Legal Aspects: How Do Food Supplements Differ from Drugs, Medical Devices, and Cosmetic Products?

Chapter

Abstract

About 2500 years ago, Hippocrates, the father of modern medicine, shaped the relationship between the use of appropriate foods for health and their therapeutic potential and quoted “…let food be the medicine….”

Keywords

Member State Medical Device Medicinal Product Product Category Food Supplement 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Abbreviations

AESGP

Association of the European Self-medication Industry

BGH

Bundesgerichtshof (German Federal Higher Court)

CECP

Committee of Expert on Cosmetic Products

CHMP

Committee on Human Medicinal Products

EAS

European Advisory Services

EC

European Commission

EFSA

European Food Safety Authority

EMEA

European Medicines Evaluation Agency

ERNA

European Responsible Nutrition Alliance

EU

European Union

GCP

Good Clinical Practice

GMOS

Genetically Modified Organism

ILSI

International Life Sciences Institute

INCI

International Nomenclature of Cosmetic Ingredients

MEDDEV

Medical Device

MRP

Mutual Recognition Procedure

OTC

Over The Counter

QUID

Quantitative Ingredient Declaration

SCC-NFP

Scientific Committee on Cosmetic Products & Non Food Products

SCCP

Scientific Committee on Cosmetic Products

UV

UltraViolet

References

  1. 1.
    AESGP (Association of the European Self-medication Industry), The European Union, Economic and Legal Framework for Non-Prescription Medicines, 2006Google Scholar
  2. 2.
    AESGP (Association of the European Self-medication Industry), The Regulatory Framework for Food Supplements in Europe, 2007Google Scholar
  3. 3.
    Altenstetter, C.: EU and Member State medical device regulation. Int. J. Technol. Assess. Health Care 19, 228–248 (2003)CrossRefPubMedGoogle Scholar
  4. 4.
    Anselmann, N.: The European legislation on medical devices. In: Palikarakis, N. (ed.) Information Exchange for Medical Devices. IOS Press, Amsterdam (1996)Google Scholar
  5. 5.
    Coppens, P., Fernandes de Silva, M., Pettman, S.: European regulations on nutraceuticals, dietary supplements and functional foods: a framework based on safety. Toxicology 221, 59–74 (2006)CrossRefPubMedGoogle Scholar
  6. 6.
    Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, OJ L 262Google Scholar
  7. 7.
    Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. OJ L151Google Scholar
  8. 8.
    Directive 93/42/EEC of the Council of 14 June 1993 on medical devices, OJL 169 1-43; last amended by Directive 2007/47/EC, OJ L 247Google Scholar
  9. 9.
    Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, OJ L121Google Scholar
  10. 10.
    Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311Google Scholar
  11. 11.
    Directive 2002/46/EC of the European Parliament and the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, OJ L 183Google Scholar
  12. 12.
    Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending for the seventh time Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products, OJ L066, 26–35Google Scholar
  13. 13.
    Directive 2003/89/EC of the European Parliament and of the Council of 10 November 2003 amending Directive 2000/13/EC as regards indication of the ingredients present in foodstuffsGoogle Scholar
  14. 14.
    Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 136Google Scholar
  15. 15.
    Directive 2004/27/EC amending Directive 2001/83/EC, OJ L 136Google Scholar
  16. 16.
    Eberhardie, C.: Nutritional supplements and the EU: is anyone happy? Proc. Nutr. Soc. 66, 508–511 (2007)CrossRefPubMedGoogle Scholar
  17. 17.
    European Advisory Services – EAS, 2005, Marketing Food Supplements, Fortified and Functional Foods in EuropeGoogle Scholar
  18. 18.
    German Medicinal Products Act (Arzneimittelgesetz, AMG) 1976, last amended by Act of 29. August 2005 (BGBI.I 2555,2570), revised by announcement of 12. December 2005 (BGBI. I 3394)Google Scholar
  19. 19.
    Gulati, O.P., Ottaway, P.B.: Legislation relating to nutraceuticals in the European Union with a particular focus on botanical-sourced products. Toxicology 221, 75–87 (2006)CrossRefPubMedGoogle Scholar
  20. 20.
    Hanekamp, J.C., Bast, A.: Food supplements and European Regulation within a precautionary context: a critique and implications for nutritional, toxicological and regulatory consistency. Crit. Rev. Food Sci. Nutr. 47, 267–285 (2007)CrossRefPubMedGoogle Scholar
  21. 21.
    Jefferys, D.B.: The regulation of medical devices and the role of the Medical Devices Agency. Br. J. Clin. Pharmacol. 52, 229–235 (2001)CrossRefPubMedGoogle Scholar
  22. 22.
    Kramer, A., Kremer, J., Assadian, O., et al.: The classification of antiseptic products to be administered to wounds – another borderline case between medicinal products and medical devices? Int. J. Clin. Pharmacol. Therap. 44, 677–692 (2006)Google Scholar
  23. 23.
    Lachout, P.: Comparative study on borderline products and borderline situations. In: CECP, Committee of Experts on Cosmetic Products (2006) Council of Europe PublishingGoogle Scholar
  24. 24.
    Li Bassi, L., Bertelle, V., Garattini, S.: European regulatory policies on medicines and public health needs. Eur. J. Public Health 13, 246–251 (2003)CrossRefPubMedGoogle Scholar
  25. 25.
    Loden, M., Ungerth, L., Serup, J.: Changes in European legislation make it timely to introduce a transparent market surveillance system for cosmetics. Acta Dermato-Venerologica 87, 485–492 (2007)CrossRefGoogle Scholar
  26. 26.
    Medicinal Products Act of 2. March 1983 on the production and marketing of medicinal products, BGBI. No. 185/1983 in the version in BGBI. No. 748/1988, BGBI. No. 107/1994Google Scholar
  27. 27.
    Pauwels, M., Rogiers, V.: EU legislations affecting safety data availability of cosmetic ingredients. Regul. Toxicol. Pharmacol. 49, 308–315 (2007)CrossRefPubMedGoogle Scholar
  28. 28.
    Permanand, G., Mossialos, E., McKee, M.: Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance. Clin. Med. 6, 87–90 (2006)PubMedGoogle Scholar
  29. 29.
    Pignatti, F., Boone, H., Moulon, I.: Overview of the European regulatory approval system. J. Ambul. Care Manage. 27, 89–97 (2004)PubMedGoogle Scholar
  30. 30.
    Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January 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, OJ L031Google Scholar
  31. 31.
    Richardson, D.: Risk management of vitamins and minerals: a risk categorization model for the setting of maximum levels in food supplements and fortified foods. Food. Sci. Technol. Bull. Funct. Foods. 4, 51–66 (2007)CrossRefGoogle Scholar

Copyright information

© Springer Berlin Heidelberg 2010

Authors and Affiliations

  1. 1.HK ConsultingBaselSwitzerland
  2. 2.Global Regulatory AffairsBayer Consumer Care AGBaselSwitzerland

Personalised recommendations