Researchers at Colorado State University in conjunction with Caliper Foods have completed the CBD industry’s first human clinical study of commercially available CBD-infused food and supplement product pharmacokinetics, in order to validate the absorption and bioavailability of CBD products.
Published in the medical journal, “Pharmaceuticals,” the study represents the first peer-reviewed investigation of consumer CBD product pharmacokinetics.
Pharmacokinetics (PK) is the science of how bioactives diffuse through the body, and it reveals the difference between what we consume and what we absorb (vs. what we excrete), as well the rate and efficiency of absorption. PK studies are critical to understanding the efficacy of any bioactive compound, including CBD, since a bioactive’s effect is a function of its presence. In other words, you can’t feel what you don’t absorb. PK studies provide the scientific foundation for claims such as “fast acting,” “long lasting,” and “superior bioavailability.”
To date, when CBD product manufacturers have claimed fast action or superior absorption, they have generally based those claims — to the extent they’ve predicated them at all — on mouse studies or analogies to non-cannabinoid bioactives (often curcumin).
Caliper’s study represents the first human clinical substantiation of such claims, as well as the first to do so using commercially available products and an IRB-approved study design. Moreover, with the CBD industry generally mired in fraud and mistrust enabled by the prominent absence of Food & Drug Administration (FDA) oversight or enforcement over the past four years, this study is unique in its academic integrity. Although Caliper provided funding for the study, Colorado State University exercised complete and independent authority over the collection, analysis, and publication of these results.
Conducted by CSU researchers and published in a special issue of the medical journal Pharmaceuticals entitled Cannabidiol: Advances in Therapeutic Applications and Future Perspectives, the study compared the pharmacokinetic profiles of three proprietary soluble CBD formats — Caliper Powder, Caliper Quillaia-based Liquid Concentrate, and Caliper Gum Arabic-based Liquid Concentrate — against two control formats: oil-based CBD tincture and unemulsified CBD isolate, which together power the majority of available consumer CBD products in use today.
The blinded, randomized, crossover study design involved 15 healthy men and women, ages 21-62, each consuming 30 mg of CBD in each product format. Participants provided venous blood samples prior to ingestion, and then at regular intervals over the ensuing four hours. Blood analysis revealed that all of Caliper’s product formats were absorbed significantly faster than either control:
“Caliper’s mission is to make consistent, convenient, and useful CBD products that feature pharmacokinetic profiles with rapid uptake and superior bioavailability — and we back it all up with rigorous clinical research. This study validates that mission,” said Nicole Maione, general manager of Caliper Consumer. “The CBD industry has unfortunately invested far more money into the promotion of unfounded marketing claims than into the research required to substantiate those claims. Caliper cares about the process as much as the data, and we want to move this industry forward by developing clinically-substantiated CBD-infused products that meet their label claims.”
“It’s incumbent upon our company, our industry, and, above all, our regulatory agencies to ensure that consumer products meet the promises made on their labels. That’s why we invested heavily in a well-designed clinical study with a credible academic partner and supported its publication in an open access, peer-reviewed journal,” said Jolene Jacobs, general manager of Caliper Ingredients. “We didn’t conduct this study on mice in a lab. We used real people and real products, and the results provide real-world support for our product’s pharmacokinetic claims. The fact that different product formats exhibited different absorption profiles demonstrates why brands need to base their claims on empirical data rather than empty buzzwords like ‘nano’ when talking about fast action or improved absorption.”
Caliper has expended considerable time and energy battling charlatanism in the CBD marketplace, including lobbying the FDA and Congress to demonstrate their concern for consumers by regulating the ongoing, widespread production and sale of consumer products infused with CBD and other hemp-derived cannabinoids. Caliper has taken the lead in pushing FDA to hold cannabinoid manufacturers to the same baseline standards for labeling accuracy, good manufacturing practices, and claims substantiation that non-CBD food & supplement manufacturers have operated under for decades.
“In their well-meaning search for better data and real world evidence, the FDA has unfortunately opted for delaying the regulatory process time and again in the alleged pursuit of enacting perfect regulation in the future over the necessity of enacting basic regulation today. The regulatory delay has, and will continue to, endanger consumers,” said Justin Singer, CEO of Caliper Foods. “We agree that real world evidence is important, which is why we’ve long urged the FDA to impose the same labelling and manufacturing requirements on hemp product manufacturers as they do on other foods and supplements. You can’t trust consumer reports of CBD usage unless you can trust the veracity of the labels on the products. As the FDA has amply demonstrated, label fraud is rampant in the CBD industry. At the same time, good manufacturing practices — the bedrock of modern food safety policy — remain unenforced, unmonitored, and unheeded by the FDA. Meanwhile, in the more than 24 months since Congress legalized the widespread production of hemp and hemp-derived cannabinoids, the FDA hasn’t lifted so much as a finger to enact basic consumer protections against fraud and unsafe manufacturing practices for consumer products. The consuming public deserves better.”
“More than 20 million Americans use CBD daily, and trends show that number continuing to rise,” says Dr. Christopher Bell from Colorado State University. “But there is so little we understand about CBD and how everything from product format to individual physiology can affect circulating blood concentrations over time. The industry simply lacks basic scientific research and substantiation. We partnered with Caliper because they share our drive to better understand CBD and its effects on the human body, which was why testing with humans — and publishing the results in a peer-reviewed journal — was essential.”