Quality Aspects in the Production of Herbal Extracts

While in Europe products containing herbal extracts as active ingredients are generally handled under the pharmaceutical law and require a marketing authorization, it seems that so-called Botanicals are handled less strictly in the United States and other countries, where Botanicals are marketed as food supplements. In 2007, the U.S. FDA published the current Good Manufacturing Practice (cGMP) for manufacturing dietary supplements in addition to the Dietary Supplement Health and Education Act of 1994 (DSHEA) [1]. Currently, Europe's Food Safety Authority (EFSA) is evaluating for food and for supplements submissions for health claims with the intention to legalize claims for risk reduction and for reduction of disease risk [2]. Furthermore the Council of Europe and the European Federation of Associations of Health Product Manufacturers made proposals for quality guides for plant based food supplements [3,4]. Both the U.S. and E.U. approaches to handle products containing herbal ingredients have proven their suitability but still attitudes to Botanicals are in motion. Taken together, though the approaches on how to deal with food supplements containing herbal ingredients in the United States and in Europe seem to converge, the question about the future position of Botanicals arises. This talk will shed light on different producer related aspects of quality as this debate will consequently also affect GMP for the manufacturer of herbal extracts. References: [1] U.S. Food and Drug Administration: Fact Sheet on FDA's Strategy for Dietary Supplements. [2] Regulation (EC) No 1924/2006 on nutrition and health claims made on food. [3] Council of Europe: Guideline on the Quality, Safety and Marketing of Plant-Based Food Supplements, 24.06.2005. [4] European Federation of Associations of Health Product Manufacturers: Quality guide for food supplements, Nov. 2007.