EXCLUSIVE: FDA Advisors Say Regulatory Certainty Needed For Cannabis Market

The cannabis sector is excited for several major catalysts that could help provide momentum after setbacks. Alongside the SAFER Banking Act in the Senate that could help provide financing to cannabis sectors, the potential reclassification of marijuana as a Schedule 1 substance could create opportunities in the space.

The reclassification of cannabis and potential safety issues were among the items covered by FDA advisors at the 2023 Benzinga Cannabis Capital Conference.

Fact-Finding Mission: Over the years, the Food and Drug Administration (FDA) has been on a fact-finding mission since the passing of the Farm Bill in 2018.

“We followed the information,” FDA Senior Advisor Patrick Cournoyer said at the Benzinga Cannabis Capital Conference on Sept. 28.

Cournoyer said there were limits to several pharmaceutical ingredients in food and a decision had to be made if cannabidiol (CBD) was safe enough to be marketed as food.

Over the last five years, Cournoyer said that the FDA has been “diligently looking” into this question and opened up for public opinion as well.

Several red safety flags were found over the years and CBD didn’t seem like a fit to the market, which led to the announcement of an oversight framework earlier this year.

“These are the real issues we were confronted with.”

FDA Senior Public Health Advisor Norman Birenbaum said that CBD poses some serious issues for regulators.

“We’ve seen a huge evolution in the market,” Birenbaum said.

New CBD products are being created and are readily available in gas stations and convenience stores, the FDA advisor said. 

"We are not saying these products are so unsafe that they need to be pulled from the market, take them off the shelves," Birenbaum said. 

"That is absolutely not what we are talking about. What we are talking about is a harm reduction framework so that there is consistency in these products, there are general safeguards and consumers can be aware." 

Related Link: FDA Wants More Cannabis Regulation 

What’s Next: Cournoyer said the FDA was pleased to see a request for information, an item that reflects the complexity of the industry.

“That supports our notion that a fit-for-purpose framework is needed here,” Cournoyer said.

Cournoyer added the FDA said in January that it was ready to provide assistance to Congress if it is requested.

The Health and Human Services recommended that marijuana be reclassified. Birenbaum broke down to attendees at the conference what that means and what the next steps are.

“It is pre-decisional and also agency-to-agency correspondence,” Birenbaum said, noting he couldn’t get into all the details at the time.

Birenbaum said an eight-factor analysis is completed that looks at abuse potential, patterns, medical use and other items.

“We look at these eight factors and make three findings.”

The three findings are: is there a medical use, what is the abuse potential, and what is the abuse liability under a physician’s supervision if a medical use.

Birenbaum said the FDA is pleased with the work it has done with the data, science and information.

“We will see what happens next.”

Read Next: Legal Shifts, Financial Waves: How Cannabis's Possible Reclassification Can Impact The Market 

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Photo: Patrick Cournoyer, Norman Birenbaum, David Mangone at Benzinga CCC 2023, photo Carlos Alvarez/Benzinga