FDA Hearing on Cannabis Products—CBD Takes Center StageJune 26, 2019 – Articles The Legal Intelligencer
There has been an undeniable explosion in popularity and availability of Cannabidiol, better known as CBD, one of the over 100 cannabinoids found in the Cannabis sativa L. plant. The interest in CBD has only picked up steam with the passage of the 2018 Farm Bill. Before the president signed the 2018 Farm Bill this past December, hemp, which CBD is a derivative of, was included in the definition of marijuana in Schedule I of the Controlled Substances Act, even though it is not the psychoactive component in marijuana. The 2018 Farm Bill removed hemp from that definition, making hemp and its derivatives, like CBD, no longer federally illegal to produce, manufacture or sell.
While the president and Congress gave hemp the go-ahead, it is now on the regulators to take the next step. The FDA has authority to regulate cannabis-derived compounds, including CBD, under the Federal Food, Drug, and Cosmetic Act. So far, though, the FDA has not done much regulating in regards to CBD. Other than approving the epilepsy medication Epidiolex, the FDA reaffirmed that any food, drink or dietary supplements infused with CBD are prohibited without FDA approval. The FDA has left topicals, even those infused with CBD, largely untouched. To date, it appears as though the FDA’s primary focus has been on the curative claims companies make about CBD.
The public is not waiting on the FDA though. Despite the FDA’s position, the marketplace for cannabis-derived products, mainly CBD in food and dietary supplements, is growing tremendously, which has created confusion about how to legally market and sell the products. To take its first step on providing some guidance to the confusion, the FDA held its first hearing on cannabis products May 31. While the hearing was technically about all cannabis-derived products and covered the cannabis space overall, the focus was clearly on CBD.
The hearing saw over 100 stakeholders speak on a variety of issues but two things were clear: the FDA has a lot of work to do in order to provide guidance on the confusion and issues surrounding CBD; and the public wants that guidance right now.
Speaker after speaker pushed for the FDA to set up a regulatory framework to legally add CBD to food, drinks and dietary supplements. The speakers were clear that this framework needed to happen now, not years down the road. Megan Olsen, assistant general counsel at the Council for Responsible Nutrition, expressed this position and stated, “Despite the FDA’s current position, the CBD food and supplement marketplace is exploding … the FDA does not have the luxury of time. They must act quickly to address the market that is out of control.”
The problem with establishing a regulatory framework, though, is the FDA’s position on CBD. Considering that the FDA considers CBD to be a “drug,” the Federal Food, Drug & Cosmetic Act prohibits it from being added to human or animal food in interstate commerce. Even though the FDA has the power to regulate exceptions to the law it has been reluctant to pull the trigger on that power. Ned Sharpless, acting commissioner of the FDA, acknowledged that the “FDA has never issued a regulation like that for any substance,” and further added “so, if we were thinking about doing that for a substance like CBD, it would be new terrain for the FDA.”
However, it was evident that not everyone believes this “new terrain” is that daunting. Speakers like Karen Howard, CEO an executive director of the Organic and Natural Health Association argued: “Hemp extract, hemp CBD and derivatives are simply not related to the product it’s being compared to, which is pharmaceutical.” Olsen further advocated that there is already a regulatory framework in place for dietary supplements that could be implemented for CBD if the FDA chose to do so.
There is a real immediate need for this framework. Speakers like Ryan Vandrey, a professor at Johns Hopkins University School of Medicine, noted that quality control regulations should be in place now because there are junk products currently in the marketplace. The lack of standards and regulations have allowed companies to sell cheap imitations and misrepresent to consumers what they are buying. Without clearly defined standards and regulations, consumers do not know how much CBD is in the products they buy, if the products are manufactured safely or what goes into the production. Standardization and quality assurance measures from the FDA were repeatedly called for in order to address these issues and prevent the junk products from hitting the shelves.
Part of the concern with product quality came from a lack of guidance on marketing, labeling and what claims companies can make about their products. There is definitely a feeling that the marketplace is a bit of a Wild West with some companies peddling “snake oil.” Jonathan Miller, general counsel for the US Hemp Roundtable, expressed concern stating: “there are bad products out there. There are products that make false claims. It’s important that the FDA develop standards.” Similarly, Crystal Guess, senior client relations associate for NuLeaf Naturals, expressed the need for guidance on product claims, stating: “We have to educate the public, and a lot of these things can be addressed through labeling and holding these companies with false claims accountable so we can raise the flags.” Overall, there was a clear call from stakeholders for the FDA to establish standards to protect the public.
The need for meaningful CBD research to help protect and benefit the public was at the forefront of many speakers’ concerns. Several speakers, like Barry Gidal, of the University of Wisconsin-Madison, noted uncertainty about CBD. As Ziva Cooper, research director for the UCLA Cannabis Research Initiative, explained: “We’re really in the infancy of understanding the physiological effects of cannabidiol.” There are a lot of questions remaining about CBD, ranging from proper dosage amounts to long-term usage effects, and it was not just the stakeholders that wanted more research. The FDA also had plenty of questions about CBD, particularly with the potential side effects, the adverse reactions, negative side effects and bad interactions with CBD.
Research limitations, however, have limited researchers’ ability to fully investigate these questions. Researches like Sue Sisley, a physician at the Scottsdale Research Institute, voiced concerns over research limitations stating: “Researches need access to options. Scientists need options when it is to embolden scientific freedom.” Igor Grant, of the Center for Medical Cannabis Research at the University of San Diego, echoed that sentiment: “We are rapidly getting behind the curve in terms of what is happening in the real world and what patients are utilizing. We need to take steps to catch up.” Even though there was consensus that more research is needed, there was a frustration expressed about the barriers in place preventing that research. As a result, there were demands for the FDA to step in to facilitate the desired additional research.
Despite the myriad of concerns addressed during the hearing, the FDA had a lot more questions than answers. The FDA set a July 2 deadline for written submissions in response to the issues raised in the hearing. The FDA will then convene a working group to explore how cannabis products may be marketed and sold legally, the impact of those products on public health, and whether new legislation or regulations will be needed. It remains to be seen whether the FDA will ultimately address the issues raised about CBD. Time will tell, but vigilance is required in the interim.
Reprinted with permission from the June 26 issue of The Legal Intelligencer. (c) 2019 ALM Media Properties, LLC. Further duplication without permission is prohibited. All rights reserved.