DEA moves some CBD medicines off Schedule 1, a limited expansion of cannabis access

(This is an abridged version of a story that appears at HempIndustryDaily.com.)

The U.S. Drug Enforcement Administration has taken some cannabidiol out of the most restrictive class of controlled substances, a move that allows the sale of the first nonsynthetic, cannabis-derived medicine to win federal approval.

It’s a decision that immediately affects CBD producers but also signals the agency’s first admission that the plant has medical value.

The DEA announced Thursday that drugs including CBD with THC content below 0.1% are now considered Schedule 5 drugs, as long as they have been approved by the U.S. Food and Drug Administration.

It is the first time the agency has lowered any type of cannabis from Schedule 1.

The action came three months after the FDA approved its first nonsynthetic, cannabis-derived medicine, a CBD preparation for rare types of epilepsy. The drug, Epidiolex, is made from cannabis grown in the United Kingdom.

The DEA announcement means Epidiolex will be distributed through traditional pharmaceutical channels, from a doctor’s prescription to a drug store, instead of through a medical marijuana dispensary or designated MMJ caregiver.

Marijuana businesses cheered the DEA change as a signal that opposition to cannabis is starting to crumble.

“We’re one step closer to finally ending prohibition and legitimizing the industry,” said James Minutello, CEO of Leaf Logix, a Glendale, California, company that makes business management software for the cannabis industry.

To read more about how the DEA action affects the broader CBD industry, click here.

28 comments on “DEA moves some CBD medicines off Schedule 1, a limited expansion of cannabis access
  1. Eric Geisterfer on

    Unfortunately, we are not “one step closer to finally ending prohibition”. Artisanal and small companies do not have the resources to pay for FDA style approval. What we are is one step closer to assuring that large pharmaceutical companies can dominate the federal medical marijuana industry. That’s why the pharmaceutical industry spends more on lobbying than any other industry.

    Reply
    • Shira Adler on

      Absolutely right! I wish my usual indomitable Pollyanna nature could see this as a good thing. It is not.

      Let’s be real folks… those of us who are actually in this industry for the right reasons, and supporting each other in the right way… are very clear… Rescheduling is NOT the answer. Doing so only puts big Pharma in the driver’s seat, limits patient access, stymies small businesses, and demonstrates little focus and support for the farmers who are genuinely and passionately committed to organic and sustainable practices.

      This move by the DEA also does not authentically or even adequately address or benefit the hemp movement, nor does it address the myriad needs we hope would be ratified in the current proposed hemp / agricultural bill.

      The only solution here is to DESCHEDULE and that must be done in partnership with decriminalization and expunging records of those carrying minor (possession) drug offenses.

      Then we can comfortably say we are united in this, a bi-partison issue — standing together in — and doing what is ethical, practical, and necessary where cannabis is concerned.

      ps I do a lot of discussion on this in my book, The ABCs of CBD, if anyone cares to read it… forgive the mention of it… not meant as a “plug” as much as I wrote it to be a legitimate (and open-hearted) resource.

      Reply
        • Richard Moschetti on

          The US Government will make Trillions of Dollars from its tax Instead of wasting BILLIONS TO STOP MARIJUANA FROM BEING ANTI-MARIJUANA…TRYING TO FIGHT LEGALIZATION

          Reply
        • Roland on

          “Tax & Regulate” is how we got in this mess in the first place.
          See Wikipedia for “Marihuana_Tax_Act_of_1937”. Those who ignore history are doomed to repeat it.

          Reply
          • Tim on

            Actually ur wrong, it was used as an excuse for racism against blacks and hispanics gave the government a reason to arrest, detain, and search them…look it up this was all apart of the head of dea at the time…actually this caused the dea to form in the first place

    • Andre Tate on

      Ttue..Did youvknow that GW Pharmaceutical is own by Bayer..
      Im an Independent Cannabis researcher who created the 1st Cannabis inhaler..Not CBD inhaler..
      and found research/ patent. From 1997…that revealed that..GW Pharma was on CBS 60 minutes several times over the past 5 years pretending to be some Private Biz hidden in The England Country side

      Reply
    • Rebecca on

      Eric is right on the money (sic) for sure as this isn’t the step we (aromatherapist) want as they are putting cannabis into the hands of big pharma and asking them to control it not the cannabis industry and assuring that the feds make their money off this again like alchohol and drugs. This is a step in the wrong direction. They know this and think this industry is going to be excited by this move, but instead we are educated in the ways of the system and those of us who know cannabis is the health answer for so many illnesses, we will continue to chip away at the “system” to bring people wellness. If only cannabis could configure our brains to think alike there might be hope for both the insurance industry and the medical world of hospitals, doctors and clinics. Patients are suffering and dying at the hands of these “so called professionals” of healthcare and big pharma is facilitating that death is the result not healing or curing. We need a conscious raising in this country and sooner than later.

      Reply
    • Eric on

      This only helps the Sackler family.
      That’s right the people that make OxyContin. It’s total bullsh*t that organic growers like myself put our entire life into making things right. Then billionaires like the Sackler family come along and ruin an entire industry again. Shame on the Sacklers, shame on anybody that purchases their crap.

      Reply
  2. Deetew on

    “This past June, the Food and Drug Administration (FDA) issued its long-expected approval of GW Pharmaceutical’s Epidiolex, a cannabidiol (CBD) oral solution for certain acute medical conditions. (Read more about it here.)

    As a consequence of the FDA’s action, the Drug Enforcement Administration (DEA) today re- scheduled Epidiolex, and any future FDA-approved CBD drug, under Schedule V of the Controlled Substances Act. Read the full unpublished order here.

    Concerns about how hemp-derived CBD products might be treated in this context prompted the US Hemp Roundtable to hire the law firm of Amin Talati Upadhye to counsel on FDA-related issues. Here is their analysis of today’s DEA order:

    Today the DEA announced that Epiodiolex, a highly purified, pharmaceutical firm of ?BD, will be placed under schedule V of the Controlled Substances Act. In doing so, DEA noted that the drug no longer meets the criteria for schedule I, following FDA’s approval of the drug for certain medical conditions. DEA also indicated that any material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana set forth in 21 U.S.C. 802(16), including any non-FDA-approved CBD extract that falls within such definition, remains a schedule I controlled substance under the CSA.

    The placement of Epidiolex under schedule V – the least restrictive schedule – recognizes the proven health benefits of CBD and its low potential for abuse. Of note, DEA’s scheduling determination is limited to only Epidiolex and generic versions of the same formulation. Therefore it is our opinion that DEA’s announcement and related statements have no bearing on the status of hemp-derived CBD.”

    https://hempsupporter.com/dea-reschedules-epidiolex-no-impact-on-hemp-derived-cbd/

    Reply
    • Joe Blow on

      They, being the DEA ARE ABSOLUTELY THE WORST TYPE OF CRIMINALS just below child molesters amd murderers, absolute CRIMINALS and so full of sh*t the administration is sickening. THEY NEED TO BE STOPPED. and all of their nonsense tactics.

      Reply
  3. cma on

    what is this lie you are promoting? they moved GW’s product to schedule 5, all CBD remains schedule 1 and federally illegal. “What this does not do is legalize or change the status of other CBD oil products,” DEA spokesman Rusty Payne told WTHR. “As of right now, any other CBD product other than Epidiolex remains a Schedule I Controlled Substance, so it’s still illegal under federal law.”

    Reply
  4. Cynthia J. Rowan on

    Wow!
    Finally, something is happening after all the hardship. CBD is an incredible molecule especially when it comes to health care. At last, DEA understood its importance and took this amazing step. But, this is just a start. Personally, for my condition, CBD is helping a lot. I purchased this amazing product, and my life changed tremendously.

    Reply
  5. DR KYLE NEVIUS on

    This is a great step in the right direction but the FDA has confused the matter because previous guides s for CBD via the farm bill allowed 3% THC as opposed to the most current 1% limit

    Unfortunately Epidiolex will not be affordable for many families because of the price tag of $32,600 a year price tag

    The same results are acquired by other leading hemp extract companies that produce the same results under good manufacturing practices (cgmp) for about $3200 a year

    Experts agree there is little difference between a full-spectrum plant product that contains 3% THC versus 1% THC

    With the 2018 farm bill looming the FDA is going to have to make up its mind, 1% or 3%?

    Reply
  6. Jef on

    It took a republican government to get CBD rescheduled after all the promises from democrats. We should be happy we have come this far. Trump said he will leave it to the states and the loser sessions went against him. It is time for use to petition our local government officials to do as we ask and not what they feel is best for them. California is one of the worst offenders of doing what is best for the officials to keep power and take it away from we the people. They have put all mom and pop growers out of business regardless of race.
    Stop with the race and religion BS it is nothing more than a tool for the democrats to keep we the people from being united and taking back the power they horde to control us with.
    Be happy and love one another. We can overcome all if we the people unite. First step never let a politician have more than 2 terms in office.

    Reply

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