GREEN TEA EXTRACT

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

Date

September 29, 2022

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information
Proper name(s) Common name(s) Source information
Source material(s) Part(s)

Camellia sinensis

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

Camellia sinensis

Leaf

References: Proper name: USDA 2018; Common names: Westerterp-Plantenga et al. 2005, Henning et al. 2004, McGuffin et al. 2000; Source information: Nagao et al. 2005, Chantre and Lairon 2002.

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

Use(s) or Purpose(s)

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Methods of preparation: Standardized extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

Antioxidants

Not to exceed 690 milligrams total catechins, and 150 milligrams of caffeine, per day (Nagao et al. 2005; Henning et al. 2004; Nakagawa et al. 1999).

Weight management

136 - 300 milligrams (-)-epigallocatechin-3-gallate (EGCG) and 75 -150 milligrams of caffeine, with an EGCG: caffeine ratio of 1.8:1 to 4:1, per day. Not to exceed 690 milligrams of total catechins (including EGCG) per day (Nagao et al. 2005; Westerterp-Plantenga et al. 2005; Chantre and Lairon 2002).

Direction(s) for use

All products

Take with food (HC 2017).

Duration(s) of Use

All products

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 12 weeks (Nagao et al. 2005; Westerterp-Plantenga et al. 2005; Chantre and Lairon 2002).

Risk Information

Caution(s) and warning(s)

All products

Contraindication(s)

No statement required.

Known adverse reaction(s)

All products

Rare, unpredictable cases of liver injury associated with green tea extract-containing products have been reported (in Canada and internationally) (HC 2017).

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

Must be established in accordance with the requirements described in the Natural Health Products Regulations (NHPR).

Specifications

References cited

References reviewed