Section 7 declarations - food or therapeutic good?

Section 7 declarations are made under the Therapeutic Goods Act 1989 (the Act) to provide greater clarity for consumers, industry and regulators about whether a product is a therapeutic good.

Essentially, a section 7 declaration enables the Secretary of the Department of Health to declare:

  • where the Secretary is satisfied that particular goods or classes of goods are therapeutic goods - that the particular goods or classes of goods are therapeutic good; and
  • where the Secretary is satisfied that particular goods or classes of goods are not therapeutic goods - that particular goods or classes of goods are not therapeutic goods.

A declaration that goods are therapeutic goods does not necessarily mean that the goods, or class of goods, is approved for supply in Australia. It is the responsibility of sponsors to meet relevant regulatory requirements.

The Act was amended, with effect from 16 December 2010, to stipulate that the Secretary can declare goods to be therapeutic goods under section 7 of the Act, even if they are also goods for which there is a standard in the Australia New Zealand Food Standards Code or have a tradition of use as food in the form in which they are presented in Australia or New Zealand. The effect is that goods that would otherwise be regulated as food, are regulated as therapeutic goods.

Declarations made