The new collaboration is made up of seven companies making CBD products: Boulder Botanical & Bioscience Labs, CBDistillery, CBD American Shaman, Charlotte’s Web, Columbia Care, HempFusion, and Kannaway. The brands have agreed to cooperate in an observational safety study that will be managed by Centennial, CO-based firm ValidCare, which says it provides ”clinical research outsourcing (CRO) and consumer intelligence solutions for the consumer packaged goods (CPG) and life sciences industries.”
Along with its end user touch points and market intelligence, ValidCare provides an online platform to help researchers more cost effectively recruit subjects for studies and manage their interactions with them. This platform will be used to conduct the CBD study in question, whose aim is simple. It’s to answer the question, is this stuff safe?
FDA’s need for more data puts a brake on process
More than a year ago FDA convened a public meeting in Washington DC to hear from hemp industry stakeholders. Its goal was to gather information to help it comply with the wishes of Congressional lawmakers including Senate Majority Leader Sen. Mitch McConnell, R-KY, who have called on the agency to create a legal pathway to market for CBD products.
During the day-long meeting last year, officials heard from dozens of speakers, including Igor Kortubash, PhD, of the University of Arkansas School of Pharmacy. Kortubash reported on a toxicity study his group had done on CBD that found markers of liver damage at high doses. Judging by the questions addressed to Kortubash, his findings made a big impression on FDA officials.
FDA promised quick action in the wake of the meeting, but even before the advent of the pandemic crisis that is dominating the agency’s resources the process seemed to have stalled and to date no decisions have been made. The communications the agency has put out in the meantime have been viewed by stakeholders as signaling incremental progress at best.
One of the main hangups appears to be FDA’s expressed need for more data on the products. The agency has reopened the federal docket that was first put into place of May last year with additional safeguards to protect trade secrets in an attempt to attract more submissions from industry.
Now the new CBD coalition has stepped forward to try to provide some of the hard data FDA says it needs and to assuage some of FDA’s concerns about whether the products in the marketplace provide a large enough margin of safety.
Toxicity, perhaps, but at what dose?
Rosemary Manzanet, MD, chief science officer of Columbia Care, a dispensary chain that offers a line of CBD supplements, said having an approved drug in the field — Epidolex manufactured by GW Pharma — that has liver warnings on its label has complicated the discussion of the safety of run of the mill CBD supplements. The data from the study done by Kortubash’s group seemed to have thrown fuel on that particular fire.
“There is this lingering question about the safety of CBD products. That goes back to Epidiolex which, when used in very high doses such as 10mg/kg of body weight, can have some liver issues,” Manzanet told NutraIngredients-USA.
“Most of us out there making consumer products are using dosages of less than .5mg/kg. For the ‘normal’ person, they are not taking 700 mg a day of CBD. They are taking more like 30 mg. We want to make a case that this is not a concern at the dosages we use in our products,” she said.
Patrick McCarthy, CEO of ValidCare, said the idea originated with his firm and was developed in collaboration with FDA. He said when he broached the possibility of such a study with the agency officials there seemed eager to have it go forward. McCarthy then sought out companies in the space to cooperate in the venture.
Large scale study
The study, which is planned for the third quarter of 2020, will aim to recruit as many as 700 subjects. Consumers using the products of the companies in question will be offered an opportunity to participate via ValidCare’s mobile phone app, which will collect basic information such as health history, which products they use and how much they take. At the end of the study, participants will be required to submit to one blood draw at a cooperating lab which will assess liver function markers and other end points.
“We expect to go live sometime in July, when a recruitment phase will start. Folks will journal their use of the products for 30 days and then there will be a five day window to get the blood draw done,” McCarthy said.
“We hope to finish no later than the end of September or sometime in October,” he added.
McCarthy said the raw data would be shared immediately with FDA and publication in a peer-reviewed journal as quickly thereafter as possible.
The study will include a wide variety of subjects, including some who are using CBD products to treat diseases, such as seizure disorders. It will also include a wide array of products. This will provide a broad range of data which McCarthy anticipates will be highly useful in shedding light on the CBD safety question.
“I really think this could be a watershed for this industry,” he said. “We have got competitors working together in a cooperative environment.”
Columbia Care’s Manzanet said she hopes the data that arises from the study will help FDA come to a quicker decision on the regulatory status of these products. The extra-legal nature of the marketplace today has allowed a diverse mix of companies with different standards and competencies to proliferate.
“A lot of people are benefited by CBD and we want to make sure that they can continue to get it,” she said. “We want to have some clarity as to how FDA sees these products. We want CBD to be in some bucket. No one wants to be out of compliance.”
"We want to send the message that we are one of the good guys and we are trying to do the right thing,” Manzanet added.