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FDA puts America on notice: Stop touting CBD claims

July 24, 2019
(CSA-Archive/iStock)
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.

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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.

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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…”

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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.

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CVS Ignores DEA, Says It’s Already Selling CBD Products

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.

Bruce Barcott's Bio Image

Bruce Barcott

Leafly Senior Editor Bruce Barcott oversees news, investigations, and feature projects. He is a Guggenheim Fellow and author of Weed the People: The Future of Legal Marijuana in America.

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  • Jason Warshawsky

    This is why formal scientific testing is needed, which would likely prove many of the claims being made.
    No different than any product that makes medical claims without scientific proof.
    If you can’t prove it (over and above anecdotal evidence) you can’t claim it, whether an herb, a manufactured chemical or water (homeopathic nonsense).
    No conspiracy, no scam, …. just a minor layer of protection for the public that buys things.

    • Serai 1

      Indeed. People like the FDA protecting us against rotten meat or tainted aspirin, but when they turn to Things We Like, suddenly they’re villains. Illogical and self-serving, folks.

    • Bill Lewis

      Did I read you correctly, are you saying the FDA is providing a minor layer of protection concerning cannabis? I disagree there so- called protection is better described as water torture…drip…drip..drip. Anything to obfuscate the healing properties of CBD’s and THC’s.

      That minor layer of protection you mention is exactly how they treat big pharma…you know it and I know it, don’t you think it’s time to grow up and be honest?

  • Eric D. Ryser

    Schedule I is the government touting the claim: “no currently accepted medical use” and “due to high abuse potential not safe to use even under medical supervision.” …which everyone knows is a blatantly false claim about cannabis. Even they know it. So, they can either practice what they preach or stfu as far as I’m concerned.

    • Serai 1

      What you need to do is get on the phone and harangue your representative and senators. Schedule I drugs can only be taken off the list by Congressional mandate. The last vote showed a majority of even Democratic reps voted against it. And they won’t change their minds if they don’t hear from their constituents. So get on the horn, tell your friends to get on the horn, and let the people in Washington know what we want!

  • Aloha. “Marihuana” prohibition is – among other things – a Hegelian Dialectic. It’s a “low intensity war”, a huge, deadly program built on a lie … purposely done to destroy one culture to the advantage of another.

    I give thanks to all those who have grown the seeds and passed along their knowledge to us down through the ages. And thanks to all those who speak-up and stand-up for personal freedom, including this website. Mahalo.

    thc-ministry.org
    the-last-marijuana-trial.com

  • Serai 1

    Yeah, you have to be careful what you claim about your product. If they’d said, “some people claim to have found relief using this for pain”, that would be alright because it doesn’t make a general claim about everybody. It’s really tricky, but it’s important to be within the law. (Of course, who knows how things will go now that there’s an administration dead set on getting rid of legal weed, and packing all the agencies with “experts” who aren’t anything like experts.)

  • Serai 1

    This is not nit-picky. These laws are there for a REASON. You have no idea how many awful products made it to the marketplace, ripping people off, making them sick, and even KILLING them, before the government stepped in and started regulating food and drug industries. If the FDA were not there providing us minimal protection, you’d have no way to know if the thing you just bought – no matter how much you like it – contains something that could make you very sick. (Those ingredient and nutrition labels? They’re only there because they are REQUIRED BY LAW. Yeah, we didn’t have those before the 70’s.) Yes, it’s inconvenient when it’s something you really like, but it’s not “big pharma out to get you OMG”. It’s laws meant to safeguard YOUR LIFE. It just takes a long time to get things to move. Don’t blame the FDA – they neither write laws nor have any power to change them. Get on the phone and yell at your senators and representative. THEY are the ones standing in the way of weed being legal. Anything else is just complaining to the wind.

  • Serai 1

    LOL. Wow. You don’t know any doctors, do you?

  • Bill Lewis

    Did you mean, ARTERIOSCLEROSIS? Hardening of the arteries. Are you using “Cats Claw”?