Herbal products: Marketing strategies and legislation

Authors

  • Pieter A. Hooyenga
  • Renger F. Witkamp
  • Kees Groen

DOI:

https://doi.org/10.22377/ijgp.v3i4.99

Abstract

Marketing of herbal products in the European Union (EU) has been regulated under national legislation for years, leading to
differences in legal status of these herbal products. In one member state, a product may be regulated as a food supplement, while in the other member state the same product is considered a medicinal product, thereby subjected to medicinal law. To provide free movement of these products in the inner market, new legislation has been set to improve harmonization. This raises the question what the appropriate positioning and marketing strategy for a herbal product will be under this new EU legislation. This review describes the legal status and registration procedures of different categories of herbal products, taking into account technical requirements and interesting market perspectives. Information was collected from legislation, guidance and official documents published by the European Commission, European Food Safety Authority and the European Medicines Agency. In addition, information was found in conference presentations and the scientific literature from Medline and Scopus. The EU market of herbal products will change considerably in the near future. Many products now marketed as food supplements will be expected to be registered as traditional herbal medicinal product in the future. However, it will take years for the EU to fully implement the new rules for harmonization.
Key words: Herbal medicinal products, food supplements, harmonization of European legislation

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References

European Commission, Directive 2001/83 as amended on the

Community code relating to medicinal products for human

use. Official Journal of the European Communities 2001. L311

p. 67‑128.

European Commission, Directive 2004/24, as regards traditional

herbal medicinal products, amendment to Directive 2001/83.

Official Journal of the European Union 2004. L136: p. 85-90.

European Scientific cooperative on Phytotherapy, ESCOP

monographs: The scientific foundation for herbal medicinal products.

, Published by: ESCOP, Exeter (GB). ISBN 1-901964‑07‑8.

World Health Organization, WHO monographs on selected medicinal

plants. 1999, Published by: WHO library Cataloguing‑in‑Publication

Data, Geneva (CH).

World Health Organization, WHO monographs on selected medicinal

plants. 2002, published by: WHO Library Cataloguing‑in‑Publication

Data: Geneva (CH).

World Health Organization, WHO monographs on selected medicinal

plants. 2007, published by: WHO Library Cataloguing‑in‑Publication

data: Ottawa (CA).

European Commission, Directive 1999/83 on the approximation

of the laws of the member states relating to analytical, pharma

cotoxicological and clinical standards and protocols in respect of

the testing of medicinal products. Official Journal of the European

Communities, 1999. L243: p. 9-11.

College ter Beoordeling van Geneesmiddelen 5 Medicines

Evaluation Board, Medicines Evaluation Board: Human Medicines:

Herbal Medicinal Products. [homepage on the internet], The

Hague (NL), [cited 19 Dec 2008], available from: http://www.

cbg‑meb.nl/en.

European Commission, Commission Decision 2008/911/EC,

Establishing of a list of herbal substances, preparations and

combinations thereof for use in traditional herbal medicinal

products. Official Journal of the European Communities 2008.

L328: p. 42-48.

Association of the European self-medication industry (AESGP),

AESGP’s Conference on ‘Changing the rules for food supplements

and herbal products in Europe.’ 2004. Published by: AESGP,

Brussels (BE).

Knoess W, Stolte F, Reh K. The regulatory framework for complementary

and alternative medicines in Europe [Europäische Gesetzgebung zu

besonderen Therapierichtungen]. Bundesgesundheitsblatt-Gesunth

eitsforschung‑Gesundheitsschutz 2008;51:771-8.

Sickmueller PDB. The BfarM in dialogue: Traditional herbal

medicines. From tradition to new perspectives [Das BfArM im

Dialog: Traditionelle pflanzliche Arzneimittel. Von der Tradition

zu neuen Perspektiven]. 2007, Published by: Bundesinstitut fur

Arzneimittel und Medizinprodukte, Bonn (DE).

European Commission, Report on the experience acquired as aresult of the application of the provisions of Chapter 2A of Directive

/83/EC, as amended by Directive 2004/24/EC, on specific

provisions applicable to traditional herbal medicinal products.

, Published by: European Commission, Brussels (BE).

European Commission, Regulation (EC) No 178/2002, laying

down the general principles and requirements of food law,

establishing the European Food Safety Authority and laying

down procedures in matters of food safety. Official Journal of the

European Communities 2002. L31: p. 1-24.

European Commission, Directive 2002/46/EC on the approximation

of the laws of the member states relating to food supplements.

Official Journal of the European Communities 2002. L183: p. 51-57.

European Commission, Corrigendum to Regulation (EC) No

/2006 on nutrition and health claims made on food. Official

Journal of the European Union 2007. L12: p. 3-18.

European Commission, Report on the use of substances other than

vitamins and minerals in food supplements. 2008, Published by:

European Union, Brussels (BE).

European Commission, Regulation (EC) No 764/2008, laying down

procedures relating to the application of certain national technical

rules to products lawfully marketed in another member state and

repealing Decision 3052/95/EC. Official Journal of the European

Communities 2008. L218: p. 21-29.

European Commission, Commission directive 2003/63, annexes

to Directive 2001/83. Official Journal of the European Union 2003.

L159: p. 46-94.

European Medicines Agency; Herbal Medicinal Product

Committee, Guideline on the use of the CTD format in the

preparation of a registration application for traditional herbal

medicinal products. 2008, Published by: European Medicines

Agency, London (GB).

European Medicines Agency; Herbal Medicinal Product

Committee, Guideline on the assessment of genotoxicity of herbal

substances/preparations. 2008, Published by: European Medicines

Agency, London (GB).

European Medicines Agency; Herbal Medicinal Product

Committee, Guideline on quality of herbal medicinal products/

traditional herbal medicinal products. 2006, Published by:

European Medicines Agency, London (GB).

European Medicines Agency; Herbal Medicinal Product

Committee, Guideline on Good Agricultural Practice (GACP) for

starting materials of herbal origin. 2006, Published by: European

Medicines Agency, London (GB).

European Medicines Agency; Herbal Medicinal Product

Committee, Guideline on non-clinical documentation for herbal

medicinal products in applications for marketing authorization

(bibliographical and mixed applications) and in applications for

simplified registration. 2006, Published by: European Medicines

Agency, London (GB).

European Food Safety Authority; Scientific Panel on Dietetic

products, Nutrition and Allergies, Scientific and technical

guidance for the preparation and presentation of the application

for authorization of a health claim. The EFSA Journal [online],

, 530: p. 1-44. Available from: http://www.efsa.europa.eu/

EFSA/efsa_locale-1178620753812_1178623592448.htm.

European Food Safety Authority; Scientific Cooperation Working

Group on Botanicals, Safety assessment of botanicals and botanical

preparations intended fur use as ingredients in food supplements.

Draft edition, 2008. Published by: European Food Safety Authority,

Parma (It).

European Federation of Associations of Health Product

Manufacturers, Quality Guide for food supplements, Guidance

for the manufacture of safe and consistent supplements across

the EU. 2007, Published by: EHPM: Brussels (BE).

European Court of Justice, Judgment of the Court-Commission

of the European Communities v Federal Republic of Germany,

case C-319/05. Official Journal of the European Communities

C8: p. 3.

Coppens P, Delmulle L, Gulati O, Richardson D, Ruhtsatz M,

Sievers H, et al. Use of botanicals in food supplements, regulatory

scope, scientific risk assessment and claim substantiation. Ann

Nutr Metab 2006; 50: 538-54.

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