White House is Reviewing CBD and Cannabis Research Guidance from FDA
July 14, 2020 in Cannabis Law
On May 28, 2020 the Food and Drug Administration (FDA) submitted a draft document regarding a federal plan for the implementation of CBD and cannabis research to the White House Office of Management and Budget (OMB). This suggests that the FDA may be moving forward towards CBD regulation. This comes exactly one year after the 2019 public hearing presented by the FDA on CBD regulations. In this article I will briefly explain the outcome of the 2019 FDA public hearing and give details about this new document of which very little is known.
Just to update you on what has already happened….
2019 FDA Public Hearing on CBD Regulation
On May 31, 2019 the FDA held a public hearing at its headquarters in Silvers Springs, MD about the regulation of CBD and THC products. BTW, the FDA oversees the regulation of all food and supplements that contain cannabis. There was a lottery to choose who was allowed to speak and/or ask questions. Both proponents and opponents of regulation were selected.
The majority of speakers were industry professionals who were looking for FDA guidance for the clarification of regulations, especially those concerned with the safety, purity and quality of products. Most of the questions asked by the FDA officials were highly focused on safety data of CBD products. While the main focus was on CBD products, THC products were also included.
The Outcome of the Hearing
The FDA concluded that it will be necessary to collect much more data about CBD before the agency moves forward towards regulation. This includes:
- Long-term use
- How CBD interacts with prescription drugs
- The effect of CBD on children
The implication was that it would be years rather than months.
In a surprising move, the FDA initially announced last January of its intention to publish guidance on CBD and cannabis research during 2020. What has not been clarified is the timetable for the OMB review and for the finalized release to the public of said document.
Fast forward to June, 2020…
The title of the document:
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research
According to the FDA spokesperson, the agency is investigating the development of broader regulations regarding CBD usage. The goal is to allow the marketing of cannabis products as dietary supplements and food items. The agency is working towards providing additional guidance and they believe they have made significant progress. However, before the FDA can provide such guidance, it is necessary for it to do “its due diligence” regarding the safety, the science, the efficacy and the quality of products containing CBD.
The FDA is well aware that the American public is anxiously awaiting these guidelines. Consumers want to feel assured that when they spend their dollars on CBD products, they are getting exactly what they paid for.
The main objective is getting access to and evaluating the necessary information to address questions about the safety of CBD products. Once that goal is achieved, the agency will be in a better position to regulate the CBD industry while maintaining the FDA’s exhaustive and thorough public health standard.
What is not clear is whether or not the FDA intends to completes its research before issuing its specific regulatory guidance. Not surprisingly, CBD producers are anxiously awaiting the regulations even more than consumers so that they can market their products.
The fact that the FDA is sending regulatory guidance to the OMB may be construed as a positive step that progress is being made. However, Scott Gottlieb, the former FDA Commissioner, pointed out that the White House’s requirement of the review of scientific documents by the OMB appears to be a tactic being used to delay the regulatory guidance. The FDA spokesman had no comment to make on the former commissioner’s statement.
The FDA spokesman wanted to reassure consumers that the agency will continue to keep the American people apprised of its progress as it unfolds, with information that is science and data based. Additionally, the FDA will continue to seek public input about the safety and effectiveness of CBD on the website’s comment section which will be accessible indefinitely. The agency is soliciting information about the different delivery methods and potential drug interactions before making a decision about marketing CBD.
While all of this is playing out, the FDA maintains, regardless of the lack of regulations, that it reserves the right to enforce action against companies that sell CBD products that make ridiculous and inflated claims about the therapeutic value of their products.
Here are just a few of the examples of products where the FDA has intervened:
1. A CBD company owned by a former NFL player suggested that their product could prevent and/or treat COVID-19
2. Injectable CBD products that were voluntarily recalled by the company
3. A CBD company whose products may have contained high levels of lead in a batch of tinctures which was voluntarily recalled by the company
The OMB’s new policies have resulted in a never seen before review of the FDA’s technical and scientific guidelines. This includes documents that have been in development and review for two years which include research on prescription cannabis medications and on studies of cannabis as an alternative treatment for opioid use disorder.
Lastly, kudos to the FDA and their efforts to force a more accurate definition of the term “healthy” on food labels which has been under OMB review since August 2019. This will assist consumers in making better food choices for themselves and their families.
marijuanamoment.com, The White House Is Reviewing CBD and Marijuana Research Guidance From FDA, Kyle Jaeger, June 2, 2020
jdsupra.com, FDA and the Regulation of Cannabis: Highlights of FDA’s Public Meeting of May 31, 2019