Stakeholders Await the FDA’s First Public Hearing About Cannabis and CBD
By J.J. McCoy and William Sumner for the Hemp Business Journal
On Friday, the U.S. Food and Drug Administration (FDA) will hold its first public hearing about regulations regarding legal cannabis and cannabidiol (CBD).
Among some 140 registered speakers scheduled to provide comment during the daylong event, stakeholders in the hemp and CBD industries say that the goal of the meeting and subsequent hearings will be to determine the extent to which the agency should regulate cannabis and CBD as tightly controlled pharmaceutical products or as less restricted nutritional supplements.
Rather than any immediate, concrete results from the hearing, stakeholders will seek to recognize trends and consensus from among those assembled.
“Effectively, the FDA is asking questions first about cannabis-derived compounds rather than marijuana versus hemp,” explained Garrett Graff, managing attorney with Denver-based Hoban Law Group, who is among the scheduled speakers. “The hearing is framed around cannabis generally, not marijuana or hemp specifically.”
He added that “what I expect on Friday are a wide variety of stakeholders – pharmaceutical companies and investors, state and local officials, marijuana businesses, etc. – [with] a wide variety of opinions, and that the FDA will need to take them all under advisement.” CBD has become immensely popular, and a very lucrative industry. By 2022, the Hemp Business Journal estimates, U.S. CBD sales will reach up to $2.3 billion. Depending how the FDA regulates CBD, such projections could change dramatically.
In stark contrast to the U.S. federal government’s decades-long prohibition of cannabis as a controlled substance having no medical value, by the late 1990s scientists with the National Institutes of Health had found potential for valuable medical effects. Indeed, the federal government saw fit to hold a patent on cannabidiol.
With some medical benefits since confirmed and approved by the FDA, further determinations now revolve around questions of extents, including production standards, concentrations, and dosing.
For each new study released about CBD’s potential to address ills including pediatric epilepsy, chronic pain or heroin addiction, disturbing news arises about mislabeling, false advertising, or tainted products peddled without consumer protections or full understanding about benefits.
“I think the FDA is looking at this fairly holistically,” Graff explained, with considerations given to the value and safety of topical applications versus food and drinks, and whether the latter are safe for ingestion by humans or animals, along with smokable or inhalable goods.
As GW Pharmaceuticals sees unexpected profits generated from the company’s patented, CBD-based prescription drug, Epidiolex, industrywide attention focuses toward the FDA and how the regulatory agency decides to classify and protect cannabis-derived products and research whether for pharmaceutical drugs or nutritional supplements.
While Graff warns stakeholders and speculators not to expect any immediate answers – “I would fully expect to see some interim additional guidance sometime this year, though I would not expect finalized guidance until 2020 and perhaps years beyond,” he said – trends will likely emerge. He suggested that interested parties should look for common themes, and ways for stakeholders and the FDA to build from consensus and compromise to find any bridges for determining what parameters should be.
By the end of the May 31 hearing, the public will have its first inkling of how the FDA is leaning.
William Sumner is a writer for the hemp and cannabis industry. Hailing from Panama City, Florida, William covers various topics such as hemp legislation, investment, and business. William’s writing has appeared in publications such as Green Market Report, Civilized, and MJINews. You can follow William on Twitter: @W_Sumner.