On May 31, 2019, FDA conducted its long awaited public hearing regarding the regulation of CBD- and THC-containing products. FDA has opened a docket for receiving additional submissions on CBD use in FDA-regulated products. There was substantial repetition of arguments by a wide variety of individuals and groups, from industry trade associations to the Cannabis Industry Victims Educating Litigators. FDA officials asked numerous questions throughout the day, most of which were focused on the availability of safety data.
A majority of the speakers during the public comment section of the meeting were in support of regulatory clarity and the safety and benefits of cannabis derived products. Most of the speakers focused on CBD, although a significant number of speakers expanded their arguments to include THC-containing products.
The FDA acting commissioner, Ned Sharpless, kicked off the hearing by asserting jurisdiction by FDA over cannabis containing foods and supplements. He added that FDA will treat all cannabis-derived products not covered by the Farm Bill as unapproved new drugs. Significantly, when he said FDA would view any food supplement containing cannabis as an unapproved new drug, he completely glossed over cosmetics. He noted that there is more that is unknown than known about cannabis. Sharpless cited the lack of data about its long-term use, interactions with prescription drugs and effects of ingestion on children.
A number of activists criticized the lack of regulation and called on FDA to remedy the problem with regulation. Other public interest groups attacked the safety of cannabis and called for, at a minimum, tighter regulation, including THC level limits. Several accused the cannabis industry of a lack of concern for safety and pursuit of substantial profit. A group of health professionals echoed these concerns. They also expressed worries about the varied effects of cannabis on different people, citing food, supplements and cosmetics as all presenting risks of excessive consumption. Both collectively and individually, these doctors and nurses called for swift regulatory action by FDA.
The hemp industry was represented by several trade associations. They universally called for an efficient pathway for the approval of CBD-containing products. All expressed concern about the hodgepodge of regulations at the federal, state and local levels. They called for self-regulation as a first line of defense. Others expressed concern about the regulatory uncertainty driving the black market at the expense of legitimate businesses.
A number of industry and trade association representatives noted that cannabis is medically beneficial and is safer by orders of magnitude than caffeine and nicotine. They reminded FDA of the tax windfall for governments. Some noted the problems with the availability of federal bank access and insurance coverage. Another major theme from industry representatives was the expressed desire that FDA take action against industry bad actors.
Andrew Kline of the National Cannabis Industry Association (NCIA) noted that the organization’s written comments are available on the FDA’s website. He asked FDA to act quickly to stem the confusion that today characterizes the regulatory regime. He also noted the financial benefits to the country, and added that the evidence shows that cannabis represents a minimal safety concern. He called for mandatory laboratory testing, as well as universal industry standards. A number of representatives of state governments called for clarity in regulation, as well as the need for the development of safety data.
Most of the afternoon was devoted to a deep dive into safety and efficacy issues. Industry representatives pledged that they have and will continue to observe Good Manufacturing Practices and safety, purity and quality goals. Some of the points made by academic researchers involved the findings of significant drug interactions with CBDs, and questions on the utility and safety of CBDs for drug use. The pharma CBD companies discussed small-scale studies supported by Investigational New Drugs that showed promising results from CBDs. Dietary supplement representatives noted adequate controls were in place in FDA regulatory oversight of supplements both pre and post marketing to establish safety, and that the existing seizure drug would not bar dietary supplements based upon the significant formulation differences between the supplement formulas and the approved drug. As to food additives and food use, the approval of the three food additive petitions were reviewed along with the position that the nutritional value of hemp was well established.
Another group of speakers were prescribing physicians recounting their patient success and stressed that CBDs, unlike opioids, did not present a risk of addiction. One of the prescribing physicians noted that medical grade CBDs were affordable for their patients who could not afford the thousands of dollars a month it would cost to obtain the FDA approved epilepsy drug off label. The importance of creating new pathways for these, less expensive drugs was raised by several speakers.
The last group who spoke were from the agricultural community. They supported use of CBD in FDA-regulated products since it provided a much needed utility for the hemp crops they were growing, and the value of supplying these crops to users to boost the US economy and expand the uses of American grown hemp.
While the FDA did ask questions of the various speakers during the course of the seven hour hearing, primarily the questions were for the presenters who had data to submit to the docket and there were general questions around dosage considerations made to the prescribing physicians and of safety substantiation to other participants. At several points, the agency reiterated its request for submissions to the FDA docket.
Another point raised was that Congress, as it did with DSHEA, could create a new pathway for these CBD products. There are currently twenty-seven federal bills pending, some of which would, if passed, provide for expanded medical use of CBDs.
Well over 100 people delivered comments, covering virtually every aspect of the debate. While no conclusions were reached, FDA heard from representatives of nearly all of the stakeholders. The agency did not indicate when they would provide more guidance, but they were left with a clear understanding of the effects of regulatory uncertainty on all parties. Several speakers bluntly told FDA that the genie was out of the bottle and that the best course of action was legislation to remove cannabis from Schedule I and regulations to ensure the safety of cannabis products, and to focus on the industry’s bad actors. Indeed, self-regulation was a recurrent theme from industry throughout the session.
It is becoming more and more clear that most of the issues raised at the public meeting will be addressed via legislation. All indications point to an interim rule by the end of 2019.
We will monitor FDA’s activities and keep you informed on an ongoing basis.