The U.S. Food and Drug Administration (FDA) issued a stern warning Wednesday to companies marketing medical marijuana to cure or inhibit cancer — including mesothelioma — and cautioned patients about unsubstantiated claims.
The FDA sent warning letters to four particular companies, citing deceptive marketing in violation of the Federal Food, Drug and Cosmetic Act.
“We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer,” said FDA Commissioner Scott Gottlieb in a press release Wednesday. “And we’re not going to look the other way on enforcing these principles when it comes to marijuana containing products.”
Although marijuana is still classified by the U.S. Drug Enforcement Administration (DEA) as a Schedule I controlled substance, 28 states and the District of Columbia have legalized some form of medical marijuana use.
At question is how it is being marketed, and for what purposes it is used.
FDA regulators believe cancer patients are being misled specifically about cannabidiol (CBD), a marijuana component that has grown increasingly popular. It is being sold in various forms, including oils, syrups, capsules, teas and topical lotions.
Patients with mesothelioma, a rare and aggressive cancer caused by exposure to asbestos, have begun using it and sharing stories of its effectiveness in stopping tumor growth.
Mesothelioma survivor Jim Huff, who was first diagnosed in 2016, said his CT scans have shown no new tumor growth, and even a slight regression, since he started taking CBD oil twice each day.
Andy Ashcraft in California, who lived seven years after his diagnosis of pleural mesothelioma, often credited his cannabis oil regimen for allowing him to live a longer, more active life than anyone expected. He died in October.
The FDA has not approved CBD oil in any product for any indication. Small research studies have shown CBD oil can be effective in managing pain, anxiety and nausea — symptoms caused by cancer or cancer treatments.
Other studies have shown effectiveness in controlling neurological condition such as epilepsy. Researchers at the California Pacific Medical Center found CBD oil stopped cancer metastasis in laboratory and animal testing but have yet to confirm it in a controlled trial involving humans.
Some cancer patients view the CBD oil as a complementary therapy, using it in conjunction with more traditional treatments such as chemotherapy and radiation. Others are using it alone.
According to the FDA, no studies have shown CBD oil can control or stop the growth of cancer cells, although individuals often have made those claims.
“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors,” Gottlieb said. “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.”
Warning letters were sent to Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting and Stanley Brothers Social Enterprises.
In each notice was a request for the company to explain how they would comply with the FDA’s warning. Failure to change their marketing could result in legal action, including product seizure and injunction.
Gottlieb believes the deceptive marketing may keep patients from more appropriate, recognized treatments.
Examples of the deceptive claims the FDA cited involving CBD include:
“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,” Gottlieb said. “We have an obligation to provide caregivers and patients with the confidence that drugs making cancer treatment claims have been carefully evaluated for safety, efficacy and quality.”