More States Move Forward With CBD-Only Measures, But Will They Help Patients?

More States Move Forward With CBD-Only Measures, But Will They Help Patients?

Lawmakers in Alabama and Utah recently approved legislation seeking to authorize the physician-supervised use of varieties of cannabis and/or extracts high in the non-psychotropic cannabinoid cannabidiol (CBD). Both measures, which I previously summarized as ‘largely unworkable,‘ have now been signed into law.

In recent days, lawmakers in three additional states — Kentucky, Mississippi, and Wisconsin — have similarly signed off on CBD-explicit legislation. These measures are now awaiting signatures from each states’ respective Governors.

Similar to Alabama’s Senate Bill 174 (aka ‘Carley’s Law), which only permits the use of CBD by prescription during the course of an FDA-approved clinical trial, the pending Kentucky and Wisconsin bills may also be classified as ‘research-centric’ measures. Kentucky’s Senate Bill 124 permits physicians “practicing at a hospital or associated clinic affiliated with a Kentucky public university” to “dispense” cannabidiol during the course of an FDA-approved clinical trial.

Wisconsin’s Assembly Bill 726 similarly limits those who may legally dispense CBD to only include those physicians who have obtained an FDA-issued investigational drug permit to prescribe it.

In Tennessee, lawmakers are also close to finalizing similar language (included in HB 2461 and SB 2531) that seeks to allow university clinical researchers to “manufacture” and “dispense” high-CBD cannabis oil “as part of a clinical research study on the treatment of intractable seizures.”

By contrast, separate, broader medical cannabis measures seeking to authorize the use of the whole plant failed this year in all three states.

As I’ve previously written, it is unlikely that specific changes in state law will stimulate these type of proposed clinical trials from taking place in these states any time soon.

Because CBD is acknowledged by federal regulators to be classified as a schedule I prohibited substance, multiple federal agencies — including the FDA, DEA, NIDA (US National Institute of Drug Abuse), and PHS (Public Health Service) must all sign off on any clinical investigation of the cannabinoid — a process that typically takes several years.

A keyword search of FDA-approved clinical trials using the terms “cannabidiol” and “United States” yields fewer than ten ongoing human trials involving CBD — less than half of which are assessing its potential therapeutic application.  Two additional safety trials assessing the use of GW Pharmaceutical’s patented high-CBD formulation Epidiolex in children with severe epilepsy are also ongoing.

Unlike the above-mentioned measures, Mississippi’s House Bill 1231, does not seek to encourage state-sponsored clinical trials. Rather, the measure exempts specific high-CBD formulated oils “that contain more than fifteen percent cannabidiol [and] … no more than one-half of one percent of tetrahydrocannabinol” from the state’s definition of a schedule I prohibited substance.

However, like Utah’s House Bill 105 (aka ‘Charlee’s Law), Mississippi’s pending law does not provide guidance as to where patients could legally obtain such extracts. Though such high-CBD products are presently available in a limited number of medical cannabis states, such as in California and Colorado, these extracts are typically only available to in-state residents who possess authorization from a physician licensed to practice in that state. Although Colorado state law also allows for a recreational cannabis market, which may be legally accessed by out-of-state residents, at present time such high-CBD concentrates are seldom available at retail outlets.

Additional cannabidiol-specific measures also remain pending in Florida and South Carolina, among other states.

  • Bubbles

    “Because CBD is acknowledged by federal regulators to be classified as
    a schedule I prohibited substance, multiple federal agencies”

    I am not sure that’s entirely accurate.

    There are companies selling high CBD concentrates legally throughout the US now. The CBD is derived from imported industrial grade hemp which the FDA apparently considers a food product. It’s the oh so popular Charlotte’s Web oil that is illegal, reason being it is cultivated here in the US and therefor cannot be legally sold anywhere but Colorado without violating interstate trafficking laws..

    • CBD Hemp Oil is a Scam

      I’m not entirely sure how accurate this is. The so-called “CBD” oil derived from hemp has been highly criticized by those with much more medical marijuana background by myself, but it appears that these “medicine” are CBD in name only, and the oils, while expensive due to their legal grey area (and no other reason, really, for the price of these so called “legal” oils is more than a trip to Colorado would cost) they pose more of a risk than a reward. The FDA doesn’t consider these oils a “food product,” in contrast they are imported and unregulated by the FDA, much like many other “alternative” medicines.

      The companies selling these hemp-based “CBD oil” are reportedly using a process that renders the hemp “unfit for human consumption” — the product itself is very low quality and produced in countries where there is zero regulation or quality standards. Basically, these companies are trying to scam as much money as possible out of people desperate for a cure. They are profiting from prohibition more than the DEA or the prison industrial complex.

      The former head of Dixie said this about this so-called CBD oil derived from hemp:

      “I am tired of so called CBD companies claiming that what they provide is medicine. Anyone using a CBD from hemp product please be aware of what you’re actually getting because it is not what you think. These formulations start with a crude and dirty hemp paste (contaminated with microbial life! I have seen this and these organisms decompose the paste. The paste perhaps even contains residual solvent and other toxins as the extraction is done in China ) made in a process that actually renders it unfit for human consumption.”

      “What these companies are doing is criminal and dangerous. In fact MJNA’s RSHO is literally just this hemp paste diluted in hemp seed oil. No refinement at all!!! And what Dixie Botanicals is offering is beyond disturbing. I cannot keep quiet any more. And since I formulated most of these products as head of Dixie science, I feel responsible for spreading the truth. I left Dixie for ethical reasons but it is not enough to just walk away. These frauds need to be exposed for what they are. Look out for my tell all article coming soon and feel free to contact me directly with questions as it is time to blow the whistle. Let’s keep this industry pure and safe.”

      — Tamar Wise, formerly head of Dixie Science.


      • Bubbles

        Thank you for sharing. It appears I have some more reading to do.

  • Mike

    Legalize it ALL already.

    Enough with dog-and-pony shows of trying to get this camel through the eye of the DEA needle. Natural cannabis is the sure way to get the benefits of the plant.

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