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绿茶在美国引发一场长达九年的“官司”——关于“Qualified Health Claims”的翻译
2016-06-01 17:39:50  

全世界的人都希望选择“健康的食品,但不是每个人都懂得健康的常识,况且这需要太多的专业知识。因此,食品标签作为传达健康知识的一个媒介,至关重要。1990年,美国开始实施《营养标签和教育法案(NLEA)》,规定食品标签上必需标注出主要营养成分的含量。此外,食品厂家还可以对特定食品做一些健康声明(health claim。比如,某一种食品可以宣称降低某疾病的发生风险,但必须向FDA(美国食品药品管理局)提出申请,得到FDA的批准后才可以使用。但FDA一般都是不予以明确批准的,即使食品企业及相关行业有大量的科学研究数据,足以证明某种食品的健康功效,FDA也会以各种理由加以限制,行使其自由裁量权,搞一套免责声明。拿绿茶为例,2004年有一家美国茶业公司向FDA提出申请,请求FDA批准可以在绿茶标签上标注降低前列腺炎、乳腺癌的风险的文字描述。没想到FDA异常强硬,并向该企业发出Warning Letter(警告函),威胁要对该企业采取强制性措施。为此,该企业与FDA进行了长达9年的旷日持久之争,并诉诸法律,最后,在法庭的裁定下,FDA不得不作出让步!

事情的经过是这样的:2004年,一家美国茶业公司向FDA提出了关于绿茶的健康声明:Health Claim Petition: Green Tea and Reduced Risk of Cancer Health Claim (Docket No. FDA-2004-Q-0427),要求FDA予以批准。

然而,FDA在评审后,答复如下:

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We urge you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 §§ U.S.C. 332 and 334]. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.

用中国话概括地说,这段英文就是勒令企业整改,而且必须在规定的时间内完成,否则,FDA将实行强制措施,恕不另行通知!

接下来,这家茶企走上了九年之久的维权之路,经历了一轮又一轮的抗争。FDA凭借公权的优势,一轮又一轮地行使着强制执法自由裁量特权,请看:

·Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer.

·One weak and limited study does not show that drinking green tea reduces the risk of prostate cancer, but another weak and limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of prostate cancer.

简而言之,FDA的意思是,尽管你企业有科学依据证明绿茶有抗癌防癌的功效,但FDA认为证据不足。所以,如果企业要在标签上标注绿茶的功效,只能按FDA的上述文字书写。

 

可想而知,企业当然不服,于是请求重审,FDA的批复如下:

·Drinking green tea equivalent to that consumed by Asian Americans may reduce the risk of breast cancer in women. There is credible evidence supporting this claim although the evidence is limited.

·Drinking green tea equivalent to that consumed by the residents living in Hangzhou, China may reduce the risk of prostate cancer. There is credible evidence supporting this claim although the evidence is limited.

FDA的这一轮评判大意是:绿茶饮用量达到亚裔美国人以及中国杭州人的标准,可降低乳腺癌和前列腺癌的风险。有可靠的证据支持此健康声明,尽管证据有限。

看完上面FDA的评述,顿生一疑问:亚裔美国人到底每天的绿茶饮用量是多少?中国杭州的民众每天喝多少绿茶?不知道FDA是有数据的自由裁量,还是随口说说?我向杭州的一位销售茶的朋友打听了一下,他说大概是每日15克左右。至于亚裔美国人每天的绿茶饮用量,则要问问FDA才晓得。

2012223,美国康涅狄格州地方法院作出“备忘录判决书”,FDA不得不再次对绿茶的有关健康声明书作出如下修订:

·Green tea may reduce the risk of breast or prostate cancer although the FDA has concluded that there is very little scientific evidence for this claim.(中译文:尽管FDA认定科学证据有限,但绿茶可以降低乳腺癌或前列腺癌的风险。)

·Green tea may reduce the risk of breast or prostate cancer. FDA has concluded that there is very little scientific evidence for this claim.(中译文:绿茶可以降低乳腺癌或前列腺癌的风险,但FDA认定该声明的科学证据有限。)

历时九年,美国的有关茶企终于获得了美国FDA这一纸宣称绿茶可以降低乳腺癌或前列腺癌风险的核准书。

在核准的最后,FDA不忘附上几句官方说辞:

Please note that scientific information is subject to change, as are consumer consumption patterns. FDA intends to evaluate new information that becomes available to determine whether it necessitates a change in the agency’s consideration of enforcement discretion. For example, scientific evidence may become available that will support significant scientific agreement, that will support a qualified health claim for the claims that have been denied, that will no longer support the use of the above qualified health claims, or that raises safety concerns about the substance that is the subject of the claim.

中文大意是:请注意,科学信息随消费者消费模式变化而变化。FDA将根据新的信息决定是否有必要对本机构行使自由裁量权之考量作出改变。例如,将有科学证据支持有效科学共识;将有科学证据支持被否认的该声明之核准健康声明;将有科学证据不支持使用上述核准健康声明;或,将有科学证据对声明之标的物之安全性表示担忧等。

再回到如何翻译“qualified health claim的问题上来,国内有人将其翻译为合格健康声称合格健康声明有限健康声明等,其实,只要稍加了解FDA是个什么机构,就不难理解qualified health claim应是经过FDA审核并批准使用于绿茶标签上的食品健康声明而已,用中文核准健康声明,或核定健康声明”表达,更合乎其原意,也更明了。

(注:对于食品、药品、保健品及膳食添加物等的出口企业而言,应特别了解和弄清楚相关国家的有规定,如需了解,欢迎咨询:深圳雅健翻译有限公司。电邮:smartransn@126.com 电话:0755-29344461 QQ963242732

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