The funding earmark is part of President Trump’s overall budget request sent to Congress on Tuesday. The development is the first, and by no means decisive step in arriving at a final budget for the upcoming fiscal year.
Despite grave disagreements about some portions of the President’s proposal, the plan to provide more funding for CBD regulation is one that is likely to garner bipartisan support, industry stakeholders agree.
Market has exploded while FDA decides what to do
FDA is requesting an additional $5 million to be devoted to the regulation of cannabis-derived products. These products started showing up on the market after the passage of the 2014 Farm Bill, especially in those states that had passed liberalized marijuana laws. The market exploded nationwide following the passage of the 2018 Farm Bill, which took Cannabis sativa as a whole plant off the Schedule One controlled substances list maintained by the federal Drug Enforcement Administration (THC, the narcotic fraction of the plant, is still on the list). No one knows how many CBD and/or hemp extract supplement and food SKUs have made it to market in the interim, but the consensus is that they number in the thousands. At the moment all of these products occupy something of a regulatory limbo.
“This new funding will enable FDA to continue regulating the usage of cannabis-derived substances, such as cannabidiol (CBD), in FDA-regulated products such as dietary supplements and when used as unapproved food and feed additives. The initiative will support regulatory activities, including developing policy, and continue to perform its existing regulatory responsibilities including review of product applications, inspections, enforcement, and targeted research,” the FDA budget request says.
Lots of facilities, but no inspections
Loren Israelsen, president of the United Natural Products Alliance, said the new funding would allow FDA to begin inspecting the many facilities that have sprung up to service this new market. Some of these facilities are manufacturing ‘full spectrum’ hemp extracts and/or CBD isolate, while others are churning out finished goods. In the absence of any specific regulations governing the CBD trade, some of these companies are touting their adherence to food and supplement GMPs as a way to differentiate themselves. Others, however, have little to say about their manufacturing certifications.
“We have urged FDA to be farm more active in inspecting facilities. We believe they have the authority to do so,” he said.
Israelsen also said the portion of the FDA request pertaining to the ‘review of product applications’ is intriguing.
“We would like FDA to open the door to New Dietary Ingredient Notifications on CBD products. This might also refer to the idea of a mandatory new product listing. Whether there is a need for that, and to what purpose, there is not a consensus within the industry on that at the moment,” he said.
What about a safe level?
Daniel Fabricant, PhD, president and CEO of the Natural Products Association, said the new funding is welcome, but to some degree puts the cart before the horse. NPA has consistently advocated that as a first step FDA should set an overall safe exposure level for CBD, which would take into account the many sources of the molecule now available to consumers, from foods, to beverages, to dietary supplements.
“This is a step in the right direction and is an indication that the Agency has the resources to regulate the industry. However, this does not go far enough to specifically address the issue of setting safe level of daily consumption for CBD products. Setting a safe level of consumption for CBD products is the best way to move forward with this promising new product while protecting consumers,” he said.
Funding welcome, but too late
Steve Mister, president and CEO of the Council for Responsible Nutrition, said his organization is in favor of more funding for FDA in whatever form. But he said this most recent request from FDA comes very late in the game.
“We worked very hard this past year to get an additional $3 million in funding for the Office of Dietary Supplement Programs (ODSP). Back in 2016 FDA indicated that it needed many more FTEs to fully staff that office and regulate the $46 billion dietary supplement market. FDA said it wanted 52 staffers, and the $3 million additional funds increase the overall personnel to about 37,” he said.
“We are pleased to see that the President’s budget includes this additional $5 million but unfortunately it is coming way too late. The time to act was a year ago when the Farm Bill went into effect. In the meantime there is a price for FDA’s inaction,” Mister added.