European regulation of herbal medicinal products on the border area to the food sector

Quintus, Christiane; Schweim, Harald G.

doi:10.1016/j.phymed.2011.10.002

Cited by 17 publications

(13 citation statements)

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“…In the European Union (EU), botanicals are sold as both foodstuffs and pharmaceuticals (Schwitters, 2012). The classification of a botanical as either food or as medicinal product depends on the function the product has, or how it is presented to a consumer (Bast et al, 2002;de Boer, 2015;Quintus & Schweim, 2012;Silano, Coppens, Larrañaga-Guetaria, Minghetti, & Roth-Ehrang, 2011). The legal frameworks of foods and pharmaceuticals are mutually exclusive: a product is either a food or a medicine, and pharmaceutical law prevails when there is doubt about the status of a product (Silano et al, 2011).…”

Section: Regulation Of Botanicals In the European Unionmentioning

confidence: 99%

“…HMPs are considered to be comparable to HDSs as HMPs substantiated with evidence on traditional use should, like food products, not cause any harm (Schwitters, 2012). In the EU, two types of medicinal product are identified (de Boer, 2015;Quintus & Schweim, 2012). Products with observed pharmacological functions are considered "medicinal product by function" (Quintus & Schweim, 2012).…”

Section: Comparison Of International Legal Framework To the Europeanmentioning

confidence: 99%

“…Previous exploratory research has identified discrepancies in either the legal frameworks of HDSs or HMPs, or was focused on the international legal frameworks of HMPs (Bagchi, ; de Boer & Bast, ; Devla, Acharya, Acharya, & Kumar, ; Fan et al., ; Liu & Salmon, ; Verma, ). The current impasse regarding botanical health claims has only been addressed shortly in previous studies, that mainly dealt with explaining the EU regulatory status and providing potential future approaches to solve the issue without including the international perspective of dealing with botanicals in foods (Anton, Serafini, & Delmulle, ; Hoogenraad & Duivenvoorde, ; Korzycka‐Iwanow & Zboralska, ; Quintus & Schweim, ; Schwitters, ). This paper analyses these international approaches, and aims to determine the role of evidence on traditional use in international legal frameworks dealing with supplements and medicines.…”

Section: Introductionmentioning

confidence: 99%

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International Perspectives on Substantiating the Efficacy of Herbal Dietary Supplements and Herbal Medicines Through Evidence on Traditional Use

Lenssen

Bast

Boer

2019

Comp Rev Food Sci Food Safe

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The efficacy of botanicals in medicines can be substantiated with evidence on traditional use, whereas in foodstuffs, this is often not possible. In Europe, for example, the evaluation and subsequent authorization of health claims on herbal dietary supplements (HDS) have been put on hold by the European Commission. This study aims to analyze the role of evidence on traditional use in international legal frameworks of foods and pharmaceuticals. Both legal sources as well as scientific studies offering insights into these regulatory frameworks were included into the analysis. The international approach toward evidence on traditional use for substantiating efficacy of botanicals varies highly. For herbal medicines, substantiating efficacy with evidence on traditional use is possible in all studied jurisdictions, except for Japan and the United States. HDS efficacy can only be substantiated with evidence on traditional use in India and New Zealand, although the enforcing authorities do not describe which data are required. Australia and Canada regulate botanicals in a separate “borderline” category from foods and pharmaceuticals. Both jurisdictions allow for substantiating efficacy with evidence on traditional use. This study's second objective was to assess the applicability of the international approaches in the European legal framework, in light of the ongoing political debate regarding the use of traditional evidence. Implementation of the analyzed international approaches would require major revisions of the current European legal framework. This review of international approaches might, however, aid in deciding upon future approaches for substantiating health claims with evidence on traditional use.

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Section: Regulation Of Botanicals In the European Unionmentioning

confidence: 99%

Section: Comparison Of International Legal Framework To the Europeanmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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International Perspectives on Substantiating the Efficacy of Herbal Dietary Supplements and Herbal Medicines Through Evidence on Traditional Use

Lenssen

Bast

Boer

2019

Comp Rev Food Sci Food Safe

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“…Moreover, products are eligible for license as a traditional herbal medicine only if they have been used to treat a specified health complaint for at least 30 years, including a minimum of 15 years at least in one country of EU. Obviously, WEU and THMPs are held to satisfy similar safety and quality standards as pharmaceutical drugs [8]. …”

Section: Botanicals In Herbal Medicinal Products Marketmentioning

confidence: 99%

“…HMPC has defined that at least one controlled clinical study or alternatively a well-documented clinical experience with sufficient supportive pharmacological data is needed to substantiate efficacy for a well-established use [10]. The current situation regarding the status of products registration is that in some European member states, herbal preparations have been regulated under food law, although they have pharmacological properties, and the tendency in these countries remains to place typical medicinal plants on the market as food products [8]. …”

Section: Botanicals In Herbal Medicinal Products Marketmentioning

confidence: 99%

Research and Development for Botanical Products in Medicinals and Food Supplements Market

Miroddi

Mannucci

Mancari

et al. 2013

Evidence-Based Complementary and Alternative Medicine

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Botanical products sold in the health area are generally intended as drugs, medicinal products, food supplements or substances for therapeutic use. Use of botanicals for improving or to care human health has evolved independently in different countries worldwide. Regulatory issues regarding botanical products designed for the food supplements or medicinal market and their influence on research and development are discussed. European Union (EU) and United States (US) policies regulating these products are focused with comments on the legislations delivered during the last ten years and differences existing in rules between these countries are emphasized. Research and development on botanical products nowdays strongly influenced by the product destination in the market. Addressed and differentiated research for either food supplements or medicinal markets is necessary to purchase data really useful for assessment of safe and effective use for both the categories. The main objective is to catalyze interest of academic and companies' researchers on crucial aspects to be taken into account in the research for the development of botanical products.

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Somnologics

Herberger

Ruether²,

Hajak

2022

NeuroPsychopharmacotherapy

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European regulation of herbal medicinal products on the border area to the food sector

Cited by 17 publications

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International Perspectives on Substantiating the Efficacy of Herbal Dietary Supplements and Herbal Medicines Through Evidence on Traditional Use

International Perspectives on Substantiating the Efficacy of Herbal Dietary Supplements and Herbal Medicines Through Evidence on Traditional Use

Research and Development for Botanical Products in Medicinals and Food Supplements Market

Somnologics

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