The White House is currently reviewing a federal plan for marijuana and CBD research.
The Food and Drug Administration (FDA) submitted draft guidance on the issue last week to the White House Office of Management and Budget (OMB).
Details about the document—titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”—are sparse. But an FDA spokesperson indicated to Marijuana Moment that it’s related to the agency’s ongoing work to develop broader CBD regulations that could eventually allow for the marketing of cannabis products as dietary supplements or food items.
“We recognize that there is substantial public interest in marketing and accessing CBD for a variety of products. We are working toward a goal of providing additional guidance, and have made substantial progress,” FDA said in a statement. “There are many questions to explore regarding the science, safety, effectiveness and quality of products containing CBD, and we need to do our due diligence.”
“As part of our work, the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed,” the statement continues. “An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products that will inform our consideration of potential regulatory frameworks for CBD while maintaining the FDA’s rigorous public health standards.”
What remains to be seen is whether FDA plans to wait for this specific guidance to be finalized and for the resulting research to be completed before it gets around to issuing final rules for CBD products in general. Stakeholders have been eagerly awaiting those regulations so they can fully take advantage of the legalization of hemp and its derivatives.
“We will continue to update the public about our path forward as our work progresses, and provide information that is based on sound science and data,” FDA said.
While sending the guidance to OMB could be interpreted as a positive development signaling that FDA is making progress on the development of regulations, former FDA Commissioner Scott Gottlieb said on Saturday that White House policies requiring OMB to review scientific documents in the first place represent an onerous step that’s delayed the issuance of guidance.
It’s also worth noting FDA’s effort to modernize definition of “healthy” on food labels to help consumers make more informed choices about diets has been under OMB review since August 2019. Will technical and scientific guidance critical to advancing patient care move faster? 2/2
— Scott Gottlieb, MD (@ScottGottliebMD) May 30, 2020
The FDA spokesperson declined to comment on the former commissioner’s statement.
The agency first announced in January that it planned to publish guidance on cannabis research this year. It’s not clear how long the OMB review will take or when the document will be finalized for public release.
In addition to sending the guidance to the White House for review, FDA is also soliciting public input about the safety and efficacy of CBD in comment period it has decided to keep open indefinitely. The agency said in an update to Congress in March that it has several specific questions it wants answered before deciding whether the cannabidiol can be lawfully marketed. That includes questions about the impact of different methods of consumption and drug interactions.
In the meantime, FDA is maintaining enforcement discretion when it comes to action against companies that sell CBD products regardless of the lack of regulations and has said it is currently targeting sellers that make especially outlandish or unsanctioned claims about the therapeutic value of their products.
It sent a warning letter to a CBD company owned by a former NFL player after advertisements it displayed suggested its products could treat and prevent a coronavirus infection, for example.
FDA sent a letter warning to a company about its marketing of injectable CBD products that led to a voluntary recall last month.
The agency also publicized a voluntary recall of another CBD product from a different company, notifying consumers about potentially high levels of lead in a batch of tinctures.
FDA has previously issued warnings to other CBD companies that have made unsubstantiated claims about the therapeutic potential of their products.
Photo by Kimzy Nanney.