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68 Am. U. L. Rev. 823 (2018-2019)
The Surprising Reach of FDA Regulation of Cannabis, Even after Descheduling

handle is hein.journals/aulr68 and id is 861 raw text is: 









         THE SURPRISING REACH OF FDA
            REGULATION OF CANNABIS,
            EVEN AFTER DESCHEDULING


                          SEAN M.  O'CONNOR*


                            ERIKA  LIETZAN*


   As more  states legalize cannabis, the push to deschedule it from the
 Controlled Substances Act is gaining momentum. At the same time, the Food
 and Drug Administration (FDA)  recently approved the first conventional drug
 containing a cannabinoid derived from cannabis-cannabidiol (CBD) for two
 rare seizure disorders. This would all seem to bode well for proponents of full
federal legalization of medical cannabis. But some traditional providers are
wary  of drug  companies pulling medical  cannabis into the regular small
molecule drug  development system.  The FDA's  focus on precise analytical
characterization and on individual active and  inactive ingredients may be
fundamentally  inconsistent with the entourage effects theory of medical
cannabis.  Traditional providers may believe that descheduling cannabis would
free them to promote and distribute their products free of federal intervention,
both locally and nationally. Other producers appear to assume that descheduling
would  facilitate a robust market  in cannabis-based  edibles and dietary
supplements. In fact, neither of these things is true. If cannabis were descheduled,
the FDA's complex  and comprehensive regulatmy framework governing foods,


    *  Boeing International Professor and Founding Director of the Cannabis Law &
Policy Project, University of Washington School of Law; J.D., Stanford Law School; M.A.,
Philosophy, Arizona State University; B.A., History, University ofMassachusetts, Boston. The
Author thanks Nephi Stella, Karen Boxx, Mowgli Holmes, Hilary Bricken, Daniel
Shortt, andJason Liu.
   **  Associate Professor of Law, University of Missouri School of La;r, J.D., Duke Law
School; M.A., History, University of California Los Angeles; B.A., History, University of North
Carolina at Chapel Hill. The Author thanks AlissaJijon and Patricia Zettler for comments
and James Kopfensteiner (University of Missouri Class of 2018) for research assistance.


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