Guest blog by Kathy Patchel, RZA Legal summer extern
Since the federal legalization of industrial hemp last year, Americans have been waiting on regulations from the FDA concerning CBD products. CBD may be derived from hemp to create a multitude of different products with varying uses. You may have seen CBD products in your local store or used them yourself. CBD products have been legal in Colorado since legalization of marijuana, from which CBD may also be derived. The issue now is that states without legalized marijuana don’t have any guidance on CBD.
The United States Postal Service provided some guidance on mailability of cannabis and hemp-related products in June 2019. But the FDA has been grappling with its task of regulating CBD and other hemp-derived products, and with just cause. Issues such as uniform testing, warning labels and other issues are apparently proving more difficult to craft.
The FDA is focused on safety and maintaining incentives for clinical research. Their concern is that if CBD is available as a dietary supplement there will be a dramatic loss in incentives for clinical research and potential for CBD will be lost. The FDA provides lots of information about how CBD and other cannabis-derived ingredients are treated under current law and policy, but not much about how it intends to move forward at this point in time.
Another major concern of the FDA is that dietary supplement companies are already starting to make unsupported claims that their CBD products can cure serious illnesses like cancer or Alzheimer’s disease which may prevent people from seeking proper care for such illnesses. The FDA has also reported finding that many CBD products often do not have any CBD or an inaccurate amount. Rest assured that any forthcoming FDA regulations will address issues such as these.
In March 2019, then FDA Commissioner Scott Gottlieb opined it would take years for the FDA to create rules to allow hemp-derived CBD to be used in food products unless Congress stepped in. The FDA held a hearing in late May 2019 for stakeholders to contribute and propertied to have regulations circulated as early as the end of summer or early fall. But still no guidance has been issued.
In late September 2019, 26 members of the house of representatives sent a letter to the FDA urging guidance on this explosive new market. That day, Senator Mitch McConnell managed to have the Senate Appropriations Committee to add provisions into an agricultural spending bill directly FDA to issue guidelines for hemp-derived CBD products within 120 days.
In October 2019, four major U.S. dietary supplement trade associations requested Congress provide guidance on CBD product marketing and sale.
Needless to say, the pressure is on for the FDA to release guidance for this booming industry that's moving forward with no signs of pumping the breaks.
So, now we wait.
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