FreshLeaf Analytics Welcomes TGA’s Final Ruling on Low-Dose Over-The-Counter CBD

FreshLeaf Analytics

Therapeutic Goods Administration (TGA) makes final ruling on over-the-counter low-dose CBD, firing the starting gun for companies in race to bring products to market, increasing dose to up to 150 mg/day with efficacy still remaining as the biggest hurdle.

FreshLeaf Analytics has again welcomed the final decision today by the Therapeutic Goods Administration (TGA) to make registered low-dose CBD products available for sale in Australian pharmacies as a Schedule 3 drug. There was a significant change to the interim decision with an increase in dose up to 150mg/ day. The implementation date has also been brought forward to February 2021. The door is now open for companies to apply for registration of their applicable products to be available over-the-counter (OTC), although products are unlikely to hit shelves until later in 2021/ 2022.


The final decision will allow the sale of registered pure CBD products (with 2% or less other cannabinoids, but only

The announcement today reiterated that product delivery mechanisms are limited to oral, oral mucosal and sublingual formulations only, ruling out vaping or topical cream products. There was also an additional requirement that products be packaged securely.


In creating a pathway for low-dose CBD products to become available over-the-counter, the TGA is opening the door for medicinal cannabis product companies to compete to bring registered low-dose CBD products to market.

The vast majority of products currently available through S4 unapproved pathways meet the criteria for S3 low-dose CBD.


The path to market, however, will not be straightforward. In order to register a product, a company must demonstrate that their products are high quality, safe, and efficacious. Proving safety and collating data on quality can be time consuming, and demonstrating efficacy to support registration, even at the proposed dose (of


  • FreshLeaf supports final decision to make low-dose S3/OTC CBD products available in Australia as a Schedule 3 medicine but acknowledges that proving efficacy may still be a challenge not all companies are prepared to undertake

  • Timeline for consumers seeing medication on shelves likely pushed to late 2021/2022

  • Up to 150 mg/ day, 30 day supply to be available over-the-counter, products expected in late 2021/early 2022

  • Oral, oral mucosal and sublingual formulations only – no vaping or topicals

  • The vast majority of products currently available through S4 unapproved pathways meet the criteria for S3 low-dose CBD

  • Products must be packaged securely

  • Potential for $200M+ market in Australia

  • ARTG registration will be required – no SAS-B

  • Use of illicit CBD products may decrease

  • Advertising to the general public will still not be allowed for OTC products

/Public Release.