Pro-biotic changes according to NHP

I have been asked to send the Beep for the probiotic and how it effect us.

It will not take all probiotic off the market, just approve a few strains. This is of great concern to some and will take many available product off the market.We have to voice our opinions with NHP. Look at the new monograph.

http://bit.ly/oZQgny

From:      BPRA_Message_BEEP <BPRA_Message_BEEP@hc-sc.gc.ca>

Subject: Message to NHPD Stakeholders regarding products containing Probiotics/Message à l’intention des intervenants de la DPSN au sujet des produits contenant des probiotiques

Date: September 14, 2011 7:53:33 AM MDT

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 http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/list/index-fra.php 

[Le texte français suit] 

September 14, 2011 

RE: Probiotics 

Dear Stakeholders, 

Since January 1, 2004, the Natural Health Products Directorate (NHPD) has received product licence applications for probiotic natural health products with general and/or specific health claims. In April 2009, the NHPD published a Probiotics Monograph outlining the minimum documentation requirements and specifications for probiotic products. 

Several information gaps were recently identified while reviewing evidence submitted for probiotic products that did not meet the monograph. As a result, the NHPD recognizes the need for clearer guidance regarding documentation requirements and for the use of the term “probiotic” for both compendial and non-compendial applications. 

The gaps in the information noted by the NHPD include: 

-        lack of strain specific evidence supporting safety and efficacy of the product 
-        scientific gaps related to efficacy in healthy populations 
-        documentation of product stability 
-        documentation of strain identity 
-        documentation of the absence of transferrable antibiotic resistance 

In an effort to address the above and to clarify the evidence requirements for these products, the NHPD has revised the Probiotics Monograph and has published an Abbreviated Labelling Standard (AbLS) for Live Microorganisms. This monograph and AbLS will act as guides for industry in the preparation of Product Licence Applications (PLAs) and to facilitate revisions to Product Licences. However, the option of providing additional evidence to support the safety and efficacy outside the scope of these documents is always available. 

The revised Probiotics Monograph and Live Microorganisms AbLS can be found in the Product Monographs section of the Natural Health Products Ingredients Database at the following link:   http://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do

Revision to Probiotics Monograph 

The Monograph has been revised to only include strains of bacteria and yeast for which specific health claims have been supported by strain specific evidence. In addition, the general claims listed on the Monograph will only be allowed as a supplement to the specific claims.  Effective immediately, to obtain market authorization for general probiotic claims, applicants may submit a non-compendial application including strain specific evidence for safety and efficacy.

Publication of Abbreviated Labelling Standard (AbLS) for Live Microorganisms 

An Abbreviated Labelling Standard (AbLS) for Live Microorganisms has been developed that supports the claim “temporarily modifies gut flora”. The use of the word “probiotic” will not be supported by the AbLS for Live Microorganisms. In order to maintain or obtain a product licence, applicants who do not have strain specific evidence for their product may submit a new or revised application that is in accordance with the AbLS, if applicable.

How should companies comply with these changes for products containing probiotics? 

Licensees and applicants with probiotic-containing products that fall outside the parameters of the revised monograph will be provided with an opportunity to supplement their application with the required testing and strain specific evidence of efficacy to support the claims being made, or make the necessary revisions to be in line with the AbLS for Live Microorganisms if applicable. The NHPD will be contacting licensees and applicants very shortly, providing detailed instructions on how to proceed.

What do the above changes mean for food products currently carrying one of the accepted claims about the nature of probiotics? 

In consultation with the Canadian Food Inspection Agency and industry stakeholders, the Food Directorate will be reviewing the guidance on accepted claims about the nature of probiotic microorganisms in food. The long term goal is to move toward specific probiotic claims on food based on strain-specific evidence, as described in the Guidance Document – The Use of Probiotic Microorganisms in Food http://hc-sc.gc.ca/fn-an/legislation/guide-ld/probiotics_guidance-orientation_probiotiques-eng.php). Food manufacturers and importers affected by this move will be given a reasonable transition period to comply with these changes. 

The Natural Health Products Direc

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