The cannabinoid popularized for its anti-inflammatory and anxiety-busting properties—cannabidiol (CBD)—takes centre stage in the United States today (May 31).
On Friday morning, the U.S. Food and Drug Administration (FDA) dove headfirst into a packed public hearing to inform its upcoming regulations around the substance.
In December, the passing of the Farm Bill removed hemp-derived CBD (which contains less than 0.3 percent tetrahydrocannabinol, or THC) from the Controlled Substances Act. This effectively made hemp a viable agricultural product, allowing companies to develop a host of CBD somewhat legal products boasting cannabis' therapeutic and medicinal benefits. Shortly after, then-FDA commissioner Scott Gottlieb publicly reminded Americans the regulatory body was responsible for drafting all food, drugs, and cosmetics laws, including those containing CBD. Now, the FDA is in the midst of drafting those regulations.
A cannabis analytics firm, Brightfield Group, estimates the U.S. hemp-derived CBD market will hit $5.7 billion US by the end of 2019. In 2018, it generated around $590 million US. Needless to say, many entrepreneurs, medical practitioners, companies, advocacy organizations, and consumers have a vested interest in how this next set of laws pan out.
Much in the same way Health Canada and the Liberal government held roundtables, public consultations, and sent a task force across the country to inform the crafting of Canada’s Cannabis Act in 2017-18, the FDA opened its floor to stakeholder feedback. And over 110 witnesses singed up to speak.
The meeting began with opening statement from acting commissioner Ned Sharpless who stated a number of high-ranking FDA officials were currently working on compiling research for the new regulations.
Amongst the speakers were a number of doctors championing CBD’s medicinal benefits and presenting clinical trial data, like anesthesiologist Dr. Deb Kimless and internal medicine physician Dr. Sue Sisley. Many called for more funding for research and supports for federal lab testing.
Representatives and founders of CBD product companies, like Genco Pura and Full Spectrum Omega, called for standardization of production practices.
An American non-profit law reform groupm the National Organization for the Reform of Marijuana Laws (NORML) advocated for a number of consumer needs including fair access, affordability, and product purity.
Even GW Pharmaceuticals, the British company responsible for Epidiolex—the first FDA-approved CBD product—showed up to shed light on dosing, labeling standards, and concentration.
The hearings were streamed in full on the FDA’s website or Fox Business’ YouTube channel. Leafly, a digital cannabis education platform, also kept a running blog of the proceedings. A government forum on the topic also gathered over 800 comments, many from patients using CBD for medicinal purposes.
Currently in Canada, federal cannabis regulations heavily scrutinize THC. The production of hemp-derived CBD is loosely regulated under the Industrial Hemp Regulations, but as it stands there are very few laws around the production, content, and retail of CBD in the Cannabis Act.More