cbd
Marijuana Science

CBD Medicines Face New National Challenges

cbdThe Cannabis Benchmarks Weekly Report tells us that a half-dozen companies who market CBD-laden medicines and foods were sent letters this month from the FDA warning them against making claims of health benefits.

CBD is the shortened name of cannabidiol, a phytocannabinoid chemical prevalent in cannabis, especially when plants are specifically bred by master growers to express this characteristic. CBD medicines are currently available to patients in 23 licensed medical marijuana states, the District of Columbia, and 15 additional states where CBD-based treatments are the only form of medical marijuana legally available to citizens.

Six American companies that market and sell CBD products received letters from the FDA this month, warning them about language used on their websites. New Cannabis Ventures, the Benchmarks publisher, claims it is “the FDA’s opinion that even marketing CBD products as a dietary supplement is at this time against the law.”

They cite this passage from one of the letters authored by the Food and Drug Administration:

“If a substance (such as CBD) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.”

The FDA tagged CBD as an Investigational New Drug (IND) in 2013. Human trials were announced late in the year.

The Agency’s position is that IND status, and the letter’s reference to “substantial clinical trials” of CBD medicines through large pharmaceutical companies like G.W. Pharmaceuticals and their ‘Epidiolex’ drug, mean no claims can be made about the effects of CBD until the trials deliver their results.

The Benchmarks report points out that the DEA considers CBD a Schedule 1 Drug. The Canadian government treats CBD as a Schedule 2 Drug.

A chart created by LeafScience summarizes the findings of the British Journal of Clinical Pharmacology, who surveyed the field of CBD science and published these conclusions:

Medical Properties of CBD Effects
Antiemetic Reduces nausea and vomiting
Anticonvulsant Suppresses seizure activity
Antipsychotic Combats psychosis disorders
Anti-inflammatory Combats inflammatory disorders
Anti-oxidant Combats neurodegenerative disorders
Anti-tumoral/Anti-cancer Combats tumor and cancer cells
Anxiolytic/Anti-depressant Combats anxiety and depression disorders

Until the clinical trials are completed, these and other recognized benefits can not be claimed in product marketing or on product labels by the six companies receiving letters.

The FDA letters give those targeted companies just 15 days to correct their public statements regarding the effectiveness of CBD-laden medicines and foods. Two companies received similar letters approx. one year ago, but it would appear that no action was ever taken against them after the letters were sent.

SUBSCRIBE TO THE CANNABIS BENCHMARKS WEEKLY REPORT HERE

OTHER LINKS:

thecompassionchronicles.com/2014/02/06/cbd-only-legislation-a-state-by-state-primer/

thecompassionchronicles.com/2014/02/06/planet-green-trees-tackles-cbd-only-legislation/

thecompassionchronicles.com/2014/01/02/cbd-and-pediatric-patients-a-new-survey-is-announced/

thecompassionchronicles.com/2013/12/19/drug-maker-will-soon-hold-patent-on-thc-cbd-as-cancer-cures-leaf-science/

thecompassionchronicles.com/2013/12/19/drug-maker-will-soon-hold-patent-on-thc-cbd-as-cancer-cures-leaf-science/

Source: The Compassion Chronicles

  • Dee

    It will be interesting what IND is honored. I have seen reports where they are stipulating that the FDA is actually using the SATIVEX IND instead of the Epidiolex IND. Which would be preposterous. If the date is 2013, there is now way it will stand, as CBD was already being marketed as a supplement at that time nationally. If they want to extend it back to 2005 for Sativex, then this would remove the cbd previously having been marketed as a supplement argument for the industry, leaving only the food supply argument….which should still be won handily. CBD, as a natural constituent of hemp oil, has been in the food supply throughout history. As sativex is 50/50 THC/CBD, an exclusive IND for CBD would seem ridiculous. I fully agree with both the HIA and CannaVest/CannaScience statements on the matter.

    • James Peters

      Sativex has now been launched in 15 countries (including the UK, Spain, Italy and Germany) and approved in a further 12, so in my view based on the data then the FDA should have approved it for the US by now too. I know in Canada they have also approved it for both cancer and neuropathic pain (GW are still conducting trials for both these) as well as MS spasticity (it’s original indication). Epidiolex is still in four global Phase III clinical trials for two different kinds of epilepsy and some of the first data will be coming out in the next few months. If CannaVest and/or CannaScience can prove their drugs work in clinical trials then they will be approved as well

      • Bongstar420

        The government could just publish research and people could buy drugs based on that. The composition of these drugs can vary widely with the same effects. Its not like there are only the Cultivars in Sativex which are “effective.” Any number of CBD cultivars will produce indistinguishable results.

        This approval process is only for rich people to monopolize the system…..Can even a middle scale grower afford FDA approval?

    • Bongstar420

      Hemp is rare and expensive to buy in the US…and before that, it was mostly restricted to specific regions and was not pervasive in human societies at all ever

      Alcohol is the only universal drug for humanity as it is pervasive through cultures around the world for thousands of years.

      • Dee

        Nutiva hemp oil is but one food based food product that would contain trace amounts of CBD that was in commerce and marketed as food well prior to both the 2004 HIA v. DEA ruling, and the various GW IND’s. I just cite that as a very well known example, folks have been chowing hemp seed and oil long before that.

  • Closet Warrior

    This isn’t Craig’s List eko fed!

  • If TTIP* is allowed into Europe with all the CRAP* that’s currently going on – the same tyrannical tentacles will be holding European consumers to ransom in exactly the same way they do our US cousins…

    The power lies with the people not with the social organs of dystopic malevolence and we as the people must push back against all our enemies both FOREIGN* & DOMESTIC* by any means necessary…

    Individual healthcare is a fundamental conspicuous human right for which the FDA & other parasitic organisations needs to “PISS OFF” and go find another turf to play on… For if we believe & KNOW* that CANNABIS* medicines CURE* our maladies, hurts & pains then SURELY* that is our FRIGGING* business!!!

    • Bongstar420

      The commoner is the cause as they prop up the offenders with their purchases and lack of understanding

  • Fungi Sclerotia 1427

    The Dietary Supplement Health and Education Act of 1994
    explicitly defines ‘supplements’ as an extract of a botanical.

    By that definition, cannabis and cannabis extracts shouldn’t be on any “schedule” whatsoever.
    [1, 2, 3, 4 or 5].

    • Bongstar420

      Same for Psilocybes, Peyotes, Opium, Khat, etc…

      You are just looking for loopholes. Stop it. They don’t exist nor should they. We should simply have correct laws.

      • Fungi Sclerotia 1427

        Ideally, we should have correct laws,
        (only regulating genuineness and purity of product, not the opposite),
        however, the government “of the people”
        seems intent on outlawing nature and natural remedies / treatments entirely.

        Had 1994 gone differently,
        (legislation contrary to the DSHE Act of 1994),
        one might now need a prescription
        in order to legally purchase a bottle of 1000mg cherry flavored vitamin C wafers,
        (which, BTW, complement the flavor and activity of psilocybes quite nicely).

  • James Peters

    From the FDA website ”In late February 2015, FDA issued several warning letters to firms that market unapproved drugs for the diagnosis, cure, mitigation, treatment, or prevention of diseases. Some of these firms claim that their products contain cannabidiol (CBD). FDA has tested those products and, in some of them, did not detect any CBD. It is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease, and often they do not even contain the ingredients found on the label. Consumers should beware purchasing and using any such products.” In my view this is a good thing as not only did most of the companies product contain no active ingredient but also there is no good data they work either

  • PhDScientist

    I like the guys at GWPH, but don’t think it would be good for the industry, America or the World if they wound up with exclusive rights to CBD or, even worse, both CBD and THC. There’s a real danger of that happening — the DEA and FDA are looking for the “Great White Hope” with respect to Medical Marijuana — they LOVE the idea of a CBD based drug from a Pharma company as a way to let them continue to keep the “whole plant” illegal. Pure THC, Marinol (TM) is already Schedule 3. (Which is a great argument for making the whole plant Schedule 4, 5, or no schedule at all)

    I was trained as a Scientist. I bought into the “Single Active Agent” theory of Pharmacology for years. But I’m now convinced that in the case of Cannabis, the entourage effect is REAL.

    Raphael Mechoulam is a top-notch researcher. Everyone who knows him and his work respects both of them completely and totally.

    Everyone who reads or posts here needs to get actively involved in the effort to make Marijuana legal and free from overly restrictive patents.

    The more “prior art” any of us can find, the better.

    Countless lives depend on getting Medical Marijuana re-scheduled or de-scheduled so it can available to all the patients who need it.

    • saynotohypocrisy

      Sorry, what’s “prior art”?

      • PhDScientist

        My definition is “Previous use or description of an invention prior to the application to patent it.”

        Google’s is —

        Prior art is any evidence that your invention is already known. Prior art does not need to exist physically or be commercially available. It is enough that someone, somewhere, sometime previously has described or shown or made something that contains a use of technology that is very similar to your invention

        • saynotohypocrisy

          Google’s standard for demonstrating prior art and thus denying the patent sounds easier to meet than yours. Do you want Google’s definition to prevail, but fear that it won’t?

          • PhDScientist

            Nope. It turns out that its a matter of how precisely you want to define it, and when you have patent fights, you fight it out in patent court because one side will argue that something is prior art and the other side will argue that its not. Here’s a link to a more formal description of “prior art”

            http://www.ipwatchdog.com/2010/10/02/what-is-prior-art/id=12677/

          • PhDScientist

            Nope. It turns out that its a matter of how precisely you want to define it, and when you have patent fights, you fight it out in patent court because one side will argue that something is prior art and the other side will argue that its not. Google “prior art” and look at a site called “ip watchdog”
            I posted a reply with a link to it, but got a “hold on, this is waiting to be approved by the weed blog” message.

          • PhDScientist

            In related news, in the four hours since my first post on this subject, 240 Americans have died of Cancer.

          • Bongstar420

            How is that not to be expected?

            Cancer happens to all animals regardless of their environments in the ultimate sense.

            The primary factor determining your cancer risk is your parents.

          • saynotohypocrisy

            Whether cancer is inevitable is a different discussion from whether cancer can be cured or stonewalled for a long time. His comment is to point out the urgency of working for treatments and cures.
            To response to a comment PhDScientist made elsewhere, the federal budget to fight cancer does seem ridiculously low compared to the damage cancer causes.

          • Bongstar420

            If I can think of it on my own, it doesn’t belong being patented.

            Its super annoying to find ideas already patented with the owners just sitting around looking for someone to parasitize by charging royalties. There are corporations that file patents only for the purposes of winning law suits, not to actually produce anything.

        • Bongstar420

          Youve discovered the patent office bugaboo….lots of invalid patents being issued because the tech is wide spread before the patent was issued.

          In a patent, a prior art is your opening statement for your actual new process.

          Patents are for parasites
          Proprietary is for earners

    • Bongstar420

      All they can get is rights to their formula which has to be more like a Utility Patent then a standard pharmacy one because Cannabis pharmacy is not new technology. Basically, they have to breed their own cultivar for a specific purpose which is what they have done. Use a different cultivar and call it generic pot. Easy as pie

      My products are pretty much Marinol class though I’d argue they are better due to food grade adjutants that I use to increase bioavailability which to the best of my knowledge Marinol is just sesame oil with THC in it.

  • saynotohypocrisy

    That’s an impressive list of benefits of CBD. If that means that cannabis breed for high CBD, low THC can be used for all these conditions, that’s very good news, all these benefits from a cheap herb with very little in the way of side effects, and even the idiot prohibitionists shouldn’t have any problem with it, because it’s low THC. That should be especially good news for countries that are more fanatically anti-cannabis than this one.

    • Bongstar420

      Dispensary shelves have mostly real “medicine-” high THC

      Its not a cheap herb if you care about quality at all

      CBD can be isomerized to THC at about a 50% conversion rate. Its a simple process really.

      And there are no drugs which are sold under the lax regulations that pot is.

      • saynotohypocrisy

        Even at $100’s an ounce, I think it’s still cheap compared to pharmaceuticals.
        But isn’t there a distinction between indoor and outdoor growing? Indoor is expensive (and bad for the environment) because it uses a lot of energy for lighting and cooling. What about outdoor growing?

        • Bongstar420

          Not really. I saw some outdoor stuff doing $17/gram when most of the indoor on the menu was $15/g.

          Its based on hype and distinctions which are cultivar related and not really the result of grower skill so much.

          Its $80/lb for lighting in flower for a good yielding cut not counting veg which is the same for outdoor growers since they all grow months of veg indoors to get their quantity. Testing is $100-200/lb alone. Outdoor growers are exclusively about quantity first.

          The primary expense is profits for retailers. The lowest mark up my stuff has been put on is 3x. I sell for around $3-4/g and they sell for about $13-15. They don’t do anything but hand it out for those mark ups. Their information is all anecdotal word of mouf. There are no research reports in the lobby informing the best routes for different conditions. They feed their drugs to hungry “patients” and those people determine what “conditions” they are good for.

          Rec, well, its the same. No one can quantify much of anything beyond myrcene and the 4 main cannabinoids.

  • Bongstar420

    Is it just me or did you neglect to mention that all the products were practicing deception?

    http://www.thedailychronic.net/2015/41401/fda-issues-warnings-to-makers-of-legal-cbd-hemp-oil-products/

    Finally, these items only come from rich people. Why support people like that? I manufacture actual legitimate CBD products that are sold for cheaper than these hemp extracts, and I am dirt poor.

  • Bill Coleman Dean

    The fda claoms only a medicine can cure a illness. Only a dr can prescribe a medicine . This is laying the groundwork for CBD to be considered a pharmaceutical medicine that has to be bought from a pharmacy. Sorry, but that’s how this country rolls. Don’t be so naive. They don’t care that you use CBD. They only care of that pharmaceutical companies don’t manufacture it for you to use.