Today’s question is about
… entrepreneurs designing and making face masks and selling to the public.
While they are showing great passion and help to the community in times of need. I very much doubt that these ‘home made safety masks’ are made to AS/NZ standards. Is what they are doing legal?
The answer to that question will really depend on the claims that are being made. Anyone can make a scarf, or bandanna, or face mask and sell it; it is if you claim it has therapeutic affects that an issue arises. The Therapeutic Goods Act 1989 (Cth) s 3 says therapeutic goods are goods:
… that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be:
(i) for therapeutic use; …
Therapeutic use includes ‘use in or in connection with ‘preventing, … a disease, … in persons’ (see also the definition of Medical Device in s 41BD). The sale of therapeutic goods is subject to the Therapeutic Goods Advertising Code (s 42BAA) and the need for goods to be on the Therapeutic Goods Register (s 9A) and to meet prescribed standards (Parts 4.2-4.5).
The regulatory scheme is too complex to explore here but it does confirm the point that the regulatory regime does depend on what claims people are making about the face masks. If they are claiming they meet a standard (like N95 and P2) then they would in fact need to meet that standard. If it is just a mask that holds a piece of cloth over your face and the seller does not make specific claims about its therapeutic use, I cannot see how that is illegal.