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Commercial Cannabidiol Caution: A New Gold Rush

      To the Editor:
      We recently read with interest the review by VanDolah et al
      • VanDolah H.J.
      • Bauer B.A.
      • Mauck K.F.
      Clinicians' guide to cannabidiol and hemp oils.
      in Mayo Clinic Proceedings, summarizing the emerging landscape of commercially available cannabidiol (CBD) preparations, which are now subject to consumption by the general public because of the purported health benefits of CBD. We agree with the authors in that an open discussion exploring patient use of such substances is necessary for a complete history as well as for establishing patient rapport. We would add a word of caution about the use of products and would also suggest readers of Mayo Clinic Proceedings consider additional factors when discussing commercial CBD use with patients.
      First, although hemp farming is now legal under federal law, and for profit CBD commercial establishments are widespread, the actual sale of hemp-derived CBD food or supplement formulations remains illegal because plant-derived CBD (Epidiolex) is a Food and Drug Administration–approved drug.
      • Cohen P.A.
      • Sharfstein J.
      The opportunity of CBD—reforming the law.
      Second, many commercial sellers of CBD imply medical claims for these products, which are both unsupported by clinical evidence and in violation of Food and Drug Administration labeling laws. Third, it should be recalled that the 2 large clinical trials that established CBD as an adjunct therapy for severe pediatric onset epilepsy syndromes—Dravet syndrome and Lennox-Gastaut syndrome—used doses of 10 to 20 mg/kg per day. Fourth, molecular analyses have revealed substantial deviation from the advertised label contents.
      • Bonn-Miller M.O.
      • Loflin M.J.E.
      • Thomas B.F.
      • Marcu J.P.
      • Hyke T.
      • Vandrey R.
      Labeling accuracy of cannabidiol extracts sold online.
      Finally, and most importantly, approximately 8% of vaping-associated lung injury was subsequent to exposure to CBD tinctures.
      • Butt Y.M.
      • Smith M.L.
      • Tazelaar H.D.
      • et al.
      Pathology of vaping-associated lung injury.
      Although it is unknown whether CBD plays a direct pathogenic role in vaping-associated lung injury, the carrier solvents for these products have not been found to be safe at the currently administered levels and new pathogenic chemical entities may be generated through aerosolization. Ultimately, given that these substances are unregulated, possibly adulterated, and not found to be clinically effective, we urge the medical community to practice caution and forbearance with respect to patient-reported benefits of commercially acquired CBD.
      With the passing of the Hemp Farming Act, academic institutions wishing to investigate hemp-derived cannabinoid products can now safely do so without being in violation of the Federal Controlled Substances Act. As a result of these new legal protections, there is an ongoing Mayo Clinic analysis of aerosolized CBD that will hopefully bring a better understanding of what potential risks lie ahead.
      Caveat emptor.

      References

        • VanDolah H.J.
        • Bauer B.A.
        • Mauck K.F.
        Clinicians' guide to cannabidiol and hemp oils.
        Mayo Clin Proc. 2019; 94: 1840-1851
        • Cohen P.A.
        • Sharfstein J.
        The opportunity of CBD—reforming the law.
        N Engl J Med. 2019; 381: 297-299
        • Bonn-Miller M.O.
        • Loflin M.J.E.
        • Thomas B.F.
        • Marcu J.P.
        • Hyke T.
        • Vandrey R.
        Labeling accuracy of cannabidiol extracts sold online.
        JAMA. 2017; 318: 1708-1709
        • Butt Y.M.
        • Smith M.L.
        • Tazelaar H.D.
        • et al.
        Pathology of vaping-associated lung injury.
        N Engl J Med. 2019; 381: 1780-1781

      Linked Article

      • Clinicians’ Guide to Cannabidiol and Hemp Oils
        Mayo Clinic ProceedingsVol. 94Issue 9
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          Cannabidiol (CBD) oils are low tetrahydrocannabinol products derived from Cannabis sativa that have become very popular over the past few years. Patients report relief for a variety of conditions, particularly pain, without the intoxicating adverse effects of medical marijuana. In June 2018, the first CBD-based drug, Epidiolex, was approved by the US Food and Drug Administration for treatment of rare, severe epilepsy, further putting the spotlight on CBD and hemp oils. There is a growing body of preclinical and clinical evidence to support use of CBD oils for many conditions, suggesting its potential role as another option for treating challenging chronic pain or opioid addiction.
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        Open Access
      • In reply—Commercial Cannabidiol Caution: A New Gold Rush
        Mayo Clinic ProceedingsVol. 95Issue 1
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          We thank Scharf et al1 for their thoughtful comments, which basically reinforce the cautionary notes we sounded in the original article.
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