我们报道，据美国营养成分网8月19日消息，国际益生菌协会（IPA）称：美国食品药品管理局已经确认将接受益生菌专著，并可在此基础上发布一个合格的健康声明。
国际益生菌协会(IPA)曾致力于为加拿大卫生部建立益生菌专著，包括16株菌株和4篇已于2009年2月被加拿大出版的已获许可的一般声称。而IPA向FDA递交的专著将以此为基础，并且可能在2011年递交。
该协会称，他们希望在明年可以有一个专著提交给FDA，他们已经有了规划：
- 建立益生菌测试标准
- 建立临床试验条款
- 改进便于消费者操作的益生菌信息网站，并于2011年第一季度投入使用。
我们编辑注：据美国营养成分网2009年2月对加拿大建立益生菌专著这一事件的相关报道看，有专家对此事提出过质疑。因为益生菌产品除了具有良好的基因型菌株以外，还需要有活菌数的标注，并且保证在保质期内的活菌数量等等数据。
原文报道：
FDA open to probiotics monograph, says IPA
Post a commentBy Shane Starling, 19-Aug-2010
The Food and Drug Administration (FDA) has confirmed it would be receptive to a probiotics monograph that may serve as the basis of a qualified health claim, the International Probiotics Association (IPA) has /confirm/ied.
The IPA was active in establishing a monograph that included 16 strains and four approved generic claims published by Health Canada in February 2009, a dossier it said could form the basis of a submission to the FDA, probably in 2011.
IPA head of marketing committee, George Paraskevakos, said the revelation had come at a two-day probiotics conference held in June at the New York Academy of Sciences, where the FDA, Federal Trade Commission and others had given presentations.
“We spoke to the FDA’s Dan Levi and welcomed how open the agency appears to be to the idea of a probiotics monograph,” Paraskevakos told NutraIngredients-USA.com.
He said the IPA hoped a monograph could be presented to the agency next year, although it had to compete with the 10-year-old organization’s resources that were already stretched over there major initiatives:
establishing standards for probiotic testing
establishing protocols for clinical trials
a revamped consumer-friendly probiotics information website due to launch in Q1 2011
“At least with the Health Canada monograph we have the ground work in place and that should speed and simplify any submission to the FDA.”
The IPA also sent a copy of the Health Canada monograph to the New York Academy of Sciences for perusal.
原文地址：http://www.nutraingredients-usa.com/Regulation/FDA-open-to-probiotics-monograph-says-IPA
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