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Tag: The Farm Bill

Texas Senate Affairs Committee Hearing on Intoxicating Hemp Products

I recently had the privilege of testifying before the Texas Senate Affairs Committee which  recently held a hearing to discuss the complexities and challenges surrounding cannabinoid products (both consumable and non-consumable). While it was obvious that Senator Perry has real issues with the state of our industry it was equally clear that the rest of the panel appeared receptive to the voices form our industry.

 

The hearing attempted to provide a comprehensive overview of the current landscape, touching on various aspects such as regulatory frameworks, health impacts, and law enforcement challenges. The discussion began with an acknowledgment of the Farm Bill passed in December 2018, which legalized hemp by distinguishing it from marijuana. Hemp, defined as cannabis with less than 0.3% Tetrahydrocannabinol (THC) on a dry weight basis, was excluded from the definition of marijuana.

Regulatory Insights from the Department of Health Services

Tim Stevenson (Ph.D.), a chemist from the Department of Health Services, provided insights into the current regulatory framework for hemp products. Smokable products are treated similarly to consumables, with the state prohibiting their manufacture but allowing their sale. Wholesalers are required to obtain licenses, and the department conducts inspections and tests for Delta-9 (D9) THC, though not for other THC isomers. This regulatory focus is primarily on manufacturers to prevent non-compliant products from reaching retail shelves.

 

Stevenson explained the chemical similarities between D8 and D9 THC, noting that the primary difference lies in the location of a double bond on their molecular structures. Despite this, both isomers bind to the same receptors in the body. He tired to argue without real data that there many products on the market that  exceeding the 0.3% THC limit in retail stores rather than at the manufacturing level

 

Stevenson also shared detailed statistics about the hemp industry in Texas: 642 licensed manufacturers, 3,633 registered hemp storers, and 7,082 retail locations across the state. The department has plans to hire 12 sanitarian inspectors specifically for hemp to ensure compliance and product safety.

 

Health Concerns and Medical Perspectives

Dr. Robert Emmick, an emergency physician, represented the Texas Medical Association, Texas Pediatric Society, and the Texas Public Health Coalition. He discussed the health implications of THC ingestion, particularly focusing on three categories of patients: pediatric accidental ingestions, acute psychosis cases, and chronic users suffering from cannabinoid hyperemesis syndrome (CHS). Emmick emphasized the severe neurological issues THC can cause in children and the potential for THC to interact negatively with other medications. As an industry we agree that children should not consume or be able to purchase cannabinoid products.

 

He advocated for the Department of Health to have jurisdiction over all consumable hemp products to ensure safety and close regulatory loopholes. He also recommended comprehensive labeling of THC products, investment in laboratory testing, and childproof packaging to protect public health. It should be noted that while not endorsing marijuana legalization, the Texas Medical Association supports the Texas Compassionate Use Program and calls for more research to provide evidence-based guidelines for THC use.

 

Law Enforcement Challenges

Major Mark Nelson from the Texas Department of Public Safety (DPS) highlighted the difficulties law enforcement faces due to the lack of clarity in current laws regarding various hemp-derived products. He admitted that  no reliable roadside tests to distinguish between legal hemp and illegal marijuana, and drug-sniffing dogs cannot make this distinction either. Nelson stressed the need for clear legal definitions to aid law enforcement in prosecuting illegal activities related to these products.

Crumbled weed in the shape of Texas and a joint. (series)

 

Legislative and Policy Perspectives

Senator Charles Perry, an author of the original hemp bill, expressed disappointment with the industry’s exploitation of legal loopholes to produce intoxicating products. He emphasized the need for a simple regulatory approach rather than chasing ever-evolving chemical formulations. Perry suggested that the Texas Compassionate Use Program is a more controlled environment for THC products, ensuring safety and integrity in the supply chain. It is clear that he wants to establish one or two preferred providers for cannabinoids under TCUP. However he could not articulate a clear vision as it seemed to dawn on him that if they made hemp based products illegals that he will be handling new business to the cartels and other criminal types and undo the good work done to date while opening the market to those that would use fentanyl.  Finally, he also reluctantly acknowledged the negative impact of these legal ambiguities on the agricultural industry’s focus on hemp fiber production.

 

Senator Jose Menendez pointed out the legalization of hemp with the lack of distinguishable testing methods, made prosecution nearly impossible. This sentiment was echoed by law enforcement officials who highlighted the difficulties enforcement under the current legal framework.

Impact on the Texas Compassionate Use Program and Medical Market

Nico Richardson, CEO of Texas Original Compassionate Cultivation, detailed the challenges faced by the state’s medical marijuana program due to the proliferation of hemp products. He explained that THCa flower, a prevalent product in the hemp industry, While he mentioned that THCA converts to D9 THC when heated. Richardson was really unable to articulate a coherent argument for why hemp should be regulated as opposed to outlawed as his argument was in essence an economically based argument that was a thinly veiled dig at his competition and showed that those in the TCUPS program were interested  only in the economics rather than the cost effective alternative soffered by cannabinoids and hemp industry.

 

It is clear thaty=  availability of cheaper, hemp products has led to a decline in patients within the Texas Original medical program. This trend threatens the future of regulated medical marijuana in Texas, as the hemp market offers more accessible yet potentially safer alternatives so long as the industry is properly regulated by the state.

 

Research and Development Recommendations

 

Dr. Peter Stout, President of the Texas Association of Crime Laboratory Directors, explained that testing for cannabis products has become more complex and expensive since the federal legalization of hemp. The turnaround time for lab results has increased from 7 days to up to 120 days due to the need for more detailed analyses. He highlighted the funding challenges faced by crime laboratories, which prioritize more critical drug testing over cannabis due to limited resources.It is interesting to note that when my firm sends product to be tested by KCA or New Bloom the turn around time is days not weeks and the costs are reasonbable.

 

Balancing Regulation and Innovation

The Texas Senate Affairs Committee hearing on hemp products highlighted the complex interplay between regulation, public health, and industry innovation.. The testimony  underscored the need for a balanced approach that protects public health, supports law enforcement, and fosters responsible industry growth.

To achieve this balance, stakeholders must address regulatory deficiencies , invest in robust testing, and research, and consider the implications of policy decisions on industry viability and ensuring that hemp is available to our veterans as well as our general  population while still being a safe and well regulated. The ongoing dialogue between policymakers, health professionals, and industry leaders will be crucial in navigating the evolving landscape of hemp and cannabis products in Texas.

 

The committee’s deliberations highlighted the urgent need for clear and comprehensive regulations to ensure the safety and integrity of hemp-derived products. By addressing these challenges head-on, Texas can create a regulatory framework that supports innovation in the hemp industry, growth of the industry and access to the much needed products to our veterans  while safeguarding public health and safety.

2023: Year in Texas Cannabis Legal Developments and National Hemp Litigation Trends

2023 saw a number of consequential legal developments for the cannabis industry despite the failure of any law, pro or con, related to cannabis to pass during the Legislative Session, due to Leadership’s showdown over competing property tax proposals, despite the postponement of the new Farm Bill until next year, and despite the FDA’s punt on CBD.  Most of the legal action this year occurred in the court system across the country, where the terrain of what part of the plant is legal in what state continuing to shift on a daily basis.  Here is the latest as of December 2023 by topic:

Smokable Hemp

 

Though the smokable hemp case was decided last year, its chilling effects were felt in 2023.  The Crown Distributing case challenged statutory language in the Texas Hemp Act that addressed manufacture and sale, where the manufacture of hemp for smoking was specifically forbidden.  The chief impediment to the passage of Texas’ 2019 hemp law was the skepticism that cannabis would only be used for industrial and therapeutic CBD purposes; therefore, they did not want it to be smoked.  They thought if they kept you from making it, then you couldn’t sell it, not thinking about the internet and interstate commerce.  State Department of Health Services (DSHS) subsequently issued a rule that also explicitly forbade the sale of smokable hemp.  Because the retail ban was not as specific in the statute, the court held DSHS did not have the authority to also ban the sale of smokable hemp.  But the manufacture ban was clear and so we are stuck with that.  Because the mere application of labels to a consumable product is “manufacturing,” this one element of the operation now has to be outsourced to another state, at significant economic disadvantage to Texans.  In 2023, DSHS posted a notice on its website about the case and that the manufacture ban would be enforced, and formally adopted a rule banning the manufacture of hemp for smoking.  DSHS also commenced inspections and has been citing local companies making their own pre-rolls.  To remedy this absurdity, this Session, Rep. Briscoe Cain filed HB 4918 to eliminate the manufacture ban in the statute.  Other Congressmen who in sessions past were vehemently against smoking were less preoccupied with the issue in 2023.  This bill died with all the others.  The next opportunity to modify the smokable hemp law will be in the 2025 Legislative Session.

 

Delta 8/THC Isomers/Intoxicating Cannabinoids

 

 Intoxicating cannabinoids have been a controversial thorn in the Legislature’s side, as each session brings fresh drama between dueling prohibitionist hemp bills that threaten to wipe out the entire industry through vague and expansive language.  At the same time, positive hemp bills are being introduced, which made for a rich session of intense lobbying, only for it to all collapse under the property tax showdown.  Particularly worrisome was Sen. Perry’s SB 264 that prohibited the manufacture, sale, or purchase of a consumable hemp product that contains synthetically derived THCs, without defining what was meant by synthetically derived.  The bill also forbade the sale or distribution of cannabinoids unless they were GRAS by the FDA, an impossibility, and created concerning beyond the law penalties.  This bill did not pass.  Recently, Rep. Stephanie Klick, the author of the Compassionate Use Program (CUP), wrote in the Fort Worth newspaper about the scourge of delta 8 and other THC isomer products and the necessity of preventing children from accessing these products.  Rep. Klick is influential on these topics and was supportive of SB 264.  The next time to address these issues legislatively will be in 2025.

 

In September 2023, the Third Court of Appeals heard procedural arguments in the lawsuit pending against DSHS over the manner in which its Health & Human Services Commissioner changed the definition of THCs in the Texas Controlled Substances Act (CSA) in January 2021.  It is the Commissioner’s mandated duty to establish and modify the CSA schedules, and she does so periodically, through a required notice and comment process.  The new THC definition makes all THCs illegal, with the exception of delta 9 from hemp under .3%, effectively making delta 8 and any other THC isomer an illegal controlled substances.  DSHS testified in the 2021 Legislative Session at a hearing on a bill to outlaw delta 8 that it considered delta 8 to be illegal already anyway due to this definition.  After a lawsuit was subsequently filed against DSHS by hemp companies, a temporary injunction was issued to suspend the effectiveness of the definition change until a later legal resolution.  The court delayed an uncommonly long time in hearing arguments in this case, likely waiting out the Legislative Session so a ruling would not be rendered moot.  The only effect of the September court ruling is that the injunction will continue to stay in place allowing business to continue as usual until a trial is held in the lawsuit which will finally determine the matter of whether the definition change was effective or not.  This should occur in 2024.

Law enforcement intervention of hemp stores selling various types of intoxicating hemp products, including THCa flower, hit a fever pitch in 2023, along with DSHS inspections and enforcement.  THCa brings its own legal conundrums and growers and sellers are subject to two distinct bodies of law that are not congruent with one another:  civil/regulatory/administrative versus criminal law and the CSA.  The Texas Crime Lab decarboxylates products, instantly converting THCa flower into marijuana, and tests other products under differing standards from hemp labs, resulting in stiff felony charges for products carrying a “compliant” hemp Certificate of Analysis.  None of these criminal cases has made it through the system, so 2024 will likely bring a reckoning on the exploitation of perceived loopholes in the hemp laws.  Note that the 2018 Farm Bill made falsification of a COA a felony – and we are seeing lots of modified COAs.

 

Hemp Laws and Lawsuits in Other States

 

States across the country are enacting legislation to severely curtail or completely eliminate hemp derived THCs and intoxicants, motivated by a mixture of governments seeking to ban intoxicating cannabinoids and marijuana industry players who have to spend considerably more on their regulated products than hemp companies do.  Procedurally, as in Texas, in most of these cases, the current postures of the lawsuits are that an injunction is in place allowing the manufacture/sale of the to-be-banned cannabinoids until trials on the merits can be conducted to resolve the legal disputes. In March, DEA declared THC-O to be a controlled substance.  In May, the DEA announced that a rule regarding synthetic cannabinoids would be forthcoming, but we have not seen it yet, and an official stated Delta 8 was considered illegal even when extracted from legal CBD.

 

So, we continue to piece together the agency crumbs and litigation across the country to determine what is likely legal or not.  2023’s notable laws and litigation included the following:

 

Kentucky, Florida, and Tennessee each enacted flaws to regulate hemp products to prevent the sale of products to those under 21 and to prohibit the sale and marketing of hemp products that appeal to children.   Florida’s Department of Agriculture also inspected thousands of hemp companies and targeted 107,000 products marketed toward children.   Florida has just been sued by a hemp company challenging the new regulations.  As a result of a similar sequence of events in Kentucky last year, in 2023, Kentucky introduced regulations aimed at preventing sales to minors.  This has just gone through the notice and comment process, and will be one to watch in 2024.   Tennessee added age requirements and a special tax for hemp products.

 

In Alaska, a law was recently enacted banning any amount of THC in a hemp derived product, reserving the sale of those exclusively for marijuana licensees.  A lawsuit was just filed by the Alaska Industrial Hemp Association and will be one to watch in 2024.

 

Minnesota birthed a burgeoning hemp product market when it made rules allowing for higher concentrations of THC in hemp products last year.  But this year, Minnesota legalized cannabis for adult use, and it appears that hemp product makers will be held to registration and other requirements just as marijuana licensees, and synthetics and smokables will be banned.  Note that you must now register with the State if you are selling hemp products into Minnesota.  Another market to watch in 2024.

In New York, an injunction was just issued to prevent enforcement of emergency regulations that put extreme potency limits on the processing and retail sale of hemp products.

 

In Arkansas, an injunction was just issued to prevent the enforcement of a newly enacted law that criminalized all hemp synthetics and psychoactive substances.

 

In Maryland, an injunction was issued to prevent enforcement of a law that prohibited the sale of any intoxicating cannabinoids from hemp, reserving those products for marijuana licensees, which resulted in the closing of many stores.

 

In Virginia, an injunction was not issued to prevent enforcement of a law that banned delta 8 and enacted extreme potency limits on hemp products.

 

In Georgia, law enforcement was ordered to return seized hemp products after a court disagreed that the products were controlled substances.  Separately, the DEA just stated that Georgia’s plan to use pharmacies for medical marijuana distribution violates the CSA.

 

New Hampshire, Vermont, Connecticut, and North Dakota banned the sale of all the THC isomers.  At the beginning of the year, Louisiana issued regulations that made 100’s of hemp products illegal.  Lawsuits resulted in a walking back.  Note that you must have your product approved by the State to sell in Louisiana.

As for “Delta 9” products, a number of states have enacted regulations and restrictions on the potency of hemp products, such as Colorado, Connecticut, Louisiana, Oregon, among other states mentioned in this article.

 

Selling and distributing hemp requires you to be familiar with all of these states’ legal ping pong matches, as the status of whether a product is legal or illegal can change overnight.  Not every state is mentioned in this article, which is meant for general informational purposes only, and not legal advice.

FDA Quits CBD Regulation

 

Things aren’t clear at the top, either.  On the day the 2018 Farm Bill was signed, FDA issued a statement that CBD may not be placed in food or beverage in interstate commerce nor marketed as a dietary supplement because CBD was already an FDA approved drug for epilepsy.  Subsequently, FDA held a number of public hearings and took reams of public comment on regulation.  Its Commissioner frequently spoke pro-actively about regulating CBD.  Then, in 2021, everything changed.  No regulatory activity at all has occurred since with CBD.

 

Nevertheless, FDA had no hesitation in throwing down plenty of roadblocks in 2023.  FDA (and sometimes FTC) sent hundreds of warning letters to CBD companies for making impermissible medical claims, and in 2023, FDA denied several investigational new drug applications, even though they contained the medical studies that FDA claimed it needed.

 

Further, at the end of 2023, the FDA punted everything altogether, issuing a statement saying Congress needed to develop a special regulatory pathway for CBD, leaving hemp companies in a precarious legal limbo situation, trying to operate responsibly in an environment that refuses to specify any uniform standards.  The lack of legal clarity prevents CBD companies from fully accessing business services and capital they need to grow.

 

 The Texas Compassionate Use Program

 2023 was the biggest year that wasn’t for the CUP since 2017.  Rep. Klick introduced HB 1805, which would have added chronic pain as a condition, would have created a 10 mg dose, and would have had a mechanism to add conditions between sessions.  This bill had broad bi-partisan support, positive hearings, and positive progress.  It really was going to make it, but for the property tax showdown.  So, we ended up with no improvements to the CUP, but that wasn’t all that happened.  In 2022, the Department of Public Safety (DPS), which oversees the CUP, began preparing for the inevitable expansion of the Program, and in January 2023, DPS opened CUP applications for the first time since 2017.  Currently, there are only three licensees to serve the whole state, all 3 of which are around Austin, and only 2 of which are operational.  DPS recognized that patients are not being effectively served across the state through essentially only one provider, so steps are being taken to expand the manner in which patient access is provided.  DPS is conducting studies to determine how many licenses should be issued, where, when, and to whom.  But, due to the lack of a change in the law, all the hype that saw 245 companies submit applications for a license, resulted in no judging yet of the applications that were due in April.  2024 should be active on the application and rulemaking front for the CUP, and 2025 will see a renewed effort to grant Texas a viable bona fide medical program.  I am hopeful that changes in federal laws and leadership will provide political cover for Texas to finally relent and let us use cannabis therapeutically at least.  Anyone that wants us to have an actual cannabis industry must begin lobbying your representatives and senators during 2024 – once they are in session, they will not be able to take your donations, so now is the time to make your voice and your interests heard.

Historic strides were also made in decriminalization and penalty reduction bills pertaining to marijuana possession this Session, but as all the bills, they died with the property tax showdown.

 

Federal Rescheduling?

A potentially significant move was made this year when the President asked Health and Human Services (HHS) and the DEA to re-evaluate and reschedule marijuana.  Because marijuana is federally illegal for all purposes as a schedule one controlled substance, businesses cannot deduct expenses or use banks, among hundreds of other issues caused by the conflict between state and federal law.  In December 2023, HHS released hundreds of pages of documents related to its recommendations to DEA for the rescheduling of marijuana to Schedule 3.   HHS’ review focused on currently accepted scientific medical uses for marijuana, as well as its abuse potential. Those redacted records are posted on the On Drugs blog by Matt Zorn and Shane Pennington.  Both pro and anti marijuana politicians have urged DEA acceptance/rejection of the recommendation. Schedule 3 would  alleviate the business issues, but will create completely unknown new ones, considering the oversight the FDA has over the dispensing of drugs on the schedules.  The hope is that the many federal agencies involved in the determination will come to an actionable consensus before the next presidential election, which would set the tone for a new era of legal cannabis in 2025, coinciding with, and potentially having positive effect on our own legislative session that year.

Rescheduling would also aid in ushering in comprehensive legalization laws to address the conflicts between the states.  The legalization bill prepared by Nancy Mace is the most business friendly and sensible effort, and it also addresses CBD regulation.  Several more states legalized in 2023 for a total of 24 adult use states, with more than 50% of the population now living in a legal state, and, a record of 70% of people supporting legalization according to Gallup, up from 12% in 1969.   2024 should be a yuge year for cannabis nationwide, unless it isn’t….

 

Contact me if you have any questions about the status of the ever-evolving laws here in Texas and beyond at [email protected].