At the U.S. Food and Drug Administration’s (FDA) public hearing on May 31, 2019 (read more about the hearing), over 100 people presented to a panel of FDA stakeholders and to over 500 attendees. Last week, FDA stated in a post that it recognizes the “significant public interest in these products, for therapeutic purposes and otherwise” but reiterated that “there are many unanswered questions about the science, safety, and quality of many of these products.”
The good news for the industry is that FDA “recognize[s] the need to be clear and open about where things stand, and about the efficient and science-based way in which we are moving forward,” including “being transparent and up-front” as they continue to collect data and information on CBD. FDA is taking an “Agency-wide, integrated, and collaborative approach” to regulating products made from CBD and is exploring potential pathways to market for CBD products. However, FDA still grapples with how to balance the desire for widespread availability of CBD products with the desire to preserve incentives for research and drug development of CBD products.
View the full Alert on the Duane Morris LLP website.
David Feldman, a Duane Morris partner and team lead of the firm’s Cannabis Industry Group, was quoted in the Corporate Counsel article, “With Gottlieb Leaving FDA, Uncertainty Over CBD and Hemp Regulation Remains.”
“There is tremendous confusion in the marketplace right now concerning what is and isn’t legal in hemp and CBD,” Feldman said. “We are comfortable as to knowing what we know is true. There is a lot of uncertainty as to what operators can and can’t do.”
Feldman said he is telling clients that there will be a path for legal hemp and legal CBD products, but that path does not yet exist. He said there is a process in place already for companies seeking approval for drugs with CBD in them, however there is still a question of what the approval process will be for food and beverages containing CBD.
To read the full article, visit the Corporate Counsel website (subscription required).
Last year was a record year for cannabis. Canada passed the Cannabis Act, making adult-use cannabis legal there. The FDA approved a cannabidiol-based medicine, Epidiolex. And the President signed the Agriculture Improvement Act of 2018, aka the 2018 Farm Bill, into law on December 20, 2018.
While the 2018 Farm Bill granted the U.S. Department of Agriculture the ability to regulate hemp, it also preserved the right for the U.S. Food and Drug Administration (FDA) to regulate products containing cannabis or cannabis-derived compounds. The FDA regulates products such as human and animal drugs, biological products, cosmetics, food and animal feed, among other things. So any inclusion of cannabis or cannabis-derived compounds, like CBD, in any of those types of products would be regulated by the FDA. The FDA has stated that this is true regardless of the source of the cannabis substance, be it hemp or marijuana.
Read the full Duane Morris alert.