On Friday May, 31st,
The FDA held a public hearing at the U.S Food and Drug Administrations White Oak Campus in Silver Spring Maryland. The topic of the hearing was, “The Food and Drug Administration’s Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds.”
I was a personal witness to over 200+ attendees who filled the seats, with the leading members of the FDA at the head of the room. The support was evident. As I took in the moment, I was inspired. The turnout, demonstrated people exercising their given right of democracy, in hopes to influence and support one of America’s fastest growing industries, the industry of Hemp and more specifically hemp-derived Cannabidiol (CBD).Following the recent passing of the 2018 Farm Bill, the U.S. Food and Drug Administration (FDA) released a statement declaring their intention to retain their authority to regulate ingestible and topical products, including those that contain hemp and hemp extracts like Cannabidiol (CBD). The Farm Bill deemed hemp and its extracts like CBD, legal at the federal level, while the FDA wants to ensure product manufacturers are not marketing CBD products as Foods, Dietary Supplements or making such claims that their CBD products will treat, cure or prevent disease. Although Hemp and its extracts, was officially removed from the Control Substances Act (CSA), defining it as a cultural commodity and no longer being classified as a controlled substance like its plant cousin Marijuana, ( as a result of the 2018 Farm Bill); the statements released by the FDA with intentions to retain their regulatory authority over CBD confused the industry abroad.
The hearing began at 8 am, with the oral comments from randomly selected industry related companies starting at 8:15 am. Over 100+ speakers voiced their agendas, opinions, and beliefs that catered to the questions the FDA submitted for the public’s response. The FDA board heard from people like Tory Spindle, with the Johns Hopkins University School of Medicine, to Johnathan Miller representing the U.S. Hemp Roundtable. Health professionals like Julian Wright in Science and Recreation to public safety officials, manufacturers and even patients receiving the FDA approved CBD drug, Epidiolex. A seemingly simple objective of allowing both CBD supplementation and pharmaceutical drug application was vastly demonstrated on this historical day, that there was and is still a lot of industry ground to cover.
Some of the highlights covered during the FDA hearing examined points like:
- There’s enough published science and anecdotal evidence to recognize the intended use of Hemp-derived CBD, providing both medical and supplemental value.
- There are 3 primary forms of CBD that may affect the body differently, influencing possible drug interactions and side effects. These CBD variations should be treated separately when addressing vulnerable populations and demographics such as the elderly, immunocompromised patients and or children.
- The 3 primary forms of CBD are CBD isolate, CBD full spectrum and CBD broad spectrum. Other forms include CBD Distillate and water-soluble CBD.
- CBD Isolate – the pure, crystalline powder that typically contains >95% CBD.
- CBD Full Spectrum (Hemp Oil)- The crude oil extracted from the grown, whole Hemp plants (not Hempseed) and includes cannabinoids (primarily CBD), terpenes, flavonoids, and other organic compounds, with .3% THC or less.
- CBD Broad Spectrum (Hemp Oil)- The crude oil extracted from the grown, whole Hemp plants (not Hempseed) and includes cannabinoids (primarily CBD), terpenes, flavonoids, and other organic compounds, with 0.0% THC.
- Drug interactions, side effects, vulnerable populations, and dosing, pertaining to ingestible and topical products made with CBD isolate were concerns the FDA expressed. The research and public data aren’t significant enough to determine the clarity needed to establish future standards regarding CBD Isolate.
- THC milligram content(<.3%) in full spectrum CBD oil-based products is currently not being disclosed on many marketed products, while it has the potential to interact with various drugs and may cause unwanted side effects. There is not enough research or public data on safety in the long term use of products that contain .3% THC as it pertains to children, pregnant women, or nursing women.
- Using CBD products made from Broad Spectrum hemp oil eliminates many if not all of the previous concerns mentioned above, however, it is still not widely available to the mass manufacturing industries due to limited access within the technological advancement in the manufacturing of CBD oil.
- The FDA is requesting more research and public data to better understand the differences in the variations of CBD material and their methods of consumption, such as inhalation, ingestion, transdermal and topical application. The Scientific data points out that the metabolism of CBD is determined by the material type, dosage and the method it is consumed.
How You Can Help-
The FDA requested public testimonials and economic data from the companies present at the hearing. If you would like to share your testimonial(s) about hemp-derived Cannabidiol, I will be submitting a compilation to the FDA docket on June 24th, 2019. You may submit your testimonial anonymously or be named. Your participation will support and protect the continued public access to CBD as both a supplement and or in the circumstances of a medical prescription to treat disease. It will also help to serve as a guide of understanding to the FDA regarding, the daily human exposure of CBD, it’s designation as a generally regarded safe food ingredient and how various populations may benefit or should seek advice from their primary care provider.
“It takes one drop of water to cause a ripple, it takes a massive force of energy to make a wave. “
To submit your testimonial on the specified Testimonial Sheet please email firstname.lastname@example.org with the Subject titled, “I Want to Help.” The testimonial sheet will then be emailed to you and included in the FDA public data docket.
CEO & Founder CBD Care Garden
Kapala Clinic. Barcelona (2018). What is the Entourage Effect?
Russo, E.B (2011). Taming THC: British journal of pharmacology, 163(7) 1344-1364
Russo, E., & Guy, G.W. (2006). A tale of two cannabinoids: Medical Hypothesis, 66(2), 234-246.