Losing Digestive Enzyme in Canada?

There is a good chance we might be without Digestive enzymes in Canada in the very near future. Most companies have had a 90 day notice to change information, even if they already have an NPN.

This is yesterdays Beep from NHP. Anyone can sign up to get these Beeps. There is an another interesting one on Pro-biotics that could also be of concern. I am including it as the NHP link to it is now not working.

I will also post the PDF from their consultant Dr. George Tardik ND (Toronto) that has advised the use of Digestive enzymes not more that 3 days in length. It make interesting reading from a Naturopath, who graduated from Canadian College of Naturopathic Medicine in Toronto, 2.5 years ago. His web site is: http://digestivehealth.ca/

This bring up several concerns.

1. Digestive enzymes are the cornerstone of many traditional programs around the world. What will we do without them?

2. They are saying that they can take away NPN, once they have already given them, on just one man’s opinion. Not referring it to PAC.

3. These enzymes have been used successfully for over 150 years in North America without any problems. This is clearly beyond their 50 year mandate.

4. Some of the products questioned have been on the market with either DIN and NPN for more than 30 years

Not to go on and on, I have posted the starting point below. We will be looking into this more in future blogs. Here is the information.

From Beep Sept 14, 2011

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

This email is being provided for information purposes only.  Please do not respond to this email as it will not be answered.

You are receiving this email because you subscribed to the NHPD Electronic Subscriber Service. To unsubscribe please visit: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/list/index-eng.php

———————————————————————-

Ce message vous est transmis à titre d’information seulement. SVP ne pas répondre à ce courriel puisqu’aucune réponse ne vous sera envoyée.Vous avez reçu ce courriel parce que vous vous étiez abonné au Service d’abonnement électronique de la DPSN.  Pour vous désabonner, veuillez suivre ce lien:  http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/list/index-fra.php 

[Le texte français suit] 

September 14, 2011 

RE: Enzymes 

Dear Stakeholders, 

As communicated on December 14, 2009 via the Natural Health Product Directorate (NHPD) email distribution list (BEEP), the NHPD has been working to establish reasonable and scientifically-based criteria for enzymes against which product licence applications (PLAs) can be assessed given the gaps in safety, and efficacy evidence for use in humans in the scientific literature.  The NHPD consulted with an independent health care practitioner (practising naturopathic doctor) to obtain advice on the clinical use of enzymes in order to facilitate the development of pre-cleared information (PCI) such as Abbreviated Labelling Standards (AbLS). The NHPD has received the consultant’s final report regarding the use of enzymes in natural health products and the document is attached for your reference. In addition to the external consultation, NHPD completed a review of the scientific literature for enzymes to determine the risk and benefits associated with their use. 

A review of the totality of evidence did not provide conclusive evidence of the safety for the long term use of enzymes.  Overall, the risk associated with the lack of safety data for enzymes outweighs the therapeutic benefits for their use in natural health products. Consequently, enzymes may not be safe when used under the existing recommended conditions of use outlined on product licences and Product Licence Applications (PLA) (i.e. – long term use). Additionally, it has been determined that there is a lack of efficacy data to support certain enzymes.   

Publication of new Abbreviated Labelling Standards (AbLS) for Enzymes 

Based on the recommendations of the independent consultation and the literature review, the NHPD has developed PCI in the form of AbLS for the following enzymes. 

The AbLS are available in the Natural Health Products Ingredients Database at the following link:   http://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do

  • Pancreatic Enzymes
  • Stem Bromelain
  • Fruit Bromelain
  • Papain
  • Fungal Proteases
  • Amylase
  • Lipase
  • Cellulase
  • alpha-Galactosidase
  • Trypsin
  • Chymotrypsin

The conclusions of the attached consultant’s final report indicate that clinical use of enzymes is generally limited to occasional use unless being used for a specific medical condition.  It has been established that the long-term safety of most enzymes in oral form for digestive purposes is not supported based on the concern that the chronic use of digestive enzymes may decrease natural enzyme production.

Based on a review of the totality of evidence, NHPD has determined that products containing any of the above-mentioned enzymes will require a maximum duration of use of 3 days unless specified otherwise. For certain specific claims, a longer duration of use may be permitted, as specified in the AbLS.  The AbLS for Lactase, published in October 2009 and available at the following link http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id=196&lang=eng, is an exception and does not require a duration of use statement when Lactase is being used to assist in the digestion of lactose-containing foods or to help prevent the symptoms of lactose intolerance.  Otherwise, the duration of use of 3 days will also apply to products containing Lactase.

How should companies comply with newly developed evidence criteria for products containing enzymes?

Licensees and applicants with enzyme-containing products will be provided with an opportunity to either submit safety and/or efficacy information or to make appropriate product changes in order to comply with the pre-cleared information available for enzymes.  The NHPD will be contacting licensees and applicants very shortly, providing detailed instructions on how to proceed.

Respectfully

The Natural Health Products Directorate

Health Canada

PDF of Dr. George Tardik’s report

 

Consultant’s Final Report_Enzymes

 

 

 

 

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