Therapeutic Goods Amendment (Declared Goods) Order 2019: Folate substances

Summary

Clarity has been provided that certain goods containing folate, which are represented as being foods for "special medical purposes" or dietary management, are considered to be therapeutic goods. This is due to the high likelihood that these goods may be used for a therapeutic purpose, i.e. to prevent, cure or alleviate folate deficiency or depression, or an inborn error of folate metabolism. This means they must be registered or listed on the Australian Register of Therapeutic Goods (ARTG) and regulated accordingly.

The Therapeutic Goods Amendment (Declared Goods) Order 2019 ("Amendment Order") is a legislative instrument made under section 7 of the Therapeutic Goods Act 1989 ("the Act"). It commenced on 5 November 2019, and declares certain goods containing folate substances to be therapeutic goods when used, advertised or presented for supply for therapeutic use, or in a way that is likely to be taken to be for therapeutic use. The effect of the Amendment Order is to clarify that these goods are therapeutic goods, and therefore subject to the national system of controls for therapeutic goods established under the Act.

Specifically, the Amendment Order declares certain goods containing folate substances that are represented as being food for special medical purposes ("FSMPs") or for the dietary management of a disease, disorder or medical condition. It therefore addresses uncertainty about the proper characterisation of those goods as a consequence of the Australia New Zealand Food Standards Code - Standard 2.9.5 - Food for special medical purposes ("Food Standard 2.9.5"). The effect is to confirm that the goods are therapeutic goods for the purposes of the Act, irrespective of any view regarding the application of Food Standard 2.9.5 prior to the making of the Amendment Order.

In declaring these goods, the delegate considered that there is a credible link between inborn errors of folate metabolism and folate deficiency, and also a plausible causal relationship between folate deficiency and depression. This means that folate is or is likely to be taken to be for therapeutic use in, or in connection with, preventing, curing or alleviating folate deficiency or depression, or curing or alleviating an inborn error of folate metabolism. Such use is therapeutic use within the meaning of the Act.

The practical effect of the Amendment Order is to ensure that these goods are regulated under the Act as therapeutic goods - principally, medicines that may be required to be registered or listed on the Australian Register of Therapeutic Goods (ARTG) in accordance with the Act and associated instruments. The appropriate regulatory pathway for goods declared by Amendment Order will necessarily depend on the amount of folate and the associated therapeutic claims.

For more information see the Orders that goods are therapeutic goods.