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FDA Submits New Cannabis Products Enforcement Policy For White House Review

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The Food and Drug Administration (FDA) has proposed a cannabis product enforcement policy to the White House for review on regulatory issues specifically related to CBD.

The Office of Information and Regulatory Affairs (OIRA) of the White House’s Office of Management and Budget (OMB) published a statement on Friday that it received the submission from the FDA, which is under the US Department of Health and Human Services (HHS).

Although the update does not include the text of the proposal now being considered by OIRA, it is titled “Cannabidiol (CBD) Product Compliance and Enforcement Policy.”

The fact that the document comes from the FDA can clarify its content, for example The agency recently missed a Congressional deadline to publish a list of known cannabinoids because federal hemp laws are set to change later this year.

Another possibility raised by industry observers is that it ties into an executive order to reorganize marijuana that President Donald Trump signed in December, which included provisions to provide federal health insurance coverage for CBD to certain patients. But that rulemaking is being facilitated by the Centers for Medicare and Medicaid Services (CMS), which is not listed as the agency that submitted the proposal to OIRA.

Marijuana Moment reached out to HHS and the FDA for comment, but a representative was not immediately available.

As part of the appropriations legislation that Trump signed into law, the 2018 Farm Bill will ban many of the hemp products that were legalized during his first term once again starting in November. The spending measure contained separate provisions, however, for the FDA and other relevant agencies to study the cannabinoid market and develop lists of cannabis ingredients.

After signing the bill, the FDA was given 90 days to publish 1) a list of “all cannabinoids known to the FDA” in cannabis 2) a list of “all cannabinoids of the tetrahydrocannabinol class that the agency believes occur naturally in the plant” and 3) a list of “binoids that have similar effects or may have effects similar to the market. cannabinoids of the tetrahydrocannabinol class”.

It was also tasked with providing the agency with “additional information and specificity” regarding the term “container” in relation to THC serving sizes of hemp product. In the bill, the term is defined as “the inner packaging, container, or container in direct contact with a final hemp-derived cannabinoid product into which the final hemp-derived product is placed for retail sale to consumers, such as a jar, bottle, bag, box, package, can, carton, or cartridge.”

The listings and information were due by February 10, but the FDA missed the deadline.

It is possible, of course, new politics The submission to OIRA is unrelated to the FDA’s mandate to create a list of cannabinoids. Others see it as the next step in expanding federal health insurance coverage, which would make CBD products available to certain patients.

An executive at a hemp company working with CMS on CBD coverage said as much last month The agency has already finalized a rule to allow for federal health insurance coverage. That rule was introduced by Trump under Title III of the Marijuana Controlled Substances Act (CSA).

Mehmet Oz, CMS administrator, spoke about the CBD components of the initiative at the order signing ceremony, with Trump and Robert F. Kennedy Jr. To the HHS secretary for “driving change” and pursuing an agenda based on a “deep passion for research.”

The plan has been to create a pilot program to give eligible patients access to hemp-derived cannabidiol that would be covered by federal health insurance plans, scheduled to launch in April, according to Oz.

While the broader rules for the CBD Medicare pilot program have yet to be released, CMS’ website briefly outlines how it navigates hemp-related issues within the LEAD, Accountable Care Organization (ACO), and Enhancing Oncology Model (EOM) regulatory models.

One outstanding question is about coverage eligibility. As the administrator described in December, it would affect those 65 and older who are eligible for Medicare, but the exact conditions were not specified. There were repeated mentions of chronic pain, particularly in relation to cancer, but the CBD eligibility criteria may include additional conditions.

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.

The proposed rule would change the regulations, which currently say that “cannabis products” cannot be covered. The policy would “prevent coverage of cannabis products that are illegal under applicable state or federal law, including the Food, Drug, and Cosmetic Act.” Because hemp and its derivatives like CBD are federally legal, the change suggests that patients in states where these products are legal can make valid insurance claims to pay for alternative treatment options, as long as the product is federally legal.

Another possibility for new submissions under the OIRA review is that it is unrelated to the FDA mandate or CMS health coverage developments. The FDA has faced scrutiny for years after refusing to enact rules that allow CBD to be legally marketed in the food supply, so there are a number of regulatory issues the proposal could address.

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Voltiris expands toward North America; energy innovation takes center stage at ACT Leamington Grower Summit

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© VoltirisAs energy continues to directly influence greenhouse strategies worldwide, new technologies and industry debates are converging on the same central question: how to produce more efficiently while maintaining optimal crop yields.

One company that sits in this evolving landscape is Voltiris, which is preparing to expand its spectral solar technology into the North American greenhouse market.

Following a recent visit to the company’s headquarters in Lausanne, Switzerland, Mona Nazari confirmed that she will lead the company’s commercial expansion in the region.

“They have developed spectral filters for solar modules designed for high-tech greenhouses,” he shares. “The technology splits sunlight, directing the photosynthetically active radiation to the crop while converting the rest of the spectrum into electricity.”

In addition to generating electricity, the system also affects the climatic conditions of the greenhouse. By filtering out parts of the infrared spectrum during periods of intense sunlight, crop temperature can be moderated.

“By filtering infrared radiation during peak periods of sunlight, plant temperatures can be reduced by up to 4°C, helping to keep crops in their optimal growing range.”

According to the company, more than 2,000 modules have already been installed with commercial greenhouse partners across Europe. Early research results also suggest crop yield benefits.

“Recent trials of Delphi have shown a 9% increase in Class I yield and a two-week extension of the harvest window.” For the industry, these types of innovations are coming at a time when energy costs and sustainability goals are becoming increasingly important factors in greenhouse design.

“Energy is quickly becoming one of the defining questions for greenhouse production,” he said. “It will be interesting to see how such solutions fit into the next generation of controlled environment infrastructure.”

Industry focus shifts to energy strategy
Many of these topics will be discussed at the upcoming Advancing Cultivation Technology Leamington Grower Summit on March 31, 2026 at the Roma Club in Leamington, Ontario.

Organizers said the event will focus on practical solutions to manage energy use, improve efficiency and protect profitability in greenhouse operations.

“This year’s program focuses on what growers need most right now: real ways to manage energy, improve efficiency and protect profitability,” the organizing team said in announcing the agenda.

One of the aforementioned presentations will be given by Amos Bassi of Philips Horticulture LED Solutions, who will present the results of a multi-year tomato trial in Dutch Botany in collaboration with Grodan.

The study examines how advanced LED lighting strategies, including intermediate lighting and higher light intensities, can significantly reduce greenhouse energy consumption while maintaining crop yields.

Climate optimization will also be addressed by Paul Arena of Svensson Climate Screens, who will present practical strategies to reduce greenhouse demand while maintaining stable greenhouse conditions. His session will explore dual screen return conditions, as well as the role of vertical airflow to improve heating and cooling efficiency in LED-equipped greenhouses.

Timme Hovinga, Priva’s product director, will analyze the energy strategy from a broader operational perspective. His presentation will explore how growers can integrate energy management into long-term greenhouse operations and how to turn energy efficiency into a competitive advantage.

Addressing Crop Health Challenges
In addition to energy issues, the summit will also address crop health challenges affecting greenhouse production.

Grodan’s Dan Skinner will present new research on pepper wilt, an increasingly complex problem for Canadian greenhouse growers.

The session will examine root zone dynamics, hygiene practices and contributing fungal pathogens to help growers improve prevention and management strategies.

With research findings, technology developments and practical grower discussions on the agenda, the ACT Leamington Grower Summit aims to provide actionable insights into the industry navigating the challenges of rapidly evolving energy and production.

For Mona, whose new role focuses on bringing energy-integrated greenhouse technologies to North American growers, the event reflects where the industry conversation is headed. “The theme couldn’t be more consistent with what Voltiris is and the value it brings.”

Register for the Advancing Cultivation Technology Summit here.

For more information:
Voltiri
(email protected)
www.voltiris.com

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“Mutual trust has grown out of our good working relationship”

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Canify AG and Africa’s first EU-GMP certified producer of medical cannabis flowers and extracts, MG Health Limited, have announced their planned merger. In a signed Memorandum of Understanding (MoU), the two companies have agreed to expand their successful two-year partnership into a joint holding structure. The group will be a fully vertically integrated medical cannabis platform, encompassing EU GMP certified production, pharmaceutical processing and multi-market distribution, with a commercial presence in more than 7 countries including Germany, UK, Australia and Poland, as well as a unique global supplier network.

The two companies have worked closely together since Q4 2024, when MG Health began supplying Canify with medical cannabis flower on an ongoing basis. This proven supply relationship now forms the operational basis for a full merger. “Mutual trust has grown from our good working relationship, so it is only logical to take our cooperation to the next level,” says Sascha Mielcar, CEO of Canify AG. “In addition to quality standards, we also share a common attitude: patients are at the center of everything we do. Our shared vision is to create a globally active pharmaceutical company with a clear focus on the highest quality standards and clinical innovation.”

The proposed merger will create a vertically integrated structure that is unique in the European medical cannabis market. The combined team will control all critical steps of the pharmaceutical value chain: from EU GMP certified flower cultivation and extraction at MG Health’s Lesotho facility, management of pharmaceutical processing regulations, and multi-channel distribution through Canify’s established network of pharmaceutical partnerships and its direct-to-patient Canify Clinics platform.

MG Health’s production platform provides the combined group with a significant structural cost advantage. Operating at an altitude of 2,000 meters in Lesotho’s Maluti Mountains, the facility has ideal growing conditions, low energy costs and year-round natural light, enabling pharmaceutical-grade production at a fraction of the cost of facilities in Europe. Beyond operational efficiency, MG Health has invested significantly in the local community, creating hundreds of sustainable jobs, expanding local infrastructure and providing education and development programs for employees, their families and surrounding communities.

“As a company that puts people first, we do not see financial success as an end in itself, but as a means to enable positive and lasting change in our society,” says Andre Bothma, CEO of MG Health. “This principle shapes our daily actions in Lesotho: from responsible, sustainable management and long-term employment opportunities to targeted educational initiatives. In Canify, we have found a partner who shares these values ​​and will carry them forward with us.”

“The merger allows us to align our processes with expertise and regulatory frameworks throughout the value chain, and therefore complement each other seamlessly,” explains Mielcarek. For example, Canify’s international supplier network can be perfectly aligned with MG Health’s expanded production and processing capabilities. “At the same time, with MG Health, we are strengthening our approach that combines pharmaceutical excellence, social responsibility and environmental sustainability.”

For more information:
Canify AG
https://canify.com/

MG Health Limited
mghealth.com/

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Alabama Medical Marijuana Sales Near Launch After Years Of Delay

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“There’s a part of me where my heart is dancing because we’re so much closer. So right now there’s more gratitude than anything.”

By Anna Barrett, Alabama Reflector

Callie’s Apothecary’s Montgomery location doesn’t look like much.

But standing on concrete floors and surrounded by metal beams, owner Vince Schilleci described what the “next to the pharmacy” storefront will look like.

And when Callie’s opens, which Schilleci believes could happen in April, it will likely be the first place to buy medicinal cannabis in Alabama.

“We’ll have someone come and check, scan the card to make sure you’re a real patient recommended for medicinal cannabis,” he said. “For privacy, you have to wait outside here until you get to the sales floor. Our goal is to get people in and out as quickly as possible, because it’s a safety issue. We don’t want people walking around.”

The opening could be a landmark, nearly five years after the Legislature passed a law authorizing medicinal cannabis, and after years of litigation and frustrating licensing processes.

Amanda Taylor, a medical cannabis patient advocate, has been part of the commission’s process since 2021. He has multiple sclerosis with 45 lesions in his brain and one in his spine. He welcomes the opening, but said in an interview Thursday that the delay caused it.

“There’s a part of me where my heart is dancing because we’re so much closer. So there’s more gratitude than anything right now,” Taylor said. “The suffering that the patients had to endure because of the lawsuits, the suffocating suffering, he took that away from the patients.”

licenses

The Alabama Medical Cannabis Commission (AMCC) has issued three dispensary licenses, and Schilleci’s shop, doing business as Alabama CCS, is expected to be the first to open, according to AMCC General Counsel Justin Aday.

“I don’t think anyone is dragging their feet. There are a lot of balls in the air with different stakeholders working,” Aday said.

CCS; GP6 Wellness, Birmingham, and Montgomery-based RJK Holdings received the licenses in December. A fourth dispensary license has yet to be awarded, but it is likely to go to Yellowhammer dispensaries, according to Aday. The commission delayed issuing Yellowhammer’s license in December because of the lawsuit, but Aday said the commission asked for a quick decision, which he hopes will be resolved soon. Once done, there will be 12 dispensaries in the state.

Schilleci said two more Callie’s Apothecary locations will be opening in a few months: one in Talladega, and one in Bessemer, following a last-minute location change in Cullman.

Schilleci said in an interview last month that the company was able to take more business risks because it did not challenge the licensing process.

“We invested in a lot of equipment, with the license in hand, instead of applying for them, we would be ready to go,” Schilleci said. “Before we had the license in hand, we gambled a bit by spending money, but things felt good.”

A pharmacy is not a pharmacy, so the staff there will not be able to give medical advice, said Schilleci. But the dispensary will have a consultation room if patients have questions about products recommended by board-certified doctors, a prerequisite for obtaining medicinal cannabis.

As of last Friday, there were 20 doctors in Alabama certified to recommend medical cannabis to patients, according to the Alabama Board of Medical Examiners. Aday said in an interview Wednesday that about nine of the certified doctors were registered through the commission’s patient registry.

“I think it would be strange to go through the process with the board of medical examiners not to use that certification,” Aday said.

Doctors will not prescribe medicinal cannabis. Instead, they will recommend a product they believe will work for a patient with a qualifying condition, including cancer, depression, Parkinson’s disease, post-traumatic stress disorder (PTSD), sickle cell anemia, chronic pain, and terminal illness.

Acceptable product forms are limited to tablets, tinctures, patches, oils, and gummies (peach flavor only), herbal raw materials and smoking forms are prohibited.

Each qualifying patient must register with the board to receive a doctor’s recommendation and receive a cannabis product from a dispensary.

“We want to make sure that we’re not only going to be professional and serve our clients, but we’re also going to be compassionate because they’re people with serious illnesses,” Schilleci said. “This is not a retail business. Yes, it’s retail, but it’s something more. At the end of the day it’s a call to serve.”

Lawsuits have hindered access to medical cannabis. Some companies sued the commission for not issuing licenses, citing a discriminatory process. In another case five parents sued the board over delays in accessing cannabis, which was dismissed in August.

Who will participate?

As of last Friday, fewer than 10 patients had signed up for medical cannabis, and Aday said it’s difficult to estimate how many patients will benefit from the program.

Schilleci knew the process of getting the product into patients’ hands would take some time, but she said she was grateful to be done soon.

“For patients, they’ve been waiting too long, it’s time to get this product to them,” Schilleci said. “I can’t get over it. It’s amazing how many people are already calling saying, ‘Hey, when are you opening? We’re ready for this.'”

Taylor said in an interview that she has received more than 700 emails from Alabamians through her work as a patient advocate, but patients will also contact her through texts, phone calls and social media.

“It can be overwhelming, but at the same time there are days with my illness where I can’t really walk much, so I can dedicate my time because I can’t do anything else,” he said.

Even though he’s nearing the end of his nearly five-year journey to medical cannabis, Taylor said it’s been exhausting.

“I mean no matter how you look at it, it’s a win for patients,” he said. “I can’t wait to celebrate for patients.”

Dispensary locations:

CCS of Alabama, LLC

    • Montgomery, Bessemer and Talladega

GP6 Wellness, LLC

    • Birmingham, Athens and Attalla

RJK Holdings, LLC

    • Oxford, Daphne and Mobile

Yellowhammer Medical Dispensary, LLC *pending license approval

    • Birmingham, Owens Cross Roads and Demopolis

This story was first published by the Alabama Reflector.

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