Rare Disease Report

FDA Issues Warning Letters to 4 Companies Claiming Their Cannabidiol Product Can Treat Cancer

NOVEMBER 02, 2017
James Radke
Pharmaceutical grade cannabidiol (CBD) is showing great promise in helping children with a variety of rare conditions manage their seizures. One company, GW Pharmaceuticals, currently has their pharmaceutical grade CBD under review by the U.S. Food and Drug Administration (FDA) to manage seizures in children with Dravet and Lennox-Gastaut syndromes and the data looks very promising.
Pure CBD is extracted from cannabis (marijuana) and is free of the psychoactive properties that make cannabis a popular product.  And while controlling seizure activity is at the forefront of the CBD studies currently underway, other studies are testing pharmaceutical grade CBD to treat other conditions such as bipolar depression, anxiety, post-traumatic stress disorder, multiple sclerosis, Parkinson’s disease, and schizophrenia.  

Unfortunately, there are many companies not involved in those clinical studies claiming that their cannabidiol containing products can treat or cure a variety of medical ailments, including cancer. 

Yesterday, the FDA issued warning letters to 4 companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes.

The companies are:
According to the FDA, the companies are using phrases such as the following to entice medically ill people to buy their product:
  • “Combats tumor and cancer cells”
  • “CBD makes cancer cells commit ‘suicide’ without killing other cells”
  • “CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow”
  • “Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer”

Per the FDA:  “Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” said FDA Commissioner Scott Gottlieb, M.D. “There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”

While cannabis and cannabidiol hold great promise as therapeutic agents for a number of conditions, any therapeutic value those products may have can only be tested through properly designed clinical trials that can be reviewed by regulatory agencies.

Commissioner Gottlieb noted, “We recognize that there’s interest in developing therapies from marijuana and its components, but the safest way for this to occur is through the drug approval process – not through unsubstantiated claims made on a website.”

Image courtesy wikimedia commons.

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