Open a magazine, visit any blog site, open a newspaper, and try not to find an article discussing the emerging trend of 'CBD' being infused in a wide range of products today. The only enormous obstacle standing in the way of the future of 'CBD' among many is the regulation process by the Food and Drug Administration(FDA). CBD is cannabidiol. Here is an introduction to CBD from the Wikipedia page below:
Cannabidiol (CBD) is a phytocannabinoid discovered in 1940. It is one of some 113 identified cannabinoids in cannabis plants and accounts for up to 40% of the plant's extract.[7] As of 2018, preliminary clinical research on cannabidiol included studies of anxiety, cognition, movement disorders, and pain.[8]Cannabidiol can be taken into the body in multiple ways, including by inhalation of cannabis smoke or vapor, as an aerosol spray into the cheek, and by mouth. It may be supplied as CBD oil containing only CBD as the active ingredient (no added tetrahydrocannabinol [THC] or terpenes), a full-plant CBD-dominant hemp extract oil, capsules, dried cannabis, or as a prescription liquid solution.[2] CBD does not have the same psychoactivity as THC,[9][10] and may affect the actions of THC.[7][8][9][11] Although in vitro studies indicate CBD may interact with different biological targets, including cannabinoid receptors and other neurotransmitter receptors,[9][12] as of 2018 the mechanism of action for its biological effects has not been determined.[8][9]In the United States, the cannabidiol drug Epidiolex has been approved by the Food and Drug Administration for treatment of two epilepsy disorders.[13] The side effects of long-term use of the drug include somnolence, decreased appetite, diarrhea, fatigue, malaise, weakness, and sleeping problems.[2]The U.S. Drug Enforcement Administration has assigned Epidiolex a Schedule V classification and CBD extracted from marijuana a Schedule I drug classification; although, CBD extracted from hemp is a federally lawful substance due to section 10113 of the Agricultural Improvement Act of 2018 removing cannabinoids and extracts of hemp under 0.3% total THC from the Controlled Substances Act.[14][15][16] Cannabidiol is not scheduled under any United Nations drug control treaties and in 2018 the World Health Organization recommended that it remain unscheduled.[17]
The main issue as of present is that the federal government still lists cannabis as a Schedule 1 drug, which makes possession of any of the drug illegal. Until the Congress changes the listing (category), cannabis and all related derived components from the plant will be considered illegal.
Now, with that being said, the non-psychoactive component of cannabis is a distribution of cannabidiols. There is a distribution of them inside each plant. As noted above, there is recent clinical research that has suggested that there are therapeutic benefits to cannabidiol for a variety of ailments: anxiety, decreased appetite, epilepsy, IBS, fatigue, PTSD, and sleeping problems. In the above excerpt, the FDA is grappling with how to allow specific applications of CBD in treatments to patients. Although, clarity is still widely needed from the federal government in moving forward.
In a future post, I will get into the specifics of cannabis in terms of dosage, infusion into products along with the analysis from a quality control standpoint. For now, the focus is on the issues immediately facing Congress from the former FDA Director Scott Gottlieb.
Reporting from 'Politico Agriculture' provided an update to the current dilemma facing the Food and Drug Administration regarding CBD in products:
GOTTLIEB SEEKS CBD CLARITY FROM CONGRESS: The departing FDA commissioner told House appropriators on Wednesday his agency faces a "conundrum" in trying to create a regulatory framework for CBD — which has been reviewed as a drug but is increasingly being used in food products.A new interagency working group announced this week will focus on potential legislative solutions for regulating the non-psychotropic substance derived from cannabis. One hypothetical framework, per Gottlieb, would allow lower concentrations of cannabidiol as a food additive and "more purified, high-concentration" CBD as an approved drug, your host reports.Trending up: Interest in the market has spiked since Congress legalized industrial hemp production in the 2018 farm bill, H.R. 2 (115). So have health-related concerns from regulators and uncertainty among consumers, growers and manufacturers about the current rules.The FDA so far has focused on targeting companies making questionable health claims about their CBD goods. Gottlieb, who is set to leave the Trump administration at the end of the week, pointed out that attempting to enforce every sale of a cannabidiol food product would strain his agency's resources.Cannabis meets the campaign trail: Interest in broader cannabis issues is also blooming among 2020 presidential contenders, writes Pro Health Care's Paul Demko. Nearly every Democratic primary candidate so far has backed some form of marijuana legalization — a stark contrast from previous election cycles when such talk was verboten.
As of present, there is little regulation at the state level. Although, states like California and Oregon have been very proactive in forming local laws which have started to be distributed among cannabis dispensaries (shops). The purpose has been to start a conversation as the laws are created locally. Since there is no guidance from the federal level. Moving forward, as Congress provides more input in the form of the direction regulation is headed, then local municipalities will have the greater footing to stand on -- in terms of commercialization in your neighborhoods around the United States.
I mentioned above that in the future, I will write about the technical (scientific) issues facing the cannabis industry. Over the last two years, I have been attending seminars and webinars along with interacting with scientific instrument companies to determine where the 'bottleneck' is occurring from an analysis standpoint. As an instrument manager (working at a university -- in the chemistry department), I would like to train our graduating scientists to help advance the emerging field of the cannabis industry. Which includes providing top-notch scientists who understand the problems of analyzing cannabis from product quality control to high-throughput testing. More about this in the future.
If you are interested in reading more about the growing industry, here are two sources. The first is Jeff Hill -- who writes on 'Medium' and has taken the last year plus to write extensively on regulatory and commercial affairs with regard to the cannabis industry. I am more experienced from the scientific standpoint at the moment -- coming from a science background and training students on how to measure/process samples which are similar to cannabis samples. Another source which might be good to read is the National Institute for Cannabis Investors website which is filled with short blog posts with relevant investing and regulatory information.
The above reading should be a good start to get familiar with the current issues are from a regulatory standpoint along with commercialization issues facing the cannabis industry. I look forward to writing some on the science side of the aisle in the near future.
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NIAID Director Anthony Fauci: How Should We Communicate About Crises?
What is going on in the FDA for Fall 2018 - message from Director Scott Gottlieb
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