Will an intensifying Administration effort make companies paranoid?

Warning Shot

On Nov. 1, 2017, the Food and Drug Administration (FDA or Administration) issued warning letters to four companies – Greenroads HealthNatural AlchemistThat’s Natural! Marketing and Consulting and Stanley Brothers Social Enterprises, LLC – referencing advertising regarding the health benefits of more than 25 of their products.

The claims, made in online stores and on social media websites, connect a common ingredient – cannabidiol (CBD), “a component of the marijuana plant that is not FDA approved in any drug product for any indication” – with positive results in cancer patients. The advertising targeted by the Administration includes phrases like “CBD makes cancer cells commit ‘suicide’ without killing other cells” and “combats tumor and cancer cells.”

Misdirection?

The problem, the FDA asserts in a summary press announcement, is that there is no substantiation that CBD has any effect on cancer. The companies are “illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes.” The Administration makes clear that selling products that make these claims without substantiation is a violation of the Federal Food, Drug and Cosmetic Act.

Beyond the illegality of the product claims, the FDA expresses concern that reliance on the products may cause cancer patients to miss out on other, established treatment options. “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.

The Takeaway

The FDA is promoting the CBD-related warning letters as yet another front in its intensifying war against products making insubstantial cancer-treatment claims. The Administration notes in its announcement that it has issued more than 90 such warning letters in the past 10 years – and that more than 12 of those letters have been issued in the past year alone.