United States: FDA Warning Letter Ruins Curaleaf's Mellow Buzz

Administration says cannabis product company is offering drugs – the medical kind

Cool-Hand Cream

If you’re of a certain age, the Curaleaf website is something to marvel at.

Go back a few decades – we won’t get specific for fear of dating ourselves – and it would have been difficult to imagine that the sale of marijuana-derived products would ever be so … corporate. But today we have Curaleaf and its competitors, companies with slick, vibrant web presences, corporatese marketing copy and staid packaging that would blend in on the shelves of any Whole Foods store.

Mainstream cannabis products have arrived – with all the countercultural disruption of a designer soap.

Curaleaf offers a wide assortment of CBD-oil-derived personal care products in a robust online store, including complexion creams, massage oils and lip balms. But the section of the company’s website dealing with its “premium mainstream cannabis brand” – vaporizer oils, lozenges and edibles – is just one quiet page sorely lacking in detail. Why so quiet?

Here Comes the Fuzz!

It’s a sign of the times that a cannabis product company’s main struggle with the Feds involves the Food and Drug Administration (FDA).

In late July, the FDA delivered a warning letter to Curaleaf calling it out for a number of branding and labeling issues.

First, it rounded up several Curaleaf products – oils, tinctures, vape pens and so on – as new, unapproved drugs because “they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.” According to the FDA, Curaleaf was claiming the products could address chronic pain, anxiety, ADHD and opiate withdrawal symptoms, as well as diseases such as Parkinson’s and Alzheimer’s … it’s a long list. (The FDA claimed that Curaleaf was similarly pushing new, unapproved drugs for animals as well.)

The FDA also alleged that the labeling on the products “failed to bear adequate directions for use,” since it was addressing “conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners.” Finally, it criticized Curaleaf for possibly marketing the products as dietary supplements. Because CBD is an active ingredient in an already approved drug product, it is not currently approved for any use in a dietary supplement or conventional food. So far, however, the FDA and Federal Trade Commission have limited their enforcement efforts to cases such as this one, in which the advertiser is representing that CBD can treat serious diseases such as Parkinson’s.

In response, Curaleaf released a statement that it’s cleaned up its act, removing all the claims identified by the FDA from its website and social media platforms.

The Takeaway

As we noted in an earlier blog post, the FDA is taking its time developing a full regulatory approach to CBD products. It held a public hearing on the matter in May, for which the public comment period recently closed. But it is moving forward; Curaleaf’s warning letter isn’t the first, and it’s not likely to be the last.

But until the FDA firms up its regulatory strategy, advertising will be fraught for any company that develops new CBD-related products – and that’s a lot of companies.

It’s not simply that the FDA hasn’t fully defined its own philosophy on the subject; in the absence of fully fleshed-out federal regulation, there’s a mix of enforcement at the state level as well. Consider New York City’s embargo of food or drink products containing CBD, which matches the FDA’s position on dietary supplements and foods, or California Assembly Bill 1417, which mandates disclosures in cannabis product advertising. If that weren’t enough, consumer actions against cannabis corporates are also on the rise – in a masterpiece of irony, a trucker is suing a cannabis company over CBD products that allegedly caused him to fail a drug test.

For the time being, marketing in the cannabis-product marketplace is going to be treacherous. Companies need to exercise caution when marketing new products, veering away from making drug claims. All these efforts need to be keyed to the jurisdictions where sales are taking place and the ongoing steps taken by the FDA as it moves forward to a final position.

If only we could think of a way to relax.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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