Cannabis Companies Push F.D.A. to Ease Rules on CBD Products

Cannabis Companies Push F.D.A. to Ease Rules on CBD Products

Mr. Scheineson suggested the F.D.A. might use its regulation of folic acid as a road map for CBD. Consumers can buy folic acid, a B vitamin, over the counter for some uses, but it must be prescribed by doctors at higher concentrations to prevent folic acid deficiency.

The agency could also require businesses to submit a petition demonstrating safety.

“There’s a very limited understanding of what would be considered a safe amount of CBD to be consumed outside of a physician’s care,” said Justin Gover, chief executive of GW Pharmaceuticals, the parent company of Greenwich Biosciences, whose cannabis-based drug, Epidiolex, was approved last year to treat seizures associated with two rare forms of epilepsy. “There should be in our view a clear differentiation between F.D.A.-approved medicines derived from cannabis, like Epidiolex and any form of CBD taken without a physician’s supervision.”

Jonathan Miller, a lawyer for the U.S. Hemp Roundtable, a coalition of dozens of hemp companies, who is speaking at the meeting, plans to tell the F.D.A. that CBD is safe, and asks for it to be fully legalized as a dietary supplement and food additive.

“Our enemy is not the F.D.A.,” Mr. Miller said. “Our enemies are CBD companies that make false claims or sell products that are bad.”

Dr. Gottlieb took special issue with CBD for pets.

“Putting CBD into pet food is absurd,” he said.

Sarah Sorscher, a deputy director with Center for Science in the Public Interest, said she was especially concerned about CBD products like gummy bears, which appeal to children. Ms. Sorscher, who missed the filing deadline to testify, also said she was concerned that consumers were turning to CBD products instead of approved therapies that could help them.

Eric Assaraf, an analyst who covers the industry for Cowen Washington Research Group, is enthusiastic about the sector, despite the uncertainties. In a late February report, he wrote that a conservative sales estimate for CBD in the U.S. could be $16 billion by 2025.

“I think we’re going to go through a period of change in this sector, as the early entrants confront regulatory challenges from the F.D.A.,” said Coleen Klasmeier, a partner at Sidley Austin’s Washington office, who advises clients in the cannabis business. “And the more established, sophisticated players, as they conclude their assessments of the business opportunities and finish setting up their supply chains and compliance, will start to enter the market in a bigger way.”

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