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Orthomol® Food Supplements in Georgia, Public Health Institute of Georgia (PHIG) Position Statement

Orthomol

Date: 25 November 2025

Status: Expert public-health opinion based on publicly available evidence

1. Mandate and scope of this statement

The Public Health Institute of Georgia (PHIG) is an independent, non-commercial public-health organization. Our mandate is to protect population health, promote evidence-based practice, and support Georgian authorities and consumers in making informed decisions about health products. This work includes independent analysis and public communication through platforms such as SheniEkimi.ge, SheniAmbebi.ge, and Supplement.ge.

This statement explains why PHIG does not recommend the use of Orthomol® micronutrient combinations in Georgia at this time, and why Orthomol is considered a high-risk brand from a public-health and regulatory perspective, particularly given its strong marketing in pharmacies, sports sponsorships, and Georgian media.

This document is not a ban and does not replace the legal authority of Georgian regulators (National Food Agency, State Regulation Agency for Medical Activities, Competition and Consumer Agency, Georgian National Communications Commission – GNCC, etc.). It is an independent expert risk assessment addressed to:

  • Consumers in Georgia
  • Healthcare professionals
  • Georgian regulators and oversight bodies
  • Distributors and retailers (including pharmacies selling Orthomol products)

2. Corporate and scientific background: Orthomol and orthomolecular medicine

Orthomol Holding GmbH (Orthomol pharmazeutische Vertriebs GmbH) is a private German family business based in Langenfeld, North Rhine-Westphalia, founded in the early 1990s. On its official website, Orthomol presents itself as a company that develops micronutrient products for specific areas of use, claiming “high-quality products and expertise in nutritional medicine.”[1] Its product portfolio consists of indication-oriented micronutrient combinations marketed as food supplements (and in some cases as food for special medical purposes – FSMP).[1,2]

Orthomol states that its products are based on the concept of orthomolecular medicine – the idea of supplying “suitable combinations of micronutrients” tailored to specific needs or illnesses, particularly when a normal diet does not provide sufficient quantities.[3] The company also emphasises that it aims to expand beyond Germany and become “one of the leaders in the area of orthomolecular medicine.”[4]

Independent medical and scientific sources describe orthomolecular medicine very differently:

  • A German and European clinical overview (Leading Medicine Guide) notes that orthomolecular medicine is regarded as a complementary / alternative medical procedure that supplements conventional therapy through micronutrient preparations, but explicitly classifies it as part of alternative medicine rather than mainstream evidence-based care.[5]
  • A 2020 open-access review on orthomolecular medicine and cancer describes orthomolecular medicine as a form of alternative medicine based on the idea that diseases reflect deficiencies in an optimal nutritional environment, and that treatment should “correct imbalances or deficiencies” with high-dose vitamins and minerals.[6]
  • Classic clinical critiques of “unproven dietary and nutritional methods” in oncology identify megavitamin therapy and similar approaches (integral to orthomolecular practice) as questionable and unproven, warning of both lack of efficacy and potential harm.[7]
  • Contemporary oncology guidelines on complementary medicine (e.g. the German AGO guideline for breast cancer) list orthomolecular substances only with very low levels of evidence (LoE 5, grade D) and highlight that some antioxidant/orthomolecular interventions (e.g. carotenoids) are associated with worse outcomes in certain contexts.[8]
  • A broader review of complementary and alternative healthcare concludes that many such interventions remain insufficiently supported by rigorous scientific evidence and must be critically evaluated before being introduced into routine practice.[9]

Taken together, these sources support the statement that Orthomol’s core therapeutic framework – orthomolecular medicine – is scientifically controversial, classified as alternative/complementary medicine, and not firmly grounded in robust clinical evidence, despite being used to market products for numerous serious health indications.

3. Regulatory borderline: Orthomol and “food for special medical purposes” (FSMP)

Orthomol has marketed several products not merely as food supplements but as Food for Special Medical Purposes (FSMP), for example formulations intended for the “dietary management” of immune deficiencies or age-related macular degeneration (AMD). This positioning was challenged in Germany by the competition association Verband Sozialer Wettbewerb (VSW), leading to a reference to the Court of Justice of the European Union (CJEU), Case C-418/21 (Orthomol pharmazeutische Vertriebs GmbH v Verband Sozialer Wettbewerb eV).[10]

In its judgment of 27 October 2022, the CJEU held that:[10]

  • A product can be classified as FSMP only where it is intended to cover specific nutritional requirements resulting from a particular disease, disorder or medical condition, and where such requirements cannot be met by modification of the normal diet alone.
  • It is not sufficient that a product merely provides a general benefit to the patient or counteracts a disorder in a way more akin to a medicinal product.

Legal and regulatory analyses of the judgment stress that the CJEU has clearly limited the scope of FSMP to genuine, disease-related nutritional needs and has warned against using FSMP as a “quasi-drug” category for products whose main function is more pharmacological than nutritional.[11,12] The decision is widely seen as a corrective to previous practices in which manufacturers – including Orthomol – classified products with disease-related claims as FSMP without robust evidence of distinct nutritional requirements.[11,12]

From a public-health perspective, this confirms that Orthomol has operated at the borderline between food, FSMP and medicinal products. When products with strong disease-related claims are not regulated as medicines, they may enter the market without the level of pre-market clinical testing and pharmacovigilance required for medicinal products.

4. Scientific evidence and potential safety concerns

4.1. Weak product-specific clinical evidence

Orthomol markets complex combinations of many micronutrients (often 20–30 or more) in single daily packs (granules plus capsules, or drinking vials plus capsules).[2,3] However:

  • There is limited high-quality, product-specific clinical trial evidence – especially large, randomised controlled trials – that show clear benefits of Orthomol combinations on hard clinical outcomes (e.g. mortality, major cardiovascular events, progression of chronic disease) compared to simpler supplementation or placebo.
  • Reviews and guidelines addressing orthomolecular approaches in oncology and chronic disease repeatedly characterise them as unproven and of low evidence level.[7–9]

In the absence of robust, transparent trial data on specific Orthomol products, marketing them as if they were clinically validated treatments for “immune deficiencies,” “stress and burnout,” “fertility problems,” or “AMD” risks overstating the evidence base.

4.2. High-dose micronutrients and tolerable upper intake levels

Orthomol formulations frequently combine vitamins, minerals and other substances at doses considerably above basic recommended daily intakes.[2,3] While individual nutrients may remain below legally set maximum levels, safety must be considered in terms of:

  • total daily intake from all sources (diet, fortified foods, multiple supplements), and
  • possible long-term effects of sustained high-dose intake for specific micronutrients.

The European Food Safety Authority (EFSA) has published detailed Tolerable Upper Intake Levels (ULs) for vitamins and minerals, emphasising that long-term intakes approaching or exceeding these levels may pose risks, particularly in vulnerable populations.[13] Peer-reviewed analyses highlight concerns for chronic high-dose use of certain micronutrients, such as nicotinamide (a form of vitamin B3), including potential impacts on metabolism, liver function and epigenetic regulation at doses far above normal dietary requirements.[14]

PHIG notes that:

  • Orthomol products are typically taken in addition to an ordinary diet and sometimes together with other supplements.
  • Orthomol’s public information does not systematically warn consumers about cumulative intake relative to ULs when several Orthomol preparations, or Orthomol plus other supplements, are used concurrently.
  • For children, pregnant women and patients with chronic disease, long-term high-dose exposure to multiple micronutrients without medical oversight is a non-trivial safety concern.

PHIG does not claim that Orthomol products currently exceed EU legal limits for vitamins and minerals. Rather, we underline that the orthomolecular strategy of “many nutrients at relatively high doses for long periods” lacks robust proof of benefit while carrying potential safety risks, especially when used beyond short-term, medically supervised indications.

5. Marketing practices and disease-related claims

Orthomol’s marketing is strongly medicalised. Official and partner materials describe products as supporting the immune system, cardiovascular health, eye health, fertility, pregnancy, cognitive function, stress resilience and more, often in formulation-specific ways (e.g. “Orthomol Immun,” “Orthomol Cardio,” “Orthomol AMD extra”).[2,3] At the same time:

  • Orthomol maintains a dedicated page on orthomolecular medicine, explicitly positioning the concept as addressing situations when illness or special stressors create increased micronutrient needs that cannot be met by diet alone – a framing close to quasi-therapeutic claims.[3]
  • Independent clinical and policy analyses emphasise that such disease-adjacent claims, when made for non-medicinal products, require particularly careful legal classification and evidence.[8–12]

German oncology guidelines and critical reviews of unproven dietary methods warn that high-dose multinutrient interventions can:

  • encourage patients to replace or delay proven therapies;[7–9]
  • expose them to potential harm (e.g. interactions, adverse effects, worse outcomes associated with certain antioxidant strategies);[8,9]
  • impose unnecessary costs without clear benefit.

6. Georgian market context: Orthomol as a “German premium brand”

In Georgia, Orthomol is actively promoted as a German premium-class line of food supplements:

  • The official Orthomol Georgia Facebook page introduces Orthomol as “German premium-class food supplements” and features repeated campaigns for products targeting immunity, women’s health, fertility, pregnancy, stress and more.[15]
  • Major pharmacy chains (e.g. PSP) maintain Orthomol brand sections on their websites, classifying Orthomol explicitly as a “საკვები დანამატი” (food supplement) with cross-categories such as “immune support,” “women’s health,” “flu and cold,” etc., and promoting the brand in high-visibility campaigns (including 50% discount offers advertised via social media).[16,17]
  • International e-commerce platforms serving the Georgian market (e.g. Ubuy) present Orthomol as a German nutritional supplement brand offering products for “immune system support, muscle care and general health,” making access possible without direct medical supervision.[18]

This marketing environment creates a strong impression that Orthomol products are:

  • an elite, medically sophisticated solution rather than ordinary supplements;
  • implicitly necessary for good health or for “managing” chronic conditions;
  • clinically established, despite the limited and contested evidence base.

Independent, evidence-based analysis of such products will continue to be made available to the public via SheniEkimi.ge, SheniAmbebi.ge and Supplement.ge.

7. Legal framework in Georgia: advertising and biologically active additives

Advertising and promotion of health-related products, including biologically active food additives, in Georgia is governed by:

  • The Law of Georgia on Advertising, which prohibits improper, unfair, unreliable, unethical and clearly false advertising and applies to all advertising activities on Georgian territory.[19]
  • Additional provisions under Georgian broadcasting and media law, and the Code of Conduct for Broadcasters, which require that advertising be clearly distinguishable from editorial content and forbid surreptitious advertising.[20,21]
  • Sector-specific guidance on promoting pharmaceutical products and biologically active food additives, emphasising that such advertising must be truthful, evidence-based, and that food supplements cannot be advertised as if they were medicinal products.[22]

Within this framework, there is a real risk that:

  • Orthomol advertising and product positioning in Georgia may blur the line between dietary supplements and medicines, especially when making strong disease-related or quasi-therapeutic claims.
  • High-visibility campaigns by major pharmacies and online channels may overstate scientific support for Orthomol products, potentially conflicting with the requirement for reliable, non-misleading advertising.

8. PHIG’s official position on Orthomol in Georgia

8.1. Non-recommendation of Orthomol products

As of 25 November 2025, based on the evidence reviewed, PHIG adopts the following position:

PHIG does not recommend the use of Orthomol® micronutrient products in Georgia for:

  • the general adult population,
  • pregnant or breastfeeding women,
  • children and adolescents,
  • patients with chronic diseases or compromised immunity.

This non-recommendation is grounded in:

  • Orthomol’s central alignment with orthomolecular medicine, a concept that independent clinical sources classify as alternative/complementary and scientifically unproven for most claimed indications.[5–9]
  • The CJEU’s clarification in Case C-418/21, which shows that Orthomol’s practice of classifying some products as FSMP operates at the regulatory edge and must be carefully distinguished from medicinal products and ordinary supplements.[10–12]
  • The absence of robust, transparent, product-specific clinical trials demonstrating clear superiority of Orthomol combinations over simpler, standard supplementation strategies in terms of clinically meaningful outcomes.[7–9]
  • Potential safety concerns linked to long-term, high-dose multi-nutrient supplementation in a context where EFSA and scientific literature stress the importance of respecting tolerable upper intake levels, and where some orthomolecular strategies (e.g. certain antioxidant combinations) may even be associated with worse outcomes.[8,9,13,14]
  • Aggressive premium-brand marketing and pharmacy-based promotion in Georgia, which may mislead consumers into believing that Orthomol products are clinically necessary or superior medicines rather than optional supplements.[15–18]

8.2. Guidance on marketing and claims in Georgia

PHIG considers that:

  • Disease-related or quasi-therapeutic claims for Orthomol products (e.g. “dietary management of immune deficiencies,” “support for AMD,” “for stress and burnout,” “for fertility”) require particular scrutiny under Georgian law and EU-aligned principles. These claims may be inappropriate for food supplements and could demand FSMP classification or medicinal product authorisation if they imply treatment or prevention of disease.[10–12,19,22]
  • Presenting Orthomol as a “German premium therapy” without transparent, high-quality evidence may mislead consumers and healthcare professionals about the true strength of the scientific base and the legal status of the products.

8.3. Clinical practice and professional responsibility

PHIG recommends that healthcare professionals in Georgia:

  • Avoid routinely prescribing or recommending Orthomol products for treatment or prevention of disease where simpler, well-validated interventions (balanced diet, evidence-based single-nutrient supplementation in case of documented deficiency, established pharmacotherapy) are available and more appropriate.
  • Clearly explain to patients that Orthomol products are dietary supplements, and that orthomolecular medicine is classified as an alternative/complementary concept with limited evidence in mainstream medicine.[5–9]
  • Report suspected adverse events associated with Orthomol products to national pharmacovigilance or food-safety systems, to strengthen national surveillance of supplement-related harms.

9. Recommendations to Georgian regulators

9.1. National Food Agency and health regulators

  • Review the registration, categorisation and labelling of Orthomol products on the Georgian market (food supplement vs FSMP), ensuring compliance with EU-aligned definitions and compositional requirements.
  • Require Orthomol’s Georgian partners to provide full technical and clinical dossiers where FSMP or strong health claims are used, including evidence that products genuinely address disease-related nutritional requirements.
  • Consider targeted random testing of Orthomol products (label accuracy, micronutrient content, contaminants) to verify compliance with national and EU-based limits and labelling standards.

9.2. Competition and Consumer Agency

  • Assess whether Orthomol-related advertising claims (e.g. “premium German brand” combined with disease-related messaging) comply with the Law of Georgia on Advertising and broader consumer-protection rules.[19,22]
  • Where necessary, issue guidance or take enforcement actions against misleading, unsubstantiated or unfair advertising in the supplement sector.

9.3. Georgian National Communications Commission (GNCC)

  • Monitor TV and online content for potential surreptitious promotion of Orthomol or similar brands embedded in health programmes, news or talk shows, in line with existing standards on hidden advertising.[20,21]
  • Ensure that Orthomol-related content in broadcast media is clearly identified as advertising or sponsorship where applicable, and not presented as neutral medical information.

10. Legal robustness of PHIG’s position

PHIG’s non-recommendation of Orthomol is based on:

  • Documented and verifiable sources on Orthomol’s own positioning, including its corporate and orthomolecular medicine pages and international expansion statements.[1–4]
  • Independent medical and scientific literature describing orthomolecular medicine as an alternative/complementary concept with limited evidence, including critical analyses of megavitamin and multinutrient approaches and formal guideline assessments.[5–9,13,14]
  • Authoritative regulatory and legal documents such as the CJEU’s judgment in Case C-418/21 and associated expert commentaries, which set clear boundaries for FSMP classification.[10–12]
  • Georgian legal and policy documents governing advertising and biologically active additives, and analyses showing ongoing concerns about hidden or misleading advertising practices.[19–22]

PHIG does not allege that Orthomol products currently on the Georgian market are illegally contaminated or that they necessarily exceed national compositional limits. Rather, based on the precautionary principle and the overall weight of evidence, PHIG concludes that:

Orthomol’s reliance on orthomolecular medicine without robust clinical proof, its borderline regulatory positioning as “medical nutrition,” its long-term high-dose micronutrient strategies, and its aggressive premium marketing together justify a clear, public non-recommendation for routine use in Georgia, unless and until substantially stronger, independently verified evidence of benefit, safety and regulatory compliance is provided.

This position is a good-faith expert opinion on a matter of public health, grounded in publicly accessible sources that can be independently verified.

Sources

  1. Orthomol. With Orthomol. Ready. For life. [Internet]. Langenfeld (DE): Orthomol; c2024 [cited 2025 Nov 25]. Available from: https://www.orthomol.com/en
  2. Orthomol. Products [Internet]. Langenfeld (DE): Orthomol; c2024 [cited 2025 Nov 25]. Available from: https://www.orthomol.com/en/products
  3. Orthomol. Orthomolecular medicine – micronutrients important for your health [Internet]. Langenfeld (DE): Orthomol; c2024 [cited 2025 Nov 25]. Available from: https://www.orthomol.com/en/company/orthomolecular-medicine
  4. Orthomol. Orthomol around the world [Internet]. Langenfeld (DE): Orthomol; c2024 [cited 2025 Nov 25]. Available from: https://www.orthomol.com/en/company/international
  5. Leading Medicine Guide editors. Orthomolecular medicine – information and specialists [Internet]. Leading Medicine Guide; c2023 [cited 2025 Nov 25]. Available from: https://www.leading-medicine-guide.com/en/treatment/orthomolecular-medicine
  6. Garrido G, et al. Orthomolecular medicine, micronutrients, high dose vitamin C and cancer – why it should be revisited. Herald Open Access [Internet]. 2019 [cited 2025 Nov 25]. Available from: https://www.heraldopenaccess.us/openaccess/orthomolecular-medicine-micronutrients-high-dose-vitamin-c-and-cancer-why-it-should-be-revisited
  7. Herbert V. Unproven (questionable) dietary and nutritional methods in cancer patients. Cancer [Internet]. 1986 Oct 15;58(8 Suppl):1930–41 [cited 2025 Nov 25]. Available from: https://acsjournals.onlinelibrary.wiley.com/doi/pdf/10.1002/1097-0142(19861015)58:8+
  8. AGO Breast Committee. Complementary medicine – survivorship (Komplementäre Therapie “Survivorship”) [Internet]. In: AGO Breast Cancer Guideline 2023. München (DE): AGO; 2023 [cited 2025 Nov 25]. p. 1–15. Available from: https://www.ago-online.de/…/AGO_2023D_23_Komplementaermedizin_REF.pdf
  9. Tabish SA. Complementary and alternative healthcare: is it evidence-based? Indian J Urol. 2008 Apr;24(3):221–6. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC3068720/
  10. European Food Safety Authority. Tolerable upper intake levels for vitamins and minerals [Internet]. Parma (IT): EFSA; 2006 [cited 2025 Nov 25]. Available from: https://www.efsa.europa.eu/…/ndatolerableuil.pdf
  11. Hwang ES, Song SB. Possible adverse effects of high-dose nicotinamide: mechanisms and safety assessment. Biomolecules. 2020 May;10(5):687. Available from: https://www.mdpi.com/2218-273X/10/5/687
  12. Court of Justice of the European Union. Judgment of the Court (Second Chamber) of 27 October 2022, Orthomol pharmazeutische Vertriebs GmbH v Verband Sozialer Wettbewerb eV, Case C-418/21 [Internet]. 2022 [cited 2025 Nov 25]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:62021CJ0418
  13. Sidley Austin LLP. Impact of the recent judgment on food for special medical purposes in the EU [Internet]. 2022 Nov 15 [cited 2025 Nov 25]. Available from: https://www.sidley.com/…/impact-of-the-recent-judgement-on-food-for-special-medical-purposes-in-the-eu
  14. Walder Wyss Ltd. Food for special medical purposes (FSMP): new specific CJEU requirements [Internet]. 2023 Jan 13 [cited 2025 Nov 25]. Available from: https://www.walderwyss.com/…/food-for-special-medical-purposes-fsmp-new-specific-cjeu-requirements
  15. Orthomol Georgia. Orthomol Georgia • ორთომოლი საქართველო [Internet]. Facebook; 2025 [cited 2025 Nov 25]. Available from: https://www.facebook.com/OrthomolGeorgia/
  16. PSP. Orthomol – ორთომოლი [Internet]. Tbilisi (GE): PSP; c2024 [cited 2025 Nov 25]. Available from: https://psp.ge/brand/orthomol
  17. Ubuy Georgia. Buy Orthomol products online at best prices in Georgia [Internet]. 2024 [cited 2025 Nov 25]. Available from: https://www.ubuy.ge/en/brand/orthomol
  18. Parliament of Georgia. Law of Georgia on Advertising [Internet]. 1998 Feb 18 (as amended) [cited 2025 Nov 25]. Available from: https://assets.tobaccocontrollaws.org/…/Georgia-Law-on-Advertising.pdf
  19. Media Development Foundation. Surreptitious Advertising [Internet]. Tbilisi (GE); 2011 Oct 12 [cited 2025 Nov 25]. Available from: https://mdfgeorgia.ge/uploads//Surreptitious_Advertising-ENG.pdf
  20. Grata International. Advertising and promotion of pharmaceutical products and biologically active additives in Georgia [Internet]. 2024 Apr 29 [cited 2025 Nov 25]. Available from: https://gratanet.com/publications/advertising-and-promotion-of-pharmaceutical-products-and-biologically-active-additives-in-georgia
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