Tag Archives: interstate commerce

Q&A: Hirsh Jain on Cannabis Rescheduling, Interstate Commerce and the Next Wave of Market Growth

By Hirsh Jain
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Cannabis federal reform has finally reached a historic moment. Medical cannabis is moving through the rescheduling process after decades under federal prohibition, marking one of the biggest developments in the industry’s history.

The final outcome could determine how companies expand, whether cannabis can move across state lines, and which markets become the next major opportunities.

Hirsh Jain, CEO of Ananda Strategy, shares his perspective on where rescheduling stands, whether interstate commerce will be allowed, and which states businesses should be watching next.

 

Where does the process stand today?

I think it is helpful to separate the rescheduling process into two parts: the rescheduling of medical marijuana and what is being described as the full rescheduling of marijuana.

Medical marijuana was rescheduled through the Todd Blanche order issued on April 23. The question now is whether that action survives the legal challenges that have been brought against it.

The lawsuits argue, among other things, that the process did not comply with the Administrative Procedure Act and that the government should have gone through a formal notice-and-comment process.

The key issue right now is standing. Before the court even considers the arguments on the merits, the plaintiffs need to demonstrate that they have suffered a concrete injury as a result of the rescheduling decision.

The Department of Justice has argued that some of the plaintiffs cannot meet that threshold. For example, one argument against MMJ Biopharmaceuticals is that it does not yet have a product on the market, meaning it has not suffered an economic injury from rescheduling.

If the court agrees that the plaintiffs lack standing, the case could be dismissed. If the court finds standing, the next question is whether to grant a stay, which would pause the rescheduling process while the broader lawsuit proceeds.

 

What about the broader rescheduling hearing?

The hearing to consider the full rescheduling of marijuana concluded on July 15. The parties have until August 17 to submit their final briefs.

I expect that this process will continue for several months.

Some people have suggested we could see a final rule by late summer or early fall, but I think that timeline is unlikely.

After the administrative law judge receives the final briefs, they need to issue a recommendation. There is no statutory deadline requiring that decision to come quickly.

Then the decision moves to the DEA administrator, who has the authority to disagree with the administrative law judge’s recommendation as long as they provide a reasoned explanation.

We have historical precedent for this. In 1988, administrative law judge Francis Young recommended that cannabis be rescheduled, but the DEA ultimately rejected that recommendation.

After the DEA administrator weighs in, the matter moves to the Attorney General for a final rule. Then there is a 30-day window where parties can challenge the decision legally.

So while I am cautiously optimistic, I think we should recognize there are many procedural opportunities for delay.

 

The DEA appeared to take a narrower approach during the hearing by focusing on medical use rather than legalization. Does that improve the chances of rescheduling?

I think that strategy made a lot of sense.

The DEA was very clear that the question before them was not whether cannabis should be legalized or whether cannabis is harmless. The question was whether marijuana has a currently accepted medical use.

By narrowing the issue, they created a stronger legal argument.

I am optimistic about the substance of the hearing. My concern is less about the underlying argument and more about the procedural mechanisms that opponents can use to slow the process.

 

Companies like Trulieve have successfully uplisted to major exchanges. What does that signal about investor confidence?

I think it demonstrates that exchanges are evaluating cannabis through a very technical legal lens.

Trulieve and Glass House structured their businesses to emphasize their medical operations and create a pathway toward federal legality.

Other companies, like Curaleaf, have taken a more cautious approach and indicated they want to wait until full rescheduling occurs before pursuing uplisting.

I think the broader takeaway is that if we are in a world six months from now where full rescheduling has occurred, we could see many more operators pursue uplisting.

 

Could rescheduling finally open the door to interstate commerce?

This is one of the biggest questions facing the industry.

Historically, interstate commerce did not exist because cannabis was federally illegal, but I think the more complete explanation is the structure created by the Cole Memorandum.

After Colorado and Washington legalized cannabis in 2012, the federal government essentially allowed states to experiment as long as they avoided certain enforcement priorities. One of those priorities was preventing diversion across state lines.

That created the foundation for state-based markets.

Even after the Cole Memo was rescinded, states continued operating under that framework. Over time, every state built its own isolated system.

Rescheduling could change that conversation by creating a stronger argument for federal legality. That could make courts more receptive to challenges based on the Dormant Commerce Clause.

But this would not happen overnight.

There are three potential pathways:

First, courts could determine that state restrictions on interstate commerce violate the Dormant Commerce Clause.

Second, individual states could reform their cannabis laws to allow interstate commerce.

Third, states could create interstate compacts in which participating states agree to allow commerce among themselves.

I think interstate commerce will happen gradually. It will likely begin with groups of states that are willing to work together, rather than a nationwide opening all at once.

 

How would interstate commerce change the industry?

It would completely change the strategy of scaling cannabis businesses.

Right now, companies often have to build cultivation, manufacturing, and distribution infrastructure in every state where they operate.

If interstate commerce becomes possible, companies could manufacture products in one location and distribute them across multiple states.

That would dramatically change the industry’s economics and reduce some of the pressure operators face today.

 

Which states do you see driving the next wave of cannabis growth?

The industry has been starved for growth over the past few years.

Between 2016 and 2023, we saw a steady stream of states launching adult-use markets. Over the past three years, that momentum slowed.

The exciting thing is that by 2027, I think we can identify several meaningful growth markets.

The biggest one is Virginia.

Virginia is currently a limited medical market, but adult-use sales are scheduled to begin in 2027. Most analysts believe the state could eventually become a multibillion-dollar market.

What makes Virginia particularly interesting is its geography. It borders states including North Carolina and Tennessee that do not currently have adult-use programs.

Virginia could become a destination market for consumers across the region.

 

What about Minnesota?

Minnesota is another market I think people should watch.

One thing Minnesota has done particularly well is create pathways for hemp operators to transition into the regulated cannabis market.

That is a model other states should consider.

The challenge in Minnesota has been supply. The state licensed retailers, but cultivation capacity and testing infrastructure have not kept pace.

The result is that many stores have limited inventory and high prices.

I think 2027 could be a turning point because more cultivation comes online, testing capacity improves, and retailers have more products to sell.

 

What medical markets are worth watching?

I think Georgia and Texas are two of the most exciting medical markets in the country.

Together, those states represent more than 40 million people.

Georgia is particularly interesting because of the changes it has made to its medical program, including expanding qualifying conditions and allowing additional product formats.

The pharmacy model is also important.

Pharmacies are trusted healthcare providers. Many consumers who may hesitate to enter a dispensary may feel comfortable visiting a pharmacy.

Georgia has the opportunity to demonstrate a different model for cannabis distribution.

 

Final thoughts: What should cannabis businesses be watching over the next year?

I think the biggest thing is understanding that the industry is moving into a new phase.

Rescheduling, interstate commerce, new state markets, and changing distribution models all have the potential to reshape how cannabis companies operate.

But none of these changes happen instantly.

 

The long-awaited moment has arrived. After building markets state by state under federal prohibition, companies are ready for a new chapter in the industry.

 

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FDA Public Hearing On Hemp: What You Need To Know

By Aaron G. Biros
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Folks from around the country and the world tuned into the U.S. Food & Drug Administration (FDA) website as they held a public hearing on Friday, May 31. Manufacturers and suppliers asked the FDA to regulate CBD like food or dietary supplements, while the FDA seemed to want more evidence on the safety of CBD products before giving the greenlight.

Background On The HearingFDAlogo

For the uninitiated, after President Trump signed the Farm Bill into law back in December 2018, Scott Gottlieb, now former director of the FDA, issued a statement the same day the Farm Bill passed, clarifying the FDA’s regulatory authority. In the statement, Gottlieb explained that Congress preserved the FDA’s authority to regulate products containing cannabis and its constituents under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In April 2019, around the same time he resigned from the FDA, Gottlieb issued another statement, acknowledging the quickly growing industry throughout the country and total lack of federal regulatory guidance. This time around, Gottlieb laid out a handful of steps that the FDA plans on taking to address regulations around hemp and cannabidiol (CBD). Those included scheduling the public hearing for May 31, where written and oral public comments were submitted by stakeholders, sharing “their experiences and challenges with these products [hemp and CBD products], including information and views related to product safety.”

That statement also announced the formation of an internal agency working group to “explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.”

Fast-forward to May 31, the day of the public hearing, and all eyes in the industry focused on what all these stakeholders had to say to the FDA about CBD. The day started off with about two hours of oral comments, each speaker had roughly two minutes to deliver their thoughts.

Karen Howard, CEO of the Organic and Natural Health Association, speaks about the quality of CBD products 

Oral Comments

Industry stakeholders representing cannabis businesses sang much of the same tune, clamoring for wise regulations on safety, testing, banking and interstate commerce, among other standards. NCIA Policy Director Andrew Kline’s comments included running through five major positions of the industry trade organization representing CBD companies. Those included recommending the FDA act quickly in setting up regulations, stressing the massive economic impact of the industry, saying that CBD products are generally safe, clamoring for voluntary, consensus-based standards and informing consumers of any potential risks. “The bottom line is this – an overwhelming preponderance of evidence indicates that cannabis and cannabis-derived compounds present minimal health and safety concerns,” Kline told the folks at the FDA. “Time is of the essence. Hemp-derived CBD products are in very high consumer demand and the industry is eagerly awaiting FDA’s regulatory framework for these products. We strongly recommend that FDA act quickly to clarify the regulatory environment because there is significant confusion in the market.”

Anna Williams, representing the American Association for Laboratory Accreditation (A2LA), stressed the importance of testing for contaminants and adulterants as well as advocating for national standards on lab testing, instead of the state-by-state network of different standards.

Patients & Public Safety

After industry stakeholders had their chance to speak, the FDA allowed a group of advocacy organizations representing patients time to speak. That included representatives for the Alzheimer’s Association and the American Epilepsy Society, both of which were hesitant to throw their full support behind CBD as medicine. Kevin Chapman with the American Epilepsy Society said he wants to see clear warning labels, testing standards, more clinical trials and more studies before the group is ready to form a position on using CBD as medicine. Keith Fargo with the Alzheimer’s Association supports clinical trials to study it more, but thinks CBD is risky for patients without serious evidence of efficacy. A representative from the Tuberous Sclerosis Alliance also echoed similar concerns. They want to see labeling of drug interactions on labels of CBD products.

One section of the oral comments included discussions about patients, public safety and retailers/distributors.

After those comments, some organizations had the chance to speak followed by comments from retailers and distributors. Patrick Bird, owner of PMB BioTek Consulting, spoke on behalf of AOAC International, where he primarily discussed public safety. He said they want cannabis products to be regulated with food safety in mind, asking for FSMA to apply to hemp products. They want to adequately ensure product safety with things like mandating HACCP plans, recall readiness, saying hemp products should be treated just like food products.

Retailers & Distributors

Peter Matz, representing the Food Marketing Institute, the trade association for the supermarket industry, said that regulatory ambiguity is a serious issue that needs addressing. “There is mass confusion in the marketplace for the public, suppliers, retailers and state regulators,” says Matz. “Demand for CBD products in human and animal use is growing rapidly. ¼ of American have already tried it. We are fielding questions from companies seeking clarity regarding the current federal regulatory framework.” He added, what many others also mentioned, that the FDA needs to move swiftly to provide a pathway to regulation.

State Regulators

Next on the docket came presentations from state government entities, including state departments of agriculture, followed by healthcare professionals. The state regulators that spoke mentioned a lot about food safety, standards, testing regulations, GMPs and things like that to protect consumer safety. “Currently states are struggling with the lack of sound scientific research available in CBD and long-term health impacts,” said Pam Miles, representing the Virginia Department of Agriculture.

The docket for state regulators delivering presentations

One interesting aspect on their talks however was telling the FDA just how large their markets have gotten already and how they need guidance on how to regulate markets in their own states. Joseph Reardon, with the North Carolina Department of Agriculture, said they already have about 600 farmers growing hemp and thousands of processors working with the product in their state. “We urge the FDA to resolve the statutory issues improperly establish a legal pathway for CBD products to enter the market place,” Reardon commented. He also asked that the FDA extend the written comment period from July to August. “We are simply looking for a regulatory framework on the extraction, production and reconstitution of CBD or cannabinoid related products.”

Healthcare & Research

Healthcare providers, and physician testimony also echoed a lot of the same concerns, including the lack of research done, concerns about effects on at-risk populations and concerns about use as ingredients in dietary supplements and food. Some of the presentations also highlighted the room for nefarious activity in an unregulated marketplace. Some went as far as to mention cases where they found CBD vape juices with DXM in it (the active ingredient in cough syrup), CBD products found to contain THC, as well as synthetic cannabinoids responsible for drug overdose deaths. Some advocates in the hemp and CBD community have equated these arguments similar to reefer madness.

The major takeaway from this hearing is that everyone wants to see more data. Researchers and healthcare providers want to study the efficacy of CBD used in medicine, regulators want public safety information, patient advocates want to see data about effects on at-risk populations, trade organizations want data to back up label claims and the FDA wants to see just how safe CBD really is.

Wyoming Legalizes Hemp, CBD Oil

By Aaron G. Biros
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Governor Mark Gordon signed HB0171/ HEA No. 0110 into law today, officially legalizing the cultivation and sales of hemp and CBD oil in the state of Wyoming. According to Buckrail.com, a Jackson, Wyoming news publication, the bill passed through the state legislature with ease, moving forward in the House on a 56-3 vote and through the Senate with a 26-3 vote.

President Trump signed the Agriculture Improvement Act of 2018 (the Farm Bill) into law late in December of 2018, which removed hemp-derived cannabidiol (CBD) from the Controlled Substances Act in states that choose to regulate it. Wyoming Governor Mark Gordon signing HB0171 means that the state intends to regulate the cultivation and sales of hemp-derived CBD.

Wyoming Governor Mark Gordon

Scott McDonald with the Wyoming Department of Agriculture told Wyoming Public Media that once the bill is signed, the state has 30 days to show their plans for regulation to the federal government. “We were kind of hoping to get something in place this spring for this growing season,” McDonald told Wyoming Public Media. “But we’re not sure that’s going to happen or not. There’s some uncertainty there, so it might be next year.”

McDonald also discussed the next steps that the WY Department of Agriculture needs to take to follow through on the bill’s promises, including figuring out a way to distribute licenses to hemp farmers, licensing laboratories to test hemp, insuring it has less than 0.3% THC and implementing a remediation plan for when crops test above that threshold.

According to Charlotte Peyton, a consultant with 30 years of experience in FDA regulations and experience working in the hemp industry, it is important to keep in mind that as soon as products containing hemp-derived CBD are sold across state lines, the FDA maintains regulatory authority. “If you manufacture and sell hemp products inside of a state with a state mandated hemp program, you are legal and protected under state laws, but the minute you sell across state lines, it becomes the jurisdiction of the federal government and, more specifically, the FDA,” says Peyton.

According to some farmers, this is good news for the local economy. Many say this could be give a much-needed boost to the state’s agricultural economy, citing hemp’s suitability to grow in Wyoming’s climate and a perceived high demand throughout the state.