logo
DEA Diversion in Cannabis Chaos: MMJ Urges Terrance Cole, President Trump DEA Nominee to Dismantle Biden Era Cannabis Obstructors

DEA Diversion in Cannabis Chaos: MMJ Urges Terrance Cole, President Trump DEA Nominee to Dismantle Biden Era Cannabis Obstructors

Yahoo04-05-2025

Message to President Trump's Appointee: Terrance Cole Must Act on Cannabis Scientific Reform.
"Mr. Cole has a historic opportunity to lead with integrity, science, and constitutional fidelity," said Boise. "He must put an end to this unlawful administrative hearing, root out DEA institutional marijuana bias, and restore lawful science-based regulatory practices."
WASHINGTON, DC / / May 4, 2025 / MMJ BioPharma Cultivation announced it will file an emergency motion and lawsuit in the U.S. District Court for the District of Rhode Island following a controversial ruling by DEA Administrative Law Judge (ALJ) Teresa Wallbaum. Judge Wallbaum recently issued a ruling to vacate a previously granted stay-clearing the path for a DEA ALJ hearing before what MMJ asserts is a constitutionally defective tribunal. Judge Wallbaum retired immediately after issuing the ruling.
The company's forthcoming legal action seeks to block the DEA's internal administrative hearing process, which MMJ argues violates the Supreme Court's landmark ruling in Axon Enterprise, Inc. v. FTC, and inflicts irreparable harm on its constitutional rights and medical mission.
MMJ Direct Challenge to DEA Overreach
The Axon decision, issued by the Supreme Court in 2023, affirmed that entities subject to unconstitutional agency proceedings can challenge them in federal court before being forced through the flawed administrative process. MMJ contends that the DEA's ALJ system, where judges are insulated from presidential oversight, runs afoul of Article II of the Constitution.
"We are not just challenging DEA policy; we are defending the rule of law," said Duane Boise, CEO of MMJ BioPharma Cultivation. "The DEA cannot ignore Supreme Court precedent and funnel applicants into hearings that are constitutionally invalid."
From Regulatory Delay to Constitutional Injury
MMJ's application to grow pharmaceutical-grade marijuana for FDA-sanctioned clinical trials was filed in 2018. Since then, the company has:
Built and passed inspection of a DEA-compliant facility
Received a DEA Schedule I analytical registration
Filed two FDA Investigational New Drug (IND) applications
Been awarded FDA Orphan Drug Designation for Huntington's Disease
Despite these milestones and the 60-day processing deadline set by the Medical Marijuana and Cannabidiol Research Expansion Act (MCREA), MMJ has waited over 2,300 days.
"The damage done by these delays is not just procedural-it's personal," Boise added. "Patients living with Huntington's and MS deserve answers and access, not bureaucratic purgatory."
Biden's Failed Cast of Characters: Milgram, Garland, Thomas Prevoznik, Matthew Strait
For years, DEA Administrator Anne Milgram, Attorney General Merrick Garland, and the broader Biden administration have stood idle-overseeing a federal agency that continues to delay and deny legitimate medical cannabis research. Despite bipartisan legislation and judicial precedent, no meaningful reform has occurred.
"The Biden administration had every opportunity to fix this. Instead, they turned a blind eye to patients and the Constitution," said Boise.
Message to President Trump's Appointee: Terrance Cole Must Act
Now, all eyes turn to Terrance Cole, President Trump's nominee for DEA Administrator, who MMJ urges to dismantle the obstructionist legacy left behind by the Biden-era leadership.
"Mr. Cole has a historic opportunity to lead with integrity, science, and constitutional fidelity," said Boise. "He must put an end to this unlawful administrative hearing, root out DEA institutional bias, and restore lawful science-based regulatory practices."
MMJ emphasized that Cole's leadership can mark a turning point: not just for the agency, but for tens of thousands of patients across the country.
"This is about reclaiming the DEA from the grip of politics and putting patients first," Boise added. "Terrance Cole can either reform the agency-or risk continuing the shameful legacy of his predecessors."
Federal Court Relief Sought
MMJ's legal filing will request:
A preliminary and permanent injunction halting the ALJ proceeding
A declaration that the DEA's ALJ process violates the Constitution
Expedited federal review in accordance with the Axon precedent
"We are not seeking special treatment," Boise concluded. "We are demanding a fair, lawful process-something every American is entitled to. The DEA must be held accountable."
MMJ is Represented by Attorney Megan Sheahan and Associates
CONTACT:Madison Hiseymhisey@mmjih.com203-231-8583
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Marjorie Taylor Greene Fumes Over Vaccine Approval: 'Not MAHA at All'
Marjorie Taylor Greene Fumes Over Vaccine Approval: 'Not MAHA at All'

Newsweek

time12 minutes ago

  • Newsweek

Marjorie Taylor Greene Fumes Over Vaccine Approval: 'Not MAHA at All'

Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Marjorie Taylor Greene has spoken out against a new COVID-19 vaccine being approved in the United States, saying the move is "not MAHA at all." Why It Matters Health Secretary Robert F. Kennedy Jr. is facing repeated backlash for some of his positions on health and medicine, including from people who would ordinarily support him. In May, prominent members of the Make America Great Again movement, including Nicole Shanahan, Kennedy's former presidential running mate, and media personality Laura Loomer, spoke out against Kennedy Jr.'s pick for U.S. Surgeon General Casey Means. In March, Kennedy Jr. sparked anger from anti-vax activists when he called on parents to "consult with their healthcare providers to understand their options to get the MMR vaccine," with one saying he is "no different than Fauci." Marjorie Taylor Greene, R-Ga., arrives for a meeting of House Republicans in the Capitol Visitor Center on May 15, 2025. Marjorie Taylor Greene, R-Ga., arrives for a meeting of House Republicans in the Capitol Visitor Center on May 15, 2025. AP What To Know The U.S. Food and Drug Administration (FDA) gave the green light for mNEXSPIKE (mRNA-1283), Moderna's new lower-dose COVID-19 vaccine, on May 31. Greene, the U.S. representative for Georgia's 14th congressional district, shared Moderna's post about the recent approval with the caption: "Not MAHA at all!!! Unreal." Not MAHA at all!!! Unreal. — Rep. Marjorie Taylor Greene🇺🇸 (@RepMTG) June 1, 2025 She was referring to Kennedy Jr.'s movement Make America Healthy Again, whose mission is to "aggressively combat the critical health challenges facing our citizens, including the rising rates of mental health disorders, obesity, diabetes, and other chronic diseases." Newsweek has contacted the United States Department of Health and Human Services outside of office hours, via email, for comment. The new vaccine is set to be used for adults 65 or older or people between the ages of 12 and 64 with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC). Approval for the jab is "based on results from a randomized, observer-blind, active-controlled Phase 3 clinical trial which enrolled approximately 11,400 participants aged 12 years and older," Moderna says. It comes after Kennedy Jr. announced that the CDC is no longer encouraging COVID-19 vaccines for pregnant women and healthy children, marking a shift in federal public health guidance. What People Are Saying Chief Executive Officer of Moderna Stéphane Bancel said in a statement: "The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19. "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health." Kennedy Jr. said about the new CDC guidance: "I couldn't be more pleased to announce that as of today the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule." What Happens Next The new vaccine is expected to be ready for those eligible to take it in time for the 2025-2026 respiratory virus season. You should not get mNEXSPIKE if you had a severe allergic reaction after a previous dose of either mNEXSPIKE, SPIKEVAX (an mRNA vaccine for preventing COVID-19) or any Moderna COVID-19 vaccine or to any ingredient in these vaccines, the company warns.

Trump Moves to Lift Biden-Era Curbs on Arctic Oil Drilling
Trump Moves to Lift Biden-Era Curbs on Arctic Oil Drilling

Yahoo

timean hour ago

  • Yahoo

Trump Moves to Lift Biden-Era Curbs on Arctic Oil Drilling

(Bloomberg) -- The Trump administration is moving to repeal Biden-era curbs blocking oil drilling across most of the mammoth petroleum reserve in Alaska that's home to an estimated 8.7 billion barrels of recoverable oil. Billionaire Steve Cohen Wants NY to Expand Taxpayer-Backed Ferry Where the Wild Children's Museums Are The Economic Benefits of Paying Workers to Move Now With Colorful Blocks, Tirana's Pyramid Represents a Changing Albania NYC Congestion Toll Brings In $216 Million in First Four Months Interior Secretary Doug Burgum announced the planned policy shift late Sunday at a town hall in Utqiagvik, a village on the Chukchi Sea coast, as he and fellow members of President Donald Trump's cabinet visit Alaska to promote energy development in the region. The measure would open up new opportunities for oil and gas development in the 23 million acre National Petroleum Reserve-Alaska, an Indiana-sized parcel in the northwest of the state that was set aside as a source of energy for the Navy a century ago. The action responds to a directive Trump issued after his inauguration in January, when he signed an executive order compelling a host of policy changes meant to expand oil, natural gas and mineral development in Alaska. The reserve holds an estimated 8.7 billion barrels of recoverable oil, according to a 2017 assessment by the US Geological Survey. And its production is set to skyrocket, with the development of recent discoveries. Alaska has forecast that crude production from the reserve will climb to 139,600 barrels per day in fiscal 2033, up from 15,800 barrels per day in fiscal 2023. Trump's measure would repeal a 2024 rule imposed under former President Joe Biden, which designated 13 million acres of the reserve as 'special areas,' limiting future oil and gas leasing, while maintaining leasing prohibitions on 10.6 million acres of the NPR-A. The rule has complicated future oil drilling and production in the reserve where companies including ConocoPhillips, Santos Ltd., Repsol SA and Armstrong Oil & Gas Inc. have been active. ConocoPhillips is developing its 600-million-barrel Willow project in the refuge, which is expected to produce first oil in 2029. Burgum's announcement was greeted by applause inside a heritage center in Utqiagvik, where local residents had gathered to speak with officials from the Trump administration, as well as Senator Dan Sullivan and Alaska Governor Mike Dunleavy, about resource development. Burgum, who leads the National Energy Dominance Council, was joined by the panel's vice chair, Energy Secretary Chris Wright and Environmental Protection Agency Administrator Lee Zeldin. Wright said he anticipated increased oil development in Alaska — possibly quadrupling oil output on its prolific North Slope — and decried years of policies he said were 'smothering' the region's potential. Rex Rock Sr., the head of the Arctic Slope Regional Corporation, one of 13 Alaska Native Regional Corporations created under federal law, said that the 2024 rule restricting energy development in the far north didn't have the backing of the region. Environmentalists had argued Biden's rule was essential to protect a large stretch of unspoiled land in the Arctic, a vast region of tundra and wetlands that teems with wildlife. And, they insisted, in a warming world there's insufficient justification for burning the large cache of oil the reserve contains. The new proposal will give the public 60 days to comment, setting the stage for a potentially rapid reversal and new leasing in the reserve. Conservationists who cheered the original protections could seek to challenge the pivot in federal court. YouTube Is Swallowing TV Whole, and It's Coming for the Sitcom Millions of Americans Are Obsessed With This Japanese Barbecue Sauce Mark Zuckerberg Loves MAGA Now. Will MAGA Ever Love Him Back? Will Small Business Owners Knock Down Trump's Mighty Tariffs? Trump Considers Deporting Migrants to Rwanda After the UK Decides Not To ©2025 Bloomberg L.P. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

ACURATE Heart Valves Halted After Consequential Study
ACURATE Heart Valves Halted After Consequential Study

Medscape

time2 hours ago

  • Medscape

ACURATE Heart Valves Halted After Consequential Study

Boston Scientific has discontinued production of its ACURATE neo2 heart valves following the release of data showing the devices were linked to higher rates of all-cause death, stroke, and rehospitalization than were other commercially available valves. The company reported the decision in a May 28 regulatory filing. 'While data continue to support the performance of the ACURATE valve system when the product's optimized instructions for use are followed, this decision was made based on recent discussions with regulators, which resulted in increased clinical and regulatory requirements to maintain approvals in global markets and to obtain approval in new markets,' Boston Scientific told Cardiovascular Business . 'Therefore, related commercial, clinical, research and development, and manufacturing activities will cease.' The company said it also would be halting production of its ACURATE PRIME valves, although the reason for that move was not clear. Disappointing Results The decision on the neo2 follows the publication May 21 of two articles from the study, one in the Lancet on the outcomes for patients and the other in the Journal of the American College of Cardiology on a relatively high rate of under-expansion of the valves. Despite its use in 50 other countries, ACURATE neo2 had not yet been approved by the US Food and Drug Administration. The Lancet study, which the company funded, involved 1469 patients undergoing transcatheter aortic valve replacement (TAVR). Its aim was to determine whether ACURATE neo2 was not inferior to its competitors. The randomized, controlled trial found ACURATE neo2 was associated with a 6.6% higher rate of a combined outcome of all-cause death, stroke, and rehospitalization after 1 year than was observed in a control group who received SAPIEN 3 or 3 Ultra or Evolut valves. The rates were also higher for each outcome (hazard ratio: 1.30 for all-cause death, 1.68 for stroke, and 1.57 for rehospitalization). Rates of cardiovascular mortality and myocardial infarction also were significantly higher at the same time point, according to the researchers. ACURATE neo2 was developed after its predecessor, ACURATE neo, a self-expanding valve for TAVR, did not achieve outcomes similar to those of SAPIEN and Evolut valves in randomized controlled trials. A problem with paravalvular leakage was found with ACURATE neo, prompting the development of neo2, which included a sealing skirt to prevent leakage, said Raj Makkar, MD, professor and associate director of the Smidt Heart Institute at Cedars-Sinai Medical Center in Los Angeles, and lead author of both papers. 'The sealing skirt worked, and the valvular regurgitation rates were lower than in ACURATE neo, but they were nonetheless still higher than in the control valves,' said, who receives research support from Boston Scientific as well as other manufacturers of heart valves. In addition to poor results on the longer-term outcomes, the ACURATE neo2 was associated with a lower rate of success, determined by whether the device was installed and operated successfully, did not require further interventions, and was not linked to complications within 30 days. One result was positive for ACURATE neo2. 'The hemodynamics were actually quite good,' Makkar said. 'This trial also highlights that, when it comes to clinical outcomes, it's not just the hemodynamics. A lot of other things come into play.' 'The ACURATE neo2 valve is an easy-to-use valve, and smaller, observational studies had suggested that outcomes were good,' Makkar added. 'But you need the rigor of a randomized controlled trial. In a randomized setting, the clinical outcomes were not as robust as they were with the other valve platforms.' Valve Expansion a Concern In a post-study analysis, the researchers went back to see if they could find any contributing factors to the ACURATE neo2's poorer outcomes. When they reviewed angiograms taken during TAVR procedures, they noticed many of the valves had not fully expanded. 'We found that under-expansion was associated with more frequent primary endpoints in contrast to valves that were properly expanded,' Makkar said. 'If you modified the device such that the radial strength were better, and we did more aggressive pre- and post-dilation, we could perhaps improve the expansion of the valve,' Makkar said. 'But whether that would lead to better clinical outcomes remains to be investigated and proven…. Dilation might increase the risk of some complications, such as stroke and aortic root injury. It is reasonable to try to safely expand the valve, but we should not expand the valve at any cost.' Makkar reported research support from Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and JenaValve.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store