L-THEANINE

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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

June 3, 2019

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

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source ingredient(s) Source material(s) Preparation
Common name(s) Proper name(s) Part(s)
  • L-Theanine
  • N-Ethyl-L-glutamine

L-Theanine

N/A

Camellia sinensis

Leaf

Isolate

L-Theanine

N/A

N/A

Synthetic

References: Proper names: NIH 2015, O'Neil et al. 2013; Common name: NIH 2015; Source materials: O'Neil et al. 2013, Zajac et al. 2003, Gennaro 2000 .

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 any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

Helps to temporarily promote relaxation (Nobre et al. 2008; Kimura et al. 2007; Lu et al. 2004).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

200 - 250 milligrams of L-Theanine, per day (Kimura et al. 2007; Lu et al. 2004; Song et al. 2002; Kobayashi et al. 1998).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

No statement required.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

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

No statement required.

Specifications

References Cited

References Reviewed