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	<title>Canna Law Blog™</title>
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		<title>Jason Adelstone to Speak at Global Cannabis Executive Summit in Toronto, June 1</title>
		<link>https://harris-sliwoski.com/cannalawblog/jason-adelstone-to-speak-at-global-cannabis-executive-summit-in-toronto-june-1/</link>
		
		<dc:creator><![CDATA[Canna Law Blog]]></dc:creator>
		<pubDate>Fri, 29 May 2026 14:00:33 +0000</pubDate>
				<guid isPermaLink="false">https://harris-sliwoski.com/?post_type=cannalawblog&#038;p=141363</guid>

					<description><![CDATA[<p>Harris Sliwoski attorney Jason Adelstone will speak at Grow Up’s CannaVision Global Cannabis Executive Summit in Toronto, an exclusive invitation-only event for CEOs, presidents, and top-level executives leading the future of the global cannabis industry. Jason&#8217;s panel is at 12:00pm EST on Monday, June 1. The title is &#8220;Moving Cannabis Across Borders: What It Takes.&#8221;</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/jason-adelstone-to-speak-at-global-cannabis-executive-summit-in-toronto-june-1/">Jason Adelstone to Speak at Global Cannabis Executive Summit in Toronto, June 1</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>Harris Sliwoski attorney <a href="https://harris-sliwoski.com/our-team/jason-adelstone/">Jason Adelstone</a> will speak at Grow Up’s <a href="https://growupconference.com/toronto/cannavision">CannaVision Global Cannabis Executive Summit</a> in Toronto, an exclusive invitation-only event for CEOs, presidents, and top-level executives leading the future of the global cannabis industry.</p>
<p>Jason&#8217;s panel is at 12:00pm EST on Monday, June 1. The title is &#8220;Moving Cannabis Across Borders: What It Takes.&#8221;</p>
<p>Jason&#8217;s work focuses heavily on international cannabis law, regulatory compliance, and cross-border business strategy. As global cannabis markets continue to evolve, operators increasingly face complex legal and commercial questions that reach beyond any single jurisdiction. These conversations have become especially important as businesses evaluate international expansion, regulatory changes, and emerging market opportunities.</p>
<p>GrowUp brings together stakeholders from across the cannabis ecosystem, making it an ideal setting for meaningful discussions about where the industry is headed and the practical challenges businesses face along the way.</p>
<p>If you&#8217;ll be attending CannaVision in Toronto, connect with Jason and say hello.</p>
<p>Learn more about the conference and session details here: <a href="https://growupconference.com/toronto">Grow Up Conference.</a></p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/jason-adelstone-to-speak-at-global-cannabis-executive-summit-in-toronto-june-1/">Jason Adelstone to Speak at Global Cannabis Executive Summit in Toronto, June 1</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
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		<title>How to Acquire a Minnesota Cannabis License</title>
		<link>https://harris-sliwoski.com/cannalawblog/how-to-acquire-a-minnesota-cannabis-license/</link>
		
		<dc:creator><![CDATA[Vince Sliwoski]]></dc:creator>
		<pubDate>Thu, 28 May 2026 14:00:02 +0000</pubDate>
				<guid isPermaLink="false">https://harris-sliwoski.com/?post_type=cannalawblog&#038;p=141371</guid>

					<description><![CDATA[<p>The Minnesota cannabis program is online and rolling out slowly. Too slowly, in this writer’s humble opinion. That said, a handful of tribal dispensaries have been operating since 2023, and adult use sales at non-tribal shops began in September 2025. To the good, sales are ticking up each month. In April, the Office of Cannabis</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/how-to-acquire-a-minnesota-cannabis-license/">How to Acquire a Minnesota Cannabis License</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>The Minnesota cannabis program is online and rolling out slowly. Too slowly, in this writer’s humble opinion. That said, a handful of tribal dispensaries have been operating since 2023, and adult use sales at non-tribal shops began in September 2025.</p>
<p>To the good, <a href="https://mn.gov/ocm/data-reports/dashboards/cannabis-market-monitor.jsp" target="_blank" rel="noopener">sales are ticking up</a> each month. In April, the Office of Cannabis Management (OCM) <a href="https://mn.gov/ocm/data-reports/dashboards/cannabis-market-monitor.jsp" target="_blank" rel="noopener">tracker</a> showed $15M in collected revenue from adult-use sales, and $10M in collected revenue from medical sales. This steady improvement, along with Minnesota’s robust population, <a href="https://harris-sliwoski.com/cannalawblog/minnesota-could-be-a-great-cannabis-state/" target="_blank" rel="noopener">regulatory philosophy</a>, and the <a href="https://harris-sliwoski.com/cannalawblog/marijuana-rescheduling-and-income-tax/" target="_blank" rel="noopener">income tax relief</a> that may come with federal rescheduling, make it an interesting time for a cannabis licensing play in the North Star state.</p>
<p>This blog post gives high-level information on acquiring a Minnesota cannabis license, in FAQ format. By way of background, I am a native Minnesotan and locally licensed business lawyer who has followed this program since inception, and supported the cannabis industry since 2011.</p>
<h2>What is the first step to getting a Minnesota cannabis license?</h2>
<p>The first step is to determine which license type you are after. Only certain license types are open for application with OCM. These include:</p>
<ul>
<li>Cannabis Retailer</li>
<li>Cannabis Wholesaler</li>
<li>Cannabis Event Organizer</li>
<li>Cannabis Testing Facility</li>
<li>Lower-Potency Hemp Edible Manufacturer</li>
</ul>
<p>Other license types are not available for application with OCM (the lottery closed last summer), but may still be sourced on the secondary market. These license types include:</p>
<ul>
<li>Cannabis Microbusiness</li>
<li>Cannabis Mezzobusiness</li>
<li>Cannabis Cultivator</li>
<li>Cannabis Manufacturer</li>
<li>Cannabis Transporter</li>
<li>Cannabis Delivery Service</li>
<li>Lower-Potency Hemp Edible Retailer</li>
<li>Lower-Potency Hemp Edible Wholesaler</li>
<li>Medical Cannabis Combination Business</li>
</ul>
<h2>What is the license acquisition process?</h2>
<p>For license types on offer with OCM, you need to <a href="https://aca-prod.accela.com/MDH/Cap/CapApplyDisclaimer.aspx?module=Cannabis&amp;TabName=Cannabis&amp;TabList=Cannabis%7C0%7CCurrentTabIndex%7C0" target="_blank" rel="noopener">create an Accela account</a>. Beyond that, the <a href="https://mn.gov/ocm/assets/OCM_Citizen_Portal_Application_Creation_User_Guide_tcm1202-669479.pdf#False" target="_blank" rel="noopener">OCM User Guide</a> contains a wealth of information on the license application process—too much to summarize here..</p>
<p>For license types on offer in the secondary market, see <a href="https://harris-sliwoski.com/cannalawblog/buying-and-selling-minnesota-cannabis-licenses/" target="_blank" rel="noopener">Buying and Selling Minnesota Cannabis Licenses</a>. I published that piece back in November, but the information is still good.</p>
<h2>What documents are required?</h2>
<p>Applicants need to provide ownership and control disclosures, a preliminary business plan, a preliminary operations plan, a security plan, and other supporting materials tied to the specific license type. OCM also requires company capitalization information, and labor peace agreements are required for many license types.</p>
<h2>Who can apply for a cannabis license in Minnesota?</h2>
<p><a href="https://www.revisor.mn.gov/statutes/cite/342.16" target="_blank" rel="noopener">MN Statute 342.16</a> contains a full list of “ownership disqualification and requirements.” Generally speaking, applicants must be at least 21 years of age, and there is no residency requirement. If the applicant or license holder is a business entity, though, that entity must be formed or organized in Minnesota.</p>
<h2>What happens after I submit the application?</h2>
<p>OCM reviews your application for basic eligibility and completeness, and qualified applicants move forward in the process. <a href="https://mn.gov/ocm/businesses/licensing/resources/licenseapplicants.jsp" target="_blank" rel="noopener">Background checks</a> are required for every qualified applicant and true party of interest (as per <a href="https://www.revisor.mn.gov/statutes/cite/342.185" target="_blank" rel="noopener">MN Statutes 342.185</a>).</p>
<h2>Do I need a location before applying?</h2>
<p>No. None of the lottery applicants we worked with had a location to start, in fact. However, you will eventually need to secure a compliant location and obtain local zoning approval.</p>
<h2>What role does local government play?</h2>
<p>Local approval is a major part of the process, “serving as a near-final approval check on cannabis businesses nearing the awarding of a state license…”, <a href="https://mn.gov/ocm/local-governments/localgovs.jsp" target="_blank" rel="noopener">to quote OCM</a>. In short, local governments must certify zoning compliance for a business to receive a state license, and, if applicable, retail registration is needed in some cases.</p>
<h2>How long does the process take?</h2>
<p>It depends. Per statue, OCM has 90 days to issue a license or a denial from the point when an applicant completes a site registration, uploads final application documents, and requests a zoning compliance certification. In our experience, local zoning step is often the hardest step, and OCM encourages applicants not to complete site registration until that hurdle is cleared.</p>
<h2>What is the most common reason applicants struggle?</h2>
<p>Finding a location and clearing local zoning is probably the biggest challenge we see. On the social equity side, we’ve also seen several applicants falter when it comes time to gather financial support. Those licenses are turning out to be far less lucrative than many initially expected.</p>
<h2>Final thoughts on Minnesota cannabis licensing</h2>
<p>Acquiring a Minnesota cannabis license is within reach for motivated parties who can follow basic protocols, marshal resources, and roll with the ongoing changes—many of which are <a href="https://mjbizdaily.com/news/minnesota-lawmakers-tweak-cannabis-laws-to-create-new-category-boost-hemp-thc/616062/" target="_blank" rel="noopener">designed to bolster the program</a>. This market is beginning to mature and still holds significant promise. <a href="https://harris-sliwoski.com/location/portland/" target="_blank" rel="noopener">Call us</a> if you are sizing up an opportunity.</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/how-to-acquire-a-minnesota-cannabis-license/">How to Acquire a Minnesota Cannabis License</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
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		<title>How to Acquire an Oregon Cannabis License</title>
		<link>https://harris-sliwoski.com/cannalawblog/how-to-acquire-an-oregon-cannabis-license/</link>
		
		<dc:creator><![CDATA[Vince Sliwoski]]></dc:creator>
		<pubDate>Wed, 20 May 2026 14:00:37 +0000</pubDate>
				<guid isPermaLink="false">https://harris-sliwoski.com/?post_type=cannalawblog&#038;p=141303</guid>

					<description><![CDATA[<p>It’s been a while since we wrote a “brass tacks” post on Oregon cannabis licensing. This blog post will cover some FAQs, from the perspective of an attorney who has worked on hundreds of these deals, since the very first licenses were transferred. Is OLCC issuing new marijuana licenses? Yes, but on a “one in</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/how-to-acquire-an-oregon-cannabis-license/">How to Acquire an Oregon Cannabis License</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>It’s been a while since we wrote a “brass tacks” post on Oregon cannabis licensing. This blog post will cover some FAQs, from the perspective of an attorney who has worked on <a href="https://harris-sliwoski.com/cannalawblog/15-years-lawyering-in-oregon-cannabis-and-beyond/" target="_blank" rel="noopener">hundreds of these deals</a>, since the very first licenses were transferred.</p>
<h2>Is OLCC issuing new marijuana licenses?</h2>
<p>Yes, but on a “one in and one out” protocol. The only way to acquire a cannabis license in Oregon (aside from a laboratory license) is to find a willing seller, and enter into a coordinated transaction with that seller and OLCC. This protocol has followed Oregon’s robust secondary market for “naked license” transfers <a href="https://harris-sliwoski.com/cannalawblog/no-new-cannabis-licenses-oregon-pulls-the-plug/" target="_blank" rel="noopener">since January 1, 2022</a>, when the OLCC stopped taking new license applications due to a saturated market and administrative backlog.</p>
<h2>What types of cannabis licenses are available?</h2>
<p>OLCC issues five main marijuana business licenses: producer, processor, wholesaler, retailer and laboratory. Producer licenses are offered at various canopy sizes, both indoor and outdoor—and a buyer is allowed to scale up or down. In other words, a micro-tier producer can agree to “sell” its license to an incoming licensee at a Tier I or II designation.</p>
<p>For the sake of completion, there is also a research certificate. Those are available from OLCC directly, and not subject to the “one in one out” policy&#8211;just like with the laboratory licenses.</p>
<h2>How do I find a license?</h2>
<p>You need to find a seller. Sometimes that happens through word of mouth and networking; other times, people source these deals through brokers. We recommend <a href="https://cannxperts.com/" target="_blank" rel="noopener">CannXperts</a> as the gold standard there. We also <a href="https://harris-sliwoski.com/cannalawblog/please-do-not-use-agreements-from-brokers/" target="_blank" rel="noopener">recommend</a>, very strongly, to never sign any type of “license sale” agreement offered by a broker. It’s a sad fact of life in my office that we deal with messed up broker situations on a weekly basis.</p>
<h2>What do licenses cost?</h2>
<p>Prices have fluctuated over the years. Today, we are seeing producer licenses trade hands in the $90K &#8211; $120K range. Processor licenses are selling for $25K &#8211; $30K. Wholesalers are going for that or less. And retail licenses are generally priced in accordance with a store’s performance. A store humming along at $1.5M in annual sales, for example, will sell for much more than a store doing $500K.</p>
<h2>What does a license purchase agreement look like?</h2>
<p>Most of them take the form of an asset purchase agreement, and may include additional assets (e.g. equipment, inventory), in addition to the license transferred. Less frequently— but especially for larger deals—we’ve structured these as stock sales. There’s typically an escrow component, as well, with an escrow agreement.</p>
<p>Prior to all of this, there is often a (non-binding) LOI, and sometimes even a non-disclosure agreement. It’s critical to have attorney eyes on anything you hope to sign; or better yet, have an attorney do the drafting so you don’t waste time and money fighting terrible forms.</p>
<h2>Can my license issue in a new location?</h2>
<p>Yes. Many of these deals have a change-in-location component, as well as a change-in-ownership. Either way, OLCC requires a land use compatibility statement (LUCS) for the incoming licensee, and will also require a notarized proof of landlord consent in the context of producer and processor licenses. The outgoing and incoming licensees will also need to pass an inspection by an OLCC inspector, at each relevant location.</p>
<h2>What should I do first?</h2>
<p>Once you find a willing seller, it’s time to do some basic diligence. This can occur prior to signing a purchase agreement, or in a defined, post-signing window. Some diligence will be basic, like whether a seller is a business in good standing with the Oregon Secretary of State (some aren’t), and whether the person representing the seller does, in fact, have authority to sell (some don’t). Other diligence will be specific to the license type: for example, in the case of retail, the seller will need to acquire a Certificate of Tax Compliance from the Oregon Department of Revenue.</p>
<h2>How do I apply? And what documents are required?</h2>
<p>You apply through OLCC’s <a href="https://www.oregon.gov/olcc/pages/camp.aspx" target="_blank" rel="noopener">CAMP online portal</a>. If you’d like a preview of what is required, the forms are <a href="https://www.oregon.gov/olcc/marijuana/pages/forms_publications.aspx" target="_blank" rel="noopener">here</a>. Certain owners will need to submit to a background check, which includes fingerprints and such.</p>
<p>After creating a CAMP account and uploading your application documents, you pay the applicable fees, and respond to any follow-up requests from the Commission. Those will typically come after your file is assigned to an investigator, which is happening within a week of completed applications at this point.</p>
<p>Anyone working on site, including owners, will also need to acquire a marijuana worker permit.</p>
<h2>How much does it cost?</h2>
<p>Costs vary by license type and, in the case of producer licenses, by canopy size. There is also a $250 application fee across all license types. Beyond that, OLCC publishes a comprehensive list of fees <a href="https://www.oregon.gov/olcc/marijuana/pages/forms_publications.aspx#:~:text=Application%20Fee%20(Initial%20License%20%26,Renewal)%3A%20%24250%20(non%2Drefundable)&amp;text=Processors%3A%20%244%2C750%20yearly%20fee&amp;text=Wholesalers%3A%20%244%2C750%20yearly%20fee&amp;text=Micro%20Wholesalers%3A%20%241%2C000%20yearly%20fee" target="_blank" rel="noopener">on its site</a>—just click the “Fees” link under the “Other Forms and Resources” header. Finally, be aware that certain jurisdictions, <a href="https://www.portland.gov/ppd/cannabis" target="_blank" rel="noopener">like the City of Portland</a>, have their own licensing requirements and annual fee schedules. Those requirements are mostly <a href="https://harris-sliwoski.com/cannalawblog/cities-should-not-license-cannabis-businesses-they-should-support-them/" target="_blank" rel="noopener">ill-conceived and redundant</a>, but you have to comply regardless.</p>
<h2>How long does it take?</h2>
<p>Timing depends on the license type, the completeness of your application, and availability of inspectors in the relevant region. We’ve seen organized transactions sale through in two or three month timeframe. It’s also worth noting that all applicants must complete the application process within 60 calendar days of investigator assignment. Otherwise, OLCC will inactivate the application, which can cause real issues in respect of purchase agreements.</p>
<h2>What mistakes should I avoid?</h2>
<p>I covered the broker thing already. Another problem we see frequently is outgoing licensees handing over the keys prior to approval, sometimes under the purview of a <a href="https://harris-sliwoski.com/cannalawblog/oregon-cannabis-beware-the-services-agreement/" target="_blank" rel="noopener">services agreement</a>, at which point financial considerations may become muddled, and compliance issues often accrue. Another problem relates to landlord negotiations and assuming a lease will be assignable when it isn’t. But, the biggest problem of all is just handing money over without protections, for any number of reasons. Unfortunately, it happens a lot.</p>
<h2>Bottom line</h2>
<p>The secondary market for Oregon cannabis license transfers is robust. From this lawyer’s perspective, the process is straightforward with no need for undue complexity. OLCC is easy to work with nowadays, and these deals have straightforward protocols from start to finish.</p>
<p>That said, there are also numerous pitfalls, and no shortage of unscrupulous characters. It’s best to work with someone who does this every day, to make sure you get in (or out) with minimal friction, and the best possible protection. <a href="https://harris-sliwoski.com/location/portland/" target="_blank" rel="noopener">Call us</a> if you are sizing up a deal.</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/how-to-acquire-an-oregon-cannabis-license/">How to Acquire an Oregon Cannabis License</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
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		<title>Medical Marijuana Rescheduling Q&#038;A: Cutting Through the Noise</title>
		<link>https://harris-sliwoski.com/cannalawblog/medical-marijuana-rescheduling-qa-cutting-through-the-noise/</link>
		
		<dc:creator><![CDATA[Jason Adelstone]]></dc:creator>
		<pubDate>Mon, 04 May 2026 14:00:40 +0000</pubDate>
				<guid isPermaLink="false">https://harris-sliwoski.com/?post_type=cannalawblog&#038;p=141251</guid>

					<description><![CDATA[<p>Since acting Attorney General Todd Blanch announced that state-legal medical marijuana would move to Schedule III, the commentary has been relentless — hot takes, doomsayers, and self-proclaimed experts flooding LinkedIn with conflicting interpretations. Much of it is speculative, overstated, and uneducated. This piece cuts through the noise and responds to the questions I have fielded</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/medical-marijuana-rescheduling-qa-cutting-through-the-noise/">Medical Marijuana Rescheduling Q&#038;A: Cutting Through the Noise</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>Since acting Attorney General Todd Blanch <a href="https://www.justice.gov/opa/pr/justice-department-places-fda-approved-marijuana-products-and-products-containing-marijuana" target="_blank" rel="noopener">announced</a> that state-legal medical marijuana would move to Schedule III, the commentary has been relentless — hot takes, doomsayers, and self-proclaimed experts flooding LinkedIn with conflicting interpretations. Much of it is speculative, overstated, and uneducated. This piece cuts through the noise and responds to the questions I have fielded the most about state medical programs.</p>
<p>The DOJ order shifts state-legal medical marijuana from Schedule I to Schedule III and establishes an optional DEA registration framework through which state-licensed operators may seek to participate. The confusion, on whether registration is mandatory, stems from confusion over two federal provisions: (1) <a href="https://www.law.cornell.edu/uscode/text/21/811" target="_blank" rel="noopener">21 USC 811(d)(1)</a>— a provision that suddenly everyone claims to understand, but few actually do; and (2) <a href="https://www.law.cornell.edu/uscode/text/26/280E" target="_blank" rel="noopener">26 USC 280E</a>.</p>
<h2>Q: Why does 21 USC 811(d)(1) matter now?</h2>
<p>It largely didn’t for industry, until now. The industry spent years chasing legislative solutions, whether full legalization, SAFE Banking, or uplisting. This provision sat ignored, despite a handful of us arguing its importance. Legal and policy wonks like me were <a href="https://harris-sliwoski.com/cannalawblog/one-signature-could-remove-marijuana-from-schedule-i-tomorrow/" target="_blank" rel="noopener">talking about 811(d)(1)</a> to any operators and industry associations who would listen. All of them brushed us aside. Ironically, many operators who ignored us then are unlikely to obtain the maximum benefits from it now.</p>
<p>21 USC 811(d)(1) allows the Attorney General to “issue an order controlling such drug” if doing so is required by U.S. obligations under the <a href="https://www.incb.org/incb/en/narcotic-drugs/1961_Convention.html" target="_blank" rel="noopener">Single Convention</a>. There is an important distinction between that language and what actually occurred: that is, DEA didn’t reschedule a “drug”; instead, it rescheduled a program. Further, under U.S. law, what constitutes a “drug” is a determination to be made by FDA under the Food, Drug, &amp; Cosmetic Act. These are likely two of the main arguments Smart Approaches to Marijuana (SAM) will make in its forthcoming litigation.</p>
<h2>Q: Does 280E apply to state licensed medical operators who don’t register with DEA?</h2>
<p>No, it does not. Tax code 280E prohibits deduction and credits for any trade or business trafficking in Schedule I or II substances. The order includes the following: “as a consequence of this rule, state licensees will no longer be subject to the deduction disallowance imposed by Section 280E.” Further, “[t]he final rule places in schedule III . . . marijuana subject to a state medical marijuana license.”</p>
<p>IRC 280E says nothing about DEA registration. The only qualification for schedule III placement, is that marijuana is subject to a state medical marijuana reprogram. Therefore, whether a state license operators is DEA registered is not a factor in whether it is operating with a schedule III substance. Only its state legality and license matters. For more information on the tax implications of this final rule, please read Vince Sliwoski’s <a href="https://harris-sliwoski.com/cannalawblog/marijuana-rescheduling-and-income-tax/" target="_blank" rel="noopener">blog post</a> last week.</p>
<h2>Q: What is the likelihood of opponents’ litigation prevailing?</h2>
<p>This question should be the first one operators ask , but surprisingly, it rarely is. If SAM, or anyone else challenging this <a href="https://www.federalregister.gov/documents/2026/04/28/2026-08176/schedules-of-controlled-substances-rescheduling-of-food-and-drug-administration-approved-products" target="_blank" rel="noopener">rescheduling order</a> prevails, all of this will be for naught. As noted above, there are substantial legal questions as to whether DEA exceeded its authority in issuing this order. I believe there is greater than a 50% chance that this order is stayed and ultimately overturned. It is not 100% certain, however, which is why I recently published a blog post calling DEA registration a “<a href="https://harris-sliwoski.com/cannalawblog/a-calculated-bet-dea-registration-is-open-and-the-clock-is-ticking/" target="_blank" rel="noopener">Calculated Risk</a>.” If you already have a medical license and all that is required is $10,000–$15,000 to hire an attorney and apply for registration, you have much better odds than playing Powerball or going to Vegas.</p>
<h2>Q: Do international treaty obligations apply to state-licensed operators?</h2>
<p>This depends on who you ask. The U.S. has maintained for years that international drug treaty obligations do not apply to state-licensed programs. <a href="https://www.marijuanamoment.net/moving-marijuana-to-schedule-iii-would-not-violate-international-treaties-legal-opinion-says/" target="_blank" rel="noopener">That position</a>, vocalized by Patt Prugh at the 2024 CND (though the video has since been removed), has not been refuted under this administration. The U.S. position is that the international drug treaties “take a ‘highly respectful’ stance toward member states’ domestic policies,” and much of those obligations apply, subject to each member state’s constitutional limits.</p>
<p>Even with the recent rescheduling order, state-licensed medical operators without DEA registration remain federally illegal and fall outside treaty scope (though this is a heavily contested issue within the international treaty community). In the face of Canada and Uruguay legalizing recreational marijuana, the Netherlands&#8217; coffee shop model, and the Dutch and Swiss scientific adult-use pilot programs, it is difficult to argue that applying the Single Convention’s constitutional limitation to state-legal, non-DEA-registered medical marijuana programs is inappropriate. Under the U.S.’ current position, only those operators that join the federal DEA registration apparatus would be required to comply with U.S. treaty obligations. Whether DEA will take this stance, however, is unknown. Under the rescheduling order&#8217;s wording, DEA could certainly apply those obligations to state-legal, but non-DEA-registered, operators. That said, enforcing these obligations would be a nightmare for DEA. Where will the funding and staffing come from?</p>
<h2>Q: How does the order affect dual-license operators?</h2>
<p>Unevenly. Medical-only states stand to benefit most. Dual-license states, those with both medical and adult-use programs, face a harder path. The DEA application asks directly: “Will your firm be handling or dispensing recreational marijuana?” It would make sense if an honest &#8220;yes&#8221; results in denial. A fraudulent “no” would likely lead to worse.</p>
<p>There is no way DEA has the staff to personally review all applications, let alone implement the program commenced in the order. As such, it is likely DEA will take two steps to aid in review: (1) launch an initial AI review of all applications; and (2) deny as many applications as possible. Denying an application because the applicant also handles recreational marijuana seems obvious. That said, if you are a dual licensee, I still think it’s worth applying, just in case I am wrong.</p>
<h2>Q: What happens with interstate commerce?</h2>
<p>Interstate transfers between DEA registrants are theoretically possible, but FDA has not clarified whether they are permissible under the Food, Drug, &amp; Cosmetic Act. Until it does, such transfers carry legal risk. Enforcement discretion may fill the gap in practice, but operators should not rely on that.</p>
<h2>Q: Can a company move product between its own DEA-registered facilities in different states?</h2>
<p>Possibly. Internal transfers between a company’s own registered locations may not constitute a “sale” or “marketing” activity under the FDCA, potentially keeping federal food and drug law out of the picture. If so, state law governs what can ultimately be sold. Transfers between separately owned DEA registrations in different states, would remain subject to the FDC&amp;A, so FDA guidance on this will be important. All of this remains unsettled, and operators should seek counsel before acting on that assumption.</p>
<h2>Q: What if state law prohibits interstate transport?</h2>
<p>State law controls DEA registration indirectly. Registration requires a valid state license. If a state enforces a ban on interstate transport through license suspension or revocation, federal authorization goes with it. Operators need to map their state-level exposure before pursuing DEA registration. If the importing state denies that transport, <a href="https://www.law.cornell.edu/wex/dormant_commerce_clause" target="_blank" rel="noopener">Dormant Commerce Clause</a> implications would certainly follow. If the exporting state prohibits such transfers, however, it remains unclear whether the Dormant Commerce Clause would apply. What is clear is that in states where legislation has already legalized interstate transport, such transfers will likely carry far less legal uncertainty upon federal legality.</p>
<h2>Q: Where do tribal operators stand?</h2>
<p>In limbo. The order does not clearly address tribal eligibility for DEA registration. The application references tribal law violations, but stops short of recognizing tribal licenses as a valid basis for registration. Tribal operators should consider applying while simultaneously pursuing advocacy. Waiting for clarity may mean waiting indefinitely.</p>
<h2>Q: What current DEA regulations will apply to state-licensed, DEA-registered medical operators, and what won&#8217;t?</h2>
<p><a href="https://www.ecfr.gov/current/title-21/chapter-II/part-1318" target="_blank" rel="noopener">21 CFR 1318</a> applies treaty obligations to DEA registrants operating with marijuana, so this section will certainly apply. The rescheduling order largely punts other requirements to state medical marijuana programs, leaving operators without a clear roadmap. DEA has promulgated an extensive body of regulations applicable to controlled substances and those who handle them (see <a href="https://www.ecfr.gov/current/title-21/chapter-II/part-1300?toc=1" target="_blank" rel="noopener">21 CFR 1300</a> et seq.) and it is not yet clear which of those regulations will be required of registered state-licensed operators, and which will be displaced by state law requirements.</p>
<p>What DEA has clarified, at least in part, is that holding a valid state license will allow registrants to bypass much of <a href="https://www.ecfr.gov/current/title-21/chapter-II/part-1301" target="_blank" rel="noopener">21 CFR 1301</a>, the section governing the registration process itself. Beyond that carve-out, however, the picture remains murky.</p>
<p>For now, operators pursuing registration are effectively agreeing to enter a federal regulatory framework without knowing its full contours. This is another dimension of the calculated risk that registration represents.</p>
<h2>Q: Does acknowledging violations of federal law prior to obtaining DEA registration put an operator at greater risk than already exists?</h2>
<p>Presumably, state-legal medical operators have been filing taxes since inception, so responding to this question in the application will not suddenly make anything newly known to the federal government. Is it a risk? Yes. But is it more of a risk than what state-legal operators have already been doing? I don’t think so.</p>
<p>One thing all operators should do is ensure their employees (down to the budtenders) are comfortable with their names and Social Security numbers being provided to DEA. An operator can make this disclosure a condition of employment, but they should give employees advance notice and the option to leave if they prefer not to be disclosed. Disclosing without such notice could lead to legal liability.</p>
<h2>Q:<a href="https://www.thecannabiscommunity.org/schedule-iii-executive-order-medical-cannabis-patients/" target="_blank" rel="noopener"> What does this mean for patients?</a></h2>
<p>Very little has changed. Medical marijuana patients remain federally illegal because the drug has not received FDA approval. Until further guidance is issued, patients should proceed as if the order does not exist: do not travel across state or international borders with marijuana, and understand that restrictions on housing and firearm ownership remain fully in effect.</p>
<h2>Q: What does this mean, if anything, for Congress overturning the intoxicating hemp products ban effective November 12th?</h2>
<p>I believe this order makes it less likely that Congress will pass an amendment or extend the effective date of the <a href="https://harris-sliwoski.com/cannalawblog/what-the-2026-federal-hemp-ban-means-for-unsold-hemp-inventory/" target="_blank" rel="noopener">hemp ban</a>. Many Republicans already oppose reversing the ban, and rescheduling has not helped. I believe many will stand firm in opposing any changes, <a href="https://www.marijuanamoment.net/gop-led-congressional-committee-votes-to-block-marijuana-rescheduling-defying-trump/" target="_blank" rel="noopener">simply as a stand against this rescheduling move by the Administration</a>.</p>
<h2>Conclusion</h2>
<p>The bottom line: rescheduling is meaningful, but its practical impact is narrow, uneven, and still developing. Anyone telling you otherwise is getting ahead of the facts. If you are navigating these questions and want an objective, experienced perspective from practitioners who have been working through these issues for years — not weeks — we are happy to offer a free consultation. Reach out to <a href="https://harris-sliwoski.com/our-team/jason-adelstone/" target="_blank" rel="noopener">our team</a> anytime.</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/medical-marijuana-rescheduling-qa-cutting-through-the-noise/">Medical Marijuana Rescheduling Q&#038;A: Cutting Through the Noise</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
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		<title>A Calculated Bet: DEA Registration is Open, and the Clock is Ticking</title>
		<link>https://harris-sliwoski.com/cannalawblog/a-calculated-bet-dea-registration-is-open-and-the-clock-is-ticking/</link>
		
		<dc:creator><![CDATA[Jason Adelstone]]></dc:creator>
		<pubDate>Wed, 29 Apr 2026 14:00:49 +0000</pubDate>
				<guid isPermaLink="false">https://harris-sliwoski.com/?post_type=cannalawblog&#038;p=141237</guid>

					<description><![CDATA[<p>For state-licensed medical marijuana operators, a narrow and potentially transformative window has opened&#8211;one that could position your business for future interstate and even global trade. While the Acting Attorney General’s rescheduling order is likely to face legal challenges, the immediate reality is this: you have a 60-day opportunity to act. As of yesterday, April 28,</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/a-calculated-bet-dea-registration-is-open-and-the-clock-is-ticking/">A Calculated Bet: DEA Registration is Open, and the Clock is Ticking</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>For state-licensed medical marijuana operators, a narrow and potentially transformative window has opened&#8211;one that could position your business for future interstate and even global trade.</p>
<p>While the Acting Attorney General’s <a href="https://www.justice.gov/opa/pr/justice-department-places-fda-approved-marijuana-products-and-products-containing-marijuana" target="_blank" rel="noopener">rescheduling order</a> is likely to face legal challenges, the immediate reality is this: you have a 60-day opportunity to act. As of yesterday, April 28, state medical marijuana licensees may apply for DEA registration to manufacture (this includes cultivation and limited processing), to distribute, and to dispense medical marijuana.</p>
<p>The DEA <a href="https://mmapplication.diversion.dea.gov/registration-instructions" target="_blank" rel="noopener">dispensary application portal</a> is already live, and applications for manufacturing and distribution are expected to follow the standard <a href="https://www.deadiversion.usdoj.gov/drugreg/registration.html" target="_blank" rel="noopener">DEA Form 225 process</a>.</p>
<p>We are not certain <a href="https://harris-sliwoski.com/cannalawblog/the-u-s-opens-its-medical-marijuana-market-to-global-trade-for-now-adult-use-rescheduling-on-deck/" rel="noopener">whether this framework will survive judicial review</a>, and if so, to what extent. What is clear, however, is that only applicants who submit within this initial 60-day window are positioned for expedited review, which is to occur within six months of an applicant&#8217;s submission. The rescheduling order provides no guidance on future application rounds or timelines, leaving significant ambiguity for those who wait.</p>
<p>In practical terms, this creates a first-mover advantage. If DEA registration ultimately becomes the gateway to a federally recognized, and potentially global, medical cannabis market, early applicants will be best positioned to participate.</p>
<p>We describe this as a “lottery ticket” not because it is speculative, but because it requires an upfront investment with uncertain outcomes. Engaging experienced counsel and preparing a compliant application typically involves costs in the range of $10,000 to $15,000 (including the DEA fee), with additional costs depending on complexity, scope, and the number of DEA registrations sought. The bet is $10,000-$15,000 for a potential upside opportunity into the hundreds of thousands or millions of dollars.</p>
<p>For those prepared to move forward, we can help you navigate this process efficiently and strategically. Our team is one of very few that is experienced in DEA registrations. We can:</p>
<ul>
<li>Provide a clear overview of the DEA registration framework and historical precedent</li>
<li>Prepare you for likely DEA follow-up inquiries and supplemental information requests</li>
<li>Assist in completing and submitting your application</li>
<li>Develop a comprehensive supporting package to strengthen your submission, should DEA seek supplemental information</li>
<li>Advise on international treaty obligations and operational compliance considerations referenced in the order</li>
</ul>
<p>If you are considering pursuing DEA registration during this window, we encourage you to connect <a href="https://harris-sliwoski.com/our-team/jason-adelstone/" target="_blank" rel="noopener">with our team</a> to discuss your options. We are available to provide a complimentary consultation and help you evaluate whether this opportunity aligns with your business strategy.</p>
<p style="text-align: center;">___________</p>
<p>For recent posts on the rescheduling order, check out the following:</p>
<ul>
<li><a href="https://harris-sliwoski.com/cannalawblog/the-u-s-opens-its-medical-marijuana-market-to-global-trade-for-now-adult-use-rescheduling-on-deck/" target="_blank" rel="noopener">The U.S. Opens Its Medical Marijuana Market to Global Trade (For Now); Broader Marijuana Rescheduling on Deck</a></li>
<li><a href="https://harris-sliwoski.com/cannalawblog/marijuana-rescheduling-and-income-tax/" target="_blank" rel="noopener">Marijuana rescheduling and income tax</a></li>
</ul>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/a-calculated-bet-dea-registration-is-open-and-the-clock-is-ticking/">A Calculated Bet: DEA Registration is Open, and the Clock is Ticking</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
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		<title>Marijuana Rescheduling and Income Tax</title>
		<link>https://harris-sliwoski.com/cannalawblog/marijuana-rescheduling-and-income-tax/</link>
		
		<dc:creator><![CDATA[Vince Sliwoski]]></dc:creator>
		<pubDate>Mon, 27 Apr 2026 14:00:00 +0000</pubDate>
				<guid isPermaLink="false">https://harris-sliwoski.com/?post_type=cannalawblog&#038;p=141232</guid>

					<description><![CDATA[<p>The DOJ Final Order on marijuana rescheduling dropped last week. Acting Attorney General Todd Blanche ordered that “FDA-approved drug products containing marijuana, as well [as] marijuana in any form covered by a state medical marijuana license, be placed in schedule III of the CSA.” The Order went further than many of us anticipated. It also</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/marijuana-rescheduling-and-income-tax/">Marijuana Rescheduling and Income Tax</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
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										<content:encoded><![CDATA[<p>The DOJ <a href="https://www.justice.gov/opa/media/1437441/dl" target="_blank" rel="noopener">Final Order</a> on marijuana rescheduling dropped last week. Acting Attorney General Todd Blanche ordered that “FDA-approved drug products containing marijuana, as well [as] marijuana in any form covered by a state medical marijuana license, be placed in schedule III of the CSA.”</p>
<p>The Order went further than many of us anticipated. It also includes a short section titled “Tax Implications.” Here is that section, in whole:</p>
<blockquote><p>&#8220;The Acting Attorney General further notes that, as a consequence of this rule, state licensees will no longer be subject to the deduction disallowance imposed by Section 280E of the Internal Revenue Code, which applies only to businesses engaged in ‘trafficking in controlled substances . . . in a schedule I or II,’ 26 U.S.C. § 280E. Nothing in this rule constitutes a determination regarding federal tax liability, and qualifying state licensees should consult with tax counsel regarding the applicability of Section 280E to their specific circumstances.&#8221;</p></blockquote>
<p>There is plenty to unpack in that paragraph.</p>
<h2>“State licensees”</h2>
<p>The Order doesn’t define “state licensee.” However, “state medical marijuana license” is now defined at 21 CFR § 1300.01 as:</p>
<blockquote><p>“a license issued by a state entity (or by a District of Columbia entity or a federal territorial entity) authorizing the licensee to manufacture, distribute, and/or dispense marijuana or products that contain marijuana for medical purposes.”</p></blockquote>
<p>Taxpayers holding these licenses, presumably, are “state licensees.” Many of these medical marijuana sellers may finally escape the stifling grasp of Section 280E.</p>
<p>Reader, I said “may.”</p>
<p>In states that allow <em>only</em> medical marijuana (e.g. Florida, Oklahoma, Pennsylvania), things appear straightforward: that is, state-licensed operators have become 280E-exempt under the Order. The marijuana being produced, processed, transferred and sold in these states all goes to cardholders—at least theoretically—and all of that marijuana is now in schedule III.</p>
<p>In states with adult-use programs, the analysis could be complex. All states with adult-use marijuana programs also have medical marijuana programs. Most of these states have blended their programs to varying degrees. In some states, a plant may begin in adult-use CTS, grown by a non-medical licensee, but evolve into a medical marijuana item somewhere along the supply chain. The resulting product may or may not be more potent, will likely be packaged differently, and may or may not be taxed. Invariably, though, it is transferred or sold to a medical marijuana cardholder. It has undergone a definitional transformation, if not a physical one.</p>
<p>The licensees in these mixed supply chains may be adult-use licensees, with “endorsements” or “registrations” or other permissions to create or handle medical marijuana products. At the grow level, the distinction is virtually meaningless—a marijuana plant is just a marijuana plant, after all. But, are these hybrid operators “state licensees” within the meaning of the Order? They handle medical marijuana, but they also traffic in non-medical marijuana. They may or may not segregate inputs; they may or may not segregate outputs. You can see where I’m going with this.</p>
<h2>“Nothing in this rule constitutes a determination regarding federal tax liability”</h2>
<p>In this respect, DOJ stays in its lane. Further along, though, the Order repeats the paragraph on Section 280E that I quoted above, adding one striking sentence:</p>
<blockquote><p>“The Administrator encourages the Secretary of the Treasury to consider providing retrospective relief from Section 280E liability for taxable years in which a state licensee operated under a state medical marijuana license.”</p></blockquote>
<p>Retrospective relief from Section 280E would be the ultimate prize for many marijuana businesses, short of an entrée to interstate commerce. The possibility is utterly tantalizing. Could it actually happen?</p>
<p>It could, although the Treasury need not heed the “retrospective relief” suggestion—it operates independent of DOJ in the executive branch. That said, the IRS has granted retrospective relief to taxpayers on numerous occasions, most recently last month <a href="https://www.withum.com/resources/irs-announces-critical-relief-for-taxpayers-following-major-tax-law-changes/#:~:text=Contact%20Us,Key%20Relief%20Provisions" target="_blank" rel="noopener">in relation to OBBA tax credits</a>. OBBA was signed into law in July of 2025, yet the IRS will allow taxpayers to amend returns as far back as 2022 for purposes of making certain elections.</p>
<p>However the Service proceeds, marijuana taxpayers would be wise to heed the Order’s advice to consult with tax counsel. An exception involves tax counsel who argue that Section 280E doesn’t apply to any marijuana businesses whatsoever. In that case, <a href="https://harris-sliwoski.com/cannalawblog/irc-280e-still-applies-to-your-marijuana-business-unfortunately/" target="_blank" rel="noopener">please read this</a>.</p>
<h2>What’s next for marijuana rescheduling, and tax</h2>
<p>I’ll be watching three things.</p>
<p>First, I’ll be watching for Treasury guidance. On Thursday, April 23, the Treasury and IRS promptly <a href="https://home.treasury.gov/news/press-releases/sb0471" target="_blank" rel="noopener">announced</a> such guidance is forthcoming. The press release forecasts:</p>
<blockquote><p>“a transition rule providing that, for purposes of Section 280E, rescheduling generally will be considered to first apply for a business’s full taxable year that includes the effective date of the Final Order…”.</p></blockquote>
<p>For most marijuana businesses, that will be calendar year 2026.</p>
<p>Second, I’ll be watching for litigation. The Order will be litigated. The fundamental question is whether DOJ exceeded its authority in issuing the Order. Challengers will argue, <em>inter alia</em>, that: 1) the Order undercut an <a href="https://harris-sliwoski.com/cannalawblog/thoughts-on-the-terrible-pageant-of-marijuana-rescheduling/" target="_blank" rel="noopener">ongoing rescheduling process</a>, not yet withdrawn; 2) that the Order’s heavy reliance on international treaty compliance, and specifically, its permissive reading of a <a href="https://www.dea.gov/sites/default/files/2024-05/2024-04-11%20-%20AAG%20Fonzone%20-%20Marijuana%20Rescheduling.pdf" target="_blank" rel="noopener">2024 Office of Legal Counsel opinion</a> on that issue, is flawed; and 3) that the bifurcation of marijuana into medical and non-medical channels by DOJ, outside of FDA purview, is statutorily incoherent.</p>
<p>Third, I’ll be watching for adult use rescheduling. In its <a href="https://www.justice.gov/opa/pr/justice-department-places-fda-approved-marijuana-products-and-products-containing-marijuana" target="_blank" rel="noopener">press release</a> announcing the Order, DOJ announced it would also “expedite the ongoing rulemaking process required to fully remove marijuana from Schedule I and place it in Schedule III under the Controlled Substances Act.” This rulemaking would apply to all marijuana, and not just medical marijuana. DOJ says DEA will “commence a new administrative hearing beginning June 26, 2026.” How that would work in an agency that no longer has an administrative law judge is a very good question. We’ll save it for another day.</p>
<p>For now, medical marijuana is in schedule III. State licensees should watch these further developments, but also focus on things they can control. These include: 1) consulting with tax counsel; 2) revisiting accounting practices, especially where allocations to medical marijuana may be distinguishable from allocations to non-medical marijuana; and 3) recall that local tax laws still apply—including state laws limiting certain deductions for all marijuana businesses.</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/marijuana-rescheduling-and-income-tax/">Marijuana Rescheduling and Income Tax</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
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		<title>The U.S. Opens Its Medical Marijuana Market to Global Trade (For Now); Broader Marijuana Rescheduling on Deck</title>
		<link>https://harris-sliwoski.com/cannalawblog/the-u-s-opens-its-medical-marijuana-market-to-global-trade-for-now-adult-use-rescheduling-on-deck/</link>
		
		<dc:creator><![CDATA[Jason Adelstone]]></dc:creator>
		<pubDate>Thu, 23 Apr 2026 16:10:53 +0000</pubDate>
				<guid isPermaLink="false">https://harris-sliwoski.com/?post_type=cannalawblog&#038;p=141218</guid>

					<description><![CDATA[<p>U.S. joins much of the world in acknowledging medical marijuana The U.S. has joined much of the world in acknowledging medical marijuana. Let international trading begin! Effective April 28, 2026, the acting Attorney General &#8220;hereby order[s] that FDA-approved drug products containing marijuana, as well marijuana in any form covered by a state medical marijuana license,</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/the-u-s-opens-its-medical-marijuana-market-to-global-trade-for-now-adult-use-rescheduling-on-deck/">The U.S. Opens Its Medical Marijuana Market to Global Trade (For Now); Broader Marijuana Rescheduling on Deck</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
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										<content:encoded><![CDATA[<h2>U.S. joins much of the world in acknowledging medical marijuana</h2>
<p>The U.S. has joined much of the world in acknowledging medical marijuana. Let international trading begin!</p>
<p><a href="https://www.federalregister.gov/documents/2026/04/28/2026-08176/schedules-of-controlled-substances-rescheduling-of-food-and-drug-administration-approved-products" target="_blank" rel="noopener">Effective April 28, 2026</a>, the acting Attorney General &#8220;hereby order[s] that FDA-approved drug products containing marijuana, as well marijuana in any form covered by a state medical marijuana license, be placed in schedule III of the CSA.&#8221; Based on this order, the United States acknowledges medical marijuana and has a fully functioning medical marijuana program (via state licensees). The final order applies to: (a) marijuana as listed in 21 CFR 1308.11(d)(23), (b) marijuana extracts as defined in 21 CFR 1308.11(d)(58), and (c) naturally occurring Delta-9-THC derived from the marijuana plant (other than the mature stalks and seeds). The order does <span style="text-decoration: underline;">not</span> reschedule all marijuana. Any marijuana or marijuana extract not covered by this order (i.e. state-legal adult-use marijuana) remains in schedule I and will be subject to a <a href="https://www.justice.gov/opa/media/1437446/dl?utm_medium=email&amp;utm_source=govdelivery" target="_blank" rel="noopener">new rescheduling hearing scheduled for June 29, 2026 at 9 a.m. ET</a>.</p>
<p>This order went much further than expected. <a href="https://harris-sliwoski.com/cannalawblog/marijuana-to-schedule-iii-is-necessary-but-lets-be-honest-about-its-limits/" target="_blank" rel="noopener">I wrote last year</a> about the limits of moving marijuana to schedule III, and how such a move would not legalize state-licensees without regulatory change. This order does just that. It amends DEA regulations to legalize state licensees. Whether such amendments will withstand judicial scrutiny remains to be seen.</p>
<h3>How the order was issued</h3>
<p><a href="https://harris-sliwoski.com/cannalawblog/one-signature-could-remove-marijuana-from-schedule-i-tomorrow/" target="_blank" rel="noopener">As I wrote about previously</a>, all it took to reschedule was a press release and stroke of a pen. Although, it was not so much a stroke of a pen as a 23-page order outlining the current move and future process. This move does not appear to place marijuana in Schedule III; rather, it places certain formulations of marijuana in schedule III&#8211;namely FDA approved products and, more impactfully, medical marijuana products that &#8220;are subject to a state-issued license to manufacture, distribute, and/or dispense marijuana products containing marijuana for medical purposes.&#8221;</p>
<p>It is important to note that this is a final order being issued under <a href="https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section811&amp;num=0&amp;edition=prelim" target="_blank" rel="noopener">21 USC 811(d)(1)</a> and not a proposed rule. Section 811(d)(1) allows the Attorney General to reschedule a substance if doing so would place the U.S. in better alignment with its international treaty obligations. I have written about this many times over the years, and provided position papers to DEA on utilizing this mechanism. Using 811(d)(1), the DOJ and DEA are not required to obtain a recommendation from HHS, though <a href="https://www.dea.gov/sites/default/files/2024-05/2016-17954-HHS.pdf" target="_blank" rel="noopener">one was provided in 2023</a>.</p>
<p>In its order, DEA also takes pains to highlight the HHS findings in its 2023 recommendation, supporting today&#8217;s move, even though such support is not needed. The acting Attorney General stated that &#8220;[a]lthough I am not required to consider this HHS recommendation when issuing an order under section 811(d)(1), because I believe there are several legally viable scheduling options that would satisfy the United States&#8217; obligations under the Single Convention . . . . I exercise my discretion in determining the most appropriate schedule by choosing the option that most closely aligns to HHS&#8217;s findings and best position the United States to carry out its obligations under the Single Convention.&#8221;</p>
<h3>Registration requirements</h3>
<h4><u>State-licensed medical marijuana operators</u></h4>
<p>The final order establishes an expedited registration process under <a href="https://www.ecfr.gov/current/title-21/chapter-II/part-1301" target="_blank" rel="noopener">21 CFR 1301</a> for state-licensed medical marijuana entities to register for a DEA license to manufacture, distribute, and dispense marijuana for medical purposes under federal law. This means that state licensed medical marijuana operators will be permitted to apply for DEA registrations, something DEA has prohibited in the past.</p>
<p>The Attorney General determined that state-licensed regulatory systems have developed robust infrastructure for preventing diversion, ensuring product safety, proper record retention, and proper facility inspections, all of which fulfill the objectives of federal registration and recordkeeping requirements. Taken as a whole, these systems &#8220;demonstrate a sustained capacity to achieve the public-interest objectives that underlie the CSA&#8217;s registration framework, including protecting public health and safety and preventing the diversion of controlled substances into illicit channels.&#8221; As such, the Attorney General determined that &#8220;incorporating state licensing systems into the federal registration framework represents the most effective and efficient means of achieving the CSA&#8217;s objectives.&#8221; The Attorney General and DEA preserve authority, however, to deny or revoke registration where specific public interest concerns arise, and to ensure compliance with the <a href="https://www.unodc.org/pdf/convention_1961_en.pdf" target="_blank" rel="noopener">Single Convention</a>.</p>
<p>Based on this state-federal partnership, DEA will amend part 1301 of its regulations to provide an expedited review process under which state licensees may submit their existing state credentials as conclusive evidence of state authorization to receive DEA registration for manufacturing, distribution, and dispensaries. Importantly, the DEA must grant registration unless doing so would be inconsistent with the public interest under 21 USC 823 factors or under the Single Convention. Applications submitted within 60 days of publication must be processed within six months, and early applicants may lawfully operate under their state-issued license during the pendency of review.</p>
<p>State registrants may also rely on state-law labeling, packaging, disposal, and physical security requirements in lieu of the federal requirements, subject to inclusion of the statutory warning label required by 21 USC 825(c).</p>
<h4><u>FDA-approved marijuana operators</u></h4>
<p>The following outlines the schedule III regulatory requirements that now apply &#8220;for those who handle marijuana exclusively in the form of an FDA-approved drug product&#8221;:</p>
<ol>
<li>Any person who handles FDA-approved drug products containing marijuana must be registered with the DEA to conduct such activities for a schedule III substance.</li>
<li>Entities that transfer marijuana to patients, including dispensaries, must register with the DEA as &#8220;practitioners&#8221; under 21 USC 823(g).</li>
<li>Schedule III FDA-approved drug products containing marijuana must be disposed of in accordance with 21 CFR 1317, in addition to other applicable state and federal requirements.</li>
<li>DEA registrant applicants must pay the annual DEA fee for registration, which are: (1) Manufacturer: $3,999 annually; (2) Distributors: $1,850 annually; and (3) Dispensaries, including pharmacies: $888 for a registration valid for 3 years.</li>
<li>Prescriptions are required to be issued prior to dispensing FDA approved marijuana drugs and must contain specific information.</li>
<li>All DEA registrants must maintain records as required by federal law and submit reports with respect to FDA-approved drugs.</li>
<li>All DEA registrants must comply with DEA security requirements, labeling and packaging, and inventory requirements.</li>
</ol>
<h3>International trade and import/export and DEA authority</h3>
<h4><span style="text-decoration: underline;">Imports and exports</span></h4>
<p><a href="https://schedulingreform.org/treaty-memo" target="_blank" rel="noopener">As I have argued along with colleagues</a>, this move to schedule III will also require amending DEA&#8217;s regulations to account for US obligations under the Single Convention with marijuana being moved into Schedule III. In DOJ&#8217;s final order, it acknowledged the same, stating that &#8220;DEA must simultaneously amend the regulations to require a permit to import or export such products.&#8221;</p>
<p>This order specifically states that &#8220;this order amends the DEA regulations (21 CFR 1312.30) to add FDA-approved drug products containing marijuana and state-licensed medical marijuana to the list of nonnarcotic schedule III through V controlled substances that are subject to the import and export permit requirement.&#8221; Registering with the DEA will allow state licenses to potentially access the international market, as DEA registrants can apply for and receive import and export licenses. Another important amendment is that DEA addressed its regulatory definition of &#8220;medicinal cannabis,&#8221; which DEA created out of thin air, to exempt state legal medical marijuana from the requirement that medicinal cannabis be FDA approved and legal to market under the Food, Drug, and Cosmetic Act.</p>
<h4><u>DEA will become a part of the state medical marijuana supply chain</u></h4>
<p>Registration with the DEA will be essential for state medical marijuana licensees, because DEA will be responsible for purchasing and selling the marijuana grown by state licensees as required by DEA&#8217;s regulations and the Single Convention. &#8220;By maintaining in schedule I all unlicensed marijuana, bulk marijuana, and any marijuana or marijuana extract that has not yet been incorporated into a FDA-approved drug product, and by requiring that state-licensed marijuana satisfy the requirements relating to the purchase and sale of marijuana by DEA, the United States will continue to meet these obligations without disruption or delay.&#8221;</p>
<p>The rule also establishes a nominal price purchase-and-resale mechanism through which the DEA acquires and resells registered manufacturers&#8217; marijuana crops, to satisfy Single Convention requirements. Query: do we really expect DEA to take possession of all flower sales within state systems? As the order is written, registered manufacturers must store crops in DEA maintained facilities until the transaction is complete, and each registrant must provide DEA information on the exact location where medical marijuana is cultivated.</p>
<h3>Research</h3>
<p>Researchers who obtain marijuana or marijuana derived products from state licensees for use in scientific research are shielded from civil and criminal liability under the CSA, provided that the researcher is registered with the DEA. This now allows for state medical marijuana and products to be researched.</p>
<h3>I.R.C. 280E</h3>
<p>The order acknowledges that state medical licensees will <a href="https://harris-sliwoski.com/cannalawblog/irc-280e-still-applies-to-your-marijuana-business-unfortunately/" target="_blank" rel="noopener">no longer be subject</a> to I.R.C. 280E, but does not make a determination on their tax status and suggests they speak to a tax consultant when making their tax determination. It goes on further to encourage the &#8220;Secretary of Treasury to consider providing retrospective relief from Section 280E liability for taxable years in which a state licensee operated under a state medical marijuana license.&#8221; Importantly, 280E will likely be a nightmare for those operating in dual licensing states where both adult-use and medical often operate under once license. Many operators, including the large multi-state operators, do not keep distinct records. Since only licensed medical operations qualify for 280E relief, unless these companies can separate their books&#8211;and in some cases their licenses&#8211;they will likely remain subject to 280E.</p>
<h3>What the order does not cover</h3>
<p>This order does not apply to: (1) anything that does not fall into the FDA-approved marijuana; (2) any products and operators not licensed by a state&#8217;s medical marijuana program; (3) synthetically derived THC (e.g. delta-10 THC) which remains in schedule I; and (4) Any hemp product exceeding 0.4mg after November 12<sup>th</sup>. Anyone dealing with non-FDA approved medical marijuana or state licensed medical marijuana will remain in violation of federal law as it relates to a schedule I controlled substance.</p>
<p>It appears that current DEA registrants manufacturing bulk marijuana will also remain in Schedule I, since they are neither FDA approved nor legalized under state legal medical marijuana programs.</p>
<h3>Outstanding issues</h3>
<p>Some outstanding questions remain. For instance, as a discuss above re: 280E, how will dual licensees that provide both adult-use and medical marijuana be treated? For example, in Arizona marijuana sold as adult-use or medical is not designated as such until the point of sale. How will medical marijuana versus the adult-use be tracked for schedule III, and more importantly, 280E purposes? One thing is likely certain: those operating in these dual licensed states that comingle medical and adult-use marijuana (whether through inventory or via the company’s books) will almost certainly be ineligible for the early expedited DEA registration discussed above.</p>
<h3>Upcoming DEA administrative law hearing</h3>
<p>The Attorney Generals order does not reschedule all marijuana. Anything not included in this order will be subject to a new administrative law hearing, which is scheduled to commence on June 29, 2026, at 9 a.m. ET. The result of this hearing will determine whether all “marijuana” is moved into schedule III.</p>
<h3>Certain legal challenges</h3>
<p>DEA does acknowledge in footnote thirty-nine that if any of the order is found illegal, the rest of the provisions shall remain. This acknowledges the reality that litigation will certainly ensue&#8211;if it hasn’t already. <a href="https://learnaboutsam.org/" target="_blank" rel="noopener">Smart Approaches to Marijuana</a> will certainly bring litigation challenging the Attorney general and DEA’s authority to issue this order and the rules related to it. While the Attorney General’s Authority to reschedule a substance under 811(d)(1) is clear, its ability to amend operational and registration regulations under the same authority is not as clear. We will be keeping a close eye on this as things progress and will publish updates as they occur.</p>
<p>In the meantime, if you are a state licensed medical marijuana operator, please don’t hesitate to reach out to our team about DEA registration. Further, if you are a foreign medical marijuana operator looking to explore US opportunities, they finally exist (at least for now).</p>
<p style="text-align: center;">____</p>
<p>For previous insights on marijuana rescheduling, please check out these blog posts:</p>
<ul>
<li><a href="https://harris-sliwoski.com/cannalawblog/marijuana-to-schedule-iii-is-necessary-but-lets-be-honest-about-its-limits/" target="_blank" rel="noopener">Marijuana to Schedule III is Necessary, But Let&#8217;s Be Honest About Its Limits</a></li>
<li><a href="https://harris-sliwoski.com/cannalawblog/one-signature-could-remove-marijuana-from-schedule-i-tomorrow/" target="_blank" rel="noopener">One Signature Could Remove Marijuana From Schedule I Tomorrow</a></li>
<li><a href="https://harris-sliwoski.com/cannalawblog/trumps-cannabis-plays-explained/" target="_blank" rel="noopener">Trump’s Cannabis Plays, Explained</a></li>
<li><a href="https://harris-sliwoski.com/cannalawblog/is-marijuana-rescheduling-finally-happening-what-to-know-now/" target="_blank" rel="noopener">Is Marijuana Rescheduling Finally Happening? What to Know, Now</a></li>
<li><a href="https://harris-sliwoski.com/cannalawblog/president-trump-issues-executive-order-directing-the-attorney-general-to-reschedule-marijuana/" target="_blank" rel="noopener">President Trump Issues Executive Order Directing the Attorney General to Reschedule Marijuana</a></li>
</ul>
<p>&nbsp;</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/the-u-s-opens-its-medical-marijuana-market-to-global-trade-for-now-adult-use-rescheduling-on-deck/">The U.S. Opens Its Medical Marijuana Market to Global Trade (For Now); Broader Marijuana Rescheduling on Deck</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
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		<title>Harris Sliwoski Welcomes Christian Sederberg</title>
		<link>https://harris-sliwoski.com/cannalawblog/harris-sliwoski-welcomes-christian-sederberg/</link>
		
		<dc:creator><![CDATA[Canna Law Blog]]></dc:creator>
		<pubDate>Thu, 09 Apr 2026 14:00:26 +0000</pubDate>
				<guid isPermaLink="false">https://harris-sliwoski.com/?post_type=cannalawblog&#038;p=141170</guid>

					<description><![CDATA[<p>Harris Sliwoski is pleased to announce that Christian Sederberg has joined the firm as Of Counsel. Based in our Denver, Colorado office, Christian brings decades of experience advising businesses, policymakers, and industry leaders across a range of complex regulatory and transactional matters, with a particular focus on the cannabis industry. Christian is widely recognized as</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/harris-sliwoski-welcomes-christian-sederberg/">Harris Sliwoski Welcomes Christian Sederberg</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p data-start="64" data-end="392">Harris Sliwoski is pleased to announce that <a href="https://harris-sliwoski.com/our-team/christian-sederberg/" target="_blank" rel="noopener">Christian Sederberg</a> has joined the firm as Of Counsel. Based in our Denver, Colorado office, Christian brings decades of experience advising businesses, policymakers, and industry leaders across a range of complex regulatory and transactional matters, with a particular focus on the cannabis industry.</p>
<p data-start="394" data-end="823">Christian is widely recognized as a leading voice in cannabis law and policy. He has worked at the forefront of the industry’s development, advising clients on business formation, corporate governance, real estate, financing, and regulatory compliance in an evolving legal landscape. His experience spans both domestic and international markets, allowing him to guide clients navigating cross-border opportunities and challenges.</p>
<p data-start="825" data-end="1277">In addition to his client work, Christian has played a meaningful, public role in shaping cannabis policy in the United States and abroad. He has held numerous leadership roles, including: serving on the board of the National Cannabis Industry Association; serving as Chairman of the Board and Interim CEO of the Cannabis Trade Federation; and serving as Chairman of the Board of the United States Cannabis Council. In 2010, he also co-founded Vicente Sederberg LLP (now Vicente LLP) and served as its managing partner for more than a decade.</p>
<p data-start="1279" data-end="1592">At Harris Sliwoski, Christian will continue advising entrepreneurs, established companies, and international operators on strategic growth, compliance, and risk management. His addition further strengthens the firm’s cannabis and regulatory practices&#8211;particularly as global markets continue to expand and mature.</p>
<p data-start="1279" data-end="1592">Welcome, Christian!</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/harris-sliwoski-welcomes-christian-sederberg/">Harris Sliwoski Welcomes Christian Sederberg</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
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		<title>Jason Adelstone to Attend the International Cannabis Business Conference in Berlin</title>
		<link>https://harris-sliwoski.com/cannalawblog/jason-adelstone-to-attend-the-international-cannabis-business-conference-in-berlin/</link>
		
		<dc:creator><![CDATA[Canna Law Blog]]></dc:creator>
		<pubDate>Mon, 06 Apr 2026 20:14:18 +0000</pubDate>
				<guid isPermaLink="false">https://harris-sliwoski.com/?post_type=cannalawblog&#038;p=141152</guid>

					<description><![CDATA[<p>Next week, Harris Sliwoski LLP attorney Jason Adelstone will be attending the International Cannabis Business Conference in Berlin, where he is looking forward to connecting with international cannabis businesses, investors, and regulatory experts from around the world. Why ICBC Berlin Matters for the Global Cannabis Market As the global cannabis market continues to expand, ICBC</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/jason-adelstone-to-attend-the-international-cannabis-business-conference-in-berlin/">Jason Adelstone to Attend the International Cannabis Business Conference in Berlin</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
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										<content:encoded><![CDATA[<p>Next week, Harris Sliwoski LLP attorney <a href="https://harris-sliwoski.com/our-team/jason-adelstone/" target="_blank" rel="noopener">Jason Adelstone</a> will be attending the <a href="https://internationalcbc.com/berlin/" target="_blank" rel="noopener">International Cannabis Business Conference</a> in Berlin, where he is looking forward to connecting with international cannabis businesses, investors, and regulatory experts from around the world.</p>
<h3>Why ICBC Berlin Matters for the Global Cannabis Market</h3>
<p data-start="541" data-end="890">As the global cannabis market continues to expand, ICBC Berlin has become one of the leading forums for discussing international cannabis business, cross-border investment, and regulatory developments. The conference consistently brings together the operators, policymakers, and investors actively shaping the future of the global cannabis industry.</p>
<p data-start="892" data-end="1100">Key issues expected to dominate conversations this year include evolving European cannabis frameworks, cross-border capital flows, and supply chain development as more countries move toward regulated markets.</p>
<h3 data-start="892" data-end="1100">The U.S. and the Global Cannabis Opportunity Gap</h3>
<p>As Jason has previously written about, the <a href="https://harris-sliwoski.com/cannalawblog/americas-missed-opportunity-in-the-global-marijuana-market/" target="_blank" rel="noopener">United States is missing a golden opportunity to join and affect the global marijuana market</a>. While other countries are building cultivation, manufacturing, and export infrastructure, U.S. operators are still unable to meaningfully participate in international cannabis commerce. With the global cannabis market projected to reach $82.3 billion by 2027, the U.S. risks missing a significant economic opportunity unless federal policy evolves.</p>
<h3>What International Cannabis Businesses Should Be Watching</h3>
<p>Still, there is reason for cautious optimism. If federal policy shifts to allow exports or broader international participation, U.S. businesses could eventually become meaningful players in the global cannabis market. In the meantime,<a href="https://harris-sliwoski.com/cannalawblog/cbd-medicare-and-the-new-fda-enforcement-memo/"> emerging federal initiatives around CBD products</a> may provide a limited pathway for U.S. companies to begin engaging in international cannabis business, particularly in jurisdictions where hemp-derived products are permitted. Until then, conferences like ICBC Berlin remain an important reminder that the future of cannabis is international.</p>
<p>Events like ICBC Berlin highlight a simple reality: the future of cannabis is increasingly global, and businesses that understand cross-border regulatory and investment dynamics will be better positioned to compete.</p>
<p>Whether your U.S. company is looking to invest in a global cannabis operator, you are an international operator looking for U.S. investment, or you simply want to understand where a particular country&#8217;s cannabis policies are headed, reach out to Jason Adelstone at <a href="mailto:jason@harris-sliwoski.com">jason@harris-sliwoski.com</a> to schedule a time to connect.</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/jason-adelstone-to-attend-the-international-cannabis-business-conference-in-berlin/">Jason Adelstone to Attend the International Cannabis Business Conference in Berlin</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
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		<title>CBD, Medicare, and the New FDA Enforcement Memo</title>
		<link>https://harris-sliwoski.com/cannalawblog/cbd-medicare-and-the-new-fda-enforcement-memo/</link>
		
		<dc:creator><![CDATA[Vince Sliwoski]]></dc:creator>
		<pubDate>Fri, 03 Apr 2026 14:00:28 +0000</pubDate>
				<guid isPermaLink="false">https://harris-sliwoski.com/?post_type=cannalawblog&#038;p=141146</guid>

					<description><![CDATA[<p>We got a new FDA cannabis enforcement memo on Wednesday, April 1, regarding &#8220;hemp-derived CBD research in medical research models.&#8221; The general thrust is FDA’s assurance that it won’t interfere with a new federal initiative, which covers up to $500 of hemp-derived products for eligible Medicare patients. That initiative is called the Substance Access Beneficiary</p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/cbd-medicare-and-the-new-fda-enforcement-memo/">CBD, Medicare, and the New FDA Enforcement Memo</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
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										<content:encoded><![CDATA[<p>We got a new <a href="https://www.fda.gov/media/191782/download?attachment" target="_blank" rel="noopener">FDA cannabis enforcement memo</a> on Wednesday, April 1, regarding &#8220;hemp-derived CBD research in medical research models.&#8221; The general thrust is FDA’s assurance that it won’t interfere with a <a href="https://www.cms.gov/priorities/innovation/substance-access-beneficiary-engagement-incentive" target="_blank" rel="noopener">new federal initiative</a>, which covers up to $500 of hemp-derived products for eligible Medicare patients. That initiative is called the Substance Access Beneficiary Engagement Incentive (&#8220;Substance Access BEI&#8221;), and it also launched on April 1. The usual suspects are suing to block this program, of course. <a href="https://www.marijuanamoment.net/judge-rejects-anti-marijuana-groups-motion-to-block-cbd-and-thc-medicare-coverage-plan-setting-hearing-for-4-20/" target="_blank" rel="noopener">They&#8217;re not doing very well</a>.</p>
<p>The FDA Memo is welcome guidance as to the Substance Access BEI. The memo was anticipated by some of us, but there is more at play here.</p>
<h2>The FDA Memo on cannabis enforcement in the Substance Access BEI program</h2>
<p>The FDA Memo is only two pages. It traces federal hemp regulation back to the 2018 Farm Bill, as reined in by P.L. 119-37, a spending bill passed in November of 2025. As <a href="https://harris-sliwoski.com/cannalawblog/notes-on-the-federal-prohibition-of-intoxicating-hemp/">we explained</a> at the time, P.L. 119-37 closed the perceived loophole on intoxicating hemp products by re-defining &#8220;hemp.&#8221;</p>
<p>The FDA Memo notes that the 2018 Farm Bill “explicitly preserved FDA’s authority to regulate products containing cannabis . . . . under the Federal Food, Drug, and Cosmetic Act [‘FDCA’].” FDA issued a similar proclamation when 2018 Farm Bill broadly legalized hemp, and it has <a href="https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd#:~:text=FDA%2Dregulated%20products?-,A.,products%20containing%20any%20other%20substance.">continued to assert authority</a> over hemp-derived products ever since.</p>
<p>But the agency is mostly just talk. Its efforts have been limited to sending (and bragging on) sporadic warning letters to select CBD sellers, who make the wildest health claims. All the while, the U.S. hemp cannabinoids market has blossomed into <a href="https://dealtracker.viridianca.com/chart_of_the_week/how-big-is-the-u-s-intoxicating-hemp-market-a-modeled-estimate/" target="_blank" rel="noopener">a $20 billion behemoth</a>, with scrupulous and unscrupulous parties selling their wares in a regulatory vacuum. After several years of this, in 2023, FDA concluded <a href="https://www.fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol#:~:text=Some%20risk%20management%20tools%20could,dietary%20supplements%20or%20conventional%20foods." target="_blank" rel="noopener">that it wouldn’t adopt rules</a> to allow CBD to be marketed as a dietary supplement in conventional food products. States have been left to fend for themselves.</p>
<p>The FDA Memo proceeds to discuss President Trump’s <a href="https://www.whitehouse.gov/presidential-actions/2025/12/increasing-medical-marijuana-and-cannabidiol-research/" target="_blank" rel="noopener">Executive Order 14370</a> of December 18, 2025, which directed the Attorney General to reschedule marijuana as a Schedule III substance under the <a href="https://www.dea.gov/drug-information/csa" target="_blank" rel="noopener">Controlled Substances Act</a> (CSA); and more pertinently for this exercise, for the National Institutes of Health to “develop research methods and models… to improve access to hemp-derived cannabinoid products in accordance with Federal law and to inform standards of care.” That&#8217;s where Substance Access BEI comes in.</p>
<p>FDA concludes its milquetoast memo with a policy statement, included here in full:</p>
<blockquote><p>The FDA does not intend to enforce sections 502(f)(1) or 505 of the [FDCA] with respect to an orally administered, hemp-derived CBD product solely on the basis that it contains CBD, provided that the product (1) is manufactured, marketed, and labeled in a manner that would be consistent with the dietary supplement framework, including bearing a supplement facts panel and structure/function claims, (2) is not contaminated, (3) is not packaged or labeled in a manner that would be attractive to or marketed for children, and (4) is provided to a beneficiary through a program of medical items or services payable under Title XVIII of the Social Security Act, under the direction of the patient’s treating physician, in a manner ancillary to the covered items or services furnished under such program.</p></blockquote>
<p>In other words, FDA will continue <u>not</u> enforcing federal law, due to conflicting developments, in this one specific context. Old cannabis industry heads may see parallels here with the <a href="https://www.justice.gov/iso/opa/resources/3052013829132756857467.pdf" target="_blank" rel="noopener">Cole Memorandum</a>. Once again, a branch of government has deferred enforcement of cannabis-related commerce on a prerogative basis.</p>
<h2>Open questions for CBD and hemp-derived products, inside and outside the Substance Access BEI program</h2>
<p>The biggest question, I think, is whether the FDA will continue non-enforcement of the FDCA as to hemp-derived products outside this specific, Medicare context—either now, or after the hemp products ban takes effect this November. My bet is FDA won’t do much prior to November, and, assuming the ban sticks, it won’t do much after. A related prediction is that FDA will maintain <a href="https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis#:~:text=Marijuana%20is%20different%20from%20CBD,it%20learns%20more%20about%20CBD." target="_blank" rel="noopener">its position</a> that CBD hasn’t been proven safe and effective (outside of the approved drug Epidiolex), notwithstanding the Substance Access BEI program.</p>
<p>Another question relates to potential tension between the “hemp threshold” adopted in the Substance Access BEI program, and the FDA Memo. This a difference was quickly noted by <a href="https://www.linkedin.com/posts/jonathan-havens_fda-cms-hemp-activity-7445315705014505472-USFA/?utm_source=share&amp;utm_medium=member_ios&amp;rcm=ACoAAAU-8JoB1-DEKI_MDzRVtino64OhJilIbzc" target="_blank" rel="noopener">Jonathan Havens, on LinkedIn</a>. He observed that the FDA Memo references a 0.4 mg-THC-per-container threshold (in keeping with P.L. 119-37), while this new Medicare program permits up to 3 mg of THC per serving in certain contexts. The question becomes whether a CBD product could be program-compliant, yet fall outside of FDA’s enforcement discretion policy due to THC content.</p>
<p>Interestingly, the answer to that question may lie with FDA. Last November, P.L. 119-37 gave the agency 90 days to further define the term “container” in relation to hemp products. The Congressional deadline of February 10, 2026 <a href="https://www.marijuanamoment.net/fda-misses-deadline-to-publish-cannabinoid-list-and-define-hemp-containers-drawing-industry-criticism/">quietly passed</a>, and we still don’t have a proposed definition of “container” to my knowledge. They don’t call it the Foot Dragging Agency for nothing, I guess.</p>
<p style="text-align: center;">_____________</p>
<p>For related posts, check out the following:</p>
<ul>
<li><a href="https://harris-sliwoski.com/cannalawblog/notes-on-the-federal-prohibition-of-intoxicating-hemp/">Notes on the Federal Prohibition of Intoxicating Hemp Products</a></li>
<li><a href="https://harris-sliwoski.com/cannalawblog/will-the-feds-enforce-the-ban-on-intoxicating-hemp-products-and-seed-sales/">Will the Feds Enforce the Ban on Intoxicating Hemp Products, and Seed Sales?</a></li>
<li><a href="https://harris-sliwoski.com/cannalawblog/hemp-companies-have-one-year-to-get-marijuana-genetics-into-or-out-of-the-us-but-a-loophole-may-still-exist/">Hemp Companies Have One Year to Get Marijuana Genetics Into or Out of the U.S…. But a Loophole May Still Exist</a></li>
<li><a href="https://harris-sliwoski.com/cannalawblog/federal-cannabis-policy-is-more-confusing-than-ever/">Federal Cannabis Policy is More Confusing Than Ever</a></li>
<li><a href="https://harris-sliwoski.com/cannalawblog/the-november-12-cliff-how-the-hemp-ban-threatens-bankruptcy-eligibility/">The November 12 Cliff: How the Hemp Ban Threatens Bankruptcy Eligibility </a></li>
<li><a href="https://harris-sliwoski.com/cannalawblog/what-the-2026-federal-hemp-ban-means-for-unsold-hemp-inventory/">What the 2026 Federal Hemp Ban Means for Unsold Hemp Inventory</a></li>
<li><a href="https://harris-sliwoski.com/cannalawblog/are-cbd-food-and-drinks-really-not-legal-really/" target="_blank" rel="noopener">Are CBD Food and Drinks Really Not Legal? Really?</a></li>
<li><a href="https://www.lexology.com/library/detail.aspx?g=0576c213-0d51-4bf9-aa73-a3049a53c15e" target="_blank" rel="noopener">Is it Legal, or Not? What to Make of All These DEA Position Letters</a></li>
</ul>
<p><strong> </strong></p>
<p>The post <a href="https://harris-sliwoski.com/cannalawblog/cbd-medicare-and-the-new-fda-enforcement-memo/">CBD, Medicare, and the New FDA Enforcement Memo</a> appeared first on <a href="https://harris-sliwoski.com">Harris Sliwoski LLP</a>.</p>
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