Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3461
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3461
Character Range: 1609116–1611634

3461                                      NATURAL FISH OIL                                                                              A, E      When therapeutic indications for this product are made against Vitamin A or colecalciferol (Vitamin D), they are mandatory components of natural fish oil.
                                                                                                                                                  When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%.
                                                                                                                                                  When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents.
                                                                                                                                                  When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label:
                                                                                                                                                  - (VITA2) 'WARNING: If you are pregnant - or considering becoming pregnant - do not take vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].' NOTE: Position this warning at the beginning of the directions for use.
                                                                                                                                                  - (VITA4) 'WARNING - When taken in excess of 3000 micrograms retinol equivalents - vitamin A can cause birth defects.' NOTE: Position this warning at the beginning of the directions for use.
                                                                                                                                                  - (VITA3) 'The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.'
                                                                                                                                                  When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D.