Regulatory issues relating to herbal products - Part 1: Legislation in the European Union, North America, and Australia

J. S. Forte, Amala Soumyanath

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

The increased public awareness about herbal products has led to a growth of the botanicals market and attracted the interest of the pharmaceutical industry. The laws that regulate the sale of manufactured herbal products differ between regions and countries of the Western world. The European Union favors the classification of the remedies as medicinal products. However, differences in the interpretation of European law by the Member States have meant that herbal products have been assigned to various sale categories across the European market. The European Agency for the Evaluation of Medicinal Products is working to introduce changes to achieve harmonization within the market. Canada and Australia have embarked on similar reforms to improve product regulation without imposing undue restrictions on marketing. In these countries, herbal products have been assigned a status that respects their therapeutic role. Changes introduced in the United States of America in 1994 led to a deregulation of the market with herbal products being classified as dietary supplements and excluded from the stricter regulatory requirements applicable to drugs and foods. However, a United States Presidential Commission has advised that a study is needed regarding an alternative system for botanical products that are not used solely as dietary supplements but that cannot meet the requirements applicable for conventional over-the-counter drugs.

Original languageEnglish (US)
Pages (from-to)23-39
Number of pages17
JournalJournal of Medicinal Food
Volume3
Issue number1
StatePublished - 2000
Externally publishedYes

Fingerprint

European Union
Dietary Supplements
North America
Legislation
laws and regulations
markets
Nonprescription Drugs
Western World
sales
dietary supplements
government deregulation
Drug Industry
Marketing
Canada
drugs
Food
marketing
Growth
Pharmaceutical Preparations
therapeutics

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Food Science

Cite this

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