General Counsel, Stakeholders Still Await FDA Guidance for CBD
In-house lawyers and other industry executives are still waiting for regulations on CBD and CBD-infused products after the FDA held its first public comments session.
June 03, 2019 at 06:46 PM
3 minute read
The original version of this story was published on Corporate Counsel
The U.S. Food and Drug Administration recently held its first public comments session on CBD and CBD-infused products, though it appears the agency is not any closer to regulating what is formally known as cannabidiol, the non-psychoactive ingredient often associated with cannabis.
"As far as the markets and the proponents of the CBD, the same is being said over and over," said Jean Gonnell, general counsel of STWC Holdings Inc. "Regulation and guidance is needed."
Steven Mister, president and CEO of the Council for Responsible Nutrition who gave comments at Friday's hearing, said the FDA is asking for safety information without giving companies a path to the market. He said part of the issue is the FDA held the hearing on CBD and cannabis, despite them being "very, very different."
"If you divorce CBD from its historical connection to marijuana, it's an herbal constituent like any other herbal constituent," Mister said.
While safety is important, Mister said, at this phase the FDA needs to allow CBD-infused products to exist in the market with the drugs CBD is an active ingredient in.
CBD was first studied for its drug properties, according to Mister, who previously served as associate general counsel of the Consumer Healthcare Products Association.
He explained a provision in the law states that if an article is first studied in clinical investigations as a drug before it's a supplement, then the drug "gets the monopoly over the ingredient."
"It has to do with this race to market to see who was there first," Mister said. "There is an exception in the law that says FDA can make a decision to allow the two to co-exist rather than giving the drug the monopoly."
Mister said the FDA had asked many stakeholders if they had safety information for the use of CBD products. However, he said, the responsible companies who would do those safety tests to produce the kinds of reports the FDA wants would not do so without a path to market.
"If you do that, all of these companies are going to jump in and do the safety studies that you want done," Mister said. "We're not saying the safety part is not important. But you've got to give companies a predictable pathway to market if you want them to do the safety studies you're expecting."
From an industry perspective, Gonnell said she would like to see any kind of guidance on CBD use.
"Anything that we can get from the federal government at this point would be incredibly helpful," Gonnell said. "The Farm Bill did great things for hemp, but there is still this gray area when it comes to CBD of where it can and cannot be used."
The public comments is not completely over. FDA is allowing for stakeholders to submit written comments up until July 2.
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