The White House has done the first a series of scheduled meetings with cannabis industry and research stakeholders To discuss a new enforcement policy for CBD products.
Representatives from the Office of Information and Regulatory Affairs (OIRA) under the White House Office of Management and Budget (OMB) spoke with Panacea Plant Sciences CEO David Heldreth on Wednesday to learn more. Awaiting Food and Drug Administration (FDA) review of cannabidiol.
Marijuana Moment caught up with Heldreth shortly after he finished attending the remote meeting, which is one of several discussions on the topic that OIRA has organized after last month’s release of a memo on the FDA’s policy review.
“Members of the FDA were present, but they were not identified other than the host. They opened the meeting by not revealing anything about the policy or when it’s going to come out and essentially not going into detail,” he said. “Then they opened the floor to me.”
Heldreth said he raised questions about the legality of a new one Centers for Medicare and Medicaid Services (CMS) initiative to cover certain hemp-derived CBD and THC products It was launched on Wednesday.
“Current FDA policy is that CBD cannot be a food additive or supplement (which is generally recognized as safe), and therefore all CBD products are technically illegal outside of vaping and smoking,” he told federal officials. “I told them they were putting the cart before the horse. This current CBD policy needed to be updated before we started a legal CBD reimbursement program.”
“Then I argued that if the policy changes it should be more than CBD isolate,” Heldreth said.
“Recent federal legislation set a THC limit of 0.4 mg per container/serving for cannabinoid extracts, but rather than the 0.4 mg THC limit for oral consumption of stem, seed, and hemp microgreens or leaves that is maintained at industrial hemp’s 0.3 percent THC level. I believe FDA policy for CBD should adopt this and define hemp leaves and microgreens as foods and as food additives. should include a policy that supports them.
He said that as a citizen of the Cherokee Nation, he expects officials to follow federal laws to make detailed inquiries about the tribes.
“I’m glad the White House held the meeting, but I don’t think there’s going to be much in this process,” Heldreth said, noting that he attended similar meetings with FDA officials in 2020 about CBD policy and “nothing changed” at the time.
“The reality is without congressional action to address the drug exclusion law, it’s difficult to legalize CBD,” he said. “However, I think items like hemp leaf will be out there and provide options.”
OIRA will also meet with Trent Woloveck of multi-state cannabis operator Jushi Holdings on Wednesday, as well as Mackie Barch of Story Cannabis and Iowa hemp farmer Earl Ramey on Thursday, and Brett Goldman of OCan Group, LLC next week.
All of this comes less than a month before changes to federal hemp laws are set to significantly shake up the industry, with a ban on most consumable cannabinoids containing THC taking effect in November. As part of the original law, the FDA was responsible for publishing a list of known cannabinoids, however He missed a deadline set by the congress to fulfill this obligation and it is not clear when that list will finally be issued.
Some have speculated that the enforcement policy guidance OIRA is reviewing is related to the executive order President Donald Trump signed in December to move marijuana from Schedule I to III of the Controlled Substances Act (CSA), which also included provisions to create a pathway for CMS CBD health care coverage.
CBD oriented plan—which A coalition of anti-cannabis groups led by Smart Approaches to Marihuana (SAM) now wants to block it in federal court—will also allow a certain amount of THC in the products, but the agency has said the planned rules could change if federal hemp policies change, under the law now set to take effect in November.
Participants would have to ensure that the CBD comes from a “law-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 a total of 3 milligrams of 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 use of eligible hemp products to improve symptom control.”
Details about the rules for the CBD pilot program came weeks after a co-founder of the Charlotte’s Web hemp company, which has partnered with CMS, had already told the agency. ended federal health insurance plans for cannabidiol.
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While CMS issued a previous final rule this past April specifically stipulating that marijuana, as well as CBD derived from federal law hemp, are ineligible For coverage of the Medicare Advantage program and other services, the agency is revising that policy.
CMS already announced some changes as part of a rulemaking process filed late last year, It affects “marketing and communications, drug coverage, enrollment processes, special needs plans and other programming areas.” for the insurance programs it oversees. One of these changes concerned the coverage of cannabidiol.
Meanwhile, regarding the marijuana components of Trump’s December executive order, Attorney General Pam Bondi ordered a quick end to the cannabis redistricting proposal, which would not federally legalize it, but would remove some barriers to research and allow state-licensed marijuana businesses to take federal tax deductions known as the Internal Revenue Service (2S)80E Service. This proposal to reconsider, however, is still pending.