FDA cracks down on bogus cannabis cancer cures
The FDA has said it is increasingly concerned about unapproved cannabis and related products that claim to prevent, diagnose and even cure cancer.
In a strongly-worded statement the FDA said it had sent warning letters to four companies warning that their actions are against US laws and put patients at risk by preventing them accessing approved therapies for serious or fatal diseases.
In this case the illegally sold products allegedly contain cannabidiol, a component of the marijuana plant that is not approved by the FDA in any drug or any indication.
Companies receiving warning letters distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer, killing or inhibiting cancer cells or tumours, or other similar anti-cancer claims.
Some of the products were also marketed as an alternative or additional treatment for Alzheimer’s and other serious diseases.
The FDA issued warning letters to four companies citing unsubstantiated claims related to more than 25 different products across several web pages, online stores and social media websites.
Claims included that the cannabis-based products combat tumour and cancer cells, that cannabidiol makes cancer cells “commit suicide”.
The companies also claimed that the products had anti-proliferative properties that inhibit cell division and growth in certain types of cancer.
They also included claims that cannabidiol may be effective in treating tumours including breast cancer.
The regulator noted that manufacturing processes of these products had not been reviewed by the FDA and that without clinical trials it is impossible to gauge whether they are effective, how they interact with other drugs, or whether they have dangerous side effects.
It has requested responses from the companies requesting how the violations will be corrected, and failure to do so may result in legal action including product seizure and injunction.
The upsurge in these bogus products reflects the legalisation of cannabis in a number of US states in the last few years. So far eight states – Alaska, California, Colorado, Oregon, Massachusetts, Maine, Nevada and Washington – have legalised its sale and possession for medical and recreational use.
This trend is distinct from a parallel one where companies are going through the FDA's channels to gain approval for new cannabis-based products. GW Pharma this week filed its formulation of purified cannabidiol, Epidiolex, with the FDA as a treatment for rare childhood epilepsy, backed by in-depth clinical trial evidence.
