There were more questions than answers at a Senate hearing on the hemp industry last week, but what is known is that the industry is exploding. Hemp-derived cannabidiol (CBD) was a $390 million market in 2018, and forecasts suggest that it will reach $1.3 billion by 2022. This forecast doesn't even include all of the CBD products derived from other forms of cannabis.
During opening comments at the hearing, Senate Agriculture Committee chairman Pat Roberts (R., Kan.) said he has talked repeatedly about two themes: providing certainty and predictability for farmers. While the hemp industry holds great opportunity, there is also “much uncertainty and risk for farmers,” he said.
“These are cautions regarding this new crop, but let me be clear: I am extremely supportive of new opportunities for farmers,” Roberts said. “It is not often that an almost entirely new crop with this level of interest and market potential comes along.”
Greg Ibach, undersecretary for marketing and regulatory affairs at the U.S. Department of Agriculture, told the Senate Agriculture Committee that while proposed rules are being circulated among several U.S. agencies, they are unable to comment, because the specifics of the rule are still under review.
USDA reported that it is in the process of starting up a hemp research program but said no good information is currently available about growing, utilizing and marketing the product.
As such, Ibach expressed concern that farmers will plunge headlong into production before they are assured that there is a market for the crop.
“We really don’t have good information,” he reiterated.
The Food & Drug Administration and the Environmental Protection Agency also have work to do regarding the emerging industry.
“For a crop to be sold in the United States, EPA must approve a pesticide use on that crop and associated pesticide labeling,” Alexandra Dunn, assistant administrator for EPA's Office of Chemical Safety & Pollution Prevention, told the committee.
Dunn reported that EPA has received requests to include hemp on the labels of 10 existing pesticides. Those are currently under review, USDA noted.
Meanwhile, the safety of using hemp in livestock feed as well as human food and beauty products is being researched.
“To our knowledge, the studies just haven’t been done. We are moving as quickly as possible to learn what is known and develop a work plan to fill in the gaps,” said Dr. Amy Abernethy, principal deputy commissioner of food and drugs at FDA.
Abernethy noted that one CBD-containing drug called Epidiolex, which was approved based on adequate and well-controlled clinical studies, revealed that CBD is not a risk-free substance.
“During our review of the marketing application for Epidiolex, we identified certain safety risks, including the potential for liver injury. In that context, the risks are outweighed by the benefits of the approved drug to the particular population for which it was intended,” she said.
Still, Abernethy said FDA recognizes that three to five years is a long time to wait for regulatory clarity, particularly given the significant public interest in hemp products, and CBD in particular. As such, she said the agency is exploring options to reach a resolution “more quickly and efficiently.”
Progress will be reported sometime this fall, Abernethy said.
Ibach said final rules and regulations for growing hemp should be published this fall and in force for the 2020 crop year.