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Many Americans, not completely satisfied with traditional western medicine, have turned to alternative and complementary medicine which explains the increasing popularity of the herbal products and the Chinese herbal medicine. The lack of government regulations and the increasing advertisements by the manufactures have created an impression to the common public that the natural herbal remedies are inherently safer and cheaper than conventional medicine. The skyrocketing rise of healthcare cost and the adverse reaction and side effects incurred from the prescribed drugs have both reinforced such an impression. Herbs in the USA and in many European countries have been prepared as capsules, tablets, teas, lozenges, juice extracts, tincture, and ointments. Most of the herbs are administered as a single herb in the USA and Europe. However, the traditional Chinese herbal medicine contains multiple active ingredients from various herbs and is prepared as concoctions by simmering them for hours to produce pharma-therapeutic properties useful for the treatment of a particular disease. Those prepared concoctions are taken gingerly with specific treatment purposes. In the USA and some European counties, herbs are distributed and labeled as dietary supplements and are taken by many individuals for a long period of time creating some medical and dental complex problems among them, especially in terms of anesthesia-surgery complications. This paper provides insight into basic differences in how herbs are prepared before administration to the patients in China versus a single unprepared herb sold in the USA and Europe. Also addressed are the interdisciplinary issues with health professionals, the proper regulations for better quality control of imported herbs, and the proper warning on the labels of the herbs. [ABSTRACT FROM AUTHOR]

Botanicals are among the fastest growing segments of the dietary supplement industry in the U.S. The Dietary Supplement Health and Education Act (DSHEA; Public Law 103-417 [Oct. 25, 1994]) provided a regulatory classification for the trade of numerous botanicals and botanically-derived products as dietary supplements. The global supply chain, the adoption of many botanicals that are also recognized as traditional medicines around the world as dietary supplement ingredients, and the differing recognition of the national and international pharmacopeias as sources for voluntary or mandatory quality standards present challenges in ensuring the quality of the ingredients and products. The complexity of quality assurance by compliance with pharmacopeial standards is illustrated in this article with a brief history of pharmacopoeias including their official recognition in national laws, their approaches to the science behind the standards, the use of reference standards for quality assessment and regulatory compliance, the use of pharmacopeial standards by the industry and regulators within the DSHEA framework in the United States, and a discussion of the global supply chain. Pharmacopeial standards can help regulators and the industry adapt to the new technologies that present both opportunities and challenges. [ABSTRACT FROM AUTHOR]

In 2012, USA Food and Drug Administration (FDA) approved 39 new drugs, however, there are only two botanical drugs (one topical and one oral) approved by FDA since the publication of the FDA's industry guidelines for the botanical drug product in June 2004. The approval shows the Western guideline can be used for herbal medicines, authors investigate current regulation on herbal medicine clinical research, identify challenges conducting clinical trials, and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area. Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials. Authors critically explore case study of the 1st FDA approved botanical drugs, Veregen (sinecatechins), green tea leaves extract, a topical cream for perianal and genital condyloma. In consideration of current regulation environment in USA, based on the findings and analysis through the literature review and Veregen case study, authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considering in a herbal medicine clinical trial. [ABSTRACT FROM AUTHOR]

The article discusses the regulatory scrutiny of Chinese medicine and physicians in Progressive-era California and Oregon. The author examines how the American Medical Association (AMA) and U.S. government utilized Orientalist ideology, or interest in Asian exoticism combined with a belief in Asian inferiority, when categorizing Chinese medicinal practices as "irregular" and therefore worthy of eradication. Particular focus is given to representations of Chinese herbal medicine.