The Controlled Substance Advisory Committee in Utah recently discussed regulatory implementation of the bill allowing the use of hemp extract for persons with intractable epilepsy. Libertas Institute was in attendance to hear about the proposed rules. You can listen to the public recording of the meeting here. (The discussion of HB 105 begins at minute 5:00 and goes until minute 35:00.)
This past legislative session, a bill overwhelmingly passed allowing Utahns affected by intractable epileptic seizures, like that of Dravet syndrome, to possess and use an oil extract from hemp plants for therapeutic self-treatment. The bill, HB 105 Plant Extract Amendments, was sponsored by Representative Gage Froerer and comes on the coattails of the federal farm bill which addresses the distinction between cannabis plant varieties used for the psychoactive drug concentration of THC (aka “marijuana”) and the cannabis plant varieties low in THC used instead for their fibrous stalks and seed-based health supplements (aka “industrial hemp”). While the DEA remains confused about the distinction and blindly departs from the rest of the developed world by banning all cannabis plants—including hemp—many states are now recognizing the economic and health benefits of agricultural development in industrial hemp. Libertas recently interviewed the first farmer in the nation to commercially cultivate non-psychoactive industrial hemp in Colorado since the ban was enacted.
The oil extract allowed by HB105 is one such beneficial product from industrial hemp. The oil is high in a substance from hemp plants called cannabidiol (CBD) but is low in the psychoactive substance tetrahydrocannabinol (THC). In fact, those researching the oil believe it is the particular ratio of high levels of CBD to low levels of THC that gives the oil its effectiveness in treating seizures.
The new law in Utah allows individuals who feel they may benefit from the use of this CBD oil to get a recommendation from their neurologist that allows them to apply for a “card” in Utah that exempts them from any penalty for possession of this hemp extract.
Currently there are actually a host of nutritional supplement and food products available for legal use in the United States that are made from hemp and contain the same low trace amounts of THC (under 0.3%) that this CBD oil contains. However, permission from the government is not needed to obtain those. This is largely because the end product is not considered a plant or plant part. In the United States such plants are banned by the DEA. Thus, all of these commercial products in the United States are made from imported hemp.
The committee’s discussion began with a legislative review report from Scott Reed of the Attorney General’s office giving an overview of bills related to controlled substances that passed during the recent legislative session. Then the committee heard from Janice Houston, state registrar for vital records, who explained the process under proposed rules for Utahns to obtain a card from the new Hemp Extract Registry. The draft rules from the Department of Health are set to be posted in the next public bulletin on June 1st after which there will be a 30 day comment period. You can follow the comment period on Utah’s public comment site.
The proposed draft rules are five pages long—the same length of the bill itself. Libertas obtained a preliminary working copy you can read here.
The conversation and comments from individuals at the committee meeting displayed the unfamiliarity common with issues surrounding cannabis, hemp, THC, and CBD. In fact, even the printed agenda included a misspelling of THC and confused the active ingredient in the oil with the proper substance CBD! The comments and discussion among those who are medical doctors and other professionals with distinguished academic credentials displayed the effect of generations of misinformation created by misdirected over-regulation which has left behind a dearth of academic research in favor of superstitious taboo instead. The discussion turned disturbingly comical at times with some prophesying a sudden rise in “intractable seizures” among young adult males desiring to obtain permission to use this non-psychoactive oil—as if an individual could choose to have “intractable” seizures and get a neurologist to put their professional career in jeopardy for a fraud to obtain a non-psychoactive substance. The snickering and the minimization by this committee of the severe problems faced by epileptic patients—especially the parents of young epileptic children—was especially problematic.
One of the committee members, Dr. Jeffrey Paul Clark, a family practice doctor from Orem who also testified against HB 105 during the legislative session, commented that he thought it was wrong to allow “anybody with intractable seizures” to use this oil which he thought should only be used for what sounded like Gaucher’s disease—a rare neurological disease. Perhaps he meant Dravet syndrome which features intractable seizures. Nonetheless, Dr. Clark felt that “everybody and their brother will be wanting” this CBD oil. The doctor didn’t elaborate as to why he thought everybody would want an expensive non-psychoactive oil or how people would choose to have intractable seizures documented by a neurologist—but he predicted that the vital records department was going to be “swamped” with requests for the new card. The registrar of vital records agreed that they were anticipating and preparing for wide interest and applications for the one year, $400 permits.
The “cards” will actually be more like certificates and will be issued on the same paper as birth certificates, incorporating some of the same security features as other vital records issued by the Department of Health. The administrative rules governing the new registry will be numbered 436-55 “Hemp Extract Registration.” The card will be good for one year, requiring annual renewal and recertification by a neurologist. The fee is going to be set at $400 because the office decided it needed to incorporate their start-up costs to administer the new registry.
One committee member inquired about the controls the agency would have in determining who gets a card and who doesn’t, asking how the department would make a decision “whether to give or not to give, to allow or not to allow” a card. The records registrar replied that because they did “not have a physician on staff” all they were “requiring” was a “successfully completed application with physician certification” and the requisite physician submitted records. Apparently there was some confusion as to the intent of the legislature which was not to give the agency any specific authority in making such determinations beyond this mere processing of applications and basic determinations on the completed, required document submissions from the applicant and their neurologist. Here we see an example of the subconscious effect of granting bureaucracies any power at all—they soon assume that they have more control than was intended by their creation. This is not a permit process—it is a registry. There is a difference. The operative phrase in the law is “the department shall issue a hemp extract registration card to an individual” who applies in compliance with the statute. The statute does not say that the department may issue a registration card, leaving some amount of discretion to the department; rather, it instructs and directs the decision of the department.
Another concern of some committee members was the lack of bureaucratic controls on the quality and make-up of the oil itself, or the lack of prescription-like controls governing the obtaining and use of the oil. Some wondered how the government would ensure that the oils obtained were of high quality and compliant with the statute. The agency will have no involvement in determinations about the make up of the oils. The statute gives no such authority. Rather, it defines the type of oil that qualifies a patient for exemption from any sort of penalty under the controlled substance laws in Utah and then places the burden on the patient to obtain the right type of oil to qualify for the exemption. This is a somewhat unique regulatory approach called freedom! In other words, it allows people to make choices and determinations and then be held accountable if and when they are not in compliance. It is, we argue, a better approach than bureaucratic micro-management on the front end.
A final interesting note is how the department is working on a feature that will allow law enforcement to search the registry. This is fraught with concerns regarding health privacy and the law and rules indicate that this feature should only be used for law enforcement to check if someone has a currently valid registration card—and that is it. Expect some policy recommendations from Libertas Institute and other interested organizations during the next legislative session to ensure that law enforcement officers do not gain access to this information without a warrant issued based on probable cause.
We invite you to read the proposed rules and submit comments to the Utah Department of Health after the formal release of the draft rules on June 1st.