Charlotte’s Web, the biggest U.S. marketer of hemp-derived CBD products, is among seven companies that has committed to participate in an industry-wide study to measure the effects of CBD on the human liver.
Researchers will study the effects on the liver from daily use of full-spectrum, hemp-derived CBD, as well as CBD isolate, in healthy adults—with a minimum participation of 700 consumers.
The human trials could help answer safety questions for FDA officials, who are continuing to examine potential pathways for the lawful marketing of various CBD products in the U.S.
FDA has raised certain safety concerns related to CBD, including its potential to cause harm to the liver. But the pending research could bolster the arguments of hemp industry executives, who have reported the agency’s liver-related concerns are based on taking a CBD isolate (in drug trials conducted by GW Pharmaceuticals plc) containing far greater quantities of CBD than found in many broad- or full-spectrum hemp extracts on the market.
"The marketplace for CBD-containing products is quickly evolving and it is critical to develop high-quality data to close the knowledge gaps about the science, safety and quality of many of these products, as well as further evaluate any potential benefits outside of the one FDA-approved drug product to treat two rare, severe pediatric epilepsy disorders," an FDA spokesperson said in an email. "We welcome reliable and high-quality data and will continue to engage with stakeholders who want to work toward this goal."
Colorado-based ValidCare, a provider of clinical research outsourcing and consumer intelligence solutions for the consumer packaged goods and life sciences industries, is spearheading the CBD study.
“The research is so important because hemp-derived CBD is being used by millions of American consumers each day, despite FDA's concern that a real liver safety issue exists,” Patrick McCarthy, co-founder and CEO of ValidCare LLC, said in an email. “This study at a minimum should help confirm or qualify FDA's concern. The data will also instruct FDA and product companies about use, safety and effect of product formulations on a broad population.”
Researchers plan to first collect evidence from healthy adults in the U.S. who have consumed oral CBD products for at least 60 days. “Measures include reported product experiences and a blood sample to understand how the consumer’s liver reacts,” according to ValidCare’s news release announcing the research.
ValidCare expects the study to commence in the third quarter of 2020 and be completed by the end of the year.
“This data will be combined with personal history, blood tests and product data to provide investigators with the opportunity to understand multiple variables across populations, products and lifestyles,” the release explained.
Regulators value these types of studies, said Tim Orr, vice president of innovation at Charlotte’s Web, who noted many animal safety studies have already been conducted. In March, Charlotte’s Web announced an expert panel concluded its full-spectrum hemp extract is GRAS (generally recognized as safe) for use in certain foods.
“Animal studies are important, and we’ve done our own studies to self-affirm GRAS … so we feel very confident about the products that we have,” he said in a phone interview. “There’s still not enough that’s been done on the human side.”
Charlotte’s Web, whose sales far exceed those of most other brands, offers CBD in various product categories, including capsules (15 or 25 mg of CBD per capsule), gummies (10 mg CBD per serving) and tinctures (up to 60 mg/mL, with ability to customize a serving and obtain 15 mg by taking ¼ dropperful).
Asked to what extent the ValidCare study would give FDA comfort to move forward with a rulemaking on CBD, Orr acknowledged FDA “is hard to read.”
But he added, “As we continue to add more information to specifically address the areas where they have concerns—in this case liver toxicity—I think they’re going to get closer … with recommendations and a path forward.”
An FDA spokesman, Nathan Arnold, recently said his agency is "working toward a goal of providing additional guidance" related to marketing CBD for various products and has "made substantial progress.”
Other participants in the forthcoming study include Boulder Botanical & Bioscience Labs, CBDistillery, CBD American Shaman, Columbia Care, HempFusion and Kannaway.
“At this time, the FDA continues to assert that, without additional data from qualified experts, they’re unable to develop an appropriate regulatory scheme specific to CBD,” said Chase Terwilliger, CEO of CBDistillery, in ValidCare’s press release. “That’s why continued data collection is vital for all parties involved and why, as a group, we’ve engaged industry and academic experts to develop the study protocol. We are confident in our products and processes and are committed to consumer safety. This data will help pave the path forward for our industry.”
McCarthy confirmed each of the companies has contributed more than $100,000 to the research. An industrywide study, Orr of Charlotte’s Web explained, enables the companies to achieve “efficiencies” and bring in more participants than if his employer conducted the study independently.
“There’s real value in us working as an industry on this,” he said.
ValidCare divulged screening more than 100 brands to participate in the research. The reasons other brands didn’t participate in the study, McCarthy noted, were related to one or more factors, including a dearth of funds (over 50%), a belief FDA won’t “act on the data” and concerns that asking customers to participate could “scare” them.
Companies also reported plans to conduct their own studies as part of an investigational new drug (IND) application to obtain FDA approval for products, and the “brand or processor doesn't think it was their job to do research (~20%) or that FDA should treat CBD from hemp as a supplement and allow GRAS,” McCarthy explained via email.