FDA: The Cannabis Regulatory Landscape is “Complex”

The path for federally-regulated cannabidiol isn’t getting any clearer. 

regulation was in the spotlight during a Food and Drug Law Institute symposium last week. The online event focused on the interplay between federal, state and local regulation, on equity, and on the Food and Drug Administration’s efforts to gather more data on CBD as a food ingredient and dietary supplement.

To that end, April Inyard Alexandrow, the science and coordinator for the FDA Cannabis Product Committee within the Office of the Commissioner, spoke about the agency’s expanding and evolving work in this area. Alexandrow stepped in for Douglas Throckmorton, deputy director for regulatory programs at the FDA, who was called away to testify in Congress. 

“Rest assured I am at the central point of contact for all cannabis related issues and inquiries,” Alexandrow said. “Complexity” was the broad theme of Alexandrow’s presentation, because it’s a “completely appropriate word to codify the cannabis regulatory landscape.” 

Alexandrow gave a sort of historical overview, noting that since Congress passed the 2018 Farm Bill, which legalized cannabis plants with .3% THC or less, defined as hemp, the FDA has “evaluated cannabis-derived products, including those that contain cannabidiol or CBD, just like any other products we regulate,” but noted that there are areas “where we still need to make progress.” 

“I want to acknowledge that FDA is not alone in this and that many of you all are working toward better data to support and shape better regulatory for this industry, which has demonstrated and continues to demonstrate so much potential,” Alexandrow said. 

The FDA published a “Voices on Policy” update in January that reiterated the FDA’s need for more — and better — cannabis-related data. FDA officials pointed out in their post that 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.” 

Alexandrow described how the CBD landscape boomed following the passage of the Farm Bill, leading to more sales in places like grocery stores, wellness centers, and online.

“Now that hemp is no longer a Schedule I controlled substance, there’s been increased attention to FDA’s role in regulating these products. Cannabis derived products, hemp in particular, has garnered tremendous public and agricultural interest because it can be used to produce so many things and contains a variety of constituents that offer therapeutic potential,” Alexandrow said. 

But, Alexandrow cautioned, the FDA has not approved the cannabis plant for any condition, and has only narrowly approved GW Pharmaceuticals’ Epidiolex, a cannabis plant-derived CBD medication,  for Dravet syndrome and tuberous sclerosis, for example. Marinol, a synthetic THC product, has been available by prescription for decades. 

“The body of evidence supporting such use outside of the context of these approved intended uses is limited, and the associated safety profile of these constituents, likewise incomplete,” Alexandrow said. 

And major questions remain, like: what are the potential adverse reactions? And what are the implications of long-term cannabis consumption? These are some of the questions that the FDA is seeking to answer through data. And while the FDA has made “progress,” there are gaps in understanding. 

The FDA has, as a result, reopened the window for public comment on scientific information about products containing cannabis or cannabis-derived compounds. The FDA has also issued draft guidance on cannabis research and drug development, and “participated in a number of listening sessions with stakeholders.” 

And, in October, the FDA 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.” 

“We’ve continued our efforts to obtain research data and stakeholder input in a way that protects public health and maintains incentives for the development of drugs containing cannabis or cannabis-derived compounds,” Alexandrow said. 

Efforts to collect data on cannabis doesn’t extend only to human use, but animals, too. But the questions that the FDA is grappling with around cannabinoids in animal feed are different than for humans, for a few reasons. One, animals can pass the “ingredient” through dairy, meat, or eggs, Alexandrow said. And animals also have a less varied diet, meaning a new ingredient could have an outsized impact. (Read Cannabis Wire’s explainer of the hemp in animal feed debate.) 

In May, the University of Tennessee Institute of Agriculture at the University of Tennessee Knoxville hosted the 2021 Hemp Products and Animal Health Conference, which covered a variety of hemp and cannabidiol-related topics, often circling back to the lack of data. 

“Hemp has been, accidentally, a special focus of mine over the last few years,” said Charlotte Conway, Deputy Director in the FDA’s Division of Animal Feeds, at the time. “This is something that I’ve spent a lot of hours talking to people about, and I’m getting very hopeful that we’re headed down the road to seeing some hemp-derived ingredients approved for use in animal food.”

Still, plenty of CBD products are on shelves for both humans and animals with labels spouting claims that are not backed by research. These products have not been evaluated for efficacy, drug interactions, or dosages. The claims made on these CBD labels could, Alexandrow said, prompt someone to use these products instead of seeking “proper” medical treatments. 

“The FDA continues to monitor this marketplace and will take action as needed when we encounter violations that misinform consumers and put them at risk,” Alexandrow said. 

The FDA and the Federal Trade Commission have issued warning letters along these lines. The FTC launched Operation CBDeceit last year, which was the Commission’s most sweeping action against CBD sellers to-date, with a focus on six companies that made “a wide range of scientifically unsupported claims about their ability to treat serious health conditions, including cancer, heart disease, hypertension, Alzheimer’s disease, and others.” 

While foods, supplements, and cosmetics, unlike drugs, don’t “in many circumstances” need FDA approval to enter interstate commerce, Alexandrow said, there is “an exception I’d like to think about with respect to CBD.” That is, food additives. 

“Before a substance is added to food, the FDA must determine it to be safe for specified conditions and approve its use as a food additive, unless the use of the substance is generally recognized as safe,” or GRAS, she said.

CBD is not considered GRAS, in part because of lacking data around general safety and pesticides. 

There are two other complicating factors. Because CBD has been approved by the FDA as a drug, in the form of Epidiolex, adding it to food is “prohibited” under the Food Drug and Cosmetic Act. A compound also can’t be added to food if it’s been subject to clinical trials, which CBD has. 

“FDA does have the authority to allow CBD in foods or dietary supplements through notice and comment rulemaking. To date, we have not issued or proposed any such rule. Among other things, we are considering whether there is adequate evidence to demonstrate that CBD could meet the legal safety standards for dietary supplements or for conventional foods,” Alexandrow said. 

Alexandrow shifted to delta-8 THC and the FDA’s concerns. In September, the Centers for Disease Control and Prevention issued its first health advisory on delta-8 THC, with the FDA also publishing a consumer update on the topic. 

“From a public health perspective, FDA not only has concerns about CBD, but also about emerging cannabinoids that pose a potential safety risk,” Alexandrow said. 

Finally, Alexandrow emphasized the need for partnerships and collaboration, both of which were extensively highlighted in the FDA’s Cannabis-Derived Products Data Acceleration Plan. 

“As the marketplace shifts, we need better data and better tools to ensure we can take this proactive approach. There are so many possibilities for this industry beyond the current state, but the complexity of this market and its continuous evolution require the establishment of collaborative opportunities to develop the science and to address outstanding safety concerns systematically and strategically,” Alexandrow said. 

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