Just a few weeks ago, Curaleaf Holdings (“Curaleaf”) announced that it would pay $875 million, mostly in stock, to acquire a Chicago based cannabis company, Grassroots. (See here.) This followed news in May that Curaleaf had reached a nearly $1 billion all-stock deal with one of Oregon’s biggest cannabis companies, Cura Partners, Inc. (See here). These deals made Curaleaf one of the world’s largest marijuana companies, if not the largest.
The FDA told the cannabis company earlier this week that it was ‘illegally selling’ CBD products with ‘unsubstantiated claims’ that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety.”
The article explains that in response to the FDA warning letter, Curaleaf (wisely) scrubbed its website and social media accounts of health claims about its CBD products. How and why a company of this size was making these types of claims in the first place, however, is truly puzzling.
We have written extensively about the FDA’s increasing intolerance for companies making “over the line” health claims about CBD and warned that retailers ought to be concerned about selling hemp-derived CBD in cosmetics. Yet everywhere our CBD business lawyers go, including in our Washington, Oregon and California offices, we see products extolling the benefits of CBD for nearly any kind of ailment – whether it affects adults, children, or pets. Although the FDA’s enforcement against businesses making health-related CBD claims has not been universal, that doesn’t make its warning letters without force as Curaleaf has learned. (Even if consumers don’t appear overly concerned.)
As a result of its claims about CBD and the subsequent warning from the FDA, Curaleaf now finds itself on the wrong side of a class-action securities complaint that was filed on August 5 in the Eastern District of New York, Michael Skibbe v. Curaleaf Holdings, Inc. et al., No. 1:19-cv-04486. The complaint alleges violations of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated by the SEC. (Feel free to email me if you’d like a copy of the lawsuit).
The gravamen of the lawsuit is that Curaleaf violated federal securities law by making knowingly making materially false and misleading statements to the investing public that artificially inflated the market price of Curaleaf securities. The complaint quotes liberally from Curaleaf’s press releases and audited financial statements concerning its line of hemp-based CBD products. These include statements such as:
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CBD has been shown in initial third-party studies to support a pet’s overall wellness including the potential to help manage pain and anxiety.
Our human customers are already reaping the benefits of CBD with Curaleaf Hemp. The same care and research went into the development of Bido. We are excited to be extending our high quality, trusted products to pet owners,” said Joe Lusardi, President and Chief Executive Officer of Curaleaf. “The launch of Bido is just one more way we are the most accessible cannabis company in the U.S.”
These statements and others drew the ire of the FDA. The FDA letter warns Curaleaf that some of the CBD products it sells are classified as “drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), 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.” The FDA letter goes on to say that Curaleaf is wrongly marketing CBD products as “dietary supplements . . . because they do not meet the definition of a dietary supplement under sections 201(ff)(3)(B) and 201(ff)(2)(A)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B) and 321(ff)(2)(A)(i).” And finally, the FDA letter takes issue with Curaleaf’s marking of “Bido CBD for Pets” line of products.
The FDA letter, says the complaint, caused damage to investors when shares of Curaleaf fell 7.27% on July 23, 2019. The plaintiffs now seek to represent a class of “all person other than defendants who acquired Curaleaf securities” between November 18, 2018 and July 22, 2019 with damages to be calculated at trial. Will this lawsuit mark the end of Curaleaf? Probably not, but my guess is that Curaleaf won’t get rid of it for pennies.
Once again: regardless whether your company is publicly traded, your company is at risk if you are making claims about the therapeutic value of CBD products. Setting aside Curaleaf, companies making health claims about CBD may be subject to claims arising under state laws prohibiting unfair and deceptive trade practices, or under the federal Lanham Act for false and misleading advertising, or even run-of-the mine personal injury claims allegedly caused by your product.
So ask your hemp-CBD regulatory attorneys to review your marketing and merchandising materials before you find yourself on the wrong side of a lawsuit. And take their advice! Curaleaf probably wishes it had done exactly that.