What do the TGA laws mean for your supplement brand or supplement store? The supplement industry is kind of like the Wild West. But instead of Cowboys vs Native Americans, we have Foods vs Medicines. There has always been much legal debate and discourse about the grey line between food products and therapeutic goods. What most people don’t realise is that the Therapeutic Goods Administration (TGA) never had any regulatory power over foods (aka supplements). The governing body for food is the Food Standards Australian New Zealand (FSANZ). The TGA would warn foods, even fine, when foods would make therapeutic claims. But this has all changed as of 24th September 2020.
As of 24th September 2020 any oral preparation (no matter liquid, powder, capsule, etc.) that makes a claim about performance or maintenance in sports, exercise, or recreation and contains a regulated ingredient is now a therapeutic good. TGA are now the regulatory body, not FSANZ. TGA have given everyone until 30th November 2020 to either register the supplement as a therapeutic good or change into a relevant food category. If this has not been done and you are caught selling your old supplements, you are now selling an unregistered medicine. Which is just as illegal as selling products like Nolvadex or Clenbutarol. This is a criminal offence.
So, what constitutes a regulated ingredient? Any ingredient prohibited by WADA, in the Poisons Regulations, or any ingredient with a pharmacological action of the above. This is pretty wow. If you haven’t learnt pharmacology, this is quite confusing. Some examples are below:
- All ecdysteroids are regulated under the rule. Ecdysteroids are selective estrogen receptor modulators (SERMs). SERMs are prohibited by WADA and are the pharmacological action of several Schedule 4 medicines.
- Raspberry ketone is regulated under the rule. Raspberry ketone is a PPAR agonist. PPAR agonists are prohibited by WADA and is the pharmacological action of cardarine a Schedule 10 poison.
- Caprylic acid (a constituent of MCT oil) is regulated under the rule. Caprylic acid is a selective androgen receptor modulator (SARM). SARMs are prohibited by WADA and are the pharmacological action of several Schedule 4 medicines.
- Mesembrine is regulated under the rule. Mesembrine is a selective serotonin reuptake inhibitor (SSRI). SSRIs are the pharmacological action of several Schedule 4 medicines.
APOC has gone above and beyond to make their products compliant with the TGA’s new legislation to help the stores who sell their products avoid legal and financial repercussions.