By William Sumner, Contributing Writer for the Hemp Business Journal
Last Friday, the U.S. Food and Drug Administration (FDA) held its first public hearing about the safety and regulation of cannabis and cannabis-derived products. At the heart of the hearing were issues of how the FDA should regulate CBD, which has been growing in popularity as both a nutritional supplement and as a patented pharmaceutical ingredient.
Though nongovernmental organizations like the World Health Organization regard pure CBD and CBD preparations (containing no more than 0.2% THC) as generally safe and nonaddictive, by the FDA's standards there remains insufficient clinical data to allow itself to confidently issue an informed verdict.
As Garrett Graff, managing attorney with Denver-based Hoban Law Group, previously told Hemp Business Journal, stakeholders and speculators should not 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. Rather, 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.
As Acting FDA Commissioner Ned Sharpless put it during the hearing, "there are important reasons to generally prohibit putting drugs in the food supply."
Similarly, CBD's legal status is likewise unclear in the EU, where the substance is classified as a "novel food" under well-defined regulations, though there remain instances of its being sold without proper governmental authorization. Last month, Bulgaria reportedly became the first EU member to officially allow a hemp-derived CBD product, when it provided Kannaway (a subsidiary of Medical Marijuana Inc.) with a free sale certificate from its Ministry of Agriculture, Food and Forestry, and the Bulgarian Food Safety Agency.
At the FDA hearing, hemp industry stakeholders primarily asked the agency to eliminate bad actors from the market, require standardized testing of CBD products, and make regulatory distinctions between CBD supplements and pharmaceutical products.
Hoping to address such concerns were more than 120 health-care professionals, hemp advocates and industry stakeholders, including representatives from companies such as CV Sciences CVSI, Elixinol Global ELLXF, and Canopy Growth CGC.
The hearing also included testimony from representatives of three top biopharmaceutical companies with respective stakes in CBD-based drugs: Corbus Pharmaceuticals CRBP, Zynerba Pharmaceuticals ZYNE, and GW Pharmaceuticals GWPH — the last being the only current patent-holder of a CBD-based drug (Epidiolex) with FDA approval for use and sale.
Unsurprisingly, pharmaceutical stakeholders argued that the FDA should be more cautious about regulating CBD. Alice Mead, vice president of U.S. professional relations for GW Pharmaceuticals' subsidiary Greenwich Biosciences, argued that the FDA's approval process is the only means by which the FDA will have its CBD questions fully answered; she noted how no one suspected that CBD might affect liver function until her company was required to conduct clinical trials.
Following the FDA hearing, stocks for several leading CBD and cannabis companies took a tumble, signaling a feeling of unease among investors: After the hearing, Canopy Growth's share price declined by nearly 5% (falling from $42.23 to about $40.18), while CV Sciences' decreased by 8%, and Elixinol saw an 18% decline.
Regardless of concerns about ambiguity, what seems most evident is that it will take a long time for the FDA to determine a regulatory path forward for CBD. Taking to Twitter, Dr. Amy Abernathy, the FDA's principal deputy commissioner and acting CIO, noted that while it is critical for the FDA to regulate CBD in a timely manner, it is also the department's responsibility to "ensure that the regulatory path is scientifically sound and in the interest of public health."
"Key questions about product safety need to be addressed," Abernathy detailed. "Data are needed to determine safety thresholds for CBD; datasets/information should be objective, of adequate quality, and available for transparent review. Lab testing and data analyses need to be replicable."
The FDA is still inviting industry stakeholders and interested parties to submit written comments online. The submission deadline is July 2.
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.
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