In Cannabis Edibles and the FDA, I discussed the basics of FDA regulation of cannabis edibles. On November 1, 2017, the FDA provided further specific examples of prohibited health claims made for cannabis products, in this case, cannabidiol (CBD):
The FDA has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. In this case, the illegally sold products allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication.
FDA Commissioner Scott Gottlieb followed up:
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.
The FDA issued warning letters, usually its first step in enforcement proceedings, to four companies. The prohibited health claims made by these companies included:
- “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 (cannabidiol) may be effective in treating tumors from cancer – including breast cancer.”
Recall from our earlier post that the FDA will treat products as drugs if their own labeling suggests they are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” Phrases like “combats tumor cells” and “[has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer” clearly suggest that the CDB product can cure, mitigate, treat or prevent cancer, and is thus a drug.
As shown by the last bullet point, it doesn’t matter if you say “may treat” cancer, instead of “treats cancer.” Any suggestion that a product might have a role in treating or diagnosing disease, or that it is intended to affect the structure or any function of the human body of humans or other animals, is a health claim that subjects the product to drug regulations (unless it falls within the narrow confines of the Dietary Supplement Health & Education Act.)
Most importantly, the FDA press release says – again – that “unlike drugs approved by the FDA, the manufacture of these products has not been subject to FDA review as part of the drug approval process….” Only the FDA can determine whether a drug can be labelled as safe and effective for a particular disease. Preventing health claims based on anecdotal evidence has been one of the FDA’s core functions since 1906.
This isn’t the first time the 800-pound gorilla has visited CBD makers. FDA issued warning letters based on similar CBD health claims in February 2015 and again in February 2016. If you want to keep this monkey off your back, don’t make health claims.
For related posts about the FDA, CBDs and health claims, check the: