Commission E, German Herbal Medicine Regulation and the Weiss Legacy

In the middle of the 1970s West Germany faced a practical problem. Its pharmacies and health-food shops were full of plant medicines — hawthorn drops for the heart, valerian for sleep, chamomile for the stomach, bitter tonics, cough teas — many of them older than anyone alive. A new drug law now said that every finished medicine, plant or not, had to show quality, safety and efficacy. Someone had to decide, remedy by remedy, what the evidence for these old preparations actually was. The body that did that work was an expert panel at the Federal Health Office known simply as Commission E, and Rudolf Fritz Weiss (1895–1991), the internist whose textbook had made plant medicine teachable, sat on it from its beginning.

This page tells that story and what followed from it: the 1976 Drug Law, how Commission E was set up and how its monographs were written, the positive and negative verdicts it reached, the European system that later took over its work, how the German approach differs from the American dietary-supplement model, the society and journal Weiss helped found, the wave of German clinical trials and the subject’s return to medical schools, the people who carried his work forward, the prize named after him, and the older German nature-cure tradition he edited books for. His life story, his textbook and the individual plants each have their own pages in this wing.

Table of Contents

  1. The 1976 Drug Law and the Old Remedies
  2. Commission E Is Formed
  3. How a Monograph Was Made
  4. Positive and Negative Monographs
  5. From Bonn to Europe: HMPC, ESCOP and WHO
  6. Germany Versus the American Supplement Model
  7. The Society for Phytotherapy and Its Journal
  8. Three Hundred Trials and a Return to the Medical Schools
  9. Successors and the Weiss Prize
  10. Kneipp, Künzle and the German Nature-Cure Tradition
  11. Key Research Papers
  12. Connections

1. The 1976 Drug Law and the Old Remedies

West Germany’s Drug Law (Arzneimittelgesetz) was passed on 24 August 1976. Its central idea was simple and, for herbal medicine, radical: finished herbal drugs had to meet the same criteria of quality, safety and efficacy as any other finished medicine. A plant extract in a bottle was a drug, and the law treated it as one.

That raised an obvious difficulty. Thousands of plant products were already on the market, and most had never been through anything resembling a modern licensing process. Demanding new clinical trials for every one of them at once would have emptied the shelves. The law’s answer, as Keller described it in a 1991 paper on the legal requirements for plant medicines, was a transition. Products that were registered in 1978 received a provisional authorization that ran until April 1990. During those years their medical value would be evaluated — mostly on the basis of the existing scientific and medical literature rather than on new studies — and the results would be written down in official monographs.

Why bibliographic evidence

Evaluating old remedies from the literature was not a shortcut invented for convenience. Many of these plants had been described, tested and argued over in German, French and Austrian medical journals for a century or more, and a physician-pharmacologist could read that record and weigh it. The work required people who knew both the old literature and modern pharmacology — exactly the combination Weiss had spent his career building, from his botany and medicine dissertations in 1922 to his decades of review papers in the journal Hippokrates.

The “traditionally used” label

Keller also described a second track. Some plant medicines were sold outside pharmacies with no claim beyond long use. These could stay on sale, but they carried a label saying they were “traditionally used” for a purpose. The phrase told the buyer that the product rested on custom rather than on a positive expert evaluation. It is the ancestor of the “traditional use” registration that Europe adopted decades later (section 5).

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2. Commission E Is Formed

The evaluation was entrusted to what Keller called “a special expert committee, the Commission E,” at the Federal Health Office (Bundesgesundheitsamt) in Berlin. The tribute to Weiss written by K.-Ch. Schimmel in 2005 dates its founding to 1978. The letter E was simply its place in a series: Germany set up several such commissions for different branches of medicine, and E was the one for herbal medicinal products.

Weiss among the members

Weiss was a member from the start. German Wikipedia lists him as a standing member from 1978 to 1990; the pharmacist Heinz Schilcher, writing his obituary in 1992, put it more warmly, saying he served “from the first minute” until his death. (The two accounts differ only in how they count his last years.) He was in his eighties during most of this service.

German Wikipedia’s article on the commission names other members alongside him: Heinz Schilcher, Max Wichtl, Karin Kraft and Bernhard Uehleke. The mix was deliberate. Physicians who prescribed plant medicines sat with pharmacists and pharmacognosists who studied their chemistry, so that a monograph had to satisfy both the bedside and the laboratory.

Why his textbook mattered here

Weiss’s life work had been to move plant medicine from what German writers called an Erfahrungsheilkunde — a healing art based on experience — to a systematic subject that could be taught and checked. Commission E was that idea turned into public administration. Each old remedy was now asked the questions his textbook asked: what is in it, what does it do in the body, and what is the evidence that it helps patients. The Lehrbuch der Phytotherapie page tells how that method took shape.

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3. How a Monograph Was Made

A Commission E monograph was a short, standardized document about one plant drug (or one fixed combination). According to German Wikipedia’s summary of the commission’s work, the panel evaluated both scientific and empirical material on the wanted and unwanted effects of each herbal drug: published pharmacology, clinical studies where they existed, and the documented experience of physicians who had used the remedy.

What a monograph recorded

The finished monographs followed a fixed pattern. They identified the plant part used, named its constituents, and set out the uses for which the commission considered the evidence adequate, together with contraindications, side effects, interactions, the dosage range then in use and the pharmacological actions. A monograph was not a research paper; it was a verdict, written so that a manufacturer, a regulator and a prescribing doctor could all read the same page and know what had been accepted.

Publication in the Federal Gazette

The monographs were published in the Bundesanzeiger, Germany’s Federal Gazette, between 1984 and 1995. German Wikipedia dates the commission’s main advisory work to 1983–1994. Read together, the dates describe a panel set up in 1978, at work on monographs from the early 1980s, and publishing them over about eleven years. An English translation of the collected monographs appeared in the United States in 1998, and for many English-speaking readers that translation was their first contact with the German system.

An example: hawthorn

Hawthorn shows how a monograph worked in practice. The 2008 Cochrane review of hawthorn extract for chronic heart failure notes in its background that Commission E approved hawthorn leaf with flower for heart failure of New York Heart Association stage II — a mild stage in which ordinary activity causes some breathlessness or fatigue. In 2005 Steinhoff compared how hawthorn was described across the pharmacopoeia, the Commission E monograph, and the later ESCOP and WHO monographs, tracing one plant through each generation of evaluation. Weiss himself had written on the mechanism of action of hawthorn in Hippokrates in 1963. The plant and its trials are covered on the Hawthorn, Valerian and Chamomile page and on the site’s Hawthorn page.

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4. Positive and Negative Monographs

The feature that set Commission E apart from a simple list of approved herbs was that it also said no. German Wikipedia gives the totals. About 380 plant drugs were reviewed. Of these, 186 single drugs and 66 combinations received a positive monograph — the commission found their use justified for the stated purposes. Another 118 drugs and 8 combinations received a negative monograph, because the commission judged that the risks outweighed the benefits or that no adequate evidence of benefit had been shown.

What a negative verdict meant

A negative monograph did not mean that a plant was poisonous. It meant that its benefit-risk balance was unfavourable on the evidence then available: either some known hazard was not offset by a demonstrated benefit, or the claimed benefit had simply not been shown. For a field that had long been described by its critics as uncritical, a public list of rejected remedies was a strong statement. It put into practice the principle Weiss had argued for in his teaching — that plant medicine had to stand “on the ground of clinical medicine,” in his own phrase as quoted by Schimmel, and accept that some of its traditions would not survive the test.

Combinations

The figures for combinations are revealing. Fixed mixtures of several plants had been extremely popular in German self-medication, but each added ingredient made the case harder to prove. The commission’s positive list included 66 combinations, and 8 were rejected in a negative monograph.

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5. From Bonn to Europe: HMPC, ESCOP and WHO

Commission E was a national body of the Federal Republic, whose capital was then Bonn. Its monographs became a model, but the work of evaluating plant medicines gradually moved to the European level. German Wikipedia summarizes today’s arrangement: national authorities work with the Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency, while ESCOP and the World Health Organization also contribute monographs.

The three bodies

Two kinds of evidence, carried forward

The European system kept the two-track idea that had already existed in German law. A plant medicine can be licensed on the basis of “well-established use,” supported by published scientific evidence, much as a positive Commission E monograph was. Or it can be registered as a traditional herbal medicine, where efficacy is considered plausible from long-standing use and the main requirements concern quality and safety — the descendant of the old German “traditionally used” label. Steinhoff’s 2005 paper on hawthorn, which followed one plant across the German pharmacopoeia, Commission E, ESCOP and WHO, illustrates how each generation of monograph built on the last.

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6. Germany Versus the American Supplement Model

The German and American systems went in different directions. In Germany, a plant extract sold with a health claim is a medicine and is regulated as one. In the United States, most herbal products are sold as dietary supplements under the Dietary Supplement Health and Education Act of 1994, which does not require proof of efficacy before sale and does not allow disease-treatment claims on the label.

A five-country comparison

In 2018 Alostad, Steinke and Schafheutle compared herbal-medicine registration in five countries: the United Kingdom, Germany, the United States, the United Arab Emirates and Bahrain. They reported that Germany, like the United Kingdom, offers a simplified registration route in which plausible efficacy rests on established traditional use, while the United States has no traditional-use category at all. Their aim was to inform countries building their own regulation, and their comparison sets out the trade-off plainly: a medicine route brings evaluation of quality, safety and efficacy, while the American supplement route offers wide availability with far less pre-market review.

What that difference means for readers

The practical result is that the same plant can occupy two very different legal positions. A hawthorn or St John’s wort extract that is a licensed medicine with a defined content in Germany may be sold in the United States as a supplement whose strength and composition vary from product to product. Much of the clinical evidence on these plants comes from standardized German extracts, which is one reason trial results do not automatically transfer to every product with the same plant name on the label.

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7. The Society for Phytotherapy and Its Journal

Commission E was a government body. The institutions that trained and connected the doctors and pharmacists behind it were private, and Weiss helped build both of the most important ones.

The Gesellschaft für Phytotherapie, 1971

In 1971 Weiss was a founding member of the Gesellschaft für Phytotherapie (Society for Phytotherapy, GPT) and served as its first chairman from 1971 to 1973; he was later named its honorary president. The society gave scientific plant medicine a professional home separate from both folk herbalism and the drug industry: a place where physicians, pharmacists and pharmacologists met as equals. He was already a long-standing member of the physicians’ naturopathy association (the ZÄN), which he had joined in 1954 and chaired from 1959 to 1961; the GPT was narrower and more scientific in its aims.

The Zeitschrift für Phytotherapie, 1980

In 1980 Weiss founded the Zeitschrift für Phytotherapie (Journal of Phytotherapy). As its founding editor he recruited two professors as co-editors: Franz-C. Czygan of Würzburg and Fritz H. Kemper of Münster. Czygan would later write a short cultural history of hawthorn as a heart remedy (2005), one of the plants Weiss had written about decades earlier.

The journal still exists. In 2020, for what would have been his 125th birthday, it reprinted a 1995 centenary editorial by Kemper and Czygan under the title Erinnerung an Professor R. F. Weiß – Altmeister der modernen Phytotherapie (“Remembering Professor R. F. Weiss — grand master of modern phytotherapy”), which described him as the founder of modern phytotherapy. Colleagues’ titles for him varied — “Altmeister,” “founder,” Schilcher’s “Nestor of scientifically oriented phytotherapy” — and the English epithet “father of modern German phytotherapy” is a rendering of the same esteem.

His own surveys of the field

Weiss kept writing summaries of where plant medicine stood. His 1975 review in Hippokrates, titled “Phytotherapie heute” (“Phytotherapy today”), appeared three years before Commission E began, as a survey of the field at the moment regulation was about to remake it.

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8. Three Hundred Trials and a Return to the Medical Schools

Regulation changed the incentives. Once plant medicines had to show efficacy, the companies and university groups that made and studied them began running clinical trials, and Germany became one of the leading centres of clinical research on herbal medicine.

The trial count

Writing in Environmental Health Perspectives in 1999, the phytomedicine researcher H. Wagner counted more than 300 clinical studies of standardized plant medicines carried out in Germany since 1980, on preparations of hawthorn (Crataegus), milk thistle (Silybum), ginkgo, St John’s wort (Hypericum), valerian (Valeriana), echinacea and others. Wagner’s paper also claimed these products were free of adverse effects; that claim is his, and it is not supported by later evidence — St John’s wort, for example, is documented to interact with a range of prescription drugs, as the site’s St John’s Wort page describes.

Prescriptions, sales and teaching

A 1998 report in the Canadian Medical Association Journal by Harrison, “Herbal medicine takes root in Germany,” described the result from outside. German physicians routinely prescribed herbal products, sales had passed two billion dollars a year, and medical schools had reintroduced teaching on the subject. Weiss lived to see the beginning of that return: in 1983 the University of Tübingen gave him a teaching post (Lehrauftrag), and in 1985, when he was about ninety, the state of Baden-Württemberg made him an honorary professor.

St John’s wort: where the evidence went

St John’s wort became the best-known test of the German approach. In 2008 a Cochrane review by Linde, Berner and Kriston pooled 29 trials with 5,489 patients with major depression. The authors found that the extracts tested were superior to placebo, about as effective as standard antidepressants, and caused fewer side effects. They also found that trials from German-speaking countries reported more favourable results than trials from elsewhere — a pattern they flagged as something readers had to take into account. Both halves of that finding are part of the Weiss legacy: a large body of real clinical evidence, and the questions about bias that come with a field whose research is concentrated in one country.

The evidence on other plants

The same mixed picture appears elsewhere. The 2008 Cochrane review of hawthorn found benefit on exercise tolerance and symptoms as an add-on treatment for chronic heart failure, while the meta-analyses of valerian disagree about whether its effect on sleep can be shown with objective measures. Those trials are described on the Hawthorn, Valerian and Chamomile page.

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9. Successors and the Weiss Prize

Weiss lectured into his nineties, but the work he started needed successors, and German Wikipedia names three whose books carried it forward.

The Rudolf-Fritz-Weiss-Preis

The Society for Phytotherapy named a prize after him, the Rudolf-Fritz-Weiss-Preis, to honour work in the field. German Wikipedia records that it was later discontinued and succeeded by the society’s present Phytotherapie-Preis. The prize sat alongside the honours he received in his lifetime: the Baden-Württemberg medal of merit (1975), the honorary professorship (1985), the Federal Cross of Merit, first class (1987), the Hufeland and Huneke medals, and honorary citizenship of Aitrach, the Allgäu village where he spent his last years. The Life and Career page tells the story behind each.

The debate he left open

Part of his legacy is an unfinished argument. If, as Weiss taught, some plant drugs are strong (forte) and others mild (mite), then the mild ones may be hard to measure in a placebo-controlled trial. In 2000 Volker Schulz argued in Phytomedicine that such trials can undervalue gentle remedies whose effects overlap with the psychological effects of treatment, and he called for a differentiated evaluation of phytotherapy’s efficacy. That is Schulz’s argument rather than Weiss’s, but it is a direct descendant of the strong-and-mild distinction.

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10. Kneipp, Künzle and the German Nature-Cure Tradition

Weiss was a scientist of plant medicine, but he never cut it off from its roots in the popular German nature-cure movement. Among his more than a hundred papers and books were editions of two of that movement’s classics.

Das große Kneipp-Buch

The first was Das große Kneipp-Buch (“The Great Kneipp Book”), built on the work of the Bavarian priest Sebastian Kneipp (1821–1897), whose water cure at Wörishofen made him famous across Europe. In a 2014 paper on Kneipp’s legacy, Locher and Pforr describe his system as resting on five pillars: hydrotherapy, phytotherapy (plant medicine), exercise, balanced nutrition and regulative therapy — the ordering of daily life. They argue that it links wellness, naturopathic and conventional medicine. Plant medicine was one pillar among five, and it was the one Weiss made into a clinical science. The site’s Sebastian Kneipp wing covers Kneipp himself.

Künzle’s Kräuterheilbuch

The second was Das große Kräuterheilbuch (“The Great Book of Healing Herbs”) of the Swiss pastor Johann Künzle, a much-read popular herbal. Weiss continued it as editor in an edition published in Olten in 1974. He also wrote a popular book of his own, Moderne Pflanzen-Heilkunde (1966), published in Bad Wörishofen, the town of Kneipp’s cure.

One tradition, two audiences

These books show the two audiences Weiss wrote for. The Lehrbuch and the Commission E monographs spoke to physicians and regulators in the language of pharmacology. The Kneipp and Künzle books spoke to households that had used herbal teas for generations. His achievement, as his colleagues described it, was to keep the two in conversation: to take the plants that ordinary German families already trusted, ask what the evidence for each really was, and write the answers down in a form that both doctors and lawmakers could use.

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Key Research Papers

  1. Weiss RF. [Phytotherapy - today]. Hippokrates. 1975;46(2):143-57. PubMed PMID: 1213908
  2. Weiss RF. [The mechanism of action of Crataegus oxycantha]. Hippokrates. 1963;34:602-5. PubMed PMID: 14046338
  3. Keller K. Legal requirements for the use of phytopharmaceutical drugs in the Federal Republic of Germany. J Ethnopharmacol. 1991;32(1-3):225-9. PubMed PMID: 1881161
  4. Harrison P. Herbal medicine takes root in Germany. CMAJ. 1998;158(5):637-9. PubMed PMID: 9526483
  5. Wagner H. Phytomedicine research in Germany. Environ Health Perspect. 1999;107(10):779-81. PubMed PMID: 10504142
  6. Schulz V. The psychodynamic and pharmacodynamic effects of drugs: a differentiated evaluation of the efficacy of phytotherapy. Phytomedicine. 2000;7(1):73-81. PubMed PMID: 10782494
  7. Czygan FC. [A short cultural history in retrospect. Crataegus as a cardiac agent]. Pharm Unserer Zeit. 2005;34(1):10-3. PubMed PMID: 15700789
  8. Steinhoff B. [The pharmacopoeia and Commission E of the ESCOP and the WHO. Hawthorn in the view of the monographs]. Pharm Unserer Zeit. 2005;34(1):14-21. PubMed PMID: 15700790
  9. Pittler MH, Guo R, Ernst E. Hawthorn extract for treating chronic heart failure. Cochrane Database Syst Rev. 2008;2008(1):CD005312. PubMed PMID: 18254076
  10. Linde K, Berner MM, Kriston L. St John's wort for major depression. Cochrane Database Syst Rev. 2008;2008(4):CD000448. PubMed PMID: 18843608
  11. Locher C, Pforr C. The legacy of Sebastian Kneipp: linking wellness, naturopathic, and allopathic medicine. J Altern Complement Med. 2014;20(7):521-6. PubMed PMID: 24773138
  12. Alostad AH, Steinke DT, Schafheutle EI. International Comparison of Five Herbal Medicine Registration Systems to Inform Regulation Development: United Kingdom, Germany, United States of America, United Arab Emirates and Kingdom of Bahrain. Pharmaceut Med. 2018;32(1):39-49. PubMed PMID: 29456449
  13. Erinnerung an Professor R. F. Weiß – Altmeister der modernen Phytotherapie. Z Phytother. 2020;41(04):191-192. DOI: 10.1055/a-1126-9219

PubMed Topic Searches

  1. Commission E monographs
  2. Herbal medicine regulation in Germany
  3. Traditional herbal registration in Europe
  4. St John’s wort for depression
  5. Weiss RF in Hippokrates

Further Reading

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Connections