国际益生菌协会：FDA将接受益生菌专著

食品伙伴网报道，�?a href='//www.sqrdapp.com/news/tag_2463.html' class='zdbq' title='美国相关食品资讯' target='_blank'>美国营养成分�?�?9日消息，国际益生菋�/a>协会（IPA）称：美国食品药�?a href='//www.sqrdapp.com/news/tag_4604.html' class='zdbq' title='管理相关食品资讯' target='_blank'>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、�br />

国际益生菌协�?IPA)曾致力于为加拿大卫生部建立益生菌专著，包�?6株菌株和4篇已�?009�?月被加拿大出版的已获许可的一般声称。而IPA吐�a href='//www.sqrdapp.com/news/tag_12.html' class='zdbq' title='FDA相关食品资讯' target='_blank'>FDA递交的专著将以此为基础，并且可能在2011年递交、�/p>

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：

• 建立益生菌测试标凅�/li>
• 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、�/li>

食品伙伴网编辑注：据美国营养成分�?009�?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、�/p>

原文报道９�/p>

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 confirmed.

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９�a href="http://www.nutraingredients-usa.com/Regulation/FDA-open-to-probiotics-monograph-says-IPA">http://www.nutraingredients-usa.com/Regulation/FDA-open-to-probiotics-monograph-says-IPA