The Food and Drug Administration is ramping up its collection of data on cannabis-derived products.
To that end, late last week, the FDA quietly released the “Cannabis-Derived Products Data Acceleration Plan” because the growth of the U.S. cannabis product market “continues to outpace the growth in the science and our understanding of the public health implications of these products.”
This isn’t the first time that the FDA has cast its net on data collection. The Administration 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. This included hemp-derived cannabinoids, like CBD, which skyrocketed in popularity. It’s been up to the FDA to craft regulations for CBD products—for humans and animals, for food and cosmetics, and just about everything in between. In the meantime, unregulated CBD products can already be found on the shelves of mainstream stores from coast-to-coast.
The new plan lays out a series of pilot initiatives and partnerships focused on data and technology. These include ways that the FDA can better understand how “safety misinformation” plays into consumer behavior, for example, and where there are opportunities for education efforts. The FDA also wants to identify whether cannabis consumers are replacing prescribed medications with cannabis products, and the “role of human and animal healthcare providers” in “promoting or preventing [cannabis-derived product] consumption.”
On the partnership front, which the FDA emphasized in its plan, the Administration is “developing an inter-Agency scientific agenda for [cannabis-derived products] through a new National Toxicology Program pilot initiative.”
Cannabis-derived products, the FDA noted in its plan, and “other emerging substances present unique challenges to one of the U.S. Food and Drug Administration’s (FDA) core responsibilities: to protect public health by ensuring that products such as human and veterinary drugs, human and animal foods, dietary supplements, and cosmetics meet required safety and quality standards.”
So, the FDA highlighted, to “best protect public health,” the Administration needs “robust information” about “potential safety problems or adverse events associated with FDA-regulated products, including [cannabis-derived products.] The Administration also needs data about how cannabis consumers use different products, emerging trends, and, importantly, the FDA “needs this information in close to real time, so that the Agency can deploy its limited resources quickly and effectively.”
The FDA highlighted in its plan that the Administration is “proactively conducting research in key areas to inform data gaps, including several toxicology, safety, and quality initiatives.” These areas include how CBD impacts male reproduction, and neurological development, how CBD plays in in vivo and vitro toxicity, how transdermal CBD products work, more work on potential risk of liver injury due to CBD use, “characterization of chemical constituents for smoked hemp flower and vaped cannabis products,” and whether labels accurately note ingredients.
But the FDA highlighted, “FDA continues to encourage industry and remind them of their responsibility to develop the needed data, aligned with FDA’s current data standards, to ensure products are safe.”
To say that the cannabis industry has been tapping its feet waiting for FDA rules on products containing CBD and other cannabinoids is an understatement.
But in addition to lacking data, there is another complication: Epidiolex, a cannabis plant-derived CBD extract, which in 2018 became the first product derived directly from cannabis plants to obtain approval from the FDA. The approval was granted to treat the seizures associated with syndromes Dravet and Lennox-Gastaut, or Tuberous sclerosis, a rare condition that results in the development of many, often benign, tumors. Because pharmaceutical compounds—in this case, CBD—cannot be added to foods, this poses a problem for, for example, companies that want to sell CBD beverages.
In December, Joseph Franklin, the policy director for former Principal Deputy Commissioner Amy 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.”