The White House has scheduled a meeting for next week with a cannabis biotechnology company executive regarding a proposed enforcement policy for CBD products.
The Office of Information and Regulatory Affairs (OIRA) under the White House Office of Management and Budget (OMB) announced earlier this month that it plans to review yet-unpublished guidance titled “Cannabidiol (CBD) Products Compliance and Enforcement Policy” that was submitted by the Food and Drug Administration (FDA).
Interested parties are able to request meetings for discuss the issue—and now the first meeting is set for April 1.
David Heldreth, CEO of Panacea Plant Sciences, told Marijuana Moment on Wednesday that he plans to use the meeting opportunity to encourage FDA to develop more holistic guidance around CBD that goes beyond isolates of the cannabinoid, which he expects the agency to default to based on its historical reluctance to regulate plants and extracts.
“I requested the meeting to push for the new FDA CBD policy to be more than an isolate or even just extract policy, and to include more items like hemp leaves or even flower for culinary use,” Heldreth said. “Hemp leaf is a protein-rich superfood that should be adopted more widely.”
The executive, who has also sought to inform federal cannabis policy with respect to a pending marijuana rescheduling rule, participated in a prior White House executive order meeting on FDA cannabidiol policy during the first Trump administration.
“I don’t feel like anything came of that, but it’s worth educating policy makers to try for a better outcome,” he said.
All of this comes months before federal hemp laws are set to significantly shake up the industry, with a ban on most consumable cannabinoid products containing THC taking effect in November. As part of the underlying law, FDA was tasked with publishing a list of known cannabinoids, but it missed a congressionally imposed deadline to fulfill that obligation and it’s unclear when that list will ultimately be furnished.
Some have speculated that the enforcement policy guidance that OIRA is reviewing concerns the executive order President Donald Trump signed in December to move marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA), which also included provisions directing the Centers for Medicare & Medicaid Services (CMS) to create a pathway for CBD health care coverage.
To that end, CMS did recently shared new details about that plan, which would make it so patients enrolled in select insurance programs could have up to $500 of hemp-derived products covered each year beginning as early as April 1.
The CBD-focused plan will also allow a certain amount of THC in products, but the agency said the planned rules are subject to change if federal hemp policy changes, as is currently expected under the law set to take effect in November.
Participants would be required to ensure that CBD is sourced from “a legally compliant source and high-quality farm,” prepared as an oral solution and tested for cannabinoid content so that available products contain no more than 0.3 percent delta-9 THC by dry weight and up to 3 milligrams of total THC per serving.
CMS said that centers participating in one of three models that receive substance access Beneficiary Engagement Incentives (BEI) will be able to “consult with eligible beneficiaries about the possible use of eligible hemp products to improve symptom control.”
The new details about the rules for the CBD pilot program come weeks after a co-founder of the hemp company Charolette’s Web, which has been collaborating with CMS, said the agency had already finalized its plans for federal health insurance coverage of cannabidiol.
While CMS implemented an earlier final rule last April specifically stipulating that marijuana, as well as CBD that can be derived from federally legal hemp, are ineligible for coverage under its Medicare Advantage program and other services, the agency is now revising that policy.
CMS had already announced certain changes as part of a rulemaking process that was unveiled late last year, affecting “marketing and communications, drug coverage, enrollment processes, special needs plans, and other programmatic areas” for insurance programs it oversees. One of those changes dealt with cannabidiol coverage.
Meanwhile, with respect to the marijuana components of Trump’s December executive order, Attorney General Pam Bondi was directed to expeditiously finalize the proposal to reschedule cannabis, which would not federally legalize it but would remove certain research barriers and let state-licensed marijuana businesses take federal tax deductions they’re currently barred from under an Internal Revenue Service (IRS) code known as 280E. That rescheduling proposal remains pending, however.
