Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - SCHEDULE 2

(regulation   6B)

Part   1 -- Prohibited representations

 

Column 1 Item No.	Column 2 Representation	Column 3 Therapeutic goods
3	a representation with respect to the use of goods in which it is stated or implied that those goods: (a) are, or contain, a vitamin--unless those goods are composed of, or contain, a substance specified in column 2 of an item in Part   3 of this Schedule or a salt or derivative of a substance and that substance is described either by the name referred to in Column   2 of that item, or by the name of its salt or derivative, or by the name specified in Column 3 of that item and not otherwise; or (b) are, or contain, a substance described as a vitamin otherwise than by a description specified in Column 2 or   3 of Part   3 of this Schedule	all therapeutic goods
4	a representation that states or implies that: (a) analgesic consumption is safe; or (b) analgesics will relax, relieve tension, sedate or stimulate	analgesics
5	a representation containing a reference to bacteriostatic activity, except where it is made in conjunction with a reference to bactericidal activity	disinfectants
6	a representation: (a) containing reference to the Rideal - Walker test or the Phenol Coefficient; or (b) on any label, containing a reference to the results of laboratory tests on micro - organisms, other than a representation provided by leaflet or on a label enclosed with the goods in their package; or (c) containing a reference to the achievement of sterility except where the representation is approved in writing by the Secretary; or (d) contradicting or conflicting with the common name; or (e) that is not more specific than the common name as a description or measure of activity against micro organisms; or (f) containing a reference to an effect against viruses, except a representation that is approved in writing by the Secretary; or	disinfectants and antiseptics
	(g) containing a reference to an effect against Mycobacterium tuberculosis and related acid fast bacteria, except a representation that is approved in writing by the Secretary; or (h) containing a reference to the disinfection of inaccessible parts of drains
7	a representation that antiseptics promote healing	antiseptics
8	a representation that states or implies that vitamin or mineral supplements: (a) are a substitute for good nutrition or a balanced diet; or (b) are in any way superior to or more beneficial than dietary nutrients	vitamin or mineral supplements
9	a representation that: (a) purports to show the recommended daily or dietary intake or allowance of a vitamin or a mineral unless the amount shown is that recommended by the National Health and Medical Research Council; or (b) expresses the quantity of a vitamin or a mineral contained in a preparation as a percentage or proportion of the recommended daily or dietary intake or allowance	vitamins and minerals
10	The following: (a) a representation regarding abortifacient action; (b) a representation regarding the treatment, cure, prevention, diagnosis (including screening) or monitoring of, or the susceptibility or pre - disposition to, one or more of the following: (i) neoplastic disease; (ii) sexually transmitted diseases; (iii) human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS); (iv) hepatitis C virus (HCV); (v) mental illness	all therapeutic goods

Part   2 -- Required representations

 

Column 1 Item	Column 2 Representation	Column 3 Therapeutic goods
1	if the advertisement is in the form of a label on the retail container--a statement that: (a) vitamins can only be of assistance if the dietary vitamin intake is inadequate; or (b) vitamin supplements should not replace a balanced diet	vitamin preparations for oral ingestion supplied in Australia

Part   3 -- Vitamins referred to in Item   3 of Part   1 of this Schedule

 

Column 1 Item	Column 2 Substance	Column 3 Name
1	Vitamin A	--
2	Thiamine	Vitamin B1
3	riboflavin	Vitamin B2
4	Nicotinic Acid
5	Pantothenic Acid	Vitamin B5
6	Pyridoxine	Vitamin B6
7	Cyanocobalamin	Vitamin B12
8	Ascorbic Acid	Vitamin C
9	Ergocalciferol	Vitamin D2
10	colecalciferol	Vitamin D3
11	alpha - Tocopherol	Vitamin E
12	Biotin	Vitamin H
13	Phytomenadione	Vitamin K1
14	Menadione	Vitamin K3
15	Folic Acid