Canada Natural Health Product (NHP) Labelling Revision Update for Products Containing Green Tea Extract (GTE)

Canada Natural Health Product (NHP) Labelling Revision Update for Products Containing Green Tea Extract (GTE)

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.

0/5 (0 Reviews)

Looking for Regulatory Compliance Help?

Whether you seek compliance with the latest regulations or need further information, connect with an experienced FDA / Heath Canada compliance consultant today.

Kindly complete our inquiry form to book your FREE consultation session, ensuring seamless adaptation and avoiding potential regulatory hurdles.

30 Minute Free Consultation

About the author

Andrew Parshad
Andrew Parshad
Andrew Parshad is President, CEO and founder of Quality Smart Solutions, a North American compliance solutions provider offering regulatory and quality assurance services to comply with FDA & Health Canada brands and ingredients regulations in the categories of dietary supplements, foods, cosmetics, OTC drugs and medical devices. Andrew started Quality Smart Solutions in 2007. Since that time he and his firm has served thousands of clients worldwide . Andrew's affiliate company, Quality IMPORT Solutions that offers import agent services into the Canadian market as a government licensed importer for foods, dietary supplements and medical devices.


Don't miss updates from Health Canada and FDA.

If you are looking for the latest regulatory updates or want the newest regulatory requirements guides, please leave your email and we'll keep you posted.

This website uses cookies to provide necessary site functionality and improve your online experience. By using this website, you agree to the use of cookies as outlined in Quality Smart Solutions's online privacy statement.