食品伙伴網(wǎng)報(bào)道，據(jù)美國營養(yǎng)成分網(wǎng)8月19日消息，國際益生菌協(xié)會(huì)（IPA）稱：美國食品藥品管理局已經(jīng)確認(rèn)將接受益生菌專著，并可在此基礎(chǔ)上發(fā)布一個(gè)合格的健康聲明。
 

國際益生菌協(xié)會(huì)(IPA)曾致力于為加拿大衛(wèi)生部建立益生菌專著，包括16株菌株和4篇已于2009年2月被加拿大出版的已獲許可的一般聲稱。而IPA向FDA遞交的專著將以此為基礎(chǔ)，并且可能在2011年遞交。

該協(xié)會(huì)稱，他們希望在明年可以有一個(gè)專著提交給FDA，他們已經(jīng)有了規(guī)劃：

• 建立益生菌測(cè)試標(biāo)準(zhǔn)
• 建立臨床試驗(yàn)條款
• 改進(jìn)便于消費(fèi)者操作的益生菌信息網(wǎng)站，并于2011年第一季度投入使用。

食品伙伴網(wǎng)編輯注：據(jù)美國營養(yǎng)成分網(wǎng)2009年2月對(duì)加拿大建立益生菌專著這一事件的相關(guān)報(bào)道看，有專家對(duì)此事提出過質(zhì)疑。因?yàn)橐嫔a(chǎn)品除了具有良好的基因型菌株以外，還需要有活菌數(shù)的標(biāo)注，并且保證在保質(zhì)期內(nèi)的活菌數(shù)量等等數(shù)據(jù)。

原文報(bào)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 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：http://www.nutraingredients-usa.com/Regulation/FDA-open-to-probiotics-monograph-says-IPA