CBD May Soon Be Further Regulated in the US

WASHINGTON, D.C., United States — The US Food and Drug Administration will hold its first public hearing Friday into how it should regulate CBD products, and it may end up limiting how much of the cannabis compound can be included in food and drinks.

Cannabidiol, the formal name for CBD, is rapidly becoming a hot wellness trend following the legalisation of hemp in the US in December. Mainstream retailers like CVS Health Corp. already sell CBD creams, sprays and lotions but the substance hasn’t yet been approved for use in food and drinks by the FDA. Unlike its cousin THC, CBD doesn’t give users a high. Instead, it’s pitched as a natural way to fight ailments like insomnia, inflammation and anxiety.

That hasn’t stopped restaurants like burger chain Carl’s Jr. from selling CBD-infused food, as there has been little enforcement.

“From the CBD companies’ perspective, if they don’t keep pushing forward they’re going to miss their window of opportunity to gain market control,” said Robert DiPisa, co-chair of the cannabis law group at New Jersey-based firm Cole Schotz. “As an attorney, I try to read everything that the FDA is putting out, I try to gather as much information as possible to guide them in the best direction I can, but the truth of the matter is everyone is running blind right now.”

This is putting pressure on the FDA to act quickly, but the agency has expressed concern that allowing the substance in food, beverages and supplements will lessen the incentive for pharmaceutical companies to conduct clinical research into the health benefits of CBD.

In announcing the May 31 hearings, then-FDA Commissioner Scott Gottlieb said in a statement that there are “open questions about whether some threshold level of CBD could be allowed in foods without undermining the drug approval process or diminishing commercial incentives for further clinical study of the relevant drug substance.”

This indicates that the FDA will set a limit on how many milligrams of CBD can be incorporated into food and drinks, DiPisa said.

“What they might end up doing is reserve the higher dosages of CBD for pharmaceutical drugs and only permit lower dosages to be incorporated in food and drinks,” he said. “That in itself would hopefully keep an incentive for the pharmaceutical companies to continue to invest in clinical research.”

The market implications are huge: analysts at Piper Jaffray & Co. estimated that the US CBD market could be worth as much as $15 billion in five years. Looser regulations would also give US cannabis companies an advantage over their counterparts in Canada, where CBD products are treated the same way as all cannabis. This means they can only be produced by licensed companies and sold in legal dispensaries. CBD is also restricted to the same product formats as cannabis, meaning only dried flower and oils are currently legal. Those will be joined by edibles, extracts and topicals later this year in Canada.

Regulating CBD is in the best interest of companies and consumers, said Bruce Linton, chief executive officer of Canadian pot company Canopy Growth Corp., which is in the process of building a 308,000 square foot CBD extraction and manufacturing facility in Kirkwood, New York.

“The principal challenge of CBD is there’s not a verified process to create the resulting products so it can’t be consistently defined,” Linton said in an interview. “Our argument is that you need to regulate it so we can actually get it stabilized and then deliver you the data you want.”

It’s critical that the FDA move quickly or ask Congress to draft new laws if it can’t get regulations in place fast enough, said DiPisa. In the meantime, the agency has been forced to crack down on companies making unproven claims about CBD’s effectiveness as a drug. Examples cited by the FDA include claims that CBD can help treat cervical cancer and Alzheimer’s disease.

“We need to get the rules in place sooner rather than later to make sure that the outliers that are doing things they’re not supposed to can fall in line or the FDA can go after them,” DiPisa said.

By Kristine Owram; Editors: Brad Olesen, Jacqueline Thorpe.

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