US-based companies have been illegally exporting cannabidiol and hemp products to people in Australia without import permission, the TGA warns
The TGA says it is aware of “false and misleading” claims being made by some companies supplying products containing cannabidiol.
“The TGA is aware of at least one company who has claimed that the TGA has invited them to register their CBD and hemp products on the Australian Register of Therapeutic Goods (ARTG) due to growing demand,” says the TGA in a warning to consumers.
“This is incorrect. The TGA does not ‘invite’ businesses or sponsors to register a product on the ARTG. The onus is on the sponsor to apply to the TGA and follow due process.
“Although the company claims they will have their products registered and approved with the TGA ‘very quickly’, these particular products are not registered by the Food and Drug Administration (FDA) in the United States and they are therefore unlikely to receive registration by the TGA.
“In addition, they are subject to regulation and export control by the United States Drug Enforcement Agency (DEA).”
The TGA says consumers should be cautious when considering importing these products, as the claims from these particular companies could mislead them into thinking that the TGA has or will review and approve the products.
This implies a level of safety, quality and effectiveness which cannot be guaranteed.
The TGA says that importation of these products is llegal unless the importer holds a licence and permit to import from the Office of Drug Control (ODC) because they:
- contain prohibited imports under the Customs (Prohibited Imports) Regulations 1956 due to the presence of CBD and extracts of cannabis in the products;
- are prescription-only medicines due to the presence of CBD and extracts of cannabis, as outlined in the Poison Standard (SUSMP);
- do not meet the CBD threshold in the Food Standards Code, and are therefore not considered to be a food;
- are not registered on the Australian Register of Therapeutic Goods (ARTG).
It says imports of cannabidiol and hemp products which do not have the relevant import permissions will be seized at the border.
“Individuals and businesses in Australia importing CBD/hemp oils are also breaking State/Territory laws on supply and use of prescription medicines,” it warns.