America’s booming CBD market received a cold splash of reality this week when the US Food and Drug Administration (FDA) issued a letter to Curaleaf, a major US cannabis and CBD brand, warning that some of its product marketing violates the Federal Food, Drug, and Cosmetic Act.
Reaction from vendors and investors was swift and harsh. Within 24 hours the national drug store chain CVS announced it would remove some Curaleaf CBD products from its shelves. Shares of Curaleaf stock fell 8% in a day.
All that happened because of a single warning letter—not a product recall, a tainted batch, or an expose on 60 Minutes. It’s worth noting that the FDA did not warn that Curaleaf’s products themselves were illegal. Rather, it was the way in which Curaleaf marketed the products.
CBD Ties the FDA Into Knots
The FDA currently has nothing to say about the legality or illegality of cannabidiol (CBD). That may change. The agency has fast-tracked a review of CBD products, held a widely seen public hearing on the substance at the end of May, and many are expecting FDA officials to announce some sort of regulatory action by the end of 2019.
The FDA has made one thing very clear about CBD, however. The agency will not tolerate manufacturers making pharmaceutical-like claims about the product. If you claim your product will heal cancer or alleviate pain, and it is not an FDA-approved drug, the agency will come knocking at your door.
Make No Claims
The Curaleaf file wasn’t even a heavy lift for the FDA. According to the warning letter, an agency official simply went to Curaleaf’s website and took notes on the phrases posted.
Here are a couple of the phrases that got the company in trouble:
- “For chronic pain,” on the page for the company’s Relieve brand CBD Disposable Vape Pen
- “Soothing tincture for chronic pain,” on the page for Relieve’s CBD Tincture
The FDA also objected to Curaleaf posting basic health claims about CBD on pages unrelated to products: “Some of the most common reasons to use CBD oil include… Chronic pain… Mental conditions like anxiety, depression, and PTSD…”
It’s a Complex Process
While there are studies and anecdotal evidence indicating that CBD may help some patients suffering from those conditions, it’s not accurate to claim that CBD can cure or offer “quick relief” from all those maladies with just a dose. That’s not to say CBD is ineffective in all cases. It means there’s more complexity involved.
Curaleaf isn’t trying to peddle snake oil. It looks like the company’s marketing and brand design team outkicked their legal coverage while trying to condense complicated information into bite-size phrases that fit in a tweet or on a web page. But at the same time, the FDA hasn’t exactly been hiding their prickliness over health claims made for cannabidiol.
Everybody involved with CBD—from cannabis and hemp growers to entrepreneurs, regulators, and patients—is struggling to handle this new product responsibly and legally. Outside of a handful of legal cannabis states (where CBD is strictly regulated and tested), there are almost no rules to go by.
Curaleaf is not the only company making health claims about its products. It’s likely the FDA went after the Wakefield, Massachusetts–based company precisely because it’s a national brand working with CVS, and the federal agency wanted to make a loud and clear statement to all the other CBD brands out there. A quick scan of the headlines in yesterday’s media will confirm: Mission accomplished.
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