More Herbal Products, Less Herbal Medicine?

Anyone walking through the Reims convention centre at the end of August 2026 could see two different futures of medicinal plant research. One future unfolded in the lecture halls and in front of the posters. There, the topics were artificial intelligence, chemodiversity and biodiversity, new analytical methods, microbiomes, sustainability and natural product drug discovery. The official programme of the 74th GA congress explicitly promised ‘cutting-edge’ research along the entire path from discovery to development (Society for Medicinal Plant and Natural Product Research [GA], 2026a). The other future became apparent among company booths, regulatory conversations and product strategies. Here, the names of the extracts, the indications and the brands seemed strikingly familiar. What was new was often the formulation, the target group, the additional indication or the adaptation to anticipated legislation – less often the medicinal product itself.

This observation is, for the time being, only that: an observation. A congress booth is not an annual report, and a panel discussion is not a pipeline registry. Nevertheless, Reims left behind a question that is larger than the event itself: if scientific research on natural products is visibly expanding, why does the industrial pipeline of herbal medicinal products look so narrow? Where is the bridge between a new pharmacological signal and a newly authorised phytopharmaceutical?

An inspection of the main scientific programme gives this impression a more concrete, although limited, basis. Excluding one untitled short-lecture slot, the conference book (GA, 2026b) lists 797 presentations: 12 plenary lectures, 104 short lectures and 681 posters. Removing six exact-title repetitions leaves 791 distinct titles, including 340 within the drug-discovery topic. Established preparations such as Silexan, EPs 7630 and EGb 761 appeared in studies of mechanisms, safety and exposure, several explicitly using cell or animal models. Patient-oriented contributions included an olive-leaf pilot study, retrospective studies of topical preparations, real-world observations of nutraceutical use and a clinical trial of tea tree oil vaginal suppositories. Workshops and commercial science pitches likewise showed active efforts to organise translation. Human research was therefore present, but its relationship to the development of new herbal medicinal products could not reliably be established from the titles. Titles cannot establish a programme’s full development stage, a preparation’s novelty or its regulatory destination. The conference book nevertheless illustrates sustained research on established preparations and multiple routes towards application, while leaving the passage to new complex botanical medicines difficult to determine.

The hasty answer is that the large companies no longer conduct research. It is understandable – and probably wrong. The more precise and more disquieting answer is that research continues, but much of it does not attain the form of a new medicinal product. The problem lies less at the beginning of the knowledge chain than in its translation.

The publicly available information from leading manufacturers already argues against the thesis of a complete halt to research. The Schwabe Group reports more than 100 employees and annual expenditure of around 35 million euros in research and development. Bionorica states that it invests a double-digit percentage of its revenue each year in the research and development of herbal medicinal products (Bionorica, n.d.; Schwabe Group, n.d.). These are corporate self-reports, not independently audited industry statistics. They do, however, refute the sweeping claim that no research at all is taking place in industrial phytopharmacy any longer.

What is decisive is a conceptual distinction that is frequently lost in the discourse on innovation. Research is not the same as product innovation. A company can invest considerable resources in mechanisms of action, new endpoints, health care data, formulations, quality control and additional indications for an established special extract without bringing forth a new medicinal product in the strict sense. Such work can be medically valuable: it may improve safety, dosing, formulation or clinical use. For the purposes of the present argument, however, it should not be confused with the development of a new therapeutic entity. Much of it strengthens or extends an existing asset rather than creating a new medicinal product.

For the purposes of this essay, a ‘new herbal medicinal product’ therefore does not denote merely a new pack size, dosage form or brand positioning. What is meant is a new therapeutic entity: a new herbal preparation or a substantially redefined extract for which quality, safety and efficacy are developed on a product-specific basis and assessed by regulators. If this stricter standard is applied, the impression from Reims gains plausibility. Even a European consensus paper authored by representatives of industry, associations and academia noted in 2024 that new herbal medicinal products are only rarely developed and that the sector is under pressure relative to botanicals in terms of speed of innovation and time to market (Heinrich et al., 2024). Precisely because several authors of this paper are affiliated with industry and its associations, it should not be read as a neutral market study. As an insider’s view of the sector, however, the diagnosis is remarkable.

Europe does not prohibit new phytopharmaceuticals. Three main pathways exist for herbal medicinal products. Registration as a traditional herbal medicinal product can dispense with clinical efficacy trials if plausible efficacy and sufficient safety are demonstrated and the product has been in medicinal use for at least 30 years, including 15 years within the European Union. Marketing authorisation on the basis of well-established medicinal use requires at least ten years of established use in the EU and relies largely on bibliographic data. A stand-alone or mixed application under Article 8(3) of Directive 2001/83/EC, by contrast, requires the applicant’s own preclinical and clinical data or a combination of the applicant’s own and published data. A complete quality dossier is required in all three cases (European Medicines Agency [EMA], n.d.-c).

This framework is itself being rewritten. The EU pharmaceutical package, which would replace Directive 2001/83/EC with a new Union code, reached political agreement on 11 December 2025 (Council of the European Union, 2025). The Council adopted its first-reading position on 28 September 2026; as of 14 October 2026, Parliament’s second-reading decision remained pending (Council of the European Union, 2026a, 2026b; European Parliament, 2023-a, 2023-b). The Council texts provide eight years of data protection followed by one year of market protection. Conditional extensions can bring the combined period to eleven years, or twelve if a transferable data exclusivity voucher is used (Council of the European Union, 2026a, Arts. 83–84; 2026b, Arts. 41–42). General application is envisaged 24 months after entry into force, subject to specified exceptions (Council of the European Union, 2026a, Art. 222; 2026b, Art. 187). For a new herbal preparation, such protection meets a particular challenge for botanical development: it prevents a competitor from relying on the innovator’s dossier, but not the registration or authorisation of another preparation of the same plant that independently meets the conditions for traditional or well-established use. The reform may therefore improve dossier protection without fully resolving the limited appropriability of product-specific botanical evidence; whether it materially changes development incentives will depend on the final text and its subsequent use.

From the standpoint of patient protection, this architecture is logical. The less historical experience exists, the more new evidence a manufacturer must generate. Economically, however, it produces a regulatory inversion: the old is granted an abbreviated pathway precisely because it is old; the new bears the full development burden precisely because it is new. For a synthetic medicinal product, this burden is often offset by a well-definable and patentable active substance. A plant extract, by contrast, is a variable multi-constituent system. Its protection rests on several layers – discussed below – that are often less clear-cut than a patent on a molecule.

A new preparation must therefore behave like a new medicinal product in regulatory terms, yet in the market it is readily perceived as an interchangeable ‘product made from plant X’. The company finances product specification, toxicology, GMP manufacturing and clinical development, while the resulting reputation may extend to other preparations of the same plant. Market access for another medicinal product still depends on its specific preparation and applicable legal pathway; a food supplement, however, faces no comparable requirement for product-specific efficacy. The evidence is specific to the product, while much of its public attribution accrues to the botanical category. Experts consulted in an FDA-funded project in the United States described a related pattern from the investor’s perspective: perceived regulatory risk and cost deter investment in botanical drugs more than in other drugs, and some participants identified the duration of exclusivity as an additional disincentive (Reagan-Udall Foundation for the FDA, 2026).

A recent report from Switzerland and the United Kingdom shows how product realities can stall even an academic trial. For a trial of an Andrographis paniculata (Burm.f.) Nees product, the researchers contacted ten companies; fewer than half held suitable GMP certification, and the supplier initially selected was unable to provide the required quality dossier in full. The authors thus describe not an exotic special case but a structural hurdle: as soon as a herbal product is investigated for a medical indication, the requirements for an investigational medicinal product apply, whereas most food supplements available on the market were never built for this transition (Bourqui et al., 2026).

The outcome is what this essay calls the phytopharmaceutical translational gap: natural product chemistry, omics, computational discovery and ethnopharmacological knowledge are growing, while the commercially viable route to a complex, clinically developed herbal medicinal product appears narrow – and may narrow further if the present incentives remain unchanged.

The translational gap should not be understood as a purely regulatory or financial failure. A candidate may disappear because its effect is too small, its clinical advantage too limited, reimbursement too weak or the addressable market too narrow. Regulatory burden, commercial protection, clinical value and willingness to pay act together: a clinically promising preparation may be commercially undevelopable, while a commercially attractive concept may fail clinically. Their relative contribution cannot be determined without data on discontinued programmes and the reasons for their discontinuation, which are rarely published.

The argument would be weak if it ignored the products that did cross the gap. Table 1 deliberately takes a broad comparative scope, spanning multi-plant extracts, essential oils, purified multi-constituent fractions and plant-derived enzyme preparations. These products belong to different regulatory classes and illustrate distinct routes from botanical material to clinically developed medicines. The selection is illustrative and cannot establish the frequency of innovation in any one class.

Table 1. Selected multi-component medicines of botanical origin, authorised on the basis of product-specific clinical data in the EU and/or the United States (an illustrative selection, not a census).

Sources: Almirall & GW Pharmaceuticals (2011); EMA (2022, n.d.-b, n.d.-d); FDA (2012, n.d.); Jund et al. (2012); Kasper et al. (2010); Pharmazeutische Zeitung (2016); Prescrire International (2015); Rücker (2012). NDA, new drug application; BLA, biologics license application.

Note: NexoBrid is included as a boundary case of a standardised plant-derived multi-enzyme preparation; it is not a herbal medicinal product in the conventional European sense.

Lasea and Sinupret extract fit the definition of a new therapeutic entity used in this essay, although neither introduces a new medicinal plant. Lavender has a long history of use, but Silexan is a specified essential oil from Lavandula angustifolia Mill., developed in its own clinical programme and authorised in Germany since 2009 (Kasper et al., 2010; Pharmazeutische Zeitung, 2016). Sinupret extract (BNO 1016) combines the same five plants as the long-established Sinupret preparations, but as a newly developed dry extract that was tested in its own randomised, placebo-controlled trial and launched in 2012 (Jund et al., 2012; Rücker, 2012). Innovation in phytotherapy therefore need not mean a new species. It can arise from a substantially redeveloped preparation of known plants – which is precisely why the product, not the plant, must be the unit of evidence.

Three observations follow from this selection. First, all of these products combine careful analytical characterisation with tightly controlled manufacturing. Three properties should be kept apart here: analytical characterisation (how completely a preparation is described), fractionation (how far it has been purified or enriched) and chemical complexity (how many constituents remain). Sinecatechins and crofelemer are purified multi-constituent fractions, and NexoBrid is an enzyme concentrate; Silexan, an essential oil, and Sinupret extract, a five-plant dry extract, remain chemically complex but are thoroughly characterised. The selection therefore does not show that simpler preparations pass more easily. It shows only that each of these products was defined and manufactured precisely enough for its clinical data to refer to a reproducible entity.

Second, authorisation is only one step in a product’s commercial life. Episalvan received a centralised EU marketing authorisation for partial-thickness wounds in January 2016; in June 2022 the authorisation was withdrawn at the holder’s request, after the company had decided, for commercial reasons, not to market the product in the EU (EMA, 2022). The same extract was authorised as Filsuvez for wounds in epidermolysis bullosa in June 2022 (EMA, n.d.-b). Its orphan designation for this condition had already been granted in February 2011, five years before the Episalvan authorisation (EMA, n.d.-a). The case therefore illustrates how indication, orphan status and commercial strategy can redirect the development of the same active substance; it establishes neither the commercial failure of an established product in a common indication nor the durable profitability of the orphan route.

Third, the exceptions raise a serious counter-argument. Perhaps the translational gap is not a loss but a filter. From morphine to artemisinin, natural product knowledge has often entered medicine as an isolated or derived molecule, and that route remains productive (Newman & Cragg, 2020). If a plant’s activity can be fully captured by one compound, there is little reason to insist on the extract. Yet a complex preparation does not need a demonstrated multi-constituent mechanism to be justified. A reproducible preparation can be justified by clinically relevant benefit even if its mechanism of action is not fully understood; demonstrated contributions of several constituents, or of their ratio, provide an additional rationale. Nor does Europe lack a pathway. The legal route to authorisation on the basis of the applicant’s own data exists, and the European products in Table 1 used it. What is uncertain is whether this route is economically viable, predictable and accessible enough for smaller developers – and it is this, rather than the existence of a pathway, that this essay calls into question.

Where the path to a medicinal product is narrow, demand for plant-based products does not disappear; it can be diverted towards categories that permit faster market entry, lower development costs and more rapidly changing formats.

For herbal substances, a European borderline area comes into play as well. One and the same botanical species may – depending on preparation, dosage, presentation and Member State – appear as a medicinal product, a food supplement, a cosmetic or a medical device. The case studies on St John’s wort, valerian, ginkgo, ginseng and green tea show that formally harmonised rules are implemented very differently at national level and that commercial decisions thereby co-determine regulatory identity (Bilia & Costa, 2021). As recently as 2026, Singh describes botanicals in the EU as a fragmented puzzle of definitional gaps, an unclear demarcation between food and medicine, inconsistent market access and inadequate safety monitoring (Singh, 2026).

The food side has its own regulatory deadlock. For more than a decade, the assessment of health claims for botanical substances under Regulation (EC) No 1924/2006 has been on hold (Lenssen & de Boer, 2025). In April 2025, the Court of Justice of the European Union clarified that such claims may be used only if they have been authorised or are covered by the transitional provisions for claims placed on hold (Court of Justice of the European Union, 2025). The result is an asymmetry. A supplement may not legally claim what its users often expect from it, yet it can be marketed without product-specific evidence. A medicinal product receives something real in return for its dossier: medicinal status, an approved indication and regulatory protection of its data. The open question is whether this return is economically sufficient for a new herbal preparation, given its development costs, cheaper products of the same plant in other categories and often limited reimbursement. This essay suggests that it may frequently not be – a hypothesis about the economic effect of the reward, not a claim that the regulatory framework offers none.

A plausible scenario for the coming years is therefore not the disappearance of the herbal medicinal product but an asymmetric development. On one side would stand a rapidly renewable market of food supplements, functional foods and wellness products; on the other, a medicinal product segment sustained by established extracts, well-known brands and companies able to carry the regulatory fixed costs. The risk lies in between – where a small company would have to develop a genuinely new extract with a clinical claim. There is a documented precedent for such a split – and for the second level distinguished in this essay, a decline in medicinal products already available. When the transition period for Directive 2004/24/EC ended in 2011, only 48 of the 315 traditional herbal medicinal products licensed in Spain in 2010 remained licensed in 2013, and at least 34% of the former products had moved to the less strictly regulated food sector (Tejedor-García et al., 2015). The higher threshold was followed not only by the disappearance of many medicinal products but also, for a documented proportion, by their redistribution to a category with lower evidentiary demands.

First: the identity of the evidence

In complex herbal preparations, the plant is not the product. Species and plant part, growing site, time of harvest, drying, extraction solvent, drug–extract ratio, purification, storage and dosage form all alter the chemical system. A positive clinical trial of a defined extract therefore does not automatically prove the efficacy of every product bearing the same plant name. If, however, the market communicates predominantly through easily recognisable botanical labels, a systematic transfer of evidence takes place: from the preparation investigated to the plant as a brand. Scientifically, this shortcut is inadmissible; commercially, it is extremely effective.

Second: pharmaceutical quality

An investigation of 73 orally administered Lavandula products from the global market, spanning different regulatory categories, found low or no amounts of the key marker compounds in 63%; 30% of the solid dosage forms repeatedly failed the disintegration test. The three products registered as herbal medicinal products in Europe were, by contrast, of good quality. The sample is not a representative survey of the European market and does not permit a blanket condemnation of food supplements. It does demonstrate, however, how great the distance between a botanical label and a pharmaceutically robust preparation can be (Jalil & Heinrich, 2025). Such findings underline why pharmaceutical quality must be demonstrated through appropriate characterisation and testing rather than inferred from a botanical label.

Third: sound clinical advice

Physicians, pharmacists and other health professionals do not advise on abstract species but on specific products, doses, risks and interactions. The more diffuse the product identity, the more difficult such advice becomes. At the same time, the language shifts: a medicinal product may claim an indication because that indication has undergone regulatory assessment; a food supplement operates with statements about well-being, support or normal functions. The biological expectation of users may nevertheless be a medical one. The result is a market in which therapeutic intention and regulatory claim diverge.

Fourth: Europe’s capacity to develop complex medicinal products

The most profound loss would be institutional. Drug development is a capability, not a single decision. It requires botanists, pharmacognosists, analytical scientists, formulation scientists, toxicologists, clinicians, statisticians, regulatory affairs experts, qualified supply chains and patient capital. If, over a period of years, hardly any new programmes are taken through to authorisation, this combination erodes. The laboratories may remain excellent while the translational infrastructure disappears. It cannot subsequently be restored at short notice by means of a funding call.

The assumption that countries outside Europe will in future simply authorise more is too crude. No serious medicines regulatory authority can ignore the variability, toxicology and efficacy of complex mixtures. What is of interest is rather whether a system recognises the particular features of botanical medicinal products and offers an explicit development pathway for them.

The US Food and Drug Administration issued its first guidance for botanical drugs in 2004 and a revised version in 2016 (FDA, 2016). It does not permit a lower standard of evidence but takes account of particular features such as complex mixtures, the absence of single defined active substances and extensive prior human experience. Only four botanical products have since been approved as prescription drugs: Veregen (sinecatechins), Mytesi (crofelemer) and Filsuvez (birch triterpenes) through new drug applications, and NexoBrid (anacaulase-bcdb) through a biologics license application (FDA, n.d.). This small number is a sobering corrective: a dedicated pathway alone does not generate a broad pipeline. On 3 September 2026, the FDA nevertheless opened a public request for information on modernising botanical drug development, with comments due by 3 November 2026 (FDA, 2026). The joint FDA–EMA workshop that followed on 25 September 2026 drew more than 1,000 participants; according to press coverage, proposals ranged from more public research funding to a separate regulatory category for botanical drugs in the United States, which would require a change in statute (Schultz, 2026). In regulatory terms, the topic is not being closed but reopened.

China exhibits a different form of institutional prioritisation. In 2025, for example, the National Medical Products Administration approved Compound Binafuxi Granules as an innovative traditional Chinese medicine of Class 1.1 (National Medical Products Administration [NMPA], 2025). India created the category of the ‘phytopharmaceutical drug’ as early as 2015 and, in 2025, specified a development pathway for purified, standardised fractions with at least four characterised constituents, preclinical and clinical data, and requirements for stability and – as far as possible – pharmacokinetics and pharmacodynamics (Indian Pharmacopoeia Commission, 2025). These models cannot readily be transferred to Europe. Traditions, health systems and cultures of evidence differ. They do show, however, that complex herbal preparations can be framed in regulatory terms as objects of innovation, rather than being left to choose only between tradition and conventional full authorisation.

A geopolitical shift is therefore conceivable, but it is a scenario, not an observation. It would probably not consist in other nations ‘waving more through’. A division of labour is possible: basic research could remain in Europe, while clinical development, first authorisation or scale-up migrate to wherever category, funding, patient access and commercial prospects are better aligned. The existence of other regulatory models does not show that such a migration is already under way; that would have to be demonstrated with data on where trials are conducted and where products are first authorised. If it did occur, Europe might later import the isolated active substance, the licence or the finished concept – and lose that part of the value chain in which botanical knowledge is turned into the capacity for medical action.

Precisely because translation is difficult, it possesses strategic value. Where many suppliers can sell a plant but only a few can offer a reproducible, clinically tested multi-constituent system, scientific depth becomes a competitive advantage. The opportunity does not lie in a softer concept of the medicinal product. It lies in making a stricter concept investable again, in both economic and regulatory terms.

1. Protect the system, not the plant

The defensible unit of a modern phytopharmaceutical is not the botanical name alone. It is the controlled chain of genotype or provenance, cultivation, harvest window, processing, extraction, chemical fingerprint, biological activity, formulation, dose and clinical context of use. Such layered protection can be assembled from process or use patents, trade secrets, plant variety rights, trademarks, exclusive supply chains, data and regulatory exclusivity. No single layer is insurmountable. Together, however, they can justify the investment in clinical evidence.

2. Make evidence product-specific – and reward it visibly

Once the efficacy of a defined extract has been demonstrated, this product specificity must remain recognisable in the summary of product characteristics, clinical guidelines, reimbursement, professional advice and procurement. Otherwise, the innovator pays for the evidence while the market attributes it to the entire plant category. A modernised European framework would not have to lower the threshold but to improve the return for crossing it: early scientific advice, clear requirements for chemical and biological comparability, appropriate data exclusivity and precise labelling of the preparation investigated.

3. Integrate pharmaceutical variability into clinical development

Complexity does not justify weaker trials; it makes the connection between the tested preparation and the clinical result more demanding. Clinical development should therefore link outcomes to batch-specific chemical fingerprints, predefined ranges of relevant constituents and, where scientifically justified, biological activity assays. Pharmacodynamic markers and exposure–response analyses may help to explain variability, while pragmatic and real-world studies can complement rather than replace randomised trials. The objective is not to prove every molecular interaction within an extract, but to ensure that the preparation used in practice remains sufficiently comparable to the preparation for which benefit was demonstrated.

4. Organise translation as shared infrastructure

For small and medium-sized enterprises, the distance from ethnopharmacology to marketing authorisation is often too long to be financed alone. European consortia are conceivable in which universities, botanical gardens, raw material producers, contract development organisations, hospitals, regulators and investors use a common platform. Public funding should reward not only publications and early signals but also the manufacture of a trial-ready product, a robust quality dossier and the transition into the clinical phases. The bottleneck is not the generation of another early signal alone. It is the development of a product capable of surviving the regulatory journey to the patient.

5. Europe needs measurability before it claims reform

At present, even the diagnosis is unnecessarily difficult. Many herbal medicinal products are authorised or registered nationally; simple, complete and continuously updated European statistics on new active substance or extract entities, extensions of indication, new registrations, withdrawals and shifts between categories are scarcely available to the public. A European Botanical Innovation Observatory could, for the first time, distinguish whether the pipeline is genuinely growing or merely rotating. It would need to record preclinical candidates, authorised clinical trials, new marketing authorisations, life-cycle extensions, withdrawals, reclassifications as food and the time between academic finding and first use in patients. Without such data, the sector remains vulnerable to two equally unsubstantiated narratives: ‘no research is being done any more’ and ‘the pipeline is healthy’. Such an observatory would also make the diagnosis of this essay testable. A growing number of new extract developments and of successful transitions into clinical trials and authorisation would weaken it; stagnating development combined with rising withdrawals or changes of regulatory category would support it.

The evidence assembled here supports concern about limited renewal of herbal medicines, but it does not provide a complete European pipeline overview. Few new authorisations, a shrinking stock of existing products and a loss of effective treatment options remain distinct claims. The Spanish experience shows that products can leave the medicinal category; it establishes neither a current Europe-wide contraction nor patient harm (Tejedor-García et al., 2015).

Registration figures, quality analyses and reports of development obstacles provide different forms of evidence, while industry statements and congress observations add context rather than independent measures of pipeline renewal. Shared authorship among some sources and the GA’s role in co-organising the cited summit likewise warrant attention when assessing the independence of support.

Continued corporate R&D, clinically developed preparations and regulatory engagement show that botanical drug development remains active (FDA, 2026; Schultz, 2026). They do not establish its rate of renewal or its accessibility to smaller developers. Expansion of supplements alongside slower medicinal renewal therefore remains a plausible scenario whose extent must be tested against data on new extract entities, clinical transitions, authorisations, withdrawals, reclassifications and discontinued programmes.

Reims was not the congress of a dying science. On the contrary, the diversity of methods and research questions revealed a field full of energy. The sense of unease arose precisely from this richness. The more vibrant the research appeared, the more conspicuous the narrow bridge to the new medicinal product became.

Perhaps, therefore, the wrong question is whether there will be more food supplements in future; very probably there will be. The decisive question is what happens to knowledge that promises more than general well-being. Does it enter a rapidly marketable product category, become an isolated drug where reduction is scientifically justified, or retain the possibility of development as a complex herbal medicine where the preparation itself carries clinically relevant value?

The future of phytotherapy will not be decided by how many plant capsules sit on the shelves. It will be decided by whether anyone is still willing to turn a plant into a medicinal product.

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Editorial Disclosure

Daniel Artur Raus is Founder and Scientific Editor of Interstitium. He took no part in the editorial assessment or publication decision for this contribution. The manuscript was handled and approved by Sandra Sáez-Morales, Associate Editor.

Contributions

Daniel Raus de Baviera: Conceptualisation, Funding acquisition, Resources, Investigation, Writing original draft. 

Inmaculada Meca-Sáez: Categorising and analysing statistical information.

Competing Interest

The author declares that he has no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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