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White House Schedules More Meetings On Cannabis Product Enforcement Policy From FDA For This Week

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The White House has scheduled a total of four meetings this week with cannabis industry and research stakeholders to discuss CBD product enforcement policy.

The Office of Information and Regulatory Affairs (OIRA) under the White House Office of Management and Budget (OMB) announced earlier this month plans to revise the yet-to-be-published “Cannabidiol (CBD) Product Compliance and Enforcement Policy.” It was introduced by the Food and Drug Administration (FDA).

Interested parties can request meetings to discuss the issue — and four meetings have now been scheduled for April 1-2.

David Heldreth, CEO of Panacea Plant Sciences, was the first to secure a meeting with OIRA, and told Marihuana Moment last week that he plans to use the opportunity. encourage the FDA to develop more holistic guidance on CBD that goes beyond cannabinoid isolates.

Since then, the White House has done it accepted requests for meetings to discuss the yet-to-be-published CBD rule 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.

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 being considered by OIRA 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 for the Centers for Medicare and Medicaid Services (CMS) to create a pathway for CBD health care coverage.

To that end, CMS recently shared new details about that plan, which will allow patients enrolled in insurance programs up to the maximum. $500 of hemp-derived products are covered annually starting Wednesday.

The CBD-focused plan will also allow a certain amount of THC in the products, but the agency said the planned rules could change if federal hemp policies change, as is currently expected under the law that will 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.”

The new details about the rules for the CBD pilot program come weeks after a co-founder of the Charlotte’s Web hemp company, which has partnered with CMS, 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.

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Entourage Health, formerly WeedMD, enters creditor protection

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Entourage Health Corp. has entered creditor protection. The company and six related entities filed on June 17 under the Companies’ Creditors’ Arrangement Act owed approximately $240.1 million to the sole affiliate of the LiUNA Pension Fund, its owner, its secured creditor and the lender that is now funding the money (First Report pp. 3-6-9

That affiliate, 2437653 Ontario Inc. No. 1 company, Entourage, secured a 2024 deal that took the former WeedMD private and off the TSX Venture Exchange (December 2024 PR). Shareholders were paid half a Canadian cent per share, or C$0.005, and the board recommended a sale in December 2024 (December 2024 PR).

Jason Alexander, head of the special committee of independent directors, recommended to shareholders. “The transaction ensures that shareholders will receive immediate tangible value while positioning the Company for future growth and flexibility,” Alexander said (December 2024 PR). The company took on $167.6 million in debt in that sale, having already breached the covenant with the same guarantee (December 2024 PR). Eighteen months later that debt was $240.1 million when it was filed, and the growth promised by the sale is a settlement (First Report 6-18 p.

Adult use is off, medical is still running
The leisure business is closing, not saving. Entourage laid off about 53 workers in early June before the order, and 22 remain (First Report p. 6 Adult use inventory is being cleared, finished products are shipped to provincial distributors, and flowers are sold in bulk to the market to other licensed growers (First Report p. 12 Color Cannabis, Dime Bag and Saturday Cannabis are the brands going down with it (First Report p. 5

What remains open is the doctor’s arm as the exclusive supplier of cannabis under the Starseed brand to local residents of the Workers International Union of North America (First Report p. 5 The pension fund that funds the procedure is tied to the same union that the medical brand serves, and the part of Entourage that serves union members is the part that is kept alive while the rest is sold for parts.

At the end of July the money runs out with no new money (First Report p. 11 The money comes again from the pension fund affiliate, a $1.1 million debtor-in-possession facility at 5% per annum, no commitment fee, no exit fee (First Report pp. 10-11). The monitor, Ernst & Young, checked terms against other DIP loans in the cannabis sector from January 2024 and concluded that a third-party lender would not lend on better terms given the state of the business (First Report p. 11 The lender, which already owed $240 million, is the only one willing to advance another million to keep the lights on through the sale.

Health Canada is the largest unsecured creditor, owed $494,505, ahead of all suppliers and competitors on the company’s books (List of Creditors p. 1 Supreme Cannabis is owed $262,133, medical platform HelloMD is owed $169,564, the Town of Aylmer is owed $144,815, the Independent Retail Cannabis Board is owed $137,098 and High Tide is owed $124,583 (List of Creditors p. 1 Unsecured claims total $3,288,333 in more than 100 names, many of which have yet-to-be-determined amounts by medical clinics (List of Creditors 1-5 p. Against $240 million guaranteed, none of them will see much.

In the June 29 return, the lender asks the judge to extend the stay until August 28, approve the DIP facility, and double the Administrative and Directors fees to $500,000 each (First Report 4-8-12. p. The directorship is rising as directors face payroll, holiday pay and excise duties over a longer period of time, and the company’s directors and officers insurance expires at the start of July (First Report p. 12

The sales process starts on the same day, based on a marketing effort that started around May and was presented before the deal that sparked interest but no one could make a deal (First Report p. 13 Insiders and affiliates have until July 6th to say they intend to bid, the bid deadline is July 30th, the successful bid must be received by August 7th, and the outside deadline is August 28th (First Report p. 15 The affiliate of the pension fund has written to the Monitor that it will not make an offer (First Report p. 16), and any other affiliate that does so must be removed from the process (First Report p. 16 The settlement request for non-cannabis equipment and the sale of the Aylmer facility, a 26,000-square-foot extraction and processing facility that has been the company’s production base at 250 Elm St.

the source

For more information:
Neighborhood Health
1.844.933.3636
(email protected)
entouragehealthcorp.com

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DEA And FDA Highlight How Marijuana Is Safer Than Alcohol And Opioids During Rescheduling Hearing’s Opening Day

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Attorneys for the Drug Enforcement Administration (DEA) on Monday highlighted testimony about the medical benefits of marijuana and its relative safety compared to other substances such as alcohol and opioids in the opening day of a hearing. The Trump administration’s cannabis rescheduling proposal.

Marijuana Moment spoke with several people in the audience for Monday’s hearing to find out how the testimony is going, despite the proceedings not being broadcast live to the public at the request of one congressman and others.

According to those sources, DEA attorney James J Schwartz stated that the government is the proponent of the proposed rule to formally move cannabis from Schedule I to Schedule III of the Controlled Substances Act (CSA), stating that the hearing is “not about the recreational use of marijuana” and “about regulation, not about legalization.”

“The government has presented no evidence to suggest that marijuana is not dangerous. All controlled substances are dangerous,
he said “However, controlled substances must be evaluated against the risks they pose, balanced against the medical benefits they provide.”

Dominic Chiapperino, director of the Food and Drug Administration’s Center for Controlled Drug Evaluation and Research and one of two DEA witnesses, testified about how federal health officials formed their recommendation to reschedule cannabis.

Opponents of the reform have used a new two-part test that they argue is a bad departure from a previous analysis, although a DEA lawyer said the hearing is not about that issue, and Chiapperino said the new test is now considered “every time” a new analysis is done on a drug.

The FDA official said the agency compared marijuana to alcohol, opioids and other substances in its scheduling analysis, and found that marijuana’s daily harms were lower than all or most of those comparators.

Cannabis is associated with fewer overdose deaths than comparable substances, Chiapperino said, and when reports of cases involving deaths mention marijuana, the deaths are often attributed to secondary incidents such as accidents or self-inflicted harm. Marijuana’s potential for overdose deaths is “much lower” than other Schedule I drugs and Schedule II drugs. Rather than opioids, the FDA official said.

As for withdrawal in regular users, Chiapperino testified that cannabis has symptoms similar to tobacco, including irritability, but alcohol has “more of a withdrawal syndrome,” which can include seizure and death.

Also on Monday, the lawyers of some of the parties against the reorganization had the opportunity to cross Chiapperino.

Kevin Sabet, president and CEO of the prohibitionist organization Smart Approaches to Marijuana, who was also invited to attend the hearing, said in a video posted on social media that it is “surreal” to see the government arguing that cannabis’s medical uses and relatively minor harms are “just lying through their teeth.”

The DEA “is in a very awkward position to argue the opposite of what it’s been arguing for the last 50 years, the opposite of what the science says, the opposite of what the evidence is,” he said, “which is, of course, to argue against the government that marijuana is more harmful than we thought, not less harmful.”

On Tuesday, opponents of the review will have an opportunity to cross-examine the FDA official, and the government’s second witness, Corey Burchman, a doctor from New Hampshire, will begin his testimony. The DEA announced in a filing last week that it will do so Testify on “How Medical Marijuana Provides Medical Benefit to Pain Patients.”

On Monday, a DEA attorney said Burchman would “describe the real-world impacts of treating pain with marijuana instead of opioids” based on his experience with both and discuss how he has “personally transitioned patients from opioids to marijuana for their pain.”

The witness will also testify about the differences between cannabis and opioids in terms of withdrawal and overdose, he said.

Before the hearing began, marijuana reform activists rallied They held a press conference outside DEA headquarters to highlight how they feel of the process – criticizing the fact that supporters of the reform were not invited to participate and that the proceedings are not reproduced live, despite the “transparency” oath of the officials.

DEA Administrator Terrance Cole only organizations and individuals opposed to marijuana reform have been invited to the hearing as a designated participant – telling followers that they do not meet the definition of “interested person” to participate because they are not “affected or prejudiced by any rule or proposed rule that may be issued.”

last week, Marihuana Moments sent petitions to DEA Chief Administrative Law Judge Derek Julius and DEA Administrator Cole asking for them reverse the decision to ban the public from tuning into the cannabis hearing via live stream. A Congressmen and other journalists later joined that request.


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The opponents who are participating in the hearing submitted statements last week anticipate the anti-marijuana arguments they intend to make during the procedure.

The hearing it will end before July 15.

Acting Attorney General Todd Blanche in April He issued an order that immediately reclassified the state’s licensed medical cannabisas well as marijuana products approved by the Food and Drug Administration (FDA) under Schedule I through Schedule III of the Controlled Substances Act (CSA).

According to a separate order signed by the acting attorney general, the upcoming hearing will include Class III marijuana.

Preliminary hearing process on the marijuana redistricting process initiated by the Biden administration It was halted last year amid allegations of improper communications and witness selection.

the current The marijuana redistricting process is being challenged in several ways which have been upheld by a federal Court of Appeals. those pieces of State attorneys general have filed lawsuits against cannabis reform, Opponents of marijuana legalization and a a cannabis-based biopharmaceutical corporation.

Meanwhile, the reorganization of state-licensed medical cannabis is already having a major impact.

The Congressional Research Service published a report on the current rescheduling of cannabis Certified patients with medical marijuana from state licensed dispensaries are now eligible for Class III. “The order appears to allow end users to use marijuana medically without a CSA prescription,” he says.

The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) has published a Draft update to a gun purchase form to recognize the legal status of medical marijuana in the reprogramming. The revised section of the question states that only the “recreational use or possession of marijuana” is federally prohibited, omitting the prior form’s mention of medical cannabis.

The US Treasury and Internal Revenue Service (IRS) said they plan to issued new tax guidelines for the marijuana industry after reprogramming. The reform will benefit state-licensed marijuana businesses by allowing them to take federal tax deductions that are currently prohibited under IRS Code Section III, known as Section 280E.

Even the DEA, which has long opposed cannabis legalization and accused the Biden administration of stalling the initiative in the reorganization process, has done so. It launched a registration process for legal marijuana businesses in the state to take advantage of the federal benefits that come with the reform.

The Department of Transport, on the other hand, issued guidelines stating this use Legal medical cannabis in the state is still no excuse for truck drivers to test positive for drugspilots and other safety-sensitive personnel.

A congressional committee recently Federal officials voted to block further steps to reschedule cannabishowever lawmakers from both parties told Marihuana Moment they don’t think that provision will be enacted become law

user photo Carlos Gracia.

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cbdMD welcomes White House call for fair treatment of hemp-derived products

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cbdMD welcomes the Administration’s call for Congress to ensure fair treatment of hemp-derived products under federal law and calls for immediate action to revise hemp regulations to ensure fair treatment of hemp products under federal law.

In a letter to congressional leadership this week, the White House Office of Management and Budget identified hemp reform as a priority strongly supported by the Administration. The petition calls on Congress to ensure fair treatment of hemp-derived products by maintaining access to appropriate full-spectrum CBD products, and by maintaining Congress’ intent to reduce products that pose health risks. The administration also urged Congress to pass a responsible federal framework or at least extend the current implementation period to give lawmakers time to get policy right. The request builds on the president’s previous public statements urging lawmakers to protect access to full-spectrum CBD products that millions of Americans rely on.

“We are encouraged to see the administration so clearly championing the responsible, scientific hemp products that consumers depend on every day,” said Ronan Kennedy, CEO of cbdMD. “cbdMD has always believed that the future of this category is built on quality, transparency, and clear rules that separate them from bad actors. A federal framework that protects consumer access, promotes safety, and provides certainty to companies that provide certainty is what this industry and the people it serves deserve. We applaud the policymakers who are working to achieve this outcome.”

“We believe CbdMD is purpose-built for this next phase of the market,” added Kennedy. “Our focus remains on serving our customers with reliable and effective products, supporting responsible regulation and building long-term value for our shareholders as the category continues to evolve. Along the way, we will continue to evaluate the opportunities this evolving environment holds.”

For more information:
cbdMD
cbdmd.com/










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