- The OMB is reviewing the FDA’s submitted draft guidance for cannabis research.
- The document is said to relate to the FDA’s continued effort to develop better regulations for the marketing of CBD.
- The FDA announced in January that they would release a final ruling in 2020, but no other timeline has been set since.
The U.S. Food and Drug Administration (FDA) submitted draft guidance for CBD and marijuana research last week to the White House Office of Management and Budget (OMB). They are currently reviewing the federal plan that is officially titled: “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.”
There are not many known details on the document other than it most likely relates to the continuing effort to develop better regulations for CBD so that it can eventually be marketed as a food item or dietary supplement.
The FDA released a rather vague statement on the federal plan under review, quoting:
“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.”
“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,” the statement continues.
“As part of our work, the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. 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 Happens Now?
The question now becomes whether or not the FDA will wait for this guidance and its resulting research before making a final ruling on CBD products as a whole. Both CBD companies and their stakeholders have been anxiously awaiting for final regulations so that its industry can reach its full potential.
“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,” the FDA said.
The FDA originally announced back in January that they had planned on publishing a guidance on cannabis research by the end of this year. This now could depend on how long the OMB review takes and could possibly further delay public release.
In addition to sending the guidance to the White House, the FDA is gathering the public’s input about the safety and effectiveness of CBD in a comment period that will remain open for the foreseeable future. The agency is looking to answer specific questions regarding drug interactions and the different methods of delivery for CBD. Once they feel they have the appropriate answers, they will begin to consider whether or not CBD can be lawfully marketed.
As for companies that have already been marketing their products due to the lack of regulations, the FDA has been tolerant so long as there are no outlandish claims about a product’s ability, especially with the sudden spike of companies that made claims regarding their product’s ability to prevent or treat the coronavirus.
It remains a waiting game for CBD and its industry as the FDA seems to be nearing a conclusion on their ruling. If the guidance goes smoothly with the OMB, then the public may see final rules and regulations put in place for CBD products and their marketing.
Until then, the FDA is continuing to send warning letters to companies that are making definitive claims about their products. There is no doubt that marketing regulations will eventually exist for CBD, but until that point companies need to remain cautious with their advertising strategies.