04/4/17

CBD and the DEA

© arnoldvanrooij

As 2016 drew to a close, the DEA announced its decision to classify cannabis extracts separately under the federal government’s Schedule I category. As Victoria Kim reported for The Fix, the ruling sent ripples of panic through the marijuana industry, playing on fears of what is ahead as our country grew closer to a Donald Trump presidency. While the DEA sees the change as marking a clear distinction between cannabis and it extracts, the marijuana industry sees it as saying that those who sell CBD oil are in violation of federal law. However, according to the DEA, the decision was made to more closely align U.S. policy with the United Nations, which already treats cannabis and its extracts separately.

Writing for Leafly, Bruce Barcott described the DEA announcement as an attempt “to criminalize the status of cannabidiol (CBD).” Hundreds of thousands of people around the country who rely on CBD products will be forced find CBD on the black market, according to the CEO of Women Grow. She said the rule “has the potential to inflict substantial harm to a legitimate industry that has been operating legally worldwide for over a decade.”  The executive director of the Cannabis Business Alliance said it creates “unfair barriers for companies with cannabidiol in their products.”

Cloaked in the guise of a bureaucratic technicality, DEA Administrator Chuck Rosenberg made an aggressive bid to wrap CBD into the Controlled Substances Act as a federally illegal Schedule I drug.

In an article he wrote for Leafly on the day of the DEA announcement, Barcott noted where the acting administrator for the DEA said the new code would allow the DEA to track quantities of marijuana extract separately from marijuana. The changes bring U.S. regulations into compliance with international drug-control treaties and present no major change in the law. “Rather it serves to clarify and reinforce the DEA’s position on all cannabis extracts, including CBD oil.” All marijuana extracts will continue to be treated as Schedule I controlled substances.

So what is the uproar if the DEA is merely bringing U.S. regulations in line with international regulations—if marijuana extracts were already Schedule I controlled substances? Barcott said the new rule clarifies the DEA’s position after the 2014 farm bill allowed certain states to grow hemp and blocked federal law enforcement from interfering with state agencies, hemp growers and agricultural research. Hemp-derived CBD oil is available nationwide on web sites and through mail order services. “Those operations survive on the assumption that cannabidiol products below the legal threshold for THC percentage in hemp (0.3 percent or less) are technically legal.” Barcott suggested the rule now says you can grow hemp, but if you try to extract CBD oil from it, the DEA considers that a federal crime.

First, hemp-based CBD products do not have the therapeutic benefits they claim to have. Writing for High Times, Mike Adams noted in his 2014 article, “The Difference Between Hemp Oil and High-CBD Strains,” that while CBD was still illegal in most of the U.S., its rise as “the rock star of the medical marijuana industry” provided the opportunity for some hemp businesses to “market a variation of knockoff CBD treatments that they claim have the same healing power as popular strains such as Charlotte’s Web.” These so-called “knockoff CBD treatments,” while technically similar to medical marijuana strains with CBD, “do not provide the same health benefits as high-CBD cannabis strains.”

However, after patients began submitting complaints about some of these products, including “Real Scientific Hemp Oil,” claiming they were making them sick, a research firm dedicated to cannabidiol education – called Project CBD – launched a full-blown investigation into the matter. After six months, the organization emerged with a 30-page report entitled “Hemp Oil Hustlers: A Project CBD Special Report on Medical Marijuana Inc., HempMeds and Kannaway,” which began as a curious look into an umbrella penny stock company, but transformed into a dissection of the hemp oil industry and its sometimes shady business practices.

Project CBD published a report in 2014 that investigated hemp oil products. The introduction of the report said that Project CBD did not believe that industrial hemp was an optimal source of CBD. On page 13 of the report is a quote from a press release of the Hemp Industries Association. The quote clearly indicates its position:

 It is important for America farmers and processors of hemp to understand that most CBD in products mislabeled as ‘hemp oil’ is a co-product of large-scale hemp stalk and fiber processing facilities in Europe where the fiber is the primary material produced at a large scale. CBD is not a product or component of hemp seeds, and labeling to that effect is misleading and motivated by the desire to take advantage of the legal grey area under federal law. Hemp seed oil does not contain any significant quantity of CBD.

So the hue-and-cry about the DEA’s clarification means that the loophole opened by the 2014 farm bill for hemp CBD products has been closed. Retailers selling “knockoff CBD treatments” of questionable medicinal value will now have to stop selling these products or face possible federal prosecution. This is a good thing. But what about the new 7350 drug code proposed by the DEA?

In the Federal Register, vol. 81, no. 240, under “Why a New Code Number is Needed,” it was noted that U.N. conventions on international drug control treated cannabis extracts differently from marijuana and THC. So creating a new drug code for marijuana extracts would allow for more appropriate accounting of these materials consistent with existing treaty provisions. The existing schedules contained in DEA regulations include marijuana as a Schedule I drug (drug code 7360). This listing includes “any material, compound, mixture, or preparation, which contains any quantity of the substance, or which contains any of its salts, isomers, and salts of isomers that are possible within the specific chemical designation.”

Until now, the DEA has used the 7360 drug code for all marijuana extracts. The proposed rule change recommends that a new drug code, 7350, should be used for marijuana extracts. Marijuana extracts “will continue to be treated as Schedule I controlled substances.” In other words, they were always Schedule I substances.

The Single Convention on Narcotic Drugs and 1971 Convention on Psychotropic Substances are international treaties that provide for the international control of marijuana. The schedules under the Single Convention prohibit the production and supply of specific drugs as well as drugs with similar effects—except for drugs under license for specific purposes, such as medical treatment and research. Many of the provisions of the Controlled Substances Act (CSA) under which the DEA operates were drafted to comply with these Conventions. Both the CSA and the Single Convention list drugs in four schedules, but their classification schemes mean different things. For one, drugs can be in more than one schedule under the Single Convention.

In the Single Convention, the most stringent controls are in Schedule IV; and all Schedule IV drugs are also listed in Schedule I. So placing a drug into both Schedule I and Schedule IV “imposes the most stringent controls under the Single Convention.” Cannabis or marijuana falls into three listings within the Single Convention. Cannabis is the flowering or fruiting tops of the cannabis plant (with the resin not extracted). Cannabis resin is the separated resin, crude or purified, obtained from the cannabis plant. Then there are the extracts and tinctures of cannabis.

The Single Convention placed “cannabis” and “cannabis resin” under both Schedule I and IV of the Convention, the most stringent level of control under the Convention. While “cannabis resin” is extracted from “cannabis,” the Single Convention specifically controls “extracts” separately. Extracts of cannabis are controlled only under Schedule I of the Convention, which is a lower level of control than “cannabis resin.”

Cannabis resin and cannabis (marijuana) will continue under the drug code for marijuana (drug code 7360). The DEA changes will distinguish cannabis extracts from cannabis resin, by defining “marijuana extract” to exclude material referenced as “cannabis resin” under the Single Convention. The new code number created by the DEA is as follows:

Marihuana Extract—7350 ‘‘Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.’’

Not only does this distinction bring U.S., CSA regulations in line with the Single Convention, it creates a category for medicinal cannabis extracts to be scheduled differently from the recreational cannabis products that fall within the “7360” drug code. Cannabis resin products such as shatter, wax, honey, budder and others will remain classified as 7360—along with the flowering or fruiting tops of the cannabis plant that are rolled into joints or smoked in pipes. But cannabis or marijuana extracts, coded with the 7350 drug code, could be reclassified into a lower CSA Schedule. As the science of CBD research demonstrates the medicinal efficacy of CBD more clearly and consistently, this could be done without rescheduling cannabis bud and flower or cannabis resin. No wonder companies selling marijuana and hemp-based CBD products don’t like the new DEA ruling.

11/8/16

This Stuff Is not Weed

38945846 - illustration of a not allowed icon with a marijuana leaf

© Juan Pablo Gonzalez | 123rf.com

Like a snowball that begins rolling down from the very top of a hill, negative consequences from synthetic drugs have been building momentum for several years. LiveScience posted an article based on a CDC report that highlighted the increase of synthetic-cannabinoid overdoses. Between 2010 and 2015 there were a total of 456 synthetic-cannabinoid intoxications recorded by 101 US hospitals and clinics included in the study. While the overdoses from these substances are still a fraction of all drug overdoses in the US, their percentage has increased every year since 2010.

The CDC report was based on data gathered from the Toxicology Investigators Consortium (ToxIC), a toxicology surveillance and research tool. The ToxIC Registry was established by the American College of Medical Toxicology in 2010. Of the 456 cases of synthetic-cannabinoid intoxication treated by physicians in the ToxIC, 277 reported synthetic cannabinoids were the only substance used. The findings of the CDC report are representative of what doctors in emergency departments from around the country are seeing.

Among the 456 cases, 70.6% were in persons aged 19-65 and 27.4% were in persons aged 13-18; 83.1% were male. The reported adverse effects were primarily cardiovascular-related (17.0%), pulmonary-related (7.6%) or central nervous system-related (66.1%).  The CNS symptoms included agitation, CNS depression or coma, and delirium/toxic psychosis. The annual percentage of cases increased significantly in all four US Census regions, except the South. “The largest overall increases during these periods took place in the Northeast, primarily driven by increases at the New York City sites.” See the chart below which was taken from the CDC report:

toxicThe CDC report mentioned a June 2015 Morbidity and Mortality Weekly Report (MMWR) for June 12, 2015 that found a 300% increase of telephone calls to poison centers related to synthetic cannabinoid use from January 2015 to April 2015. The report suggested that synthetic cannabinoids posed an emerging public health threat. The number of calls spiked dramatically in mid-April. Look at the report for a chart showing the spike from less than 100 calls per week in the third week of March 2015 to over 500 weekly in the third week of April 2015.

Then there are the “bath salts.” The New York Times published an article referring to Brooklyn users of K2, a synthetic cathinone (bath salts), as “zombies.” In an area around the subway station at Myrtle Avenue and Broadway, emergency workers transported 33 people with suspected K2 overdoses to the hospital in ONE DAY. Brian Arthur, who filmed and then posted what he saw on online said: “It’s like a scene out of a zombie movie, a horrible scene . . . . This drug truly paralyzed people.” While responders helped an unsteady man into an ambulance, another man nearby was slumped against a fire hydrant.

Pairs of police officers walked the blocks around Broadway and Myrtle Avenue, checking the vital signs of men they found unconscious. Anyone who was unresponsive was loaded onto a stretcher and taken away in an ambulance.

Keep in mind this was after legislation by The New York City Council last Fall banned synthetic cannabinoids and threatened businesses and owners who sold K2 with closings, hefty fines and jail time. So it seems that the synthetic drug trade in NYC simply switched to synthetic cathinones.

A 2012 article in the Journal of Medical Toxicology, “The Toxicology of Bath Salts,” provides some background information on the emergence of synthetic cathinones as a drug of abuse. Synthesis of cathinone derivatives occurred as early as the late 1920s. Methcathinone was synthesized in 1928 and mephedrene in 1929. While a few of the derivatives have been investigated for medical use, only bupropion (Wellbutrin, Zyban) have been approved for a medical use in the US and Europe. Wellbutrin is approved to treat depression; Zyban is used as a smoking-cessation aide.

Numerous synthetic cathinone derivatives have become popular for use as “legal highs.” Exactly when these derivatives gained popularity amongst club goers and others seeking new drugs of abuse is difficult to pinpoint, but mentions in Internet drug forums began in 2007.

In “Synthetic Cathinones: A New Public Health Problem,” Karila et al. described the major clinical effects of synthetic cathinones and their impact on public health. Together with synthetic cannabinoids they account for more than two thirds of the New Psychoactive Substances (NPS) available. Again, cardiac psychiatric and neurological adverse effects are the most common ones requiring medical care. “These drugs, still not controlled by international laws, are often produced and used to mimic the effects of controlled drugs such as cocaine, methylenedioxymethamphetamine (MDMA, ecstasy), and methamphetamine.”

If you’re skeptical about what I’ve written so far, try this article from High Times, “What’s in Synthetic Cannabis and Why Is It So Dangerous?” In order to study the endocannabinoid system in the body, scientists created these compounds for research purposes. The author is quick to point out that synthetic cannabis does not contain cannabis or synthetic cannabinoids. While the compounds bind to cannabinoid receptors in the brain, they only have a “slight relation” to natural THC. “Doctors do not fully understand how most of these compounds interact with the body, and some can be extremely harmful and even deadly.”

The author suggested they would be better named: synthetic cannabinoid receptor agonists (SCRA). THC is only a partial agonist of CB1 and CB2,the cannabinoid receptors, where SCRAs are designed to bind strongly to the receptors and exert THC-like effects. These effects can be 100 times more potent than cannabis. The unusually strong binding of SCRAs to cannabinoid receptors can produce unforeseen downstream effects in the brain and nervous system.

If you consume any of these chemicals, you are literally performing an experiment on your body, and a dangerous one at that. People have suffered from seizures, cardiac arrest, kidney failure, severe reduction in body temperature, etc. and doctors don’t know how it happens or who is more susceptible.

Not only are there many different classes of these compounds, each one of the general classes of compounds contains dozens of different related compounds. “Regulatory agencies play a game of cat and mouse with designer drug manufacturers as they constantly use different compounds to bypass laws.”  While the Us government continues to make different groups of SCRAs illegal, underground chemists seem to be one step ahead, making newer compounds that tend to be more toxic and harmful than the previous generation.

Steer clear of these dangerous substances, treat them like dangerous addictive drugs on par with methamphetamine, ecstasy pills and prescription narcotics. This stuff is not weed, and when your friends smoke it you should confront them about it and make them understand they are putting their lives at risk. Even if you need to pass a drug test, don’t use this stuff; even one toke of Spice can land you in intensive care and put you on a dialysis machine with kidney failure.

Let the fact sink in that what we just reviewed was a clear warning from High Times to avoid synthetic cannabinoids. Alternately, there are synthetic cathinones that can turn you into a zombie. Think about the consequences before you try some.