FDA Issues Warning Letters To Cannabidiol Product Manufacturers Over Health Claims
November 21, 2017
On November 1, 2017, the Food and Drug Administration (FDA) published a release concerning its issuance of warning letters to four companies concerning the marketing of products containing cannabidiol (CBD).
CBD is a cannabinoid found in hemp which lacks the psychoactive ingredient THC. Hemp and its derivatives are legal to import to the US and ship from state to state. According to a 2013 review published in the British Journal of Clinical Pharmacology, CBD may help in reducing nausea and vomiting; seizures; psychosis disorders; inflammatory disorders; tumor and cancer cells; and anxiety and depression disorders. CBD can be marketed in a variety of product types, such as oil drops, capsules, and topical lotions. CBD oil is legal in New York State.
The four companies that received warning letters from the FDA — Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC — are accused of illegally selling CBD products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes. The FDA’s warning letters further provide that the four companies distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimer’s and other serious diseases.
Examples of claims made by these companies include:
- “CBD makes cancer cells commit ‘suicide’ without killing other cells”
- “…considering the lack of risks associated with CBD it is an attractive alternative or addition to anyone’s treatment for Alzheimer’s disease.”
- “Adding CBD oil as part of your daily Alzheimer’s medicine routine has a good chance at delaying the progression of the disease…”
“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.”
Each company is being offered fifteen (15) working days after receipt of the warning letter to notify the FDA in writing of the specific steps that it has taken to correct the violations. The FDA letters warn that the company’s failure to correct the violations promptly may result in legal action, including product seizure and injunction.