CBD is officially a drug now, according to the FDA.
And since CBD is now officially a drug, the FDA will wear the one ring to rule them all. For all the activism, struggling, voter initiatives and farm bills that are successful, it still takes just one little warning letter from the FDA to a company like Curaleaf to kill their business overnight.
We recorded this podcast episode on July 22, 2019, when we got into San Jose for the NCIA #CannabizSummit trade show. The very next morning the FDA sent a warning letter to Curaleaf, the company that supplies CBD products to Walgreens and other heavy hitters in the retail pharmacy space. The FDA letter stated that four of the CBD products were mislabeled and making claims as drugs without testing or approval.
The Curaleaf website has made some changes to it’s verbiage in the past few days, it’s as of yet impossible to know what turns the relationship may take with Walgreens, and what the FDA’s next steps in the CBD marketplace may turn out to be.
When you think you want to sit at the grownups’ table…
At the end of the day, THC producing companies should take notice of the situation, and should pay particularly close attention to the reason that the FDA has decided that they have jurisdiction over the products – because of Epidiolex. If you are not familiar with the product or the story, check it out here. It’s somewhere between fascinating and paint drying, depending on how much information you are looking for and what you already understand about the reasoning that government agencies use when they determine jurisdiction and enforcement processes.
[LISTEN: ‘Best of’ Cannabis Industry Episodes – PODCAST EPISODE]
As the cannabis industry matures, we suspect that this situation will repeat itself more than once. For many years, legal marijuana advocates have played the ‘medical marijuana’ card in order to open retail shops or run delivery services in the vast majority of states that have some form of legalization.
While this may have worked as a stopgap measure to keep the dispensaries open and the growers planting, if the FDA starts recognizing cannabis products – or hemp in this case – as actual drugs, then they will be able to require so many things that the industry absolutely is unable to provide, at least not in an amount of time that is possible while still running a business that isn’t allowed to generate any income or sales.
The Murky Waters of CBD Regulation in July 2019
While the FDA hadn’t issued a blanket statement classifying all CBD products as drugs by July 2019, they did take action against specific companies making unsubstantiated medical claims. This action sent a clear message to the industry about the agency’s concerns.
Curaleaf Gets a Warning Shot:
In July 2019, the FDA sent a warning letter to Curaleaf, a prominent CBD company. The letter highlighted the company’s marketing practices for various products, including tinctures, lotions, and vape pens. The FDA argued that the way Curaleaf advertised these products suggested they were intended to treat or cure various medical conditions like cancer, Alzheimer’s, and chronic pain.
Why the Warning? Classifying by Intent
The FDA’s stance wasn’t a definitive classification of all CBD as a drug. However, they argued that Curaleaf’s marketing claims, which went beyond general wellness benefits, pushed their CBD products into the category of “unapproved drugs.” The 2018 Farm Bill legalized hemp cultivation, but it didn’t address the legality of products marketed with specific medical claims.
The Impact: A Chilling Effect
The Curaleaf warning letter sent a ripple effect through the industry. Companies became more cautious about their marketing language, fearing similar FDA action. This stifled innovation and growth in the industry.
The Remaining Gray Area:
Despite the Curaleaf case, the overall regulatory landscape remained unclear in July 2019. The FDA hadn’t established clear guidelines for the industry, leaving many questions unanswered.
- Could CBD products be marketed for general wellness benefits?
- What kind of research was needed to substantiate specific health claims?
- How would the FDA regulate the potency and labeling of CBD products?
Looking Forward: A Call for Clarity
The Curaleaf case highlighted the need for clear federal regulations on CBD. Consumers were left confused about product safety and effectiveness, and businesses struggled to navigate the murky legal waters. The FDA continued to gather data and hold public hearings, with the expectation of issuing more concrete guidelines in the future.
In Conclusion:
The situation in July 2019 showcased the complexities surrounding regulation. While the FDA hadn’t definitively classified all CBD as a drug, their actions against companies like Curaleaf sent a clear message. The industry awaited further guidance from the FDA to establish a framework that balanced consumer safety with market growth.