by Vince Sliwoski – Dec 6 2017
via The Portland Mercury
Dear Pot Lawyer,
I developed a medicinal CBD oil. It shrinks cancer tumors, beats back depression, and helps with arthritis, pulmonary issues, and more. What’s the best way to market that, legally?
This is a great question and your product sounds amazing. However, you cannot legally market cannabidiol (CBD) oil as having medical or therapeutic benefits. That is 99 percent the case under Oregon law and 100 percent the case under federal law. Sorry.
The Oregon Liquor Control Commission’s rules on adult use (“recreational”) cannabis provide that “marijuana advertising may not make claims that recreational marijuana has curative or therapeutic effects.” Period. The Oregon Health Authority (OHA) rules contain the same tough language for medical cannabis, “unless the claim is supported by the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner consistent with generally recognized scientific procedures and principles) and for which there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims.” Yes, the OHA rule is long and windy. But the takeaway is that today, there probably isn’t a “totality of publicly available scientific evidence” or “significant scientific agreement” to support a claim that CBD has broadly curative properties as you describe. With respect to your particular product, there is probably no agreement at all.
None of this is to say that your CBD oil does not have healing properties. Many, many people medicate with cannabis and specifically with CBD. But “marijuana” has remained a Schedule I controlled substance for the past half-century. This status has created incredibly high research barriers and scattered findings. Today, most cannabis studies are strictly observational, small-scale, and non-replicated. The large-scale, double-blind, clinical studies that we conduct with other substances are vanishingly rare. And that is a shame.
As restrictive as the Oregon rules are, though, the federal rules are worse. Almost every year, like clockwork, the Food and Drug Administration (FDA) fires off cease-and-desist letters to advertisers of CBD products who make medical claims. If your product label suggests that the substance “is intended for use in the diagnosis, cure mitigation, treatment, or prevention of a disease,” the FDA may send you one of their dumpy letters. Even if you are sourcing your CBD from Farm Bill-permitted hemp, or from Israel or China, FDA may come for you.
Not to pile on, but even if federal research rules were relaxed, it would be difficult to market your CBD oil in the way that you want. The FDA will always regulate claims for non-food substances as if they were pharmaceutical drugs, and pharmaceutical drugs are not broadly approved in the way they once were. For example, most researchers believe that older, general utility drugs like aspirin would never be approved if put to trial today. We all take aspirin and know it’s good for “this and that,” but getting approval to say something as vague as that is almost impossible these days for new products. That includes CBD oil, unfortunately.