Everything You Wanted to Know About CBD & Hemp, But Were Afraid to Ask
April 16th, 2019
San Diego Cannabis Industry Association (SDCIA) shines some southern California sunshine on the vexing issue of Cannabidiol (CBD).
From left to right. Patrick Murphy from the Law Office of Kimberly R Simms; Kelly Hayes from Greenspoon Marder, Josh Swider from Infinite Labs, at the San Diego Cannabis Industry Association. (Photo Author’s Own).
When President Trump signed the 2018 Farm Bill into law last December, the bill included provisions to de-schedule industrial hemp and its by-products. This has created a whole lot of confusion in the industry as to the legality of CBD. CBD, which is derived from both hemp and marijuana, has been pushed to the center of the legalization debate. It is a complex question with a major impact on cultivators, manufacturers, retailers and consumers, who rely on CBD to improve their health.
The SDCIA is one of several industry associations tackling this thorny question for their members. CFN Media went along to their recent CBD & Hemp educational event to find out how this question is being managed by cannabis companies.
The event was packed to the rafters with the majority of attendees from the industry’s front lines. An expert panel was assembled including the right mix of knowledge from different perspectives. The expert CBD panel included Linda Strause, PhD from G. Randall & Sons/Randy’s Club, Kelly Hayes from Greenspoon Marder, Josh Swider from Infinite Labs, Dr. Tim Shu of VET CBD and Patrick Murphy from the Law Office of Kimberly R. Simms, APC. Topics included CBD Myths versus Reality; Impact of the 2018 Farm Bill; and CBD Legal do’s and don’ts.
Participants at the recent SDCIA information session in San Diego, California (Photo: author’s own)
As an educational evening, the organizers sought to not only provide clarity to this vexing issue but also to create a common baseline of facts about CBD, hemp and Cannabis. The lively panel was very well moderated by Rocky Goyal – the owner of the iconic local San Diego dispensary Apothokare.
Legal concerns were top of the list. Legal concerns from claims, out to labeling and distribution. Panelist and attorney Patrick Murphy, summed up the legal landscape well saying: ‘’We know clearly what we can’t do but we don’t know what we can do.’’
I asked Patrick what do he advise his Firm’s clients? ‘’What we try to impart to our clients is that the hemp-derived CBD and Cannabis-derived CBD need to be considered as separate and distinct from each other. Surprisingly, even though the 2018 Farm Bill now defines hemp as an agricultural commodity under federal law and removes its current federal drug status, at this point in time, regulations surrounding hemp-derived CBD actually have less clarity than Cannabis regulations.’’
Definitely it goes that engaging in the hemp industry requires that businesses have a firm grasp of the regulatory landscape before operating. It’s paramount these businesses speak with an attorney familiar with the hemp and Cannabis industries to ensure their products are legally compliant.
Dr. Linda Strause also advised that anyone new to the Cannabis industry should know that we are still in a non-regulated industry where even hemp remains in an evolving regulatory landscape. Essentially, Dr, Strause advised companies attending to develop their own risk matrix for their products and keep on top of those evolving regulations.
Here are some of the points covered in this free-ranging expert panel conversation with plenty of input from the audience.
The term Cannabis is the botanical taxonomy for Cannabis sativa L. from which both marijuana and hemp are derived. Hemp is defined as having less than 0.3% THC. Both hemp and marijuana produce the CBD molecule.
The Endocannabinoid System (ECS) is a global modulator system that helps our bodies maintain homeostasis across all our other physiological systems including our central nervous system, peripheral nervous system, inflammatory system, endocrine system, neuromuscular system, gastrointestinal system, excretory system, to name a few. The ECS is composed of both receptors and endocannabinoids.
When it comes to Cannabis products, whether marijuana or hemp, medical claims are strictly prohibited unless the products have gone through the FDA regulations process to demonstrate, in controlled, randomized, and blinded clinical trials, that it is both safe and efficacious.
Judging by the reception and engagement of these facts by the audience, the meeting went a long way towards creating a common base line of the above CBD facts.
CBD and the 2018 Farm Bill
Before the Farm Bill, Cannabis and any derivatives were Schedule 1, which made hemp as dangerous as fentanyl and heroin in the eyes of the Federal Government. The Farm Bill created a distinct separation of “hemp” and “marijuana.” Key language in Section 1103 of the Farm Bill defines hemp as:
“The plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
So, the Farm Bill descheduled explicitly removed industrial hemp and its byproducts from the Controlled Substance Act as long as it stayed under the threshold of less than 0.3 percent THC. The CBD molecule is derived from the Cannabis plant and from hemp plant, regardless of THC levels. CBD industry advocates latched on to the Bill’s assertion that “all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers” as descheduling CBD when derived from industrial hemp. However, several governmental agencies are responsible for CBD’s ability to be unleashed as mass marketed molecule in the human food chain.
The 2018 Farm Bill may have legalized hemp, but it failed to develop a systematic approach in which people can grow it as freely as they can grow tomatoes or cucumbers. So it’s going to be a highly regulated – some say over-regulated – crop in the United States for both human consumption and industrial production.
USA Government agencies reaction to descheduling of hemp
While the United States Department of Agriculture (USDA) oversees laws related to the cultivation of industrial hemp, the United States Food and Drug Administration (FDA) oversees medicine and food additives. The FDA does not differentiate between CBD derived from hemp or Cannabis and until the agency approves CBD and establishes a regulatory framework, adding CBD to food and beverages is illegal.
FDA’s outgoing Commissioner, recently told lawmakers his agency is using its “enforcement discretion” to target products containing CBD. “We’re using enforcement discretion right now,” FDA Commissioner Scott Gottlieb, MD, said during a hearing before a subcommittee of the U.S. Senate Committee on Appropriations in March in a response to a question from Sen. Patrick Leahy (D-Vermont). “I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider ‘over-the-line’ claims.”
While early CBD research has shown promise as a treatment for conditions like epilepsy, autism and anxiety, as a consumer product it’s unproven and has been largely been operating without the ability to mount broad scale clinical trials to prove out and quantify the benefits of CBD. Despite this confusion CBD brands distributed in the regulated dispensary market are the safest bet for distribution because they adhere to the existing Cannabis market regulation.
Dr. Tim Shu of VETCBD with moderator Rocky Goyal owner of Apothokare dispensary in San Diego at the SDCIA industry event. (Photo: Author’s own)
One such company on the panel was VETCBD whose founder Dr. Tim Shu was on the panel. CBD for pets is taking off in North America since the Farm Bill passed. The VETCBD line consists of Cannabis products with CBD and THC, formulated and dosed specifically for animals, and produced, distributed, and sold within the regulated California Cannabis market. Their hemp line, Dr. Shu’s Pet Care, will be sold outside of the Cannabis marketplace, and will adhere to the same testing standards found in the regulated Cannabis market.
Applying the standards of California Cannabis industry to the new Hemp industry is a safe move. California has one of the most regulated Cannabis industries in the world. With that comes some of the highest standards of testing. This is in stark contrast to the hemp industry, for which there are no testing standards. For their hemp product line, Dr. Shu’s Pet Care, bringing the standards of Cannabis testing to this new and loosely regulated market by testing for potency, pesticides, microbials, solvents, and heavy metals. This allows consumers to have the same quality standards in a hemp product they would expect from a regulated Cannabis product.
I was vaguely aware that animals can benefit from Cannabis and CBD the same way humans can. But I can see why this market of pet CBD is booming. It’s because animals also have endocannabinoid systems which are involved in regulating many physiological functions. It’s not only for cats and dogs either. Over the years Dr. Shu recalled that he had numerous species benefiting from Cannabis, including horses, pigs, ferrets, birds, rabbits, and rats.
The CBD molecule is the same whether it comes from hemp or marijuana variants of the Cannabis sativa L plant. However one of the most important factors in product formulation is the presence of other cannabinoids in a product in addition to CBD, like THC, CBC, and CBG. Studies have shown that when CBD is combined with other cannabinoids, greater therapeutic effect is achieved compared to when CBD is used alone, like in isolate forms. This is known as the “entourage effect” and products containing a variety of cannabinoids are called “full spectrum”. Many people know THC because of its psychoactive effects, but THC has many medicinal benefits as well, including pain relief, nausea control, appetite stimulation, and anti-inflammatory properties. THC can be used safely and effectively in animals for medical purposes, but dosing and formulation are key factors to prevent unwanted side effects.
Other brands who were not panelists included local San Diego hero Therapy Tonics. Their CEO Chris Coggan was happy to attend. ‘’It was a great event – not just for the knowledge sharing from the panel, but a great way of meeting the local Cannabis community. It’s much needed knowledge– as you can see – it’s standing room only!’’
I asked the organizers after the event whether the event was a success in their eyes. Organizer Christian Valdez was happy with both the turnout and the knowledge shared. ‘’Our objectives were to share knowledge, dispel myths and create a common base line of facts about CBD for our members. So, you can see we have advanced a lot in the conversation –but there is still some way to go.’’
San Diego’s Marina Village was the picturesque setting for the recent SDCIA panel.(Photo Author’s Own)
Expect to see more events from the San Diego Cannabis Industry Association on this topic. ‘’Yes, for sure, we’ll continue the knowledge sharing because that is what our members want.’’ And what would his team do differently next time? ‘’Definitely a bigger venue and perhaps longer session and more expert panels. ‘’
Events like these and the recent news that Walgreens and CVS have started listing CBD products suggest that the sky is truly the limit for the CBD molecule – regardless if it comes from hemp or marijuana. The overall takeout was that when the federal government finally and totally ends prohibition of Cannabis, it is only then that CBD and its many benefits as a medicine will truly flourish.
At time of writing the FDA announced they have scheduled public hearings on May 31stto discuss Cannabis derived products.
(Special thanks to Linda Strause PhD and Dr. Tim Shu for fact-checking this article for veracity).
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