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AUTHOR: Heather Allman

PUBLISHER:  CANNABIS LAW REPORT

This highly anticipated FDA guidance at the federal level takes a big step in the right direction towards nationwide standardized clinical research and the cannabis plant.

FDA In Brief: FDA Issues Draft Guidance to Encourage Cannabis-Related Clinical Research

On July 21, 2020, the U.S. Food and Drug Administration, or FDA, issued the official Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry.

This highly anticipated FDA guidance at the federal level takes a big step in the right direction towards nationwide standardized clinical research and the cannabis plant, making the following three points:

  • The draft guidance describes the FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds.

On this first point, Amy Abernethy M.D., Ph.D. and FDA Principal Deputy Commissioner, had the following to say:

“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research. As that body of research progresses and grows, the FDA is working to support drug development in this area.”

  • The draft guidance covers sources of cannabis for clinical research, information on quality considerations and recommendations regarding calculating tetrahydrocannabinol (THC) levels.

In another excerpt attributed to Dr. Abernethy of the FDA, she touches on this ongoing, rigorous development process that will help to guide future U.S. cannabis therapies:

“It is critical that the FDA continues to do what we can to support the science needed to develop new drugs from cannabis. The FDA believes the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs that contain cannabis or cannabis-derived compounds, are available to patients in need of appropriate medical therapy.

The agency is committed to supporting the development of these new drugs through the investigational new drug, drug review and drug approval processes – and one key element of this support involves development of guidance, like this one.”

  • This draft guidance also digs deeper into explains key FDA regulatory concepts for those who may be less familiar with the U.S. Food and Drug Administration and their authorities concerning cannabis.

In mid August 2020, Jeff Greene, of the Florida Hemp Council, and Derek Thomas, of Veritas Farms –both industry experts– talked with me concerning  the new July 21, 2020 FDA draft guidance. We discussed the implications for the future of CBD and cannabis clinical research.

CLR: What do these new rules say and what do they mean for Florida hemp program and hemp brands, namely the general areas of the rules that you feel will prove to be most helpful?

Jeff Greene: “The willingness of the FDA to accept a source other than the University of Mississippi will open the door for a tremendous amount of research. The issue currently is that the University research system is almost exclusively concentrating on COVID-19 and with the Fall semester in doubt, funding for these institutions are tenuous at best. Our hope is that the State Universities embrace hemp for cannabinoid testing and work collaboratively with Florida manufacturers to bring that research to market.”

Derek Thomas: While we cannot offer a legal interpretation of the legislation, the legislation is intended to reinforce and further define the path that cannabis organizations must follow in order to undertake clinical research programs. This piece of legislation from the FDA is supportive of organizations who intend to undertake clinical research, which will be helpful in the long term understanding of how and why cannabinoids and terpenes may benefit specific conditions.”

CLR: Jeff, please discuss specific obstacles currently being faced by your organization or brand noting how the new rules will specifically hinder current and ongoing research or progress in the Florida hemp program, and your hopes for the future? 

Jeff Greene, Florida Hemp Council (center)

JG: “Currently, universities are exclusively doing the research. It is our hope that us, working with local government, will allow us to establish a Public/Private partnership Research Park to study the medicinal, as well as other manufactured products. The current hindrance is consistent banking relationships, although that is improving somewhat, and credit, although private equity and angel investors are heavy in the space.  

Our hope for the future is government grant programs designed to promote public access to research, international exportation allowances and importation limitations to allow for the industry to get off the ground. A consistent testing methodology is something that the FDA has muddied the waters on. In one report, they stipulate that they have developed a testing protocol, but when pressed won’t release it to the public.  Our hope is that testing in the cannabis space is brought into a space that is quantifiable sooner rather than later.”

CLR: How the new rules will specifically hinder current/ongoing research or progress for hemp brands and what are your hopes for future, Derek?

Derek Thomas, Veritas Farms

DT: “The current guidance does little to clear up immediate challenges facing the industry, issues —such as recommended servings, basic structure function claims, mixing into food and beverages, and unified testing standards. All of these areas need clarification for the category to begin a healthy and sustainable path.”

CLR: In light of these new FDA rules, what is one key element of overarching plan to maintaining existing high caliber hemp brands, businesses, and ancillary services?

JG: In our current climate, with cannabis and thus CBD being deemed an essential service, most of my bigger brands are taking the time to garner Current Good Manufacturing Practice (cGMP) status to take the first step towards the conformity process. From there, labeling and web/print marketing is being curbed by FDA letters and Trade Association recommendations.”

DT: One critical element is the brands efforts to be transparent in their supply chain, processes, and testing. Until the FDA releases final guidance for the industry, the onus will continue to fall on brands to provide their Certificates of Analysis, and on consumers to do their due diligence into the brands they buy from.”

CLR: Today, with cannabis and thus CBD being deemed an essential service.

Please describe the current —and emerging— CBD consumer/client demographic. Has the FL hemp program and hemp brand client base changed or pivoted since the pandemic? How so?

JG: “The current consumer profile is wide. Age and gender are not huge contributing factors. Due to price, it may trend a little older clientele that can afford the products, but that will change as prices drop. Due to the COVID-19 pandemic, the sedentary nature of people and the anxiety as a result of the situation, in my opinion, the market has increased dramatically. Getting those people educated on the products, getting access to the products, and getting the products to market are the big changes.

More and more stores are being opened to sell hemp products and more online stores are opening and expanding. With the massive retail closures, our industry is coming in and getting great terms on leases and marketing is starting to open up too.

Facebook still has not corrected their algorithm to make hemp viable, but LinkedIn, and to some degree Instagram, has been forward thinking and acting.”

DT: The current CBD consumer client is broad and encompassing of many sub demographics. It’s essentially 18-80, from stressed college students, young and older professionals, retirees, athletes and even pets!

During the COVID-19 pandemic, I think many consumers who may have been hesitant to try CBD before, are now willing to try it, as many are facing additional stressors from which they want relief.”

CLR: What was one of your company’s responses to COVID-19 pandemic, or what responsibility does your company or organization feel to clients? 

JG: Immediately, we took all of our meetings virtual, we have become an expert on Zoom and other video conferencing tools and expect to do that until deep into 2021. 

We believe we should lead by example and continue to do good work and innovate, but be aware of those that are concerned about the world and how to navigate it.  Virtual offices and video conferencing have been around for a while, I think they are here to stay.”

DT: As a health and wellness company, we feel an immense amount of responsibility to our customers and the greater community. At the onset, we implemented new safety standards at our farm and manufacturing facility to ensure the continual safety of our staff and customers. 

Additionally, we partnered with Miami-based distillery, Toast Distillers, Inc., to produce hand sanitizer.”

CLR: How has COVID-19 affected the Florida hemp program research and hemp brand research?

JG: During the initial stages of the pandemic, the spring grow season was just getting off the ground. I suspect that many farmers pulled back and did not grow or did not grow as much. The universities closed except for essential workers and I am not sure how much research was lost, not only in hemp, but also, honestly, on any agricultural research.

For us, finding a university to do some unique research was impossible as Boards of Trustees and decision makers were paralyzed to make any decisions until they got the pandemic under control.”

DT: The COVID-19 pandemic has caused some delays in the progress of the hemp industry, due mainly to the additional challenges of operating any business during the pandemic. Supply chains may be crunched from the shut-down of supporting ancillary services, and organizations may be reconsidering their R&D budgets to ensure they have operational capital to make it through a sustained recession or depression environment.”

CLR: As a player in the Florida hemp market, what keeps you awake at night?

JG: Understanding the State and Federal playing fields gives me some comfort, but probably the greatest concern for sleep would be either a huge over-reach by the FDA —or the fact that once the FDA makes their ruling, a massive entry into the space will occur by legacy companies pushing out all the entrepreneurs.

In the space today, you are either building your company to be the 800-pound gorilla or to be acquired by the 800 pound gorilla. The real question is still the same: who is going to be that entity.”

DT: My biggest concern is inappropriate federal regulation from the FDA. Our hope is that the guidance will be in fair consideration of consumer health and safety while considering fairness for current operators in the space.”

Jeff Greene of the Florida Hemp Council (JG)

  • About The Florida Hemp Council: The Florida Hemp Council (FLHC), a non-profit organization, was established to bring necessary resources to the Florida hemp industry and work together to overcome challenging times and remain sustainable. The Florida Hemp Council’s mission is to create a thriving ecosystem aimed at catapulting the Florida hemp industry to the forefront as leaders in hemp and hemp product production.

 

Derek Thomas of Veritas Farms (DT)

  • About Veritas Farms, Inc: Veritas Farms, Inc. (OTCQB: VFRM) is a vertically integrated agribusiness focused on producing superior quality, whole plant, full spectrum hemp oils and extracts containing naturally occurring cannabinoids.  The Company currently operates a 140-acre farm and production facilities in Pueblo, Colorado, and is registered with the Colorado Department of Agriculture to grow industrial hemp. The Company markets and sells products under its Veritas Farms™ brand and manufactures private label products for a number of leading distributors and retailers.