FDA issues warnings to companies illegally selling cannabidiol products claiming to treat cancer

The FDA issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat or cure cancer without evidence to support such outcomes — which is a violation of the Federal Food, Drug and Cosmetic Act.

In this case, the illegally sold products allegedly contain cannabidiol, a component of the marijuana plant that is not FDA approved in any drug product for any cancer indication.

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “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.”

The companies that received warning letters — Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC — distributed products with unsubstantiated claims, including the prevention, reversal or curing of cancer; killing/inhibiting cancer cells or tumors; or other similar anticancer claims.

The unsubstantial claims totaled more than 25 different products — including oil drops, capsules, syrups, teas, and topical lotions and creams — spanning multiple product webpages, online stores and social media platforms.

The FDA noted the manufacturers of these products have not been subject to FDA review as part of the drug approval process, and there has been no FDA evaluation of whether these products are safe or effective.

“There are a growing number of effective therapies for many cancers,” Gottlieb said. “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.”

The FDA has requested responses from each of the companies to state how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and injunction, the release 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,” Gottlieb said. “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.”

This action adds to the more than 90 warning letters the FDA has issued in the past 10 years — including more than 12 this year — to companies marketing fraudulent products with cancer claims.

“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,” Gottlieb said.