At present let’s speak about Curaleaf and the trifecta of very unhealthy issues that befell the corporate over a latest two-week span. Then, let’s see what we will study from this brutal sequence.

To recap, between July 22 and August 5, Curaleaf: 1) was hit with an FDA warning letter for “illegally promoting” CBD merchandise and making “unsubstantiated claims” that the merchandise deal with most cancers, Alzheimer’s illness, opioid withdrawal, and ache and pet anxiousness; 2) was hit with a category motion securities lawsuit by a sharp-looking plaintiffs’ agency for making knowingly false and deceptive statements to the investing public, that artificially inflated the value of its inventory; and three) was fined $250,000 by the State of Massachusetts for failing to reveal a change of possession to state regulators.

At this level, Curaleaf administrators and officers are most likely nervous to get away from bed. However it’s all very fascinating for the remainder of us, so let’s break it down.

The FDA Warning Letter

If you’re promoting CBD merchandise and you haven’t learn this letter, you must. It’s right here. As you learn, understand that Curaleaf claims to be the “world’s largest cannabis firm by income and the most important within the U.S. throughout key working metrics.” After which marvel at how ham-handed this entire factor is.

There are two issues occurring right here. First, FDA is chasing Curaleaf for promoting CBD merchandise that aren’t typically acknowledged as protected and efficient (a.ok.a. GRAS) for his or her designated makes use of, and that qualify as unapproved “new medication” beneath the Meals Drug and Beauty Act. Tremendous. We will’t be too arduous on Curaleaf for that: everyone seems to be racing to make and promote these merchandise however FDA coverage. Essentially, the wager firms are making with CBD merchandise is that income upside (objectively massive) will outstrip authorized publicity (subjectively small).

However the loopy half is making these claims. Don’t make these claims. Well being claims for unapproved merchandise are an invite for FDA to put in writing you letters and worse. We’ve been sounding the bell for at the least a number of years on this weblog on that challenge within the particular context of CBD. The truth that an organization the dimensions of Curaleaf was saying issues like “cures most cancers” and “treats Alzheimer’s” in varied media is de facto astonishing, and raises critical operational and governance questions.

An fascinating challenge going ahead will likely be whether or not Curaleaf continues to promote the offending “unlawful” merchandise (like everybody else), however with out making well being claims. Mega-retailer CVS has already pulled a few of them.

The Securities Lawsuit

We coated this one final week, so I’m going to be transient. It’s truthful to say that go well with wouldn’t have occurred if the FDA had not acted, however that’s how this stuff work. The core declare right here is that the FDA letter, attributable to Curaleaf’s actions, brought about Curaleaf’s inventory value to fall 7%, wiping out important shareholder worth in a single day. There are actually different legislation corporations piling on and jockeying to signify class plaintiffs, and Curaleaf should work diligently and creatively to beat again the damages allegations. For what it’s value, the inventory has been muddling alongside since July 23 and as of yesterday, August 13, it closed very close to the place it landed after the short drop.

The State Compliance Boondoggle

The story right here is that the corporate accomplished a merger with out permission, which is mostly a no-no in states with marijuana applications. Massachusetts was about as good as may very well be about it, at the least whereas issuing 1 / 4 million greenback advantageous. The state acknowledged Curaleaf’s “good-faith however mistaken interpretation of the Fee’s rules”, which is a pleasant manner of claiming that the corporate didn’t have unhealthy intentions: it was simply kind of dumb.

As with the FDA claims challenge, it’s arduous to grasp how an organization this huge and with so many sources may very well be so careless. Fairly probably, it’s a case of doing an excessive amount of too quick. Curaleaf closed a inventory acquisition it valued at roughly $875 million final month, and it additionally introduced the acquisition of Oregon’s Choose model a number of months prior for $948 million (this once more was an all-stock deal; one might actually quibble with these valuations). Nonetheless, in state cannabis licensing, compliance is king and there’s no good excuse for breaking fundamental guidelines.


It’s been enjoyable choosing on Curaleaf right here (in full disclosure, I papered a $5 million mezzanine mortgage to one among its latest acquisitions some time again, on behalf of a 3rd get together). It’s additionally essential to take some classes away from this, other than the very apparent “adjust to all the principles” missives. There are two massive ones, at the least for my part.

First, errors are likely to snowball. It might appear tempting to make an unapproved well being declare, for instance, on the speculation that an FDA lecture is the worst potential end result. However an FDA lecture can beget additional and probably extra important complications, together with litigation. Even when Curaleaf had been a $2 million, closely-held firm with handful of traders, there are at all times dangers of fiduciary and management-focused claims.

Second, relating to state compliance, it’s typically not higher to ask forgiveness than permission. Ask for permission, and don’t proceed till you’re very certain that every one is evident. Even in conditions the place cannabis licensees self-report violations, normally and in most states our expertise has been that companies go arduous on violators (and it’s getting worse). Hashish enterprise transactions may be terribly irritating as a result of regulatory delays, however you merely need to plan for it on this trade.

We are going to examine again on Curaleaf in some unspecified time in the future down the road. For now, play it straight as we wind down the summer time.