Back in December 2018, Congress passed a bill legalizing the cultivation and sale of industrial hemp and its derivatives. CBD or cannabidiol is one of the chemicals produced by the cannabis plant, and research has found it to be effective against a wide range of medical conditions. An industry quickly grew to cater to the rising demand for CBD and by the time tons of companies were marketing and selling CBD products, the industry was still barely regulated.
For more than a year, advocates, stakeholders, and lawmakers have urged the U.S. Food and Drug Administration (“FDA”) to create a comprehensive regulatory structure and rein in the rogue elements in the industry. In May, the FDA authored a proposal plan titled Cannabis and Cannabis-derived Compounds: Quality Considerations for Clinical Research and sent it to the Office of Management and Budget. The White House recently completed its review of the proposal, according to a report by InsideHealthPolicy.
Although very few details about the proposal have been made public, an FDA spokesman previously said that it is 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 in a variety of products. We are working toward the goal of providing additional 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.”
According to a recent statement from an FDA representative, the agency “cannot provide an update of when or even if this guidance will issue” despite the review being finalized. However, they stated that it would be announced via the Federal Register should it move to publication. This comes only days after the FDA released a spending bill that includes a provision providing “funding to develop a framework for regulating CBD products.” It also includes provisions to protect medical legalization laws from federal interference, provide marijuana businesses access to banking services, to expand cannabis research, and to oversee the country’s nascent hemp and CBD industries.
The FDA has in the past said that it has several specific questions it wants to be answered before deciding whether CBD can be lawfully marketed. This includes questions about the impact of different methods of consumption and drug interaction. The agency has consequently asked for public input on the safety and efficacy of CBD in a comment period that will be open indefinitely.
It wouldn’t be surprising to hear that sector players like Sugarmade, Inc. (OTCQB: SGMD) are eagerly waiting to learn what the research guidelines drafted by the FDA say about the industry.
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