Anticipated FDA guidelines fall short of cannabis sector’s expectations

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A new guidance document released by the U.S. Food and Drug Administration finally addresses the topic of clinical research as it relates to cannabis and derivative products.

But the seven-page draft, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry,” is a bit of a letdown for both the marijuana and hemp industries.

The document, released Tuesday, focuses on topics such as pharmaceutical quality and chemistry, manufacturing and controls.

And that’s what the hemp industry, especially the hemp-derived CBD sector, has been awaiting.What it doesn’t do is set up regulations or rules for cannabis businesses.

The FDA said the guidance illustrates the agency’s “current thinking” about clinical research and the development of drugs containing naturally derived cannabis or cannabis-derived compounds.

The document does not, however, shed any light on how the FDA views research as it relates to medical marijuana.

Such research must be approved by the U.S. Drug Enforcement Administration, but the DEA continues to drag its feet on many pending applications.

Jonathan Havens, a Washington DC-based cannabis attorney with Saul Ewing Arnstein & Lehr, pointed out that the FDA guidelines contain “a footnote … that the DEA is committed to opening up additional forces.”

“But so far, that hasn’t happened,” he told Hemp Industry Daily.

So, as the wait for cannabis research continues, the suffering continues for medical marijuana patients, according to another cannabis attorney, Shawn Hauser.

Hauser, who is with Denver-based Vicente Sederberg, noted that many MMJ patients could be more effectively treated with higher-THC products.

“The federal government continues to drag its feet on expanding the supply of federally legal marijuana for research, despite the increasing number of qualified applicants,” she told Hemp Industry Daily.

“This issue should be front and center until we have a supply of quality product to support legitimate research and development of cannabis-based medicines in the U.S.”

Perhaps the most concrete takeaway from the FDA’s document is that the agency “will consider the public comments” before finalizing the guidance, Havens said.

Public comments on the clinical research guidance are due within 60 days of the document’s publication in the Federal Register.

“I’m not sure that we’re going to see a set of regulations coming out of this,” Havens said.

 

Continue at: https://mjbizdaily.com/anticipated-fda-guidelines-fall-short-of-cannabis-sectors-expectations/

 

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