On November 14, 2017 the Natural and Non-prescription Health Products Directorate (NNHPD) announced that there are several updates to the NHP Monograph for Green Tea Extract based on reports from Canada and worldwide that there may be a link, albeit the risk is rare, of the use between green tea extract and risk of a rare and unpredictable liver injury. The risk statement is already required with products falling within the scope of the current Green Tea Extract monograph. The updated monograph will elaborate on these warnings and risk statements. As well, the subpopulation of children and adolescents will be excluded from the monograph and will be restricted to adults 18 years and older.
The following changes to and additional risk statements will be required (with new verbiage in bold):
- “If you have a liver disorder, consult a healthcare practitioner prior to use. Stop use if you develop symptoms of liver trouble such as yellowing of the skin/eyes (jaundice), stomach pain, dark urine, sweating, nausea, unusual tiredness and/or loss of appetite and consult a healthcare practitioner”
- “Rare, unpredictable cases of liver injury associated with green tea extract-containing products have been reported (in Canada and internationally)”
Products that contain Green Tea Extract as a non-medicinal ingredient are required to report the amount of EGCG in the green tea and required to add the above stated risk statements.
As Health Canada must be notified stating companies containing GTE either as medicinal or non-medicinal ingredient the dates are as follows:
GTE as a non-medicinal ingredient and quantity of EGCG – December 14, 2017
GTE as a medicinal ingredient attestation – November 14, 2018
If you have a NPN licensed product containing Green Tea extract either as a medicinal ingredient or non-medicinal ingredient please contact Quality Smart Solutions today to assist you in notifying Health Canada about this important label update.