The American University law review最新文献

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 regulatory framework governing foods, drugs, and dietary supplements would preclude much of this anticipated commerce. For example, any medical claims about cannabis would require the seller to complete the rigorous new drug approval process, the cost of which will be prohibitive for most current traditional providers. Likely also unexpected to some, there is no pathway forward for conventional foods containing cannabis constituents, with the (probably exclusive) exception of certain hemp seed ingredients, if those foods cross state lines. And it will certainly come as a shock to many that federal law already prohibits the sale of dietary supplements containing CBD--including those already on the market as well as those made from "hemp," which has recently been descheduled under the 2018 Farm Bill. This Article describes in detail the surprising reach of the FDA and then outlines three modest, but legal, pathways forward for cannabis-based products in a world where cannabis has been descheduled.

The digital universe remains a black box. Despite attaining high-technology capabilities like artificial intelligence and cognitive computing, "Big Data" analytics have failed to keep pace with surging data production. At the same time, the falling costs of cloud storage and distributed systems have made mass data storage cheaper and more accessible. These effects have produced a chasm between data that is stored and data that can be readily analyzed and understood. Enticed by the promise of extracting future value from rising data stockpiles, organizations now retain massive quantities of data that they cannot presently know or effectively manage. This rising sea of "dark data" now represents the vast majority of the digital universe. Dark data presents a quandary for organizations and the judicial system. For organizations, the inability to know the contents of retained dark data produces invisible risk under a spreading patchwork of digital privacy and data governance laws, most notably in the medical and consumer protection areas. For courts increasingly confronted with Big Data-derived evidence, dark data may shield critical information from judicial view while embedding subjective influences within seemingly objective methods. To avoid obscuring organizational risk and producing erroneous outcomes in the courtroom, decision-makers must achieve a new awareness of dark data’s presence and its ability to undermine Big Data’s vaunted advantages.