WA Selling US Health Supplements in Australia - Do I Need Approval?

[Curious george]

I have a health supplements brand which is manufactured and sold in the U.S.

If I were to sell them in Australia, would I need to get approval under the Australian Consumer Law or Commercial Law?

 

[Tim W]

Quite possibly.

The first thing you need to do is work out whether your product
is a medicine or a food. That is not your decision.
The Therapeutic Goods Administration
has developed a tool to help you get started. Find it -> here

Even if TGA decides that the product does not need their approval,
then you may still need approval from the food authority in WA.
Because if it isn't a therapeutic good, then it's probably food.

 

[Sarah J]

I agree with Tim, may possibly need to have it registered or licenced. In any event, you will need to check with the Department of Health's Therapeutic Goods Administration. Have a read of "an overview of the regulation of complementary medicines in Australia" and if you're still unsure, speak with the administration.

 

[Sophea]

Hi Curious George,

The law in Australia dictates that products containing certain medicinal ingredients - like herbs, vitamins, minerals, nutritional supplements, homoeopathic and aromatherapy preparations etc (referred to as 'complementary medicines') are regulated as medicines under the Therapeutic Goods Act 1989 (the TGA).

Your product will be considered a complementary medicine under this act if it consists principally of one or more specific active ingredients which are contained in Schedule 14 of the TGA Regulations, including:

1. an amino acid
2. charcoal
3. a choline salt
4. an essential oil
5. plant or herbal material (or a synthetically produced substitute for material of that kind), including plant fibres, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll
6. a homeopathic preparation
7. a microorganism, whole or extracted, except a vaccine
8. a mineral including a mineral salt and a naturally occurring mineral
9. a mucopolysaccharide
10. non human animal material (or a synthetically produced substitute for material of that kind) including dried material, bone and cartilage, fats and oils and other extracts or concentrates
11. a lipid, including an essential fatty acid or phospholipid
12. a substance produced by or obtained from bees, including royal jelly, bee pollen and propolis
13. a sugar, polysaccharide or carbohydrate
14. a vitamin or provitamin

More information here: http://www.tga.gov.au/publication/australian-regulatory-guidelines-complementary-medicines-argcm

Note also that the TGA also regulates the manner in which you are allowed to market or advertise "therapeutic goods" such as supplements via the Therapeutic Goods Advertising Code and Trade Practices Act. It requires that marketing be done in a way that is socially responsible, does not mislead consumers and promotes the quality use of the product.

However, supplements that are available on international websites are not regulated by the TGA - in this case, the onus is on the Australian consumer to make sure of what is in the supplement and ensure it is legal to bring into Australia and consume the relevant ingredients.