Fentanyl Bill Gives Control of CBD to Big Pharma

Fentanyl Bill Controls CBD Production

Fentanyl. What a problem that has been.

Kentucky’s HB333 might resolve Fentanyl issues but may create problems for its nascent hemp industry.

Like many of the new problematic drugs, Fentanyl is a powerful opioid that was created in hopes of finding the “holy grail,” or the synthetic morphine substitute that has no addictive qualities. The search continues for this holy grail and in the search, pharmaceutical companies have created numerous failing synthetic substitutes. These failings have caused the worst opioid epidemic in modern history, coupled with regulatory controls that pushed the unintentional American addict into the throes of America’s heroin blackmarket.
Fentanyl “is a powerful synthetic opioid analgesic that is similar to morphine but is 50 to 100 times more potent.  It is a schedule II prescription drug, and it is typically used to treat patients with severe pain or to manage pain after surgery.”

Unfortunately, drug dealers are mixing Fentanyl with heroin creating a powerful, knock-out disaster leading to high overdoses in America, particularly in Ohio and Kentucky. Kentucky is combating this issue with HB333, a bill meant to re-schedule Fentanyl as a Schedule I Narcotic. Which is great, for the most part…

Fentanyl Bill Gives Control of CBD to Big Pharma

But a major issue with HB333 is unrelated to Fentanyl.  Hidden in the Fentanyl Bill is a definition of marijuana. It states what marijuana includes and does not include. Industrial hemp is excluded from the definition but the bill also continues to exclude the transfer, dispensing and administering of cannabidiol (CBD) from anyone except prescribing physicians and prescription medications approved by the FDA. This definition extension might create future problems for Kentucky’s hemp industry where 60% of research is geared towards hemp-derived cannabidiol production and is in fact, entirely unnecessary to state in a bill related to Fentanyl.

Let’s break it down.

 

Section 25 reads:

(25)[(22)] “Marijuana” means all parts of the plant Cannabis sp., whether growing or not; the seeds thereof; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin or any compound, mixture, or preparation which contains any quantity of these substances.

 

 

 OK. That is the definition in the Controlled Substance Act.

 

The definition continues…
 

The term “marijuana” does not include:

 

(a) Industrial hemp as defined in KRS 260.850:

 

Great!

 

KRS 260.850 defines hemp as:

(4) (a) “Industrial hemp” means all parts and varieties of the plant cannabis sativa, cultivated or possessed by a licensed grower, whether growing or not, that contain a tetrahydrocannabinol concentration of no more than that adopted by federal law in the Controlled Substances Act, 21 U.S.C. secs. 801 et seq.

 

The tetrahyrdocannabinol (THC) concentration in this definition is 0.3% and only pertains to THC and no other cannabinoids.

 


(b) “Industrial hemp” as defined and applied in KRS 260.850 to 260.869 is excluded from the definition of marijuana in KRS 218A.010:
Ok.
But these definitions are cloudy because of how the Drug Enforcement Agency (DEA) has recently defined industrial hemp. Recently, the DEA, USDA, and U.S. Department of Health and Human Services (FYI: the Dept of Health and Human Services has held a patent for cannabidiol (CBD) as a neuroprotectant and antioxidant since 2001) released Guidance Principles which attempted to redefine industrial hemp as:

“used exclusively for industrial purposes (fiber and seed) with a tetrahydrocannabinols (the s is very important) concentration of not more than 0.3 percent on a dry weight basis…”

 

 Hemp fiberhemp seeds

 

 

 

 

Why is it a problem?

This definition intentionally ‘limits’ research to fiber and seed only, with the intention of limiting research geared towards cannabinoid production, like cannabidiol. Cannabinoids like cannabidiol are found in the flowers of hemp. Growing hemp for seed without producing flowers would be like growing corn without the husk. I’m not sure Monsanto can even make that happen.

 

In addition, the ‘s’ at the end of tetrahyrdocannabinols also adds potential limitations on production by adding more cannabinol compounds into the 0.3 percent basis. These compounds should not be included within THC, and other than THC-A, do not produce psychotropic effects. In addition, the only purpose of attempting to ‘re-define’ industrial hemp would be for financial gain by pharmaceutics giants as explained below.
Fortunately, the Guidance Principles do not trump federal law (Sec. 7606 of the 2014 Farm Bill) but KRS 260.850 relates tetrahydryocannabinol concentrations to the Controlled Substance Act (CSA). The DEA controls the CSA. In the Guidance Principles, the DEA alongside the very entity that holds a patent for cannabidiol (CBD), the U.S. Department of Health and Human Services, appears to purposefully prevent the production of natural-based therapeutic cannabinoids by redefining industrial hemp as exclusively the fiber and seed.

Even more issues.

 

In addition, given the above knowledge, we move on to Sections 25b and 25d. These are more concerning lines defining what is not considered ‘marijuana’.

 

(b) The substance cannabidiol, when transferred, dispensed, or administered pursuant to the written order of a physician practicing at a hospital or associated clinic affiliated with a Kentucky public university having a college or school of medicine;[ or]

(d) A cannabidiol product approved as a prescription medication by the United States Food and Drug Administration;

 

When reviewing all the information, it seems as though this Fentanyl Bill is pushing CBD production into a synthetic pharmaceutical market only, limiting hemp production to seed and fiber agricultural commodity markets. This needs major attention.
While they exclude the use of pharmaceutical-grade CBD as marijuana, given the convolution of the Guidance Principles, it seems to be the second step in separating the production of hemp flowers for CBD and other cannabinoids from industrial hemp production. This would squash a fledgling industry that is benefiting farmers and Kentucky’s economy and prevents further development of hemp-related CBD research that makes up 60% of Kentucky’s hemp pilot program.

What about the DEA’s new Marijuana Extract code?

 

In addition, the DEA recently separated marijuana from marijuana extract on the Controlled Substance Act. According to the DEA, marijuana extract includes hemp-derived cannabinoids and cannabidiol (CBD); however, the Farm Bill protects hemp-derived cannabinoids, so one can understand the confusion. The DEA stated that they separated the two,
“to better track these materials and comply with treaty provisions.”

Okay. That’s a good idea to separate them. But there is more to it than data quality.

 

In the Federal Register,

“a pharmaceutical firm currently involved in cannabinoid research and product development praised DEA’s efforts to establish a new drug code for marihuana extracts as a means to more accurately reflect the activities of scientific research and provide more consistent adherence to the requirements of the Single Convention.”

 

There is not a doubt in my mind that this pharmaceutical firm is GWPharma, a cannabis pharmaceutical company based in the U.K. that has recently completed their Phase III CBD medical trials for Epilepsy and Parkinsons, finding positive results. While this research is breakthrough in the cannabis industry and will be extremely beneficial for diseases and future research, there are negatives associated. GWPharma is making a big push into the U.S. as they shift their focus from R&D to commercialization. They are as far along as voting on restructuring their board to align their governance with U.S. corporate policy and have hired a major Kentucky lobbying firm to push their actions forward with small tweaks in bill language, as seen here.
Of course a pharmaceutical company like GWPharma would applaud the DEA’s new drug code for marijuana extract, because the separation of marijuana from marijuana extract, alongside all of the above is necessary for any cannabis extract, like CBD and other cannabinoids, to become re-scheduled as a Schedule II narcotic and therefore available for commercialization. This re-scheduling would state that marijuana extracts have medical benefit and would open significant quantities of research funding.

This is great! Right? Well, kind of…

 

It’s great for research but re-scheduling marijuana extract to a Schedule II would push pharmaceutical companies to synthesize cannabinoids, just like they have with opioid drugs like OxyContin and Fentanyl, which we know from experience were only beneficial for the company’s and family’s that made them (i.e. the Sackler family). In addition, this re-scheduling would be an attempt to only allow pharmaceutical companies to research and manufacture cannabinoids (which they would synthesize) and could prevent farmers and processors in Kentucky and beyond from growing a crop where research is just scratching the surface and results are positive.
Ultimately, the long game is NOT to prohibit hemp-derived CBD from productive agricultural markets, for example CBD-derived nutraceuticals, which would be natural-based compounds derived from farmers. Instead, we must work with pharmaceutical companies to provide this product to the masses for the betterment of humanity in both nutraceutical and pharmaceutical markets. The Kentucky Department of Agriculture (KDA) is working around the clock to ensure this Fentanyl Bill does not accidentally regulate industrial hemp-derived CBD in an unintended manner. As a group, we must take caution and question how this language wound up in the Fentanyl Bill to start and carefully consider how this might ‘accidentally’ occur in future bills, drug-related or not.

Closing out the Synthetic Revolution

 

If we look back at history, on November 3rd, 1929, the National Research Council’s Committee on Drug Addiction made it a point to direct funding in a “unanimous opinion of committee and advisors” to research and have a foundation in synthetic compounds. At the time, they were unable to synthesize cannabis, so instead of researching cannabis’ natural-compounds, which they couldn’t control, they regulated it and focused their attention on a drug they could synthesize: Opioids.
But, after 80 years of failed attempts at finding the “holy grail” from a synthetic opioid, pharmaceutical firms are seeking to expand their research efforts into a plant that can finally be synthesized: Cannabis.
Lobbying groups and pharmaceutical firms are working with the DEA, USDA and U.S. Department of Health and Human Services to ensure that ‘marijuana extract’ or any cannabinoid is conveniently placed into the hands of Big Pharma. Efforts like the above are just a few examples of the long road ahead that cannabis, including hemp, has as de-regulation occurs across America and eventually across the world.
Cannabis was regulated under the Marijuana Tax Act of 1937 at the onset of the Synthetic Revolution. With the rise in knowledge, the aging millennial generation, and a shift in demand towards natural alternatives, the synthetic revolution is coming to a close. Cannabis can be one of the leading factors in pushing out the synthetic revolution, creating a paradigm shift back towards natural products.
But it starts with you. Don’t let Big Pharma destroy this crop like has destroyed so many families– to benefit its own agenda and bottom line. Support the industry.  Educate yourself. Support natural hemp. Call your Senators and Representatives and encourage them to protect farmers by deleting the controversial provision or amending it to clarify that hemp-derived CBD should be exempted from the definition of marijuana. Be critical. Read Bills thoroughly.  Donate to hemp research. Buy hemp products. Share information. Join the solution!

Update:

HB333 passed in the House of Representatives in a near unanimous vote; however, work is being done to adjust the definition of industrial hemp defined within HB333 before Senate vote. Lobbying groups are working against this adjustment to support a foreign entity over a re-emerging domestic agricultural crop. Counter the lobbying group by calling the Senate where the bill lies and tell them to delete the controversial provision or amend it to clarify that hemp-derived CBD should be exempted from the definition of marijuana.

Action:

Kentucky legislative hotline

1-800-372-7181

Tell them your name and address and you want to tell your Senator that you do not approve of Section 25 of HB333 as it relates to industrial hemp and they need to delete the controversial provisions and/or amend it to clarify that hemp-derived CBD grown under the 2014 Farm Bill should be exempted from the definition of marijuana.

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