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Drugs and Health Products

Organism - Piper methysticum

NHPID Name:
Piper methysticum

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Proper Name(s):

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Category:
Approved Herbal Name

Schedule 1:

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Roles

Medicinal

Rationale:
Classified as an NHP under Schedule 1, item 1 (a plant or a plant material) of the Natural Health Products Regulations.
Reference:  NNHPD

Restrictions:

General

Detail:
Due to risk of hepatotoxicity with kava products, the amount of kavalactones in Piper methysticum must be declared in the Natural Health Product Licence Application Form, or at a minimum in the cover letter. Human clinical data must be provided for safety assessment, unless: 1) the amount of kavalactones does not exceed 125 mg per single dose; 2) the amount of kavalactones does not exceed 250 mg per day; and 3) the product contains an aqueous extract of the whole or peeled rhizome, with a maximum quantity crude equivalent of 3 g/day.

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