Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3925
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3925
Character Range: 1841338–1844102

3925                                      PIPER METHYSTICUM                                                                        A, H      Kavalactones (of Piper methysticum) is a mandatory component of Piper methysticum.
                                                                                                                                             Only for oral use when the dosage form is 'tablet' or 'capsule'; or when the container type is 'tea bag'.
                                                                                                                                             When used in oral medicines, the maximum daily dose of kavalactones (of Piper methysticum) must be no more than 250 mg.
                                                                                                                                             If the dosage form is tablet or capsule then the quantity of kavalactones (of Piper methysticum) must be no more than 125 mg per tablet or capsule.
                                                                                                                                             Oral medicines containing more than 25 mg of kavalactones (of Piper methysticum) per dose require the following warning statement on the medicine label:
                                                                                                                                             - (PIPER) 'Not for prolonged use. If symptoms persist - seek advice from a healthcare practitioner. Not recommended for pregnant or lactating women (or words to that effect). May harm the liver'.
                                                                                                                                             The plant part must be root or rhizome.
                                                                                                                                             When for oral use, the medicine may only contain dried whole or peeled root or rhizome or aqueous dispersions or aqueous extracts of whole or peeled root or rhizome.
                                                                                                                                             When for topical use on the rectum, vagina or throat, the medicine may only contain dried whole or peeled root or rhizome or aqueous dispersions or aqueous extracts of whole or peeled root or rhizome.
                                                                                                                                             When the container type is tea bag the maximum quantity per tea bag must be no more than 3 grams of dried whole or peeled root or rhizomes.