is notified = potential infringement.
• Influencer marketing initiated before the date of effective notification = liability on the part of the entity commissioning the campaign.

Prohibition on suggesting medicinal properties – wider scope

The amendment expands liability for violations of advertising requirements from labeling to the entire marketing message. Previously, sanctions primarily covered incorrect packaging labeling. Following the amendment, a company is responsible for every communication channel – online advertising, point-of-sale materials, newsletters, or YouTube videos – if the message suggests that a varied diet does not provide sufficient nutrients, or if a supplement is presented as a medicinal product.

4. Public register – the company’s reputation under public scrutiny

The Chief Sanitary Inspectorate (GIS) has maintained a register of dietary supplements before, but the amendment will significantly expand its scope and availability. The data will be published on the e-Sanepid platform and will include:

• the name of the product and its qualitative composition (without quantitative data – the recipe remains protected),
• product qualification proposed by the entity,
• information about the initiation or ongoing investigation,
• data on the detection of a prohibited ingredient.

5. Fines – increase by over 330%

The maximum administrative fine for violating food safety regulations is increasing from 30 to 100 times the average monthly salary. At the current salary level, this means:

The new penalties are imposed administratively (not as fiscal or misdemeanor offenses), which means faster proceedings and no need to prove intentional guilt. A mere finding of a violation is sufficient. The increased level of sanctions has a real deterrent effect, especially for companies with turnover in the tens of millions of zlotys.

The biggest risks – a practical overview

Artykuł CLIENT ALERT Dietary supplements market in Poland Amendments to food safety regulations | May 2026 pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.