FDA Warns of Unapproved Marijuana-Based Treatments Marketed for Cancer

Yesterday, the FDA issued warning letters to 4 companies illegally selling marijuana-based products online that claim to prevent, diagnose, treat, or cure cancer, despite being unapproved, according to a press release. This action is part of the agency’s ongoing effort to shield patients from fraudulent, unapproved drugs.

Selling unapproved products with unsubstantiated claims violates the Federal Food, Drug, and Cosmetic Act. These actions can also put patients at a significant risk, as the products have not been proven to be safe and effective.

The misleading marketing may also prevent some patients from accessing FDA-approved treatments for serious and life-threatening diseases, including cancer, according to the release.

The FDA expressed concern about the increasing number of products that claim to cure serious diseases that are unapproved.

In this case, the illegal products allegedly contain cannabidiol (CBD), a component of marijuana that has not been approved for any indication, according to the release. CBD is marketed in numerous product types, including teas and lotions.

The 4 companies allegedly sold the CBD-based products with claims regarding preventing or curing cancer, killing cancer cells, or similar claims, according to the FDA. Some of the products were also sold as a therapy for Alzheimer’s disease and other serious conditions.

“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, MD. “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.”

The FDA has identified more than 25 products that have been sold online with unapproved claims about treating cancer, including:

· “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” and

· “Non-psychoactive cannabinoids like CBD may be effective in treating tumors from cancer—including breast cancer”

However, these products and claims have not been reviewed by the FDA, so the agency has not evaluated whether the drugs work, the dosage, drug interactions, and various safety concerns, according to the release.

The FDA has requested the companies remedy their actions. If they do not, the companies may face legal action, according to the release.

“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, and are monitored by the FDA once they’re on the market,” Dr 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. We support sound, scientifically-based research using components derived from marijuana, and we’ll continue to work with product developers who are interested in bringing safe, effective, and quality products to market.”