Science-based CBD Policy Emerging as Industrial-Scale CBD Production Takes Off
In March of this year, then-FDA Commissioner Scott Gottlieb gave a speech at the National Association of State Departments of Agriculture’s annual conference in which he discussed the FDA’s interest in building a stable foundation for CBD regulation in the U.S. (read my previous discussion of this subject here).
Now, only three months later, the U.S. Food and Drug Administration (FDA) expanded upon its previous statements regarding cannabis and CBD to further clarify its stance and planned course of action on the subject. This is a much-needed step given recent updates from CBD producers; one Kentucky-based company, for example, plans to make CBD accessible to everyone who needs it through a new industrial-scale extraction process that is set to flood the market with massive amounts of hemp-derived CBD.
Sound, Science-Based Policy
Science forms the basis for many conclusions reached by the FDA and is paramount in making decisions that have the potential to impact Americans’ health and wellness.
In a recent statement, the FDA had the following to say:
“We recognize that there is significant public interest in [CBD] products, for therapeutic purposes and otherwise. At the same time, there are many unanswered questions about the science, safety, and quality of many of these products. As we approach these questions, we do so as a science-based regulatory agency committed to our mission of protecting and promoting public health.
“[T]he FDA’s role is becoming more practically relevant to many affected stakeholders. We recognize the need to be clear and open about where things stand, and about the efficient and science-based way in which we are moving forward. This includes being transparent and up-front with the public and all of our stakeholders as we continue to collect information and data to deepen our understanding of CBD.”
The true magnitude of the CBD regulation issue became particularly clear at the FDA’s recent public hearing, where the Agency provided stakeholders with a platform for sharing their feedback and experiences. This feedback was solicited in order to provide the FDA with scientific data and other information related to cannabis and cannabis-derived compounds like CBD. As CBD Health & Wellness magazine pointed out in its summary of the hearing, there were several significant takeaways in addition to the overall uncertainty about the safety of CBD, including:
The ability to lawfully market cannabis- and hemp-derived products and CBD in food and dietary supplements;
Clear safety standards and strong enforcement;
Support for research evaluating the therapeutic effects of CBD;
Consistent terminology as it relates to these products;
Industry standards that address potentially dangerous manufacturing quality issues of some of the products currently on the market.
The FDA’s Next Steps
Following the May 31st hearing, the FDA plans to use the information collected through the public docket to better articulate specific details. That which is already reliably known about cannabis and CBD products will be compared against gaps in existing knowledge in order to identify additional research that can be performed quickly and efficiently in order to answer critical questions about the safety and efficacy of CBD. Some of the questions the Agency plans to address first include:
How much CBD is safe to consume in a day?
How do per day consumption amounts differ based on which form is used?
Are there drug interactions that need to be monitored?
What are the impacts on special populations such as children, the elderly, pregnant or nursing women, etc.?
What are the risks of long-term exposure/use?
In order to put these questions and more to rest, the FDA is doing what it can to facilitate and preserve incentives for clinical research, encouraging researchers to study these topics by submitting an Investigational New Drug application to the FDA’s Center for Drug Evaluation and Research.
Jon Fedele, CEO of the full spectrum hemp-based CBD company PūrWell, offered his reaction to the news to Doctor Jane directly:
“I applaud the FDA’s willingness to establish clear and fair regulations for the industry. The American public deserves to know that the CBD products they are purchasing are safe, efficacious, and that they come from reputable companies who comply with those laws.”
Perfect Timing for CBD Regulation
The FDA’s continued commitment towards creating regulatory guidelines for cannabis and CBD products presently benefits from peak relevance, as the popularity of both cannabis-derived (regulated due to THC content) and hemp-derived CBD (widely available online and in retail stores like CVS, Bed Bath and Beyond, and Sephora due to its negligible THC content) products continues to skyrocket.
According to a recent article from Green Entrepreneur, the average price for broad-spectrum CBD is currently about $350 per 1000 milligrams. These products are being used in many cases on a daily basis for support with an array of health problems, from PTSD and anxiety to insomnia and chronic pain. Unfortunately, many sufferers simply can’t afford to spend this amount of money on CBD products on a regular basis. Patients who weigh 180 lbs and have found, for example, that the most effective dose for them is 5 mg per pound of body weight per day, will get only 11 days of use out of that $350 bottle.
Enter carbon transformation and soil scientist Paul Baskis, whose Kentucky-based company Draconis Extraction Technology (DET) has patented a new extraction process called commercial-scale ethanol extraction. Baskis has designed this process in such a way that traditional extraction costs will be pushed down, lowering the price of CBD products by dramatically boosting the supply--all without sacrificing the quality of the product (another major concern when it comes to existing methods of mass producing hemp-based CBD).
Although the 2018 Farm Bill (which I discussed previously here) made industrial hemp and hemp-based CBD products somewhat legal across the U.S., the FDA’s concerns about cannabis-derived CBD still hold for this similar but legal version of CBD. In other words, there is a vast amount of research yet to be done on the range of uses, long-term effects, possible side effects and more of hemp-derived CBD, just as there is for its cannabis-derived cousin. With companies like DET set to massively boost CBD availability, it’s even more imperative that the FDA continues to push forward with its regulatory guidelines for these products.
This is another reason why I always encourage consultation with the team here at Doctor Jane or with a licensed physician familiar with cannabis and CBD before you use any type of CBD product, whether cannabis- or hemp-based. This is also why I have spent significant time and effort developing both personal and professional relationships with each of the vendors that supply products to the Doctor Jane online store, where we sell hemp-based CBD products that I have personally vetted and use myself on a daily basis.
For those of you interested in more information regarding the types of CBD products available, the methods of consumption that exist and some simple guidelines for determining your best dose, you can download our free infographic on CBD dosing information and guidelines today!
Today’s blog post is written by Rick Liogier-Weyback, MD, founder and president at Doctor Jane and our licensed medical cannabis physician. If you are considering cannabis treatment or are wondering if medical cannabis may be right for you, please contact our team at your earliest convenience.
About Doctor Jane
Doctor Jane is South Florida’s most discreet, professional, and convenient concierge medical cannabis practice. Dr. Luis Enrique R. Liogier-Weyback and his wife, Katie Liogier-Weyback, B.S., R.N., founded Doctor Jane on the core tenets of bringing personal, convenient, professional and discreet patient care to the medical cannabis treatment process. Doctor Jane provides South Florida patients and their caregivers with a safe space where they can exercise their right to access medical cannabis therapy in an environment of their choosing, free from stigma and complications.
Visit our website to find out more or to schedule your own medical cannabis consultation. www.DoctorJane.net.