Department of Health Sciences, VU University Amsterdam, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands.
Benef Microbes. 2012 Jun 1;3(2):85-9. doi: 10.3920/BM2012.0008.
Probiotics are microbes that are claimed to promote health and well-being when added to foods. However, the European Food Safety Authority (EFSA) has so far advised negatively about health claims for probiotics. Companies and scientists have protested against these rejections, sometimes in vigorous language. I argue that EFSA could not have acted differently, given EU regulations and the lack of convincing evidence for some of the claimed effects of probiotics on human health and well-being. One EU regulation that makes it hard to demonstrate the benefits of probiotics is the prohibition of medical claims, i.e. claims that a food prevents or cures a disease. If this prohibition did not exist, manufacturers of nutritional treatments might circumvent the costly procedures required for drugs, and market their products to ill people without thorough proof that they are effective and safe. However, the prohibition is also a legal fiction, because promotion of health and prevention of disease is largely the same thing. EFSA has recently indicated that it will allow health claims based on the ability of probiotics to reduce infections. To a certain extent, this abolishes the distinction between health claims and medical claims. It remains to be seen if probiotics producers can convince EFSA that their products prevent or cure infections and other diseases in humans.
益生菌是被声称在添加到食品中时可以促进健康和福祉的微生物。然而，到目前为止，欧洲食品安全局（EFSA）对益生菌的健康声称持否定态度。公司和科学家对此提出了抗议，有时甚至言辞激烈。我认为，考虑到欧盟的法规以及益生菌对人类健康和福祉的一些声称的影响缺乏令人信服的证据，EFSA 不可能采取不同的行动。使益生菌的益处难以证明的欧盟法规之一是禁止医疗声明，即声称一种食品可以预防或治疗疾病。如果不存在这种禁令，营养治疗的制造商可能会规避药品所需的昂贵程序，并在没有充分证据证明其有效和安全的情况下向患病者推销其产品。然而，这种禁令也是一种法律虚构，因为促进健康和预防疾病在很大程度上是一回事。EFSA 最近表示，它将允许基于益生菌减少感染能力的健康声称。在一定程度上，这取消了健康声称和医疗声称之间的区别。益生菌生产商能否说服 EFSA 相信他们的产品可以预防或治疗人类的感染和其他疾病，还有待观察。
