Among the many things that the White House has its sights set on this year, cannabis and CBD research is one of them; cannabidiol, A.K.A. ‘CBD’, is a non-psychoactive constituent of the cannabis plant.

A draft cannabis guidance document from the Food and Drug Administration (FDA) was submitted to the White House Office of Management and Budget (OMB) on May 28. Titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,” the federal research plan will explore the science, safety, quality and efficacy of cannabis and CBD-containing products. 

Now that the draft guidance has been submitted, the White House must carry out a review before CBD regulations can be finalized. Although the document’s contents are vague, a spokesperson for the FDA has confirmed that the goal is to enable CBD sellers to market their products as food or dietary supplements.

“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,” reads a statement from the FDA. “We need to do our due diligence.”

Stakeholders eagerly awaiting finalized regulations for cannabis and CBD research guidance 

On January 15, the Health subcommittee of the House Committee on Energy and Commerce held a legislative hearing focused on cannabis policies for the forthcoming decade. The hearing’s discussions centered around cannabis decriminalization proposals and essential research into cannabis, hemp and CBD. However, five months on and the White House OMB has yet to review regulations that will prompt research – and marketing – to be executed in a lawful manner. 

The FDA has affirmed that, as part of its work, the Agency will focus on the continued exploration of different pathways to ensure the lawful marketing of CBD products. Stakeholders have been reassured that the Agency will continue to provide regular updates to the public regarding the progress of cannabis and CBD regulations. All information, according to the FDA, will be drawn up based on accurate science and data.

“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,” the Agency’s statement reads.

Concerns that review process will delay cannabis and CBD research guidance  

Although many people may view the submission of cannabis and CBD research guidance as a sign that things are moving in the right direction, not everyone is convinced. Former FDA Commissioner Scott Gottlieb is feeling cynical about the fact that the guidance must go through the OMB before regulations are developed properly. Gottlieb says that the process of issuing guidance could be delayed as a result.

“OMB new policies have led to the unprecedented review of FDA’s technical and scientific guidelines, documents in development and review for two years, including on clinical research on prescription cannabis compounds and endorphins for studies of opioid use disorder,” says Gottlieb.

Despite major interest in developing cannabis-based medicines across the U.S. – as well as the FDA’s acknowledgment of the therapeutic qualities that cannabinoids may possess – research has been put on the backburner. This has resulted in many companies making false claims about cannabis and its derivatives. Consequently, the Federal Food, Drug and Cosmetic Act (FD&C Act) is being violated and consumer health is put at risk. The wait continues.