Claims about hemp and CBD oils misleading consumers

This TGA behind-the-news article was published on 15 May 2018. Behind-the-news articles are published in response to issues that are of interest to the community at a point in time, for example, subjects that have been in the media.

The Therapeutic Goods Administration is aware of false and misleading claims being made by some companies supplying products containing cannabidiol (CBD).

Companies located in the United States have been illegally exporting cannabidiol (CBD) and hemp products to persons in Australia without import permission.

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. 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).

Consumers should remain cautious, as these claims can mislead them into believing the products have been or will be reviewed and approved by the TGA for use, implying a level of safety, quality and effectiveness.

The importation of these products is illegal 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)

Imports of these goods that 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.