The U.S. Food and Drug Administration (FDA) has been working to develop broader Cannabidiol (CBD) regulations that may eventually allow cannabis and cannabinoid products to be marketed and legally sold as dietary supplements and food products. As of May 2020, the FDA had submitted draft guidance to the White House Office of Management and Budget (OMB).
The document submitted by the FDA was titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.” The White House is now reviewing and cultivating a federal plan for Cannabis and CBD research. Although we don’t have much information about what is in the document, an FDA spokesperson alluded to the document containing details related to the ongoing work to expand regulations around Cannabis and CBD products.
The FDA stated, “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.” Furthermore, the FDA spokesperson said “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.”
An important part of the work behind setting guidelines for cannabis and cannabinoid products is to evaluate how much data is needed to safely allow CBD to be labeled as dietary supplements.
There are a number of questions that the FDA is considering and they encourage government partners and stakeholders to submit relevant information to assist in the rulemaking process. This public engagement will support the rulemaking process for evaluating cannabinoid products, and provide a pathway forward for the marketing of CBD.
This is a step forward for the cannabis and hemp industry, however, it’s not clear how long the OMB will take to review the document and finalize it for public release. The ongoing efforts to refine CBD rules and research guidelines give hope to many businesses in the industry along with scientists and CBD advocates eager to educate the public.
Our team at Strainz is hopeful that progress will be made and more people will be able to access accurate science based information and gain access to high-quality cannabinoid products.