CBD

The FDA and the DEA Are Butting Heads Over CBD

The DEA is resisting a recommendation that the cannabis-derived compound be moved to the least restrictive category of controlled substances.

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Bruce R. Bennett/ZUMA Press/Newscom

A letter from the Department of Health and Human Services (HHS) to the Drug Enforcement Administration (DEA) reveals that medical reviewers at the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA) believe the federal government should lift its ban on cannabidiol, a cannabis-derived compound commonly marketed as CBD.

HHS Assistant Secretary Brett Giroir sent the letter, which Marijuana Moment's Tom Angell obtained and published this week, to DEA Acting Administrator Robert Patterson, who has since retired, in May. "After reviewing the available information," Giroir writes, the FDA and NIDA "conclude that CBD and its salts [should] be controlled in Schedule V of the Controlled Substances Act." Drugs in Schedule V, which is the least restrictive category for controlled substances, have demonstrated medical value and are deemed unlikely to cause harm, abuse, or addiction. By contrast, drugs in Schedule I, where CBD currently sits as a component of marijuana, are supposed to have no recognized medical value and a high potential for abuse.

Giroir's letter also reveals that the DEA told HHS in April, 2018, that descheduling CBD would violate the United Nations Single Convention on Narcotics, a decades-old treaty to which the U.S. is a signatory. The DEA insists that CBD can be legalized only one product at a time, as particular preparations undergo clinical trials and receive FDA approval. Last month, for instance, the DEA put the CBD medication Epidiolex in Schedule V after the FDA approved it as a treatment for two severe forms of epilepsy.

The FDA, by contrast, has argued that CBD itself should be moved to Schedule V. In fact, the FDA report Giroir shared with DEA says that CBD should be descheduled altogether if the Single Convention is ever amended. Currently, the treaty requires signatories to regulate and control cannabis and all of its derivatives:

That recommendation speaks to the safety of CBD, which is marketed across the United States as a treatment for conditions ranging from stress to epilepsy. As far as I know, the FDA has never argued that a drug in Schedule I should be descheduled altogether.

In a fight between scientists and drug cops, however, the drug cops win. The Controlled Substances Act, passed in 1970, empowers the attorney general to disregard recommendations from HHS. If Attorney General Jeff Sessions' ongoing obstruction of cannabis research is any indication, it is likely that the DEA will, for the foreseeable future, resist a broad rescheduling of CBD.

"DEA will continue to support sound and scientific research that promotes legitimate therapeutic uses for FDA-approved constituent components of cannabis, consistent with federal law," Acting DEA Administrator Uttam Dhillon said in a press release announcing the rescheduling of Epidiolex. The agency patted itself on the back for that decision:

Marijuana and CBD derived from marijuana remain against the law, except for the limited circumstances that it has been determined there is a medically approved benefit. In those instances, such as here, the drug will be made appropriately available to the public for medical use.

The drug is already widely available to the public for medical use, both as a component of most cannabis products and as a concentrate that is probably similar to Epidiolex (although we can't know that for sure, thanks to the federal prohibition on studying the effects of state-legal cannabis products in humans). There is broad support across the global medical community for CBD's therapeutic value, and the World Health Organization released a report in June that found

CBD "exhibits no effects indicative of any abuse or dependence potential", "may be a useful treatment for a number of other medical conditions", and "is generally well tolerated with a good safety profile". It also found "no evidence of recreational use of CBD or any public health-related problems associated with the use of pure CBD".

To make matters slightly more frustrating, attorney Rod Kight argues that not all forms of CBD are covered by Schedule I, because not all forms of CBD come from marijuana:

It is true that CBD derived from marijuana is also controlled. This is because CBD derived from an unlawful source is itself unlawful. But that's just the beginning of the inquiry. There are legal forms of cannabis, including industrial hemp, non-psychoactive hemp, and the mature stalks of the plant, which are an exception to the definition of marijuana. (Additionally, CBD can be derived from sources other than cannabis.) When CBD is derived from a lawful source it is lawful.

Except law enforcers don't treat any form of CBD as lawful. That CBD products have proliferated as quickly as they have says more about law enforcement priorities and resources than any consensus among cops and prosecutors about the legality of CBD.

In addition to citing the Single Convention on Narcotics as a reason to keep CBD in Schedule I, the Justice Department (which includes the DEA) has used the treaty as an excuse for blocking cannabis research. In April, Sessions cited the treaty when explaining to Congress why he continued to sit on applications for new manufacturers of research cannabis. As I wrote at the time, Sessions seems to be intentionally misreading the treaty to suit his anti-pot prejudices. That excuse probably won't hold water much longer: We now know that Sessions' obstruction of cannabis research conflicts not just with the wishes of Congressional Republicans but with the scientific advice of HHS and the FDA.

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  1. Obviously we need to withdraw from the Single Convention on Narcotics.

    1. Stop making sense! Making sense is NOT compatible with the policies of Government Almighty!

    2. A proper Supreme Court would say the Single Convention has no force. If it’s a treaty, then the UN can’t just change their wording of it on a whim, it has to be re-ratified. Or say that because the UN has changed it, it is no longer ratified and no longer applies.

      1. Treaties should be about relationships between nations. They should never dictate our internal laws.

        1. I was under the impression that treaties could not dictate internal laws, by Supreme Court precedent. That if Congress did not implement treaty provisions, tough nougies.

          1. It all depends…but in this case Congress has passed drug laws which can be defended as implementing the Narco-treaty.

    3. Wasn’t the GOP supposed to be anti-UN anyway?

      “We want the US out of the UN! ….except when their rules support our prohibitionist agenda, of course.”

  2. I wonder if members of Congress are following this debate among the agencies over what the law should be.

    I bet they’re saying, “thank goodness we don’t have to make these controversial decisions!”

    Then they turn to their pollsters and say, “if these regulators made an unpopular decision, let me know so we can issue an angry press release.”

    1. Congress entirely delegated to DEA AND EPA what drugs and species and materials are to be regulated.

      DEA is required to look to FDA and HHS for “science” upon which decisions are made.

      However, Congress allows EPA to rely on its own “science” and does not require that underlying science be transparent. That’s a problem.

  3. Are these people born this level of evil or do they work their way up to it?

    1. I was just reading an article about psychopathy yesterday. Some neurologists claim they spot psychopaths in infancy. So, maybe at least some are born that way.

      1. This may interest you…

        http://www.sciencedaily.com/re…..110841.htm Psychologists define the ‘dark core of personality’

      2. Another one for you…

        The Science of Good and Evil, January 2018 National Geographic, by Yudhijit Bhattaharjee , see http://www.nationalgeographic……ttesville/

  4. Legislation is such a weird business. In some ways, it’s entirely voluntary, unlike the laws of gravity or thermodynamics or even economics. Is that what distinguishes hard science from soft pseudo-science? But I digress.

    Legislators pass legislation. Bureaucrats interpret it anyway they want. Courts slap them down anyway they want. People obey legislation to varying degrees. Money and connections lubricate the system in weird ways. Police and prosecutors ignore some unenforceable legislation and enforce others, based on a shit-ton of variables which no one really understands.

    As long as legislation was limited to, say, teenage curfews, no one really cared. But when legislation can bit your for no reason, out of the blue, and you didn’t even know it existed before, people tend to get paranoid and lash out. Right now, it’s more profitable to react by snitching on neighbors and enemies than to mind your own business. You can’t mind your own business, due to random legislation biting you, so why not use that hidden legislation to get the government to bite competitors or neighbors?

    What a fucked-up world.

  5. >>>citing the Single Convention on Narcotics as a reason

    fuck you, punting to international law

    1. Treaties are the law of the land.

      1. They shouldn’t be. They should be concerned only with external affairs.

        1. Are you saying the Framers were wrong?

          1. No. The states should be required to abide by US treaties in their dealings with other nations.

      2. How can a treaty change by mere UN vote? Doesn’t that require re-ratification as a new treaty?

        1. It should.

        2. Depends on the wording of that particular treaty. Congress may have ratified a treaty that delegates changes to the UN, with no subsequent ratification needed.

          For example, Congress ratified the IRAN Amity Treat with wording about ratification by legislative bodies, but revocation by the President only, with on year’s notice.

          It really depends on the wording in the original treaty..

      3. stupid treaties need the most attention.

    2. Meanwhile the GOP is supposed to be all about “fuck the United Nations”. Fucking hypocrites.

  6. FDA vs. DEA on CBD? OMG. SMH.

    1. WTF?

    2. But they’re all GMTA on FYTW.

  7. Quite a reversal

    In 2015, Obama’s DEA openned a comment period on delisting MJ. The Drug Enforcement Act requires that DEA look to FDA and HHS for “science” on schedules. DEA was open to delisting.

    But Obama’s FDA come out firmly against delisting, and no rule change went forward.

    Now the “Yes” and “no” are reversed.

  8. Would Trump just fire Sessions. What the hell is the hold up?

    1. Joykiller Jeff will probably get shitcanned sometime after November 7, 2018.

      Something something rock the boat.

  9. As I understand it doesn’t get you high. Other than the epilepsy drug does it actually do anything or is just another one of those supplements?

  10. If CBD is made legal the gov’t would have to pay for it via Medicare / Medicaid. They save a ton of money keeping it on schedule I.

    1. They would save many more tons of money by prescribing CBD instead of Big Pharma’s creations.

  11. A better question than whether the DEA can reschedule CBD, is to ask how a ratified treaty that has the same legal weight as a federal statute can do something that could not be done without a constitutional amendment to a different drug — the feds had the same supremacy in 1918 that they do today in 2018, and they could not nationally prohibit alcohol by statute without amending the Constitution first!

    If a statute cannot do it alone, and a treaty is equal to a statute, then the Controlled Substances Act is now — and always was — unconstitutional!

  12. Drugs vary in potency and their resulting dangers to individuals in society. That is why they are regulated and restricted.

    Alcohol is water soluble, you feel sick when you overdo it, It leaves your body in a few hours after doing its damage and your brain and body can recover.

    Opioid drugs like carfentanil will kill people on contact.

    Marijuana is fat soluble, you’re body let’s you overdo it and it stays in the fatty tissues of your brain for months so your body never recovers. Medical research has proven it causes mental illness. It is increasingly genetically modified to strengthen its effects and is regularly mixed with other more dangerous drugs.

    1. “Drugs vary in potency and their resulting dangers to individuals in society. That is why they are regulated and restricted.”

      It has absolutely nothing to do with government enabled rent seeking!

  13. “The DEA is resisting a recommendation that the cannabis-derived compound be moved to the least restrictive category of controlled substances.”

    TDS colored glasses.

    How about
    “The FDA is recommending that the cannabis-derived compound be moved to the least restrictive category of controlled substances.”

    Another Libertarian Moment, brought to you by Trump and the Deplorables.

  14. I agree!!! You can discuss with other side. That’s how you learn and expand your view points.
    http://www.mkoutletfire.com/mi…..-grey.html

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