Dear Licence Holder,
Please be advised that a Summary Safety Review (SSR) has been published by Health Canada on November 15, 2017, regarding green tea extract (GTE)-containing natural health products (NHPs). Health Canada will also be publishing an Information Update (IU) to inform Canadians about GTE-containing health products and the potential risk of liver injury (hepatotoxicity). Additionally, a Health Product Risk Communication (HPRC) will be sent to healthcare professionals to inform them about this safety risk. These documents will also be available in Health Canada’s Recalls and Safety Alerts database, which can be accessed at: http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php.
The Marketed Health Products Directorate (MHPD) has recently completed a safety review of GTE to determine whether the appropriate level of risk mitigation is currently in place for GTE-containing products or if any further risk mitigation measures are warranted. The safety review has concluded that there may be a link between the use of green tea extract and a risk of rare and unpredictable liver injury. While this risk is already identified in Health Canada’s Green Tea Extracts monograph, Health Canada’s review found that cases of liver injury continue to be reported in Canada and worldwide, and that Canadian safety information could be stronger.
As a result, the Natural and Non-prescription Health Products Directorate (NNHPD) will be posting the updated product monograph for Green Tea Extracts (attached) to strengthen warnings concerning this rare but potentially serious risk. NNHPD is requesting changes to licences and labels for all products containing GTE as a medicinal ingredient, and is no longer permitting GTE as a medicinal ingredient in products which are intended for children and adolescents. In addition to specifying a subpopulation of 18 years of age or older, the updated GTE monograph will specify the following risk information:
Enhancement of the current cautionary risk statement to the following:
Addition of the following risk information:
For products containing GTE as a MI:
You are requested to confirm the market status of your impacted product(s) and quantity of epigallocatechin gallate (EGCG) in them, as well as revise your product licence(s) and associated label(s) to comply with the above-listed revisions. As a means of facilitating these revisions, the NNHPD has developed a GTE Amendment Attestation form (attached) to be submitted for each product containing GTE as a MI. This attestation form must be signed by the Senior Official of the company holding the licence and returned to the NNHPD. Following receipt of the the signed attestation, the NNHPD will update the risk information of the product licence according to the monograph revisions. Applicants signing the GTE Amendment Attestation form are attesting that they will update their product labels to include the revised risk information by November 14, 2018. By signing this attestation form, the applicant is confirming awareness that operating outside of the attestation may result in compliance and enforcement action. If the attestation is not received by the NNHPD within the prescribed timeframe, further action may be initiated, which may include the issuance of a Section 16 notice as per the Natural Health Products Regulations (NHPR).
Please submit your GTE Amendment Attestation form for each impacted product using the subject “Green Tea Extract – label revisions” by November 14, 2018. Please include the natural product number (NPN), the file number and the company code on your correspondence.
For products containing GTE as a NMI:
You are requested to confirm the quantity of GTE per dosage unit in all of your products that contain this NMI. To facilitate the submission of this information, it is recommended that the quantities of GTE be submitted in the following format:
|Product Brand Name||NPN||File Number||Quantity of GTE/dosage unit||Market status of product|
|Product XYZ||12345678||654321||2 mg/tablet||Marketed in Canada|
Receipt of Responses:
Please note that given the large volume of impacted products, the processing of your attestation (for products containing GTE as a MI) will not be subject to regular performance standards. In order to facilitate timely processing of attestations, please notify the NNHPD prior to submitting a large volume of responses (i.e. 20 or more impacted products). The NNHPD will work with you to develop a plan for submitting these attestations, to action them in a timely manner.
Please also note that if some or all of your products are or will no longer be marketed in Canada, you are asked to submit your request to discontinue these product licences immediately.
dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries.