FDA Cracks Down on Marijuana Cancer Cure Claims

Nick Mulcahy

November 01, 2017

The US Food and Drug Administration (FDA) has issued warning letters to four companies selling products online that allegedly contain cannabidiol, which is a nonintoxicating component of the marijuana plant. The companies claim that their products can prevent, treat, or cure cancer.

The cancer claims are not supported by evidence, the FDA points out.

Selling unapproved products with unsubstantiated therapeutic claims is a violation of the Federal Food, Drug and Cosmetic Act and thus is illegal.

The four companies are Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC. Each company markets cannabidiol online in a variety of product types, such as oil drops, capsules, syrups, teas, topical lotions, and creams.

The warning letters are part of an ongoing campaign from the FDA to curb healthcare fraud. In April, the agency issued more than a dozen other warning letters to companies marketing "bogus cancer cures," as reported by Medscape Medical News.

Cannabidiol, or CBD, is a component of the marijuana or cannabis plant and is not FDA approved in any drug product for any indication. It is distinct from tetrahydrocannabinol, or THC, in marijuana, which is intoxicating.

However, cannabidiol is undergoing "substantial clinical investigation" as a cancer treatment, says the FDA.

For example, GW Pharmaceuticals and Otsuka Pharmaceutical Company currently are conducting a phase 2/3 trial in the United States to evaluate the efficacy and safety of Sativex, a cannabinoid formulation, in the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized long-term opioid therapy.

FDA Commissioner Scott Gottlieb, MD, said the agency is in support of investigating marijuana-based products.

"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," he said in a press statement.

In the same statement, the FDA published examples of cannabidiol product claims culled from the four companies' websites:

  • "CBD combats tumor and cancer cells;";

  • "CBD makes cancer cells commit 'suicide' without killing other cells;

  • "CBD...[has] antiproliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;" and

  • "Nonpsychoactive cannabinoids like CBD may be effective in treating tumors from cancer ― including breast cancer."

It is possible that some of these claims may be accurate. Cannabidiol has been the subject of basic science studies as an anticancer agent. However, the claims that the companies are making have no place in product marketing, the FDA stressed.

Furthermore, the FDA is concerned not only about baseless and illegal product claims but also about driving cancer patients away from legitimate treatments.

"When people are allowed to illegally market agents that deliver no established benefit, they may steer patients away from products that have proven, antitumor effects that could extend lives," said Dr Gottlieb, who is a cancer survivor, having been successfully treated for Hodgkin's lymphoma.

However, there are only small numbers of such patients, a recent study suggests.

Researchers at Yale Cancer Center in New Haven, Connecticut, combed through 10 years (2004-2013) of records in the National Cancer Database to find 280 early-stage cancer patients (with either breast, prostate, lung, or colorectal disease) whose initial treatment was coded as "other-unproven: cancer treatment administered by nonmedical personnel."

Very few patients completely reject first-line conventional cancer treatment for alternative and unproven therapies.

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