Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_2300
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 2300
Character Range: 1112214–1114931

2300                                      GARCINIA GUMMI-GUTTA                                       A         The requirements specified in paragraphs (a) to (c) below applies to a medicine that contains the ingredient that is:
                                                                                                               - listed in the Register before 1 March 2025; and
                                                                                                               - released for supply before 1 March 2026:
                                                                                                               (a) Only for use in oral medicines.
                                                                                                               (b) Must be obtained from the rind of the fruit only.
                                                                                                               (c) Must not contain any directions for use for children or pregnant or lactating women.
                                                                                                               The requirements specified in paragraphs (d) to (g) below apply to a medicine that contains the ingredient that is:
                                                                                                               - listed in the Register on or after 1 March 2025; or
                                                                                                               - released for supply on or after 1 March 2026:
                                                                                                               (d) The route of administration for medicines that contain Garcinia gummi-gutta must be limited to oral.
                                                                                                               (e) The plant part must be limited to fruit peel.
                                                                                                               (f) The following warning statement is required on the medicine label:
                                                                                                               'In very rare cases, Garcinia gummi-gutta may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.'
                                                                                                               (g) Medicines containing Garcinia gummi-gutta must not be directed for use in children, or in pregnant or lactating women.