CBD Faces More Regulation and Research

FDA needs additional information before drafting CBD regulations.

January 16, 2020

ALEXANDRIA, Va.—Everyone interested in CBD has been waiting for the FDA to establish guidelines for the use and regulation of the product. However, there are big gaps in data that the FDA needs to fill to best regulate the substance, leading the agency to consider the unusual step of collecting the data itself, Politicopro reports.

It would be unusual for the FDA to spearhead research into any product, but cannabidiol, the popular cannabis and hemp by-product decriminalized by the 2018 farm bill, has proven to be a difficult challenge. CBD-infused products have flooded the marketplace, and lawmakers are urging the agency to speed up regulation.

“This may be the opportunity to shift that thinking and say what we've just got this incredible blank space that we need to start to fill in,” said Amy Abernethy, principal deputy commissioner, who’s leading the efforts to write CBD regulations. “Either we're going to create the data collection agenda, or we're going to set the agenda and let others do it.”

Last summer, the FDA requested public feedback on devising a CBD regulatory framework after holding a day-long meeting on the topic. FDA recommendations were expected at the end of summer, but so far, no formal update has been forthcoming. This week, Abernethy said that the agency has been communicating its thinking in other ways, namely through warning letters and Twitter, as it continues to evolve.

“As we have developed reasonably solid conclusions about a particular category or space, we’ve tried to get that information out to the public as quickly as possible,” she said, citing warnings the FDA issued in November to 15 companies for illegally selling CBD products. At that time, the FDA said it cannot conclude that CBD is generally safe.

The agency has reached out directly to companies, largely drug makers, that may have relevant information. That includes GW Pharma, manufacturers of the first-approved CBD medicine, the epilepsy drug Epidiolex. The drug maker’s data link high concentrations of CBD to risk of liver damage. Older studies on animals suggest concerns with male fertility after CBD or broader cannabis use, Abernethy said.

Meanwhile, Collin Peterson, House agriculture chairman has introduced legislation that would require the federal government to regulate CBD products like dietary supplements, Politicopro reported.

“The last two farm bills were landmark successes for hemp, but we are still very early in this process, and growers need regulatory certainty,” Peterson said. “This bill will allow [the] FDA to regulate CBD that comes from hemp as a dietary supplement, providing a pathway forward for hemp-derived products.