When it comes to “real world data” about cannabidiol, or CBD, use, there just isn’t much.
That was a focal point of a “Voices on Policy” update published on Friday by FDA Commissioner Stephen Hahn and Principal Deputy Commissioner Amy Abernethy. The update comes as Hahn, Abernethy, and others at the FDA finalize long-awaited rules that will determine the future of the booming CBD industry in the US.
The FDA has been collecting information about CBD since shortly after the passage of the 2018 Farm Bill, which legalized hemp, defined as cannabis plants with .3% THC or less, which is abundant in CBD. It is the FDA’s responsibility to establish regulations for CBD products—for humans and animals, for food and cosmetics, and just about everything in between. Complicating the FDA’s task in developing rules for CBD is the reality that unregulated CBD products can already be found on the shelves of mainstream stores from coast-to-coast.
The post from Hahn and Abernethy doesn’t provide a timeline or any other concrete details about what those rules will contain, nor does it indicate whether the FDA plans to collect a specific amount of data prior to publishing those rules. Nonetheless, the post lays out in perhaps the clearest terms yet the robust research on CBD and humans that the FDA believes is necessary and hopes to facilitate.
The FDA has so far been focused on two main paths to “develop better information on CBD”: engagement with stakeholders and “sampling and testing” of CBD products already on the market. But when it comes to fully understanding CBD use and its related safety, the FDA officials pointed out in their post, much of the existing CBD data consist of “spontaneously reported adverse events,” whereas “more systematic data collection and analysis will be crucial for understanding relative safety risks.”
“We think that real-world data (RWD) on CBD use and safety has a crucial role alongside data from other types of studies to fill in the current gaps in our understanding,” they wrote, emphasizing that real-world data “may identify new potential adverse events or subpopulations of CBD users that should be the focus of follow-up studies.”
Among the key questions that the FDA has identified: What “specific products” are most often used? When people consume CBD, what other products (like over-the-counter or prescription medications) are they also using, and what are the risks associated with combining CBD products with others? Also, because the popularity of CBD has so recently surged in the United States, data collection systems “may not yet have specific codes that can precisely identify specific CBD products,” the FDA officials noted.
The FDA is seeking to obtain this “crucial” CBD data through partnerships, and pointed to COVID-19 to show that data can be collected rapidly if the right collaborations are formed.
“We see a critical opportunity for the FDA to work collaboratively with partners in government, industry, and academia to develop the foundation for more robust CBD data collection and analysis projects,” they wrote.
The FDA plans to use existing data systems, like poison control databases or electronic health record systems, to build out data on CBD-related adverse events, for example. The FDA also plans to collaborate to create an “open, opt-in registry for users of CBD,” while evaluating data to extract information about safety risks while still protecting consumer privacy data.
As many federal leaders have conceded, when it comes to CBD, the toothpaste is already out of the tube.
“Although the 2018 Farm Bill expressly did not change the FDA’s authorities regarding the regulation of CBD and other cannabis derivatives, the fact that these substances are no longer controlled substances has triggered increased interest in and availability of these ingredients for commercial development,” Hahn and Abernethy acknowledged in their January 8 post.
To say that cannabis companies care about the FDA’s forthcoming regulations is an understatement. More than a dozen companies met with the FDA and the White House last fall to discuss the draft enforcement policy on CBD products. Once the White House Office of Management and Budget signs off, the enforcement policy will provide the most robust framework to-date for the regulation of these already-mainstream products.
The Council for Responsible Nutrition, a Washington, D.C.-based trade and lobbying group, criticized the FDA for dropping the notice as a news dump, “late in the day, late in a week that has seen a national crisis,” adding that it was “nothing more than an end-of-Administration desk-clearing exercise from an FDA that has failed to lead in this crucial policy area.”
The “FDA’s essay on data quality misses the point entirely – and fundamentally misunderstands how [Dietary Supplement Health and Education Act of 1994] works. As a botanical, under DSHEA , the presumption in the law actually runs the other way. Put plainly, consumers should have access to CBD dietary supplement products absent some reason shown why they should not,” Steve Mister, the president and CEO of CRN said in a statement. “FDA could fix this problem today by exercising authority it is clearly given in the law, and immediately enforcing the full array of FDA dietary supplement regulations on the CBD dietary supplement industry.”
One concern shared by both the FDA and responsible players in the CBD industry is that many CBD products on the market today, even those sold in mainstream stores, are mislabeled, untested, and boast unproven claims.
In a recent research article published in the peer-reviewed Journal of Food Composition and Analysis, FDA researchers tested CBD products and found that many CBD products contained CBD concentrations that didn’t match the label. The researchers tested 147 product samples labeled as containing hemp or CBD. They found 11 cannabinoids, but also, “fewer than half of products surveyed contained cannabidiol concentrations within 20% of their label declarations,” researchers noted. “These findings emphasize the need for further testing and representative investigation of the cannabidiol marketplace.”
In December, Joseph Franklin, the policy director for Abernethy, spoke at a virtual conference on cannabis and cannabidiol hosted by the Food and Drug Law Institute, a non-profit founded in 1949 and based in Washington, D.C.
During the conference, Franklin noted that there remain many unknowns with CBD, including potential interactions with prescription drugs, issues with male reproductivity, and CBD use in special populations, like people who are breastfeeding. The FDA, he said, is “like a broken record at this point” in its calls for “more data.”
“At that time, FDA very quickly recognized that it needed to become much more active in the CBD-related space, and cannabis space more generally,” Franklin said. “We quickly issued public statements and put together internal processes to start developing the science and developing policy on CBD in cannabis.”
