For the past year or so, the U.S. Food and Drug Administration (“FDA”) has been under mounting pressure from advocates and stakeholders to create a comprehensive regulatory plan for the growing CBD industry. Although the nascent industry is already worth millions in sales and filled with tons of sellers, it is barely regulated. Not only has this made it difficult for businesses to operate, but it has called into question the efficacy and safety of the products being sold.
Last week, the agency submitted a draft of a federal plan for marijuana and CBD research titled ‘Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research’ to the White House Office of Management and Budget (“OMB”). Although details on the contents of the document are sparse, an FDA spokesman indicated that it is related to the agency’s ongoing work to develop broader CBD regulations. These regulations would 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. 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,” said the FDA in a statement.
“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.”
Stakeholders will now have to wait and see if the FDA will wait for the guidance to be finalized by the OMB and for the required research to be completed before crafting a regulatory structure for the industry.
However, according to former FDA Commissioner Scott Gottlieb, White House policies requiring OMB to review scientific documents in the first place is an erroneous step that delays the issuance of guidance. “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,” he says.
The FDA, on the other hand, says that it “will continue to update the public about our path forward as our work progresses, and provide information that is based in sound science and data.”
Industry watchers say the cannabis industry, including entities like SinglePoint, Inc. (OTCQB: SING), is hoping that the FDA will not release research guidelines that make it almost impossible to perform any meaningful research.
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