Regulation for CBD products is turning into a definitions game. In one country, the cbd has been declared a medicine. In another, it’s a dangerous drug.
Nonpsychoactive cannabidiol (CBD) is shaking things up in the world of drug policy. The emerging CBD market sparked the launch of several distribution startups which supply hemp-based CBD extracts and isolates online and in stores. Now, regulators in two countries are struggling to figure out just where these new products fit. In the UK, CBD is now considered medicine. In the USA, the cannabinoid is seen as a dangerous, schedule 1 drug.
Last year , the United Kingdom made some big changes to cannabis policy. After receiving credible claims that many medical conditions respond well to cannabidiol (CBD), the Medications Health Care Products Regulation Agency (MHRA) declared that the cannabinoid is, indeed, medicine.
So, the MHRA sent cease and desist letters to CBD distributors, who were given 28 days to stop supplying products. They were to instead register their products and comply with rigorous testing to the meet the regulation requirements for medicines.
For some, like Tony Calamita, director of CBD Oils UK,
The letter basically says they now consider CBD a medicine, which means to advertise and sell it in the UK you require a marketing authorisation license, which potentially costs millions in research and years in clinical data.
According to the BBC, MHRA made this decision in an effort combat strong medical claims used in the marketing of CBD products. These claims, they argued, potentially misled patients and put them at risk. Making such overt claims is not allowed under MHRA regulations.
Meanwhile, there has also been some criticisms of the declaration for another reason: do dietary CBD products now qualify as a therapeutic drug, to be regulated like a pharmaceutical medication?
Canabidol, a manufacturer of hemp-derived CBD products, claim that the MHRA does not have the jurisdiction to place restrictions on food goods and supplement products that are not marketed for therapeutic uses.
The US hemp and CBD industry currently face a similar dilemma. The Drug Enforcement Administration (DEA) recently introduced a new drug code for cannabis extracts. The rule included specific language about CBD, articulating:
For practical purposes, all extracts that contain CBD will also contain at least small amounts of other cannabinoids. However, if it were possible to produce from the cannabis plant an extract that contained only CBD and no other cannabinoids, such an extract would fall within the new drug code 7350.
Under this new ruling, cannabis-derived extracts that include CBD will continue to be illegal under the Controlled Substances Act, where cannabis is classified as a schedule 1 drug. Schedule 1 substances are thought to have no medical value.
According to the DEA, cannabis, now including CBD extracts, is bunk-buddy to some of the hardest drugs around, like heroin.
Though, the DEA suggests that the move is a positive one, a change which may eventually make it easier for medical cannabis research. Though, as the law currently stands, the cannabis plant is illegal for scientists to research in the US without special permission, which is difficult to come by.
DEA spokesman Russ Baer told The Cannabist,
The gist of the issue is that DEA established 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.
We have not changed any control status with this Federal Register Notice. Everything remains schedule I, so no other provisions of the law (registration, security requirements, research protocols, etc.) change. Companies will simple [sic] use a new code for extracts. -Baer
The 1964 Single Convention on Narcotics is a United Nations agreement takes a prohibitionist stance to general cannabis cultivation and use, including use for cultural purposes. However, it allows for the scientific study of narcotic drugs.
The convention articulates cannabis cultivated for medical or scientific purposes should follow the guidelines of the opium poppy, which is tightly controlled.
Yet, in order to really open up medical research access, the DEA would need to reschedule the plant to a Schedule 2 substance or above. In an earlier interview with Science Magazine, David Bradford, a health economist at the University of Georgia, Athens, explains,
They’re setting a standard that can’t be met. That level of proof is never going to be forthcoming in the current environment because it requires doing a really extensive clinical trial series, and given that a pharmaceutical company can’t patent whole plant marijuana, it’s in no company’s interest to do that.
Both the United States and the United Kingdom have taken different approaches to the recent interest in CBD. Though the MHRA’s acknowledgment of the value of CBD is refreshing and long sought-after, their new definition raises more barriers for CBD distributors and aligns the cannabis product with medical products, not food products.
In the United States, the DEA has continued to demonstrate a strong-armed approach to cannabis policy, denying an early schedule change for cannabis in August 2016.
However, while both countries have made some less-than-popular moves in 2016, the two have expressed some leniency toward scientific research on cannabis products.
Albeit, the leniency in the United States is marginal thus far.