By: Jessica Wasserman and Nabil Rodriguez
After a ten hour marathon public hearing in Washington D.C. on Friday, one thing is clear: there is an urgent need for FDA to regulate and provide certainty for the already-existing CBD marketplace. The ball is now in FDA’s court as Congress watches to see whether FDA will move forward, as it has committed to Congress in several hearings over the past months. Written comments are due to FDA by July 2, and soon after that, FDA is expected to clarify the regulatory framework to reduce confusion in the marketplace. The hearing demonstrated the pent up demand for action and if FDA does not act, consumers and other stakeholders will likely continue to petition Congress for action.
This was FDA’s first meeting to hear presentations from manufacturers, neurologists, attorneys, parents, innovators and leaders of hemp and CBD voice their concerns on the implementation of the 2018 Farm Bill. The hearing was intended to listen, question, and ultimately understand the scientific data, general information, and immediate issues surrounding CBD products that will need to be addressed as FDA considers legal pathways for CBD.
Greenspoon Marder Partner Jessica Wasserman was in attendance to assist clients preparing for their presentations.
As a general consensus, the speakers working in and concerned with the CBD market want clarity and consistency for the purposes of product safety. Others requested consistent definitions, safety standards and protocols, and there was a push for interim guidance while FDA considers the rules needed to regulate the vast CBD market.
Several speakers expressed a deep concern for consumers that use and depend on CBD to treat certain conditions. The fact is, however, that there are numerous CBD products currently flooding the retail CBD market. These CBD products range from foods to topical CBD lotions, as well as toothpicks, sublingual products and CBD patches. As more expansion and product development occurs, several issues become unavoidable with a largely unregulated market. These issues include potential labeling abuse – products marketed as having either more or less CBD than advertised, and certain products that test with absolutely no CBD present or instead test positive for THC. Inevitably, those that are most harmed in these instances are the consumers.
Over the course of ten hours, opinions ranged from support to strict opposition. Suggestions ranged from consistency testing at both the cultivation and final manufacturing stages, to additional research establishing safe levels of CBD in a single serving and daily amount.
Although the meeting was only one day, the FDA is accepting written comments until July 2. Should you have any interest in submitting a written comment for FDA consideration, please contact a Greenspoon Marder attorney.