When is a vitamin not a vitamin in listed medicines?

The TGA’s most recent version of the Advertising Guidelines highlights the fact that advertising of listed medicines cannot include claims that a therapeutic good contains ‘vitamins’ unless it contains a substance listed in Part 3 of Schedule 2 of the Regulations. This means that if you have the ingredient menaquinone-7 in your product under the Regulations it is prohibited to claim that it is ‘Vitamin K2’ or that the medicine contains a ‘vitamin’ as this does not appear in Part 3 of Schedule 2.

Under the Therapeutic Goods Regulations the word “vitamin” can only be used for the specific ingredients listed in Schedule 2 Part 3 of the Regulations.

Schedule 2 of the Therapeutic Goods Regulations, Part 1  Prohibited representations, Item 3 identifies that for all therapeutic goods it is a prohibited 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

This means that advertising (including labelling) cannot include claims that a therapeutic good contains a ‘vitamin’ or ‘vitamins’ unless it contains a substance listed in column 2 of Part 3 of Schedule 2 of the Regulations.

For example:

• If your product contains the permitted ingredient nicotinamide or nicotinic acid, according to the Regulations the use of the term Vitamin B3 is currently a prohibited representation as it is not listed as a vitamin in Part 3 of Schedule 2 of the Regulations.
• If your product contains Mecobalamin (co-methylcobalamin) under Schedule 2 of the Regulations it is prohibited to refer to it as a vitamin including Vitamin B12 or the product as containing a vitamin if there are no other ingredients in the product that are listed in Schedule 2 Part 3 of the Regulations..
• If your product contains the ingredient menaquinone-7 it is prohibited to claim that it is ‘Vitamin K2’ as this common name of the vitamin does not currently appear in the Regulations.

We understand that these terms are commonly used throughout industry, however the use is, in fact, in breach of the Regulations. Additionally, while we believe this regulation is outdated and no longer suitably situated in the therapeutic goods legislation (given the complexity to update the Therapeutic Goods Regulations, and the need to be able to update it regularly so that new ingredients not on the list may be added in a timely manner), as it is still current and was deliberately referred to in the most recent advertising guidance the above examples being prohibited representations mean the TGA could take compliance actions against sponsor’s who refer to any substance as a vitamin that is not listed in Column 2 Part 3 of Schedule 2 of the Regulations, on  labels, in advertising or the name of the medicine.

Sponsors are reminded that 30 June 2022 marks the end of the transition period to update advertising to comply with the updated Therapeutic Goods Advertising Code (Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021).

Staying compliant with legislation does not need to be stressful or costly. The team at AWRS are always ready to help you with any concerns you might have. Contact us