Legislation on Nutraceuticals and Food Supplements: A Comparison between Regulations in USA and EU

  • Roberto Giunta
  • Giovanni Basile
  • Arianna Tibuzzi
Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 698)


This chapter provides a short review of the main regulations concerning functional food and nutraceutical products set out by the US Food and Drug Administration and in the European Union by the European Commission. The directives are presented in chronological order with an overview on the reaction and feedback they received from consumers and manufacturing industry. A comparison between the US and EU regulations, their acceptance and impact on the market is presented, together with a final suggestion to enhance the future development and distribution of functional products, which belong to an equivocal area between food and drugs.


Dietary Supplement Food Supplement Functional Food European Food Safety Authority Health Claim 
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.


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  1. 1.
  2. 2.
    Larsen LL, Berry JA. The regulation of dietary supplements, J Am Acad Nurse Pract 2003; 15(9):410–414.PubMedCrossRefGoogle Scholar
  3. 3.
    Blendon RJ, DesRoches CM, Benson JM et al. Americans’ views on the use and regulation of dietary supplements, Arch Intern Med 2001; 161(6):805–810.PubMedCrossRefGoogle Scholar
  4. 4.
    AARP Public Policy Institute. Dietary supplements and older consumers. Data Digest 2001; 66:1–8.Google Scholar
  5. 5.
    72 Fed. Reg. 34752. FDA Issues Dietary Supplements Final Rule. 2007.Google Scholar
  6. 7.
    Kiely M, Flynn A, Harrington KE et al. The efficacy and safety of nutritional supplement use in a representative sample of adults in the North/South Ireland Food Consumption Survey. Public Health Nutrition 2001; 4(5a):1089–1097(9).PubMedGoogle Scholar
  7. 8.
    Knight, Sam. “Controversial EU Vitamins Ban To Go Ahead.” The Times, July 12, 2005. Europe news section, Online edition.Google Scholar
  8. 9.
    “Court Victory for Vitamin Firms.” BBC News, January 30, 2004. BBC Health section, Online edition.Google Scholar
  9. 10.
    “EU Health Foods Crackdown Wrong.” BBC News, April 5, 2005. BBC Health section, Online edition.Google Scholar
  10. 11.
    Commission reply PE 374.206 to Petition 0694/2005 by Graham Allen Green (British), on the Food Supplements Directive. May 12, 2006.Google Scholar
  11. 12.
    “Vitamin Controls Cacked by Europe.” BBC News, 2005.Google Scholar
  12. 13.
    “EU Court Backs Health Supplements Ban.” The Guardian, July 12, 2005. Society health section, Online edition.Google Scholar
  13. 14.
    Regulation (EC) No 1924/2006 of the European Parliament and of the Council of December 20, 2006 on nutrition and health claims made on foods.Google Scholar

Copyright information

© Landes Bioscience and Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Roberto Giunta
  • Giovanni Basile
  • Arianna Tibuzzi
    • 1
  1. 1.CNR-National Research CouncilIC-Crystallography InstituteMonterotondo Scalo (Roma)Italy

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