CBD Drug--but not CBD Itself--Rescheduled

cbd rescheduled

DEA Tries to Balance Broken Attitude Towards CBD, Reschedules Some CBD Oils

In an order released at the end of September, the Drug Enforcement Administration (DEA) announced that they are definitively reclassifying a number of cannabidiol-based (CBD) drugs down to Schedule V. It is the first time that a drug naturally derived from, and not synthetically created to resemble, cannabis has been either approved by the Food and Drug Administration (FDA) or reclassified by the DEA.

 




The State of CBD in America
 

CBD, now frequently popping up across grocery stores and smoothie bars, is being touted by the health food community for its anxiolytic and anti-inflammatory properties. But more than just an anecdotal supplement, CBD has also been found to be a highly successful antiepileptic that is becoming considered one of the more effective treatments for a number of otherwise intractable seizure disorders. Because of the limited side effects resulting from CBD use, many parents have turned to CBD oil to treat their children’s epilepsy, occasionally having to go to extreme measures in the U.S. and abroad to make sure their kids can access the treatment.

In the past few years, as anecdotal and historical knowledge about CBD’s antiepileptic and neuroprotective properties have spread and acquired research backing, the optics of fighting against parents trying to heal their kids have become overwhelming for the federal government.

Back in 2017, the DEA took an opportunity to make their opinion on CBD clear in response to a series of raids by the Indiana Alcohol and Tobacco Commission and state excise police on stores selling CBD oil. DEA spokesman Rusty Payne detailed his disgust about the local cops’ decision to NBC affiliate WTHR, 

“We are in the middle of an opioid crisis in this country. That’s our biggest priority right now. People are not dying from CBD. Some would argue lives are being saved by CBD. Are we [the DEA] going to get in the middle of that? Probably not. … I think what [state officials and police] need to do is the same thing we’re doing, and that prioritizes what is truly the biggest issue affecting public safety right now … heroin, fentanyl, prescription drugs. That has to be our priority right now. Not CBD.”





The FDA Shakes Up the CBD Landscape

At the end of June, the FDA approved Epidiolex, a cannabis-derived CBD oil containing less than 0.1% THC. The DEA’s response to the drug’s approval was lengthy and belabored, explaining,

“Now that Epidiolex has been approved by the FDA, it has a currently accepted medical use in treatment in the United States. … Accordingly, Epidiolex no longer meets the criteria for placement in Schedule I. … DEA must therefore take the appropriate scheduling action to remove the drug from Schedule I.”

CBD, being a component of cannabis, is classified internationally under the UN’s 1961 Single Convention standards as a Schedule I drug (one with high potential for abuse and no medical benefit). The SC imposes import and export standards on drugs based on their classification, and because Epidiolex is imported from the U.K. the DEA has had to battle with addressing the discrepancies between the way they internally classify CBD (under the U.S.’s Controlled Substances Act) and their need to bring the medication into the country.

The DEA’s solution to the problem of importing Epidiolex has been to nationally reclassify the drug and its generic versions as a medicine. Based on feedback from the Department of Health and Human Services (HHS), the DEA has “order[ed] that the Epidiolex formulation (and any future FDA-approved generic versions of such formulation made from cannabis) be placed in schedule V of the CSA” with a permit required for import/export.

The DEA’s letter makes clear that quotas restricting the “excessive production and accumulation” of these CBD medications “beyond that necessary to satisfy legitimate needs” will remain in place, as “the bulk cannabis material used to make the Epidiolex formulation (as opposed to the FDA-approved drug product in finished dosage form) will remain in schedule I of the CSA.” This means that “any material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana … including any non-FDA approved CBD extract … remains a schedule I controlled substance under the CSA” (emphasis theirs).

In short: CBD itself is still technically as illegal as heroin. DEA spokesman Payne spoke with WTHR once again this year, clarifying the department’s position to those who aren’t sure: “What this does not do is legalize or change the status of other CBD oil products."





An Unclear Future for CBD at the Hands of the DEA, British Big Pharma

Though Epidiolex is the first naturally cannabis-derived product to pass the FDA’s muster, its reclassification story echoes when the first-ever cannabinoid was reclassified for medical use back in 1986. The drug, a synthetic version of THC called Marinol used primarily to treat AIDS and cancer-related wasting syndromes (cachexia), was moved by the DEA from Schedule I to II and then down to Schedule III over a decade later in 1999. 

Despite often being shown to offer better treatment than synthetic isolated cannabinoids like Marinol, both natural isolated THC and cannabis as a whole have remained squarely trapped in Schedule I limbo.

Even high-strung states like Indiana have begun to implement policies allowing the use of CBD oils containing up to 0.3% THC. So with the DEA taking a back seat to CBD production, the next expected battle is not between CBD producers and the feds but rather low-level oil producers and pharmaceutical giants.

U.K.-based pot pharma giant GW Pharmaceuticals, the company that makes Epidiolex, unsuccessfully lobbied South Dakota in 2017 to keep CBD classified as Schedule I in the state. Despite the company’s obstructionist attempt to keep a stronghold over the state’s CBD oil industry, the law passed anyway and SD reclassified CBD as Schedule IV.

It can be expected that the company would make similar moves on a national level if wide attempts to reclassify CBD are made. It’s not unreasonable to speculate that the DEA’s decision to not reschedule CBD at large is as much a response to its historic tendencies, as was the case with THC and Marinol, as it is to external pressures from groups like GW Pharmaceuticals.

 




Up to the DEA

Regardless of the exact reasons, the result is that state and federal laws concerning CBD have reached an impasse that depends on the DEA sticking to their word and focusing on the opioid crisis instead of attacking the small-scale cannabidiol industry. Lots of people’s health depends on this unspoken agreement. Until the DEA can come to terms with the fact that the non-addictive active ingredient in a Schedule V medication should not be considered a Schedule I drug, there will always be an air of uncertainty surrounding CBD for its producers and users alike.


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