Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_2643
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 2643
Character Range: 1219665–1222010

2643                                      HYDROXYCITRATE COMPLEX                                     A         The requirements specified in paragraph (a) 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) Hydroxycitrate complex must contain one or more of the three salts (calcium, sodium or potassium hydroxycitrate) of hydroxycitric acid.
                                                                                                               The requirements specified in paragraphs (b) to (d) 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.
                                                                                                               (b) Hydroxycitrate complex must contain one or more of the three salts (calcium, sodium or potassium hydroxycitrate) of hydroxycitric acid.
                                                                                                               (c) When for oral use, the following warning statement is required on the medicine label:
                                                                                                               'In very rare cases, hydroxycitrate complex 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.'
                                                                                                               (d) Medicines containing hydroxycitrate complex must not be directed for use in children, or in pregnant or lactating women.