FDA and EMA Align on Botanical Drug Approval: What the New Regulatory Challenges Mean for Herbal Supplement Standards in 2026

On September 25, 2026, the U.S. Food and Drug Administration and the European Medicines Agency convened a joint public workshop in Amsterdam that drew more than 1,000 attendees — in person and online — to confront a shared problem: botanical drugs are among the most commercially demanded and scientifically complex products in modern medicine, yet regulatory pathways for approving them remain deeply misaligned between the world's two largest pharmaceutical markets.

The session ran from 10:00 to 13:05 CEST (4:00–7:05 a.m. ET), an inconvenient hour for North American participants that nonetheless failed to deter the crowd. That turnout alone signals how urgently the industry wants clarity.

A botanical drug product is defined as a drug product derived from one or more botanical raw materials — including plants, algae, macroscopic fungi, or combinations thereof — intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. This definition, grounded in FDA's 2016 guidance framework, distinguishes botanical drugs from conventional small-molecule pharmaceuticals and from dietary supplements, placing them in a regulatory no-man's-land that the September 2026 workshop was specifically designed to address.

The gap between the two regulatory systems is not subtle. The table below captures the core structural differences laid out during the workshop's second session:

Dimension	FDA (United States)	EMA (European Union)
Legal basis	Food, Drug and Cosmetic (FD&C) Act + regulations and guidances	Traditional herbal designations + HMPC monographs; bottom-up, market-experience-driven
Approvals to date	4 (sinecatechins, crofelemer, birch triterpenes/FILSUVEZ, anacaulase-bcdb)	Substantially more; traditional-use registration available across member states
Batch-to-batch consistency requirement	Rigorous multi-marker characterization; minimal batch variation required	Standardization to a single marker compound may suffice
Estimated relative cost	Up to 10× higher than EU equivalent	Baseline reference cost
Market access scope	Single national market (U.S.)	Can target entire EU or selected member states
Safety evidence standard	Prospective clinical data typically required	Historical market use within EU accepted as primary safety evidence
Adulteration risk (supplement channel)	Significant rates documented in dietary supplement category	Lower under botanical drug framework

The contrast is stark enough that it has produced a practical outcome: very few companies attempt the U.S. botanical drug pathway at all, and many submissions that do proceed reportedly fail because quality parameters cannot be demonstrated to FDA's satisfaction.

Why did the FDA and EMA hold this workshop now?

The timing of the September 2026 workshop reflects converging pressures from multiple directions. Consumer demand for herbal products in the U.S. has been rising sharply — a trend documented by Stefan Gafner, Chief Science Officer of the American Botanical Council, who opened the workshop's first session with sales data showing the category's rapid expansion. Alongside that commercial growth, sponsor interest in the botanical drug NDA/BLA pathway has also increased, even though the approval record remains thin.

The workshop agenda was chaired jointly by Marta Sokolowska, Deputy Center Director of Substance Use and Behavioral Health at FDA's Center for Drug Evaluation and Research, and Steffen Thirstrup, Chief Medical Officer of the EMA. The welcome address was delivered by Emer Cooke, EMA's Executive Director. The presence of agency heads at that level — not just technical staff — signals that this is a strategic priority for both regulators, not a routine scientific exchange.

Parallel to the workshop, FDA had also issued a Request for Information seeking stakeholder perspectives on botanical drug development bottlenecks, and convened a roundtable with the Reagan-Udall Foundation for the FDA. The dual tracks — agency-to-agency harmonization and agency-to-industry dialogue — suggest FDA is building a more structured regulatory posture for this category rather than continuing to handle submissions on a purely case-by-case basis.

What are the four botanical drugs actually approved in the U.S., and what do they reveal?

The four approved botanical drugs in the U.S. represent a narrow but instructive reference set. Three were approved via the NDA pathway: sinecatechins (a green tea extract approved for genital warts), crofelemer (a red sap extract approved for diarrhea in HIV patients on antiretroviral therapy), and birch triterpenes under the brand name FILSUVEZ (approved for a rare skin disease). The fourth, anacaulase-bcdb, was approved via the BLA pathway.

Each approval represents a distinct characterization strategy. The FILSUVEZ case study was examined in detail during the workshop's second session by Charles Wu of FDA and Jacqueline Wiesner of EMA's Committee for Herbal Medicinal Products (HMPC). What each agency required was telling: FDA demanded extensive characterization of the full suite of birch triterpenes and rigorous proof that the manufacturing process could minimize batch-to-batch variation. The EMA required standardization to only one of those terpenes.

For quality assurance directors and regulatory affairs leads preparing botanical INDs, these four approvals are the closest available benchmarks for what FDA considers acceptable. The lesson from the FILSUVEZ comparison is that the U.S. agency's expectations around identity testing, specification-setting, and process validation under 21 CFR Part 211 are substantially more demanding than what the EU requires — and that gap is not merely procedural. It reflects a different philosophy about what constitutes adequate evidence of quality for a complex, biologically variable substance.

What makes botanical drugs so difficult to characterize and approve?

Botanical drug products are defined as inherently complex mixtures. Unlike a single-molecule pharmaceutical where the active ingredient can be precisely synthesized and its purity measured against a known standard, a botanical drug may contain dozens or hundreds of phytochemical constituents, many of which vary depending on the plant's geographic origin, growing season, harvesting method, and post-harvest processing.

Batch consistency — the ability to demonstrate that one manufacturing run produces a product chemically equivalent to the previous one — is straightforward for a synthetic drug and genuinely difficult for a botanical extract. FDA's 2016 guidance on botanical drug development addressed these dimensions, but as the workshop made clear, guidance alone has not resolved the development bottlenecks sponsors face in practice.

The issue of drug interactions compounds the challenge. Dominique Hamerlijnck of the European Lung Foundation, speaking from a consumer perspective during the first session, noted that information about potential interactions between botanical drugs and conventional pharmaceuticals is available but extremely difficult for patients to find. The data is scattered across multiple websites and often cataloged under Latin binomial species designations — a naming convention that is scientifically precise but practically inaccessible to most patients and many clinicians.

This is not a trivial concern. Herbal products sold as dietary supplements in the U.S. — outside the botanical drug framework — have been documented to carry significant adulteration risks. Gafner's presentation made the point explicitly: botanical health products are very unlikely to be adulterated when sold under the botanical drug framework as it exists in the EU, whereas similar products sold as dietary supplements in the United States can be subject to adulteration at significant rates. For consumers who rely on herbal products for genuine health purposes, that distinction matters enormously. It is also a regulatory argument for why a clearer, more accessible U.S. botanical drug pathway could improve public health outcomes, not just commercial ones.

If you're evaluating herbal supplement quality in the current environment, our analysis of Arjuna for heart health and berberine for insulin resistance illustrates how the evidence base for specific botanicals varies widely — a microcosm of the broader regulatory challenge.

What role do pharmacists and community health systems play in the EU model?

Jorge Batista, speaking on behalf of the Pharmaceutical Group of the European Union (PGEU), which represents community pharmacies across EU member states, described the active role that pharmacists play in the administration and counseling around botanical drugs in Europe. This is a structural feature of the EU system that has no direct equivalent in the United States.

The EU's bottom-up regulatory approach means that many botanical products have accumulated decades of documented traditional use within member state markets. That real-world evidence base — pharmacovigilance data, adverse event reporting, and practitioner experience — feeds back into the HMPC's assessment process and can substitute for prospective clinical trials in some cases. Community pharmacists are a key node in that data collection and patient counseling infrastructure.

In the U.S., the dietary supplement channel handles most herbal product sales, but pharmacists have limited formal role in that space. The botanical drug pathway, if it were more accessible, would bring pharmacist involvement into the picture — but the current cost and complexity barriers mean that few products reach that threshold.

What did the panel discussion propose as solutions?

The workshop's third session was a panel discussion moderated by Menglu Yuan of FDA and Olga Palomino of the HMPC, with panelists including Angela Mueller and Christelle Anquez-Traxler of the Association of the European Self-Care Industry (AESGP), Holly Johnson from the Botanical Safety Consortium (listed in the agenda under AHPA affiliation), and Susan Winckler of the Reagan-Udall Foundation for the FDA.

Several concrete proposals emerged from that discussion, though none came with a clear implementation timeline.

The most structurally significant suggestion was the creation of a third regulatory category in the U.S. — something positioned between pharmaceutical drugs and dietary supplements — specifically designed to house botanical drugs. This intermediate category would, in theory, require less rigorous clinical evidence than a full NDA while imposing more quality and safety standards than the current dietary supplement framework under DSHEA.

Winckler was direct about the obstacle: creating such a category would require an amendment to the FD&C Act, which she described as unlikely in the current legislative environment. That assessment reflects a realistic reading of Congressional priorities, but it also means the structural gap is unlikely to close through legislation in the near term.

The other major proposal was more targeted research funding — public investment in botanical drug characterization science that would reduce the private cost burden on sponsors. This is a recurring theme in discussions like these, and its repetition reflects both its logical appeal and its political difficulty. Federal research budgets for this category have historically been modest.

Roy Upton, founder of the American Herbal Pharmacopoeia, who has been tracking the renewed push for botanical drug development with attention to potential unintended consequences for the supplement market, offered a measured assessment: "The workshop demonstrated growing international interest in the development and regulation of botanical medicinal products and highlighted both significant opportunities and substantial challenges. The discussion also show the value of learning from existing regulatory experience, particularly the more than two decades of experience within the European system, while recognizing the distinct statutory and regulatory environment in the United States."

That last clause — "the distinct statutory and regulatory environment in the United States" — is doing significant work. It acknowledges that the EU's experience is instructive without suggesting it is directly transferable. The FD&C Act's structure, FDA's evidentiary standards, and the U.S. political economy of drug regulation are all different enough from the EU's framework that harmonization will require more than goodwill between agencies.

What does this mean for herbal supplement standards going into 2026 and beyond?

For companies currently selling herbal products as dietary supplements in the U.S., the immediate regulatory environment is unchanged. DSHEA remains the governing framework, and the botanical drug pathway remains a high-cost, high-barrier option that only a handful of products have navigated successfully.

The September 2026 workshop nonetheless signals a directional shift worth tracking. FDA's parallel activities — the Request for Information, the Reagan-Udall Foundation roundtable, and the joint workshop with EMA — collectively suggest the agency is building toward a more structured and more accessible regulatory posture for botanical drugs. If that posture materializes in updated guidance or new regulatory frameworks, it could affect how supplement companies position their products, what quality standards they voluntarily adopt, and how they communicate with consumers about the evidence base for their formulations.

For regulatory affairs leads monitoring ICH Q10-aligned quality system requirements, the EMA's involvement in this process introduces the prospect of aligned dossier expectations. That alignment would affect Module 3 content strategy and post-approval change management protocols for any sponsor seeking simultaneous U.S. and EU market access — a scenario that is currently rare for botanical drugs but could become more common if the cost and complexity barriers in the U.S. are reduced.

The adulteration data presented by Gafner is also relevant for supplement companies that have no intention of pursuing the botanical drug pathway. If FDA uses this workshop's momentum to tighten quality enforcement in the dietary supplement channel — perhaps through expanded use of its existing GMP authority or through new guidance on identity testing for botanical ingredients — companies that have relied on minimal quality controls will face pressure to upgrade their analytical capabilities.

Consumers navigating this space face a practical challenge that Hamerlijnck articulated clearly: the information they need to make informed decisions about botanical products — including interaction risks, evidence quality, and product identity — is technically available but practically inaccessible. That accessibility gap is as much a public health issue as a regulatory one, and agency harmonization alone will not close it.

For those evaluating specific botanical supplements in the interim, the quality of the underlying evidence varies enormously by ingredient and application. Our coverage of berberine for blood sugar, Arjuna for cardiovascular support, and blood pressure supplements reflects the kind of ingredient-level scrutiny that the regulatory framework is only beginning to systematize.

What should supplement buyers and formulators watch for next?

The workshop organizers confirmed that a recording of the session would be made available for those who could not attend. The Federal Register comment period associated with FDA's Request for Information represents a concrete near-term checkpoint for organizations tracking how FDA and EMA will define acceptable characterization standards for botanical active ingredients entering the prescription drug pipeline.

For formulators, the FILSUVEZ case study is the most actionable precedent currently available. It demonstrates that FDA will require multi-marker characterization and rigorous batch consistency data, while the EU will accept single-marker standardization. Any company developing a botanical product for dual-market submission needs to build its analytical package to FDA's higher standard from the outset — retrofitting EU-standard data to meet FDA requirements after the fact is a documented failure mode.

For buyers of herbal supplements in the current market, the adulteration data is the most immediately relevant finding. Products sold under the dietary supplement framework carry meaningfully higher adulteration risk than products sold under the EU's botanical drug framework. Third-party testing certifications — from organizations like USP, NSF International, or ConsumerLab — remain the most practical proxy for quality assurance in the absence of a more rigorous U.S. regulatory pathway.

The September 25, 2026 workshop did not resolve the structural tensions between the FDA and EMA frameworks. It did, however, put those tensions on the record at the highest regulatory level, with more than 1,000 industry participants watching. That visibility creates accountability — and accountability, over time, tends to produce movement even when legislation does not.