Rousseaux Colin G, Schachter Howard
Department of Cellular and Molecular Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Birth Defects Res B Dev Reprod Toxicol. 2003 Dec;68(6):505-10. doi: 10.1002/bdrb.10053.
Herbal remedies and alternative medicines are used throughout the world, and in the past herbs were often the original sources of most drugs. Today we are witnessing an increase in herbal remedy use throughout the Western world raising the question as to how safe are these preparations for the unborn fetus? Many women use herbal products during pregnancy. The dilemma facing most regulatory authorities is that the public considers these products as either traditional medicines or natural food supplements. The user sees no reason for regulation. Most countries have laws concerning foods, drugs, and cosmetics, the details of which seldom clearly define to what section of the law and regulations alternative remedies belong. In most countries alternative remedies are regulated as foods, provided that no medicinal claim is made on the label. The global regulatory sector, however, is changing rapidly. The Therapeutic Goods Administration (TGA) in Australia created a Complimentary Medicines Evaluation Committee in late 1997 to address this issue, and Canada has created a new Natural Health Products Directorate in the realigned Therapeutic Products and Foods Branch in 2000. In parallel, the European Agency for the Evaluation of Medicinal Products has drafted test procedures and acceptance criteria for herbal drug preparations and herbal medicinal products. In the US, the Food and Drug Administration classifies these natural products as dietary supplements. Manufacturers must label a dietary supplement thus: "this statement has not been evaluated by the FDA [, and] this product is not intended to diagnose, treat, cure or prevent any disease." Whether these products are foods or drugs is undecided. To add complexity to this issue, most of the potential deleterious effects of natural products on the unborn may be related to hormonal effects (e.g., phytoestrogens) and nutriceutical drug interactions (e.g., St. John's Wort and antidepressants), rather than direct embryotoxicity per se. We suggest that ensuring quality of herbal products should receive immediate attention by regulatory authorities, before embarking on the more arduous tasks of safety and efficacy.
草药疗法和替代药物在世界各地都有使用，过去草药常常是大多数药物的最初来源。如今，我们看到整个西方世界使用草药疗法的情况在增加，这就引发了一个问题：这些制剂对未出生的胎儿有多安全？许多女性在怀孕期间使用草药产品。大多数监管机构面临的困境是，公众将这些产品视为传统药物或天然食品补充剂。使用者认为没有监管的必要。大多数国家都有关于食品、药品和化妆品的法律，但其细节很少能明确界定替代疗法属于法律法规的哪一部分。在大多数国家，只要标签上没有药用声明，替代疗法就作为食品进行监管。然而，全球监管领域正在迅速变化。澳大利亚治疗用品管理局（TGA）在1997年末设立了一个补充药物评估委员会来处理这个问题，加拿大在2000年对治疗产品和食品部门进行重新调整后设立了一个新的天然健康产品管理局。与此同时，欧洲药品评估局已经起草了草药制剂和草药药品的测试程序及验收标准。在美国，食品药品监督管理局将这些天然产品归类为膳食补充剂。制造商必须这样给膳食补充剂贴标签：“本声明未经FDA评估，本产品无意用于诊断、治疗、治愈或预防任何疾病。”这些产品是食品还是药品尚无定论。使这个问题更加复杂的是，天然产品对未出生胎儿的大多数潜在有害影响可能与激素作用（如植物雌激素）和营养药物相互作用（如圣约翰草与抗抑郁药）有关，而不是直接的胚胎毒性本身。我们建议，在着手进行更艰巨的安全性和有效性任务之前，监管机构应立即关注确保草药产品的质量。
