Health claim regulation of probiotics in the USA and the EU: is there a middle way?
Health claim regulation of probiotics in the USA and the EU: is there a middle way?
复制标题
美国和欧盟对益生菌健康声称的监管：有中间道路吗？
DOI：
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发表时间：
2013
影响因子：
5.4
通讯作者：
Diane E. Hoffmann
中科院分区：
文献类型：
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作者：
Diane E. Hoffmann
在美国和欧洲，超市和药房都充满了益生菌 - 含有活体生物的产品，声称它们可以改善健康。这些产品的可用性对应于消费者对改善或维持健康和健康的食品的需求不断增长。最有说服力的说法包括消费可能赋予健康益处。尽管其中一些主张可能具有优点，但尚未得到证实。对于许多产品，索赔是基于研究不足，能力不足的研究或混合研究结果，但个人消费者发现该产品对其有益。在试图规范健康主张的情况下，与安全不同，政府实体可能会采取代表哲学范围对面的立场。在频谱的一端，他们可能采取有限的法规方法，主要依赖于尊重个人自主权的市场，并承担成熟的消费者和诚实的卖家；另外，他们可能会基于一种信念，即消费者需要保护免受寻求利润的制造商。美国和欧盟在此监管范围上采取了两种不同的方法。
In both the USA and Europe, supermarkets and pharmacies are brimming with probiotics - products containing live micro-organisms claiming they improve health. The availability of these products corresponds to a growing consumer demand for foods that improve or maintain health and wellness. The most persuasive include claims that consumption may confer health benefits. While some of these claims may have merit, others have not been substantiated. For a number of products, claims are based on insufficient research, underpowered studies, or mixed research results, yet individual consumers find that the product is of benefit to them. In attempting to regulate health claims, as distinct from safety, government entities may take positions which represent opposite ends of a philosophical spectrum. On one end of the spectrum they may take a limited approach to regulation relying primarily on the marketplace that respects individual autonomy and assumes a sophisticated consumer and honest sellers; alternatively they may choose substantial regulation based on a belief that consumers need protection from profit-seeking manufacturers. The USA and the European Union have taken two different approaches on this regulatory spectrum.