FDA to Curaleaf: Stop making medical claims about CBD

FDA to Curaleaf: Stop making medical claims about CBD

Curaleaf is one of the biggest cannabis and CBD companies in the world, and the company got a letter from the US Food and Drug Administration this week with some of the most strict warnings we’ve seen yet. In the letter, the FDA tells Curaleaf that it’s claiming on its website that CBD will help with ailments like chronic pain, ADHD, Parkinson’s, Alzheimer’s, and lots of other health issues, but that the FDA has not approved the drug for those uses (and in fact, the science just isn’t there for a lot of those claims yet anyway). The FDA gives Curaleaf fifteen working days to take action on the violations, as well as for them to relate back to the FDA what was done (and any other reasoning required). The FDA even threatens, if their request isn’t fulfilled, “legal action without further notice, including, without limitation, seizure and injunction.” As we said, that’s as harsh a warning as we’ve seen about CBD yet.

Curaleaf is a publicly traded company, and the stock dropped 14% on news of the letter’s arrival (and has since rebounded to a 5.6% loss). Curaleaf says it is reviewing the letter with its legal counsel, and is committing to comply with any requirements from the FDA. So this isn’t the end of the line for the company, but it’s a big sign that the FDA will step in if it feels that the CBD market is big enough and that unjustified claims are being made. CVS does sell CBD in its pharmacy stores, including some Curaleaf products, but CVS has also announced that while it’s not removing CBD entirely, it will remove Curaleaf’s products, and that seems like it might be a sizable consequence.

It’s true that while CBD can be helpful for some people in some cases, its actual scientific efficiacy isn’t yet clear at all (and even a placebo can sometimes seem very helpful anyway). The FDA has promised to release clearer regulation around CBD products, and while the rules aren’t clear yet, they’ve made this one very clear: Companies are not allowed to make medical claims that are unjustified and unproven. Hopefully a few things will happen here: Curaleaf will abide by the FDA’s rules as promised, the FDA can release clearer rules around what can and can’t be said and marketed around the product, and of course, more research can be done into just what the effects of CBD (and eventually cannabis) are, and how they can help people. We’re in an interesting time right now, and with this letter, the FDA has just drawn a pretty sharp line on where they think this market can and can’t go.

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