The White House has convened its first meeting in a series with stakeholders from the cannabis industry and research sectors to discuss a proposed new enforcement policy for CBD products. Representatives from the Office of Information and Regulatory Affairs (OIRA), under the Office of Management and Budget (OMB), engaged with David Heldreth, CEO of Panacea Plant Sciences, to gather insights on the anticipated Food and Drug Administration (FDA) approach concerning cannabidiol.
Heldreth shared his experiences after the remote meeting, noting that while FDA representatives were present, they did not disclose their identities beyond the host. He stated, “They opened the meeting with statements that they cannot reveal anything about the policy or when it will come out and essentially won’t provide any details.” After their introduction, Heldreth had the opportunity to voice his concerns.
Legal Considerations for CBD Products
Heldreth questioned the legality of a new initiative by the Centers for Medicare & Medicaid Services (CMS) aimed at covering certain hemp-derived CBD and THC products. He explained, “Current FDA policy is that CBD can’t be a generally recognized as safe (GRAS) food additive or supplement, and as such technically all CBD products are illegal outside vaping and smoking.” He emphasized the necessity for the FDA to revise its existing CBD policy to facilitate any legal reimbursement program for CBD.
He noted that if policies change, they should extend beyond just CBD isolate. “Recent federal legislation set a THC limit at 0.4 mg per container for cannabinoid extracts, but created an industrial hemp carve-out at a 0.3 percent THC level for stalk, seed, and hemp microgreens for oral consumption,” he added. “I believe the FDA policy for CBD should acknowledge this and include regulations that define hemp leaves and microgreens as food.”
As a member of the Cherokee Nation, Heldreth expressed his hope that federal officials will adhere to laws mandating consultations with specific tribes regarding this issue. While he appreciates the White House’s engagement, he remains skeptical about significant changes arising from the meetings, referencing a similar lack of progress from discussions with FDA officials in the past.
Upcoming Meetings and Industry Implications
The OIRA is set to continue its discussions with other industry representatives, including Trent Woloveck of Jushi Holdings and Mackie Barch of Story Cannabis, focusing on the implications of upcoming federal hemp law changes expected to impact the industry significantly. Notably, a ban on most consumable cannabinoid products containing THC is slated to take effect in November.
As part of the existing legislation, the FDA was tasked with publishing a list of known cannabinoids but has missed a congressional deadline for this obligation. There is speculation that the enforcement guidance being reviewed relates to an executive order from December aimed at rescheduling marijuana under the Controlled Substances Act, which would potentially alleviate certain research barriers and allow state-licensed marijuana entities federal tax deductions.
Participants in the federally proposed CBD pilot program will need to ensure that their products meet specific criteria, including being sourced from legally compliant farms and tested to contain no more than 0.3 percent delta-9 THC by dry weight. CMS aims to facilitate consultations about the use of eligible hemp products to enhance symptom control.
Finally, as CMS revises its previous policies that excluded coverage for marijuana and CBD derived from federally legal hemp, stakeholders remain hopeful for a more accommodating regulatory environment that acknowledges evolving market dynamics. Nevertheless, the path forward hinges on legislative action to address existing barriers in the drug preclusion law.