Major Monograph Changes for Green Tea Extract 

On July 25, 2025, the Natural and Non-prescription Health Products Directorate (NNHPD) released an updated monograph for Green Tea Extract. This update is part of the broader initiative that began in 2023, and it introduces several significant changes that could directly affect products containing this ingredient. 

Key Changes to the Green Tea Extract Monograph 

Common Names 

The list of acceptable common names has been reduced from five to one. Going forward, the following names can no longer be used on product labels: 

• Camellia sinensis extract 
• Tea extract 
• Thea sinensis extract 
• White tea extract 

Risk Statements 

Several important updates have been made to risk and safety statements: 

• Mandatory for all products:
  “Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking prescription medications.” 

• Required if providing more than 40 mg of caffeine per day:
  “Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have high blood pressure or glaucoma.” 

• No longer required:
  “Rare, unpredictable cases of liver injury associated with green tea extract-containing products have been reported (in Canada and internationally).” 

Weight Management Claims 

If your product includes weight management claims, additional restrictions now apply: 

• Labels must include the risk statement: “Do not use if you are pregnant.” 
• Diuretic claims are no longer permitted. 
• Green tea cannot be combined with stimulant laxatives at therapeutic doses. 
• Since weight management is considered a long-term process, the duration of use must not imply short-term benefits. 

Compliance Timelines 

As outlined in the Management of Applications, any product referencing this updated monograph must file an amendment or notification to reflect the changes within: 

• 3 years of the monograph’s publication, or 
• The next post-licensing change, or 
• The next label run — whichever comes first. 

What This Means for You 

If your licensed product contains Green Tea Extract, these changes may impact your labeling, claims, or risk statements. 

Not sure whether your product is affected — or whether other monographs have been updated since your license was issued? Our regulatory experts can help you navigate these changes and ensure your products remain compliant. Contact us today. 

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