How Will FDA Bring Order to the Wild West of Cannabis Regulations?
By Frederick R. Ball and Carolyn A. Alenci, Duane Morris LLP
Edited by William A. Garvin, Buchanan Ingersoll & Rooney PC
The cannabis industry is the next frontier, growing rapidly and becoming one of the highest grossing industries in the country. The problem is, through no fault of its own, it is also the “wild west” of industries in many ways operating without guidance or regulation from the federal agencies that have jurisdiction of its products.
On May 31, 2019, the U.S. Food and Drug Administration (FDA) held a public hearing to allow stakeholders to share their experiences and challenges with cannabis or products containing cannabis-derived compounds. For this hearing, FDA requested information, scientific data, and stakeholders’ views on the safety of CBD-containing and cannabis-derived products. FDA hoped to obtain input on possible strategies that will allow for lawful marketing of CBD-containing and cannabis-derived products in a predictable and efficient manner, while still providing incentives for drug development with CBD and cannabis-derived compounds. Over 100 academic, industry, medical, and consumer stakeholders spoke or gave presentations at the hearing to a packed audience of about 500 attendees. In addition, over 1300 written comments have been posted to the FDA’s public docket FDA-2019-N-1482 for this hearing.
The hearing opened with remarks from Acting Commissioner Dr. Norman Sharpless. As expected, he made no new announcements about FDA’s current thinking about regulating products containing cannabis or cannabis-derived compounds. He did restate the FDA’s current position that CBD and THC cannot lawfully be added to a food or dietary supplement and that FDA does not have a policy of enforcement discretion with respect to these products.
After Sharpless finished his remarks, the presentations from stakeholders began. It was clear from the FDA panel’s questions to the presenters that FDA is looking for as much data from as many sources as possible to gain a better understanding of the safety and efficacy of cannabis-derived products. In particular, FDA’s repeatedly sought data and feedback concerning dosing of these products and, more specifically, how that was determined. Similarly, FDA asked questions about how different routes of administration affect the safety of the products, and how they function in the body based on these various routes of administration. For example, with respect to cosmetics, FDA inquired whether there was any data on how CBD or other cannabis-derived compounds are absorbed and how they function once absorbed through the skin. FDA also questioned stakeholders on data regarding interactions between cannabis/cannabis-derived compounds and other drugs and any documented side-effects or adverse event reports. With its public health mission close at heart, FDA also sought feedback and data on how cannabis and cannabis-derived compounds affect certain patient populations, such as pregnant women and children.
Academics who spoke made it clear they would like to satisfy FDA’s thirst for data. In fact, they want to help FDA obtain that data. Unfortunately, the current regulatory landscape does not allow easy access to high-quality cannabis products. As such, academia’s primary request was to reduce the barriers to research under the current regulations to allow for them to conduct the research required to generate the data that FDA is requesting.
FDA’s desire for voluminous amounts of data before moving forward, however, is in tension with industry stakeholders, who want prompt and expedited regulations. Many of the industry stakeholders believe that cannabis and cannabis-derived compounds should fall within the dietary supplement and food additive guidelines. But this is in direct contradiction to FDA’s current position that cannabis and cannabis-derived compounds were not in legal use before the 2018 Farm Bill descheduled hemp and hemp-derived CBD. Further, industry and academic stakeholders could not agree on how to develop a risk-based approach based on available science to develop an appropriate framework for FDA to regulate cannabis and cannabis-derived compounds. Nevertheless, industry believes that, at a minimum and to move things forward more quickly, FDA should rely on the dietary supplement framework to regulate hemp and hemp-derived CBD. Industry is willing to file applications for treatment as a New Dietary Ingredient (NDI) and for generally recognized as safe (or GRAS) status if FDA would allow them to pursue that path. However, it is not clear that sufficient data currently exist for either of those pathways.
Based on the FDA panelists’ questions, one of the key concerns and struggles FDA has is whether deregulating cannabis and cannabis-derived compounds could affect the incentive for research on these products as drugs. Of course, industry and academics alike deny that having products containing cannabis on the market would hurt research. For instance, cannabis is currently being sold in various states and around the world, but companies continue to file investigational new drug applications and protocols for clinical trials on drugs containing cannabis. In fact, when you run a search on clinicaltrials.gov for the key word “cannabis,” there are over 800 hits. Further, even if cannabis-derived compounds, such as CBD, were allowed to be a dietary supplement at lower doses, there is still incentive to research its uses as a drug product at higher doses. Some stakeholders even argued that if FDA does not provide a mechanism to market cannabis-derived compounds, such as CBD, outside of the new drug application process, this will just fuel further black market sales and perpetuate the sale of low quality, potentially contaminated products. This would not help the industry and would not further FDA’s mission to protect the public health.
Despite disagreement on these issues, both industry and FDA agree that the regulations need to provide guidance and rules on labeling, good manufacturing practices, required testing through certified laboratories, validation, and track and trace requirements. For example, industry spokespersons recommended regulations on limits on process byproducts and contaminants in a final product and the use of all or at least certain pesticides. Likewise, there should be labeling and testing requirements for claims made about potency and concentration of cannabis or cannabis-derived compounds in any given product. In line with those requirements, guidance is needed on how to determine potency and concentration. For instance, the definition of hemp describes THC levels in terms of dry weight, but concentration on packaging is generally determined based on the finished product. Also, is there a difference between naturally low-THC cannabis and those where the THC is removed through processing? Similarly, there should be accountability for claims related to the type of cannabis or cannabis-derived compound in a product. For instance, that there needs to be standardization of terms like “broad spectrum,” “full spectrum,” “isolate,” and ‘THC-free”. Some states, like Oregon and Vermont, already have many of these requirements or have proposed rules that set standards for labeling and testing. In theory, these requirements will eliminate low quality products and bad actors from the industry. Industry hopes that this, in turn, will help to increase consumer trust for the industry as a whole. Moreover, FDA could look to the experiences of those states when drafting rules.
FDA also expressed concern over marketing cannabis products to children. This is not surprising given that FDA has been cracking down on tobacco and vape manufacturers marketing their product towards children and young adults. In particular, FDA is concerned about the sale of items that are attractive to minors, such as food that looks like candy or packaging that includes superheroes and cartoons. Many states, such as Oregon and Pennsylvania, already have requirements that packaging of cannabis products cannot be geared toward children. And many states and companies put age and youth restrictions on the sale of cannabis and products containing cannabis-derived compounds. FDA questioned some industry stakeholders about how they decided on an age restriction. Most used 21, like the legal drinking age, but when pushed further could provide no data-driven reason for this age restriction.
In addition, feedback on side-effects and potential for abuse from the industry, medical professionals, and consumers ranged all across the spectrum. Some speakers discussed children and people they knew who committed suicide or had other mental health issues due to cannabis use syndrome, while other speakers claimed absolutely no side effects or addiction from cannabis. However, it is important to note that many times these speakers did not distinguish between THC and CBD where side effects are concerned. Therefore, it will be important that FDA consider these separately as it decides how it will regulate cannabis and products containing cannabis-derived compounds. What warnings will be required and for which cannabis-derived compounds? For example, will all products be required to include sweeping warnings like, “There may be health risks associated with consumption of this product” or “Should not be used by women who are pregnant or breastfeeding”? Or will only certain types of products require these warnings? Does the data support certain warnings for THC and others for CBD?
Even though the hearing is over, it is unclear how these issues will be resolved. FDA is still taking written and electronic comments and submissions to docket number FDA-2019-N-1482 through July 2, 2019. Therefore, stakeholders with any comments, concerns, or, most importantly, data should post to the public docket by July 2, 2019. FDA has stated that it is targeting August to start providing findings from its internal working group. Those who are involved in this industry should watch FDA carefully over the next several months, because the recent public hearing has given FDA enough information to take strong steps to regulate this industry in a more aggressive fashion if FDA decides to do so.